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COMMON WAYS TO AVOID THECOMMON WAYS TO AVOID THE
MOST FREQUENT GMP ERRORS
COMMON WAYS TO AVOID THE
2 March 2016
COMMON WAYS TO AVOID THE
MOST FREQUENT GMP ERRORS
Page 1
Intro…..
"Most of the 483s and warning
of the common GMP errors.of the common GMP errors.
mistakes (and ways to avoid
based on the historical data
common good manufacturing
pharmaceuticals can be easily
simple rules. "
warning letters are issued because
. I have described common. I have described common
them) in the following slides
data and experience. Many
manufacturing practice errors in
easily avoided by following a few
Page 2
Intro…..
“Safety - First, Last, and Always”
"We all must observe safety rules,"We all must observe safety rules,
to protect the product from contamination
ultramodern equipments, in our
that cost millions of dollars, and
nevertheless, some of the products
with are potently bio hazardouswith are potently bio hazardous
through some pieces of equipment
First, Last, and Always”
rules, for our own safety andrules, for our own safety and
contamination. We work with
our laboratories and facilities
and with exciting technology,
products and materials we work
hazardous. Electricity running
Page 3
hazardous. Electricity running
equipment also presents a risk. “
Intro…..
"Guards, such as on packaging
reason. Locating eyewashes,
equipment "emergency stop"equipment "emergency stop"
company's evacuation procedures
maintenance on vessels,
lyophilizers, learn the appropriate
follow them thoroughly without
deviations. That includes companydeviations. That includes company
orders and lockout and tag out
the equipment is not in use before
"
packaging equipment, are there for a
eyewashes, fire extinguishers, and
stop" buttons, learn yourstop" buttons, learn your
procedures. If you clean or do
tanks, steam lines, or
appropriate safety precautions and
without any shortcuts and
company policy regarding work
Page 4
company policy regarding work
out procedures to ensure that
before you begin maintenance.
Check points:
1. Personal & Product Safety
not wearing your safety glasses.
have to protect them. Always wearhave to protect them. Always wear
shoes, respirators, and other personal
Take the time to think things thoroughly
your instinct. Avoid situations that
and let your supervisors or others
Material Safety Data Sheets (MSDS)Material Safety Data Sheets (MSDS)
you work in your work place.
Safety: One common GMP mistake is
. Your eyes are too precious, we
wear your safety glasses, safetywear your safety glasses, safety
personal protective equipment.
thoroughly. Stay alert, and trust
that look potentially dangerous,
others know about it. Read the
(MSDS) for all the materials that
Page 5
(MSDS) for all the materials that
Check points:
2. Labelling Instructions: Identifying
vendor had changed the process
manufacturing due the change
"looked different from our routine
and signs carefully. Check for "released"
material has not expired and
Caution and warning signs in your
local language spoken in the plant
Identifying and suspecting that a
process in a raw material
change in label instructions
routine supplies" Read all the labels
"released" labels. Ensure that the
that it’s the correct material.
your plant should be printed in the
Page 6
plant.
Check points:
3. Alertness in Work: Be especially
when you are tired, called away,
safety violations occur most oftensafety violations occur most often
before lunch, before your shift
home, when someone interrupts
thought, and so on. Be especially
The most common injuries in our
back injuries, so use proper liftingback injuries, so use proper lifting
think about what you are about to
or back at risk.
especially careful around breaks,
away, and so on. GMP regulation and
often right before break times,often right before break times,
is over, when it's time to go
interrupts you or breaks your train of
especially vigilant during those times.
our business seem to be hand and
lifting techniques, slow down, and
Page 7
lifting techniques, slow down, and
to do before putting your hands
Check points:
4. Gowning Practice: Wear only appropriate clothing.
Supervisors are responsible for providing on
(including training in proper attire, such as sterile
then monitoring employees to make sure that they are wearing
appropriate clothing.
One common GMP error is not wearing your lab coat while you
are in the laboratory (or visitors or contractors not wearing hair
coverings, shoe coverings, lab coats, and so on). Splashes can
be dangerous and can ruin your clothes. While visiting bulk drug
plants, don't wear designer suits or shoes.
Wear only appropriate clothing.
Supervisors are responsible for providing on-the-job training
(including training in proper attire, such as sterile gowning) and
then monitoring employees to make sure that they are wearing
One common GMP error is not wearing your lab coat while you
are in the laboratory (or visitors or contractors not wearing hair
Page 8
coverings, shoe coverings, lab coats, and so on). Splashes can
be dangerous and can ruin your clothes. While visiting bulk drug
plants, don't wear designer suits or shoes.
Check points:
4. Gowning Practice:
Another common error is wearing your lab coat or plant uniform
outside the building and also proceeding to wash room with theoutside the building and also proceeding to wash room with the
same. Some 483 observations noted that employees were
smoking outside of buildings while wearing their plant uniforms.
Jewellery is not allowed in certain areas. Check with your
supervisor if you're not sure..
Another common error is wearing your lab coat or plant uniform
outside the building and also proceeding to wash room with theoutside the building and also proceeding to wash room with the
same. Some 483 observations noted that employees were
smoking outside of buildings while wearing their plant uniforms.
is not allowed in certain areas. Check with your
Page 9
Check points:
5. Cleanliness: Keep surfaces and equipment clean. Follow
approved cleaning procedures, and use approved cleaning
solutions, People may become sick and in the most serious casesolutions, People may become sick and in the most serious case
due to cleaning was inadequate, and the cleaning process had
never been validated. One of the first things that investigators
or visitors notice while they visit your plant is the facility's
general cleanliness. Ensure that each equipment was cleaned by
checking the "Cleaned Equipment" status tag and equipmentchecking the "Cleaned Equipment" status tag and equipment
logbook. If possible, open the equipment and look inside to
make sure that no rinse solvent was accidentally left behind.
Keep surfaces and equipment clean. Follow
approved cleaning procedures, and use approved cleaning
solutions, People may become sick and in the most serious casesolutions, People may become sick and in the most serious case
due to cleaning was inadequate, and the cleaning process had
never been validated. One of the first things that investigators
or visitors notice while they visit your plant is the facility's
general cleanliness. Ensure that each equipment was cleaned by
checking the "Cleaned Equipment" status tag and equipment
Page
10
checking the "Cleaned Equipment" status tag and equipment
logbook. If possible, open the equipment and look inside to
make sure that no rinse solvent was accidentally left behind.
Check points:
6. Health & Hygiene: Wash your hands. Most pharmaceutical
plants have signs in the bathrooms reminding employees to
wash their hands before returning to the plant or work area. Ifwash their hands before returning to the plant or work area. If
you've ever put your hand on a plate and cultured the bacteria
present, you know that bacteria are everywhere, in large
quantities, although omnipresent in life, they are not something
that any one of us wants in our medicines or injectables.
Wash your hands. Most pharmaceutical
plants have signs in the bathrooms reminding employees to
wash their hands before returning to the plant or work area. Ifwash their hands before returning to the plant or work area. If
you've ever put your hand on a plate and cultured the bacteria
present, you know that bacteria are everywhere, in large
quantities, although omnipresent in life, they are not something
that any one of us wants in our medicines or injectables.
Page
11
Check points:
7. Report an Illness: Working personnel should notify their
supervisors when they have a cold or any viral infections. It is a
GMP requirement that employees and temporary employees doGMP requirement that employees and temporary employees do
this. On those days when you're not feeling
be assigned to attend GMP classes, revise SOPs, or catch up
your scintillating GMP reading, such has articles like this one.
Working personnel should notify their
supervisors when they have a cold or any viral infections. It is a
GMP requirement that employees and temporary employees doGMP requirement that employees and temporary employees do
this. On those days when you're not feeling up to par, you can
be assigned to attend GMP classes, revise SOPs, or catch up on
your scintillating GMP reading, such has articles like this one.
Page
12
Check points:
8. Use of Approved Material: Use only Approved & Released
raw materials, packaging components, and labels. Use no
expired materials. Under cGMPs, only released materials can be
used in all clinical and commercial lots of product. A common
error is to store expired materials with current materials. Proper
segregation is required and Remove and/or destroy all expired
materials.
Use only Approved & Released
raw materials, packaging components, and labels. Use no
, only released materials can be
used in all clinical and commercial lots of product. A common
error is to store expired materials with current materials. Proper
segregation is required and Remove and/or destroy all expired
Page
13
Check points:
9. Committing Mistakes due to shortfall of TIME:
though the pace of our industry is fast, and everyone has more
to do than they can possibly get done, everyone deserves the
time to think things through. Hence, think before plan and plan
before doing the work or committing the time lines...
All the time, everybody will be rushed in their work area, where
there is greatest possibility of committing the critical mistakes in
work area which hampers the GMP status of the product /
activity.
Committing Mistakes due to shortfall of TIME: Even
though the pace of our industry is fast, and everyone has more
to do than they can possibly get done, everyone deserves the
time to think things through. Hence, think before plan and plan
before doing the work or committing the time lines...
All the time, everybody will be rushed in their work area, where
there is greatest possibility of committing the critical mistakes in
Page
14
work area which hampers the GMP status of the product /
Check points:
9. Committing Mistakes due to shortfall of TIME:
There is no such thing as a dumb question. Better to ask and
get an answer than to assume and risk a batch, It's critical thatget an answer than to assume and risk a batch, It's critical that
supervisors make sure their people feel comfortable asking
those questions and admitting their mistakes.
Committing Mistakes due to shortfall of TIME:
There is no such thing as a dumb question. Better to ask and
get an answer than to assume and risk a batch, It's critical thatget an answer than to assume and risk a batch, It's critical that
supervisors make sure their people feel comfortable asking
those questions and admitting their mistakes.
Page
15
Check points:
10. Documentation: Always fill in the blanks. Record all
requested information. If it’s truly not applicable, write N/A;
your initials, and the date. If pages or sections of forms are not
applicable, line through them, write N/A, your initials, and the
date. The correct information must be entered on batch records,
equipment logbooks, and test result forms, otherwise, your QA /
Regulatory Inspector will find out with you soon why you didn't
complete the work and sometimes it leads to in complete
documentation for the activity is been done.
Always fill in the blanks. Record all
requested information. If it’s truly not applicable, write N/A;
your initials, and the date. If pages or sections of forms are not
applicable, line through them, write N/A, your initials, and the
date. The correct information must be entered on batch records,
equipment logbooks, and test result forms, otherwise, your QA /
Regulatory Inspector will find out with you soon why you didn't
Page
16
complete the work and sometimes it leads to in complete
documentation for the activity is been done.
Check points:
11. Online Entries:
Record results as you get them. One common GMP error is to
speed through documents at the end of the day or at the end ofspeed through documents at the end of the day or at the end of
your shift, filling in all the blanks at one time. But we all know
that it is impossible to remember what we did five minutes ago,
much less eight hours ago. You have to train yourself and your
people to record results and information as you get it
records, lab notebooks, and test result forms.records, lab notebooks, and test result forms.
Record results as you get them. One common GMP error is to
speed through documents at the end of the day or at the end ofspeed through documents at the end of the day or at the end of
your shift, filling in all the blanks at one time. But we all know
that it is impossible to remember what we did five minutes ago,
much less eight hours ago. You have to train yourself and your
people to record results and information as you get it - on batch
records, lab notebooks, and test result forms.
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17
records, lab notebooks, and test result forms.
Check points:
11. Online Entries:
Print clearly in logs, and fill them out completely. Fill out all logs
and other documents completely. Your handwriting must beand other documents completely. Your handwriting must be
clear and legible. If your handwriting, like mine, is difficult to
read, then print.
Print clearly in logs, and fill them out completely. Fill out all logs
and other documents completely. Your handwriting must beand other documents completely. Your handwriting must be
clear and legible. If your handwriting, like mine, is difficult to
Page
18
Check points:
12. Use Indelible Ink:
The industry standard is black / blue indelible ink because it
photocopies well and does not smear. Pencil is unacceptablephotocopies well and does not smear. Pencil is unacceptable
because it smears easily and can be erased and also it releases
graphite particles which cannot be controlled in clean rooms
especially.
The industry standard is black / blue indelible ink because it
photocopies well and does not smear. Pencil is unacceptablephotocopies well and does not smear. Pencil is unacceptable
because it smears easily and can be erased and also it releases
graphite particles which cannot be controlled in clean rooms
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19
Check points:
13. Banish the correction fluid:
prohibited.
14. Line through, Initial, and date all changes:
way to make a change is to line through the error once using
your indelible ink pen, clearly write the correction above or
beside it, and initial and date the correction.
13. Banish the correction fluid: Using correction fluid is
Line through, Initial, and date all changes: The correct
way to make a change is to line through the error once using
your indelible ink pen, clearly write the correction above or
beside it, and initial and date the correction.
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20
Check points:
15. Data Falsification: Never backdate or falsify the records.
Always use today's date when documenting your work. If you do
not, you are falsifying records.not, you are falsifying records.
For example, if One has manufactured a batch of a product
today, and did not fill out a line on a batch record, a QA
employee would stop by as part of his online review and ask the
person whether he had completed that step or not. If the
chemist did remember completing it, He would write in thechemist did remember completing it, He would write in the
Comments section of the document that QA had noticed that he
had failed to document the step and that he had in fact
completed it.
Never backdate or falsify the records.
Always use today's date when documenting your work. If you do
For example, if One has manufactured a batch of a product
today, and did not fill out a line on a batch record, a QA
employee would stop by as part of his online review and ask the
person whether he had completed that step or not. If the
chemist did remember completing it, He would write in the
Page
21
chemist did remember completing it, He would write in the
Comments section of the document that QA had noticed that he
had failed to document the step and that he had in fact
Check points:
15. Data Falsification:
He would initial and date the comment the day that he was
writing it.writing it.
Preferably, to raise the deviation in those situations and re
the personnel whoever involved in that activity.
He would initial and date the comment the day that he was
Preferably, to raise the deviation in those situations and re-train
the personnel whoever involved in that activity.
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22
Check points:
16. Constructive Thoughts /Actions:
Take action to make things better. we may reach a conclusion
faster than someone else. Have the courage to bring up things
that need to be improved. Be the responsible employee who
picks the piece of paper from the floor rather than steps over it.
As your move up in your career, people are going to trust
you with information that is confidential and sensitive. You
must honour their confidences but also take action.
Constructive Thoughts /Actions:
action to make things better. we may reach a conclusion
faster than someone else. Have the courage to bring up things
that need to be improved. Be the responsible employee who
picks the piece of paper from the floor rather than steps over it.
As your move up in your career, people are going to trust
you with information that is confidential and sensitive. You
Page
23
their confidences but also take action.
Check points:
17. Calibration Status: Ensure that equipment is calibrated
before using it. Equipment that must be calibrated in a
manufacturing or laboratory environment typically has anmanufacturing or laboratory environment typically has an
equipment calibration tag on it which indicates the date
the equipment was last calibrated, who did the calibration, and
next calibration due date. Check to make sure that your
equipment is within calibration before you use it. Otherwise,
your results or measurements could be inaccurate.your results or measurements could be inaccurate.
Ensure that equipment is calibrated
before using it. Equipment that must be calibrated in a
manufacturing or laboratory environment typically has anmanufacturing or laboratory environment typically has an
equipment calibration tag on it which indicates the date
equipment was last calibrated, who did the calibration, and
next calibration due date. Check to make sure that your
equipment is within calibration before you use it. Otherwise,
your results or measurements could be inaccurate.
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your results or measurements could be inaccurate.
Check points:
18. Numbering System: Record ID, part, lot, document,
revision, and other control numbers. When something goes
wrong with a product lot, trying to determine the true source ofwrong with a product lot, trying to determine the true source of
the problem is often like solving a mystery. The GMPs require
that you assign and use unique numbers on each lot of your raw
materials, reagents, documents, and all lots of produced product
to permit traceability should there ever be a problem.
While, filling out a batch record or recording your results, recordWhile, filling out a batch record or recording your results, record
equipment, lot, sample, reference sample, and document and
revision numbers.
Record ID, part, lot, document,
revision, and other control numbers. When something goes
wrong with a product lot, trying to determine the true source ofwrong with a product lot, trying to determine the true source of
the problem is often like solving a mystery. The GMPs require
and use unique numbers on each lot of your raw
materials, reagents, documents, and all lots of produced product
to permit traceability should there ever be a problem.
While, filling out a batch record or recording your results, record
Page
25
While, filling out a batch record or recording your results, record
equipment, lot, sample, reference sample, and document and
Check points:
19. Eatables are Prohibited in Work area:
food, gum, tobacco, or house plants into production and
laboratory areas. A common GMP error is bringing drinks into a
laboratory. Smoking, eating, and drinking are prohibited in a
GMP facility. You do not want to have food inside a GMP facility
because rodents and other pests will try to enter the area to get
the food. A beetle can bore through 0.125 inch of solid plastic to
get to food or the glucose or sucrose stored on pallets in your
warehouse. Houseplants may have insects on their soil and
leaves.
Eatables are Prohibited in Work area: Do not bring
food, gum, tobacco, or house plants into production and
laboratory areas. A common GMP error is bringing drinks into a
laboratory. Smoking, eating, and drinking are prohibited in a
GMP facility. You do not want to have food inside a GMP facility
because rodents and other pests will try to enter the area to get
the food. A beetle can bore through 0.125 inch of solid plastic to
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26
get to food or the glucose or sucrose stored on pallets in your
warehouse. Houseplants may have insects on their soil and
Check points:
20. Pest & Rodent Control: Check your pest control devices
frequently with the ID no and location of it. If you use an
outside pest control service, test it by placing a plastic mouse inoutside pest control service, test it by placing a plastic mouse in
one of the traps. If the service doesn't find it, it's not doing a
thorough job inspecting and cleaning the traps. Because rats like
to run along walls - they do not see well, and they feel safer
against a wall - rodent traps should be placed along walls.
Antidotes should be available in the site in case of any situationAntidotes should be available in the site in case of any situation
of inhaling or taking it inside.
Check your pest control devices
frequently with the ID no and location of it. If you use an
outside pest control service, test it by placing a plastic mouse inoutside pest control service, test it by placing a plastic mouse in
one of the traps. If the service doesn't find it, it's not doing a
thorough job inspecting and cleaning the traps. Because rats like
they do not see well, and they feel safer
rodent traps should be placed along walls.
Antidotes should be available in the site in case of any situation
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Antidotes should be available in the site in case of any situation
Check points:
21. Thorough Review of Document:
document / record, check for data accuracy, for completeness,
and correct calculations. In our industry, a signature is a legal
and an ethical responsibility. If you have signature authority and
are asked to sign on something, you must do to the best of your
ability, review it thoroughly and completely, make sure that
everything that needs to be attached is attached, and make
sure that all calculations are correct. Never sign something
without thoroughly reviewing it first. Never sign something that
you know to be wrong. Get it corrected and then sign it.
21. Thorough Review of Document: Before signing on any
document / record, check for data accuracy, for completeness,
and correct calculations. In our industry, a signature is a legal
and an ethical responsibility. If you have signature authority and
are asked to sign on something, you must do to the best of your
ability, review it thoroughly and completely, make sure that
everything that needs to be attached is attached, and make
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28
sure that all calculations are correct. Never sign something
without thoroughly reviewing it first. Never sign something that
you know to be wrong. Get it corrected and then sign it.
Check points:
22. Duplication of Data is Prohibited:
Record data directly on the appropriate form or notebook. Do
not write original data on scrap paper, napkins, or paper towels
and then transfer the information to the appropriate form or
notebook. If you accidentally record your data on a piece of
scrap paper, staple it to the form or notebook, because it is
original data. Always attach printouts and labels where
indicated. Never throw away original data.
Duplication of Data is Prohibited:
Record data directly on the appropriate form or notebook. Do
not write original data on scrap paper, napkins, or paper towels
and then transfer the information to the appropriate form or
notebook. If you accidentally record your data on a piece of
scrap paper, staple it to the form or notebook, because it is
original data. Always attach printouts and labels where
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indicated. Never throw away original data.
Check points:
23. OOS Handling:
Never simply average Out-of-Specification
passing result do not continue testing samples until you get
enough that pass. As a result of the Barr case, there has been a
lot of scrutiny in this area. Every company should have an SOP
that discusses how to handle out
how to handle failure investigations. Encourage your people to
tell you that what went wrong during the analysis / batch
handling when OOS result has obtained.
Specification results to obtain a
passing result do not continue testing samples until you get
enough that pass. As a result of the Barr case, there has been a
lot of scrutiny in this area. Every company should have an SOP
that discusses how to handle out-of- specification results and
how to handle failure investigations. Encourage your people to
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tell you that what went wrong during the analysis / batch
handling when OOS result has obtained.
Check points:
24. Secondary Check: Have another person perform double /
secondary check as Indicated in the batch record / Document /
Record. Double checks are mandatory for critical steps, like
weighing and adding raw materials, because people have
discovered that historically those are problematic areas.
Secondary check means that one person performs the work
while another person observes and makes any suggestions or
corrections. Individuals then sign or
where indicated. GMPs require that you have sufficient staff to
do this.
Have another person perform double /
secondary check as Indicated in the batch record / Document /
Record. Double checks are mandatory for critical steps, like
weighing and adding raw materials, because people have
discovered that historically those are problematic areas.
Secondary check means that one person performs the work
while another person observes and makes any suggestions or
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corrections. Individuals then sign or initial the batch record
where indicated. GMPs require that you have sufficient staff to
Check points:
25. Proper closing of inter linked
receiving, and other doors closed. A common error is to leave
shipping and receiving doors open after a delivery has arrived
an open invitation for pests of all kinds. Owls, snakes, rats, and
mice have been found in warehouses looking for food, water,
and shelter. A field mouse only needs 0.25 inch to get under a
door, so check the bottom of your outside doors. If there is a
gap, you could be inviting a rodent problem. The
that you have an effective pest control program; keeping your
receiving doors closed will help.
Proper closing of inter linked Doors: Keep shipping,
receiving, and other doors closed. A common error is to leave
shipping and receiving doors open after a delivery has arrived -
an open invitation for pests of all kinds. Owls, snakes, rats, and
mice have been found in warehouses looking for food, water,
and shelter. A field mouse only needs 0.25 inch to get under a
door, so check the bottom of your outside doors. If there is a
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gap, you could be inviting a rodent problem. The cGMPs require
have an effective pest control program; keeping your
Check points:
26. Auditee Attitude: During an Inspection, answer all
questions honestly and directly. Do not guess or speculate. Do
not volunteer information. Refer questions that you cannot
answer to your supervisor. FDA and other regulatory agencies
know that this is how employees are trained. Don't be evasive,
and don’t try to hide the truth. Don't guess, and don't state your
opinion. "If you think we're bad, you should see those guys
down the hall!"
During an Inspection, answer all
questions honestly and directly. Do not guess or speculate. Do
not volunteer information. Refer questions that you cannot
answer to your supervisor. FDA and other regulatory agencies
know that this is how employees are trained. Don't be evasive,
and don’t try to hide the truth. Don't guess, and don't state your
opinion. "If you think we're bad, you should see those guys
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Check points:
27. Highlighting the Mistakes:
Report mistakes - or suspected mistakes
to your supervisor after the identification of it. Management will
hate making mistakes by employees, rather be perfect. But the
truth is that we're all human, and human beings make mistakes.
As a supervisor, encourage your people to tell you things. Don’t
jump all over them when they do so they never do it again. And
don't go looking for scapegoats.
Highlighting the Mistakes:
or suspected mistakes - as soon as possible
to your supervisor after the identification of it. Management will
hate making mistakes by employees, rather be perfect. But the
truth is that we're all human, and human beings make mistakes.
As a supervisor, encourage your people to tell you things. Don’t
jump all over them when they do so they never do it again. And
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34
Check points:
27. Highlighting the Mistakes:
If something goes wrong in your group, you as a supervisor or
manager must accept responsibility for the mistake see what
you can reconstruct or recover, and figure out how you can
prevent the mistake from happening it again and train your
personnel on such cases not to repeat the same or occur the
same in future.
Highlighting the Mistakes:
If something goes wrong in your group, you as a supervisor or
manager must accept responsibility for the mistake see what
you can reconstruct or recover, and figure out how you can
prevent the mistake from happening it again and train your
personnel on such cases not to repeat the same or occur the
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Check points:
28. Continues reading / reviewing of SOP’s:
Read and become familiar with all SOPs and other documents
that relate to your work. You must know your SOP’s. A commonthat relate to your work. You must know your SOP’s. A common
483 observation continues to be "Firm failed to follow its own
SOP." If an SOP needs to be revised, tell your supervisor and
offer to help revise it and get it approved.
Continues reading / reviewing of SOP’s:
Read and become familiar with all SOPs and other documents
that relate to your work. You must know your SOP’s. A commonthat relate to your work. You must know your SOP’s. A common
continues to be "Firm failed to follow its own
SOP." If an SOP needs to be revised, tell your supervisor and
offer to help revise it and get it approved.
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Conclusion:
Apart from the above mentioned, following also to be
required to ensure avoiding the
discipline, Attitude in work area, Co
Cordial relations in work area with supervisors and with
sub-ordinates, loyal to the company / position or
designation and finally professional attire in our part.
Apart from the above mentioned, following also to be
required to ensure avoiding the GMP Errors like Self
discipline, Attitude in work area, Co-operation, Team work,
Cordial relations in work area with supervisors and with
ordinates, loyal to the company / position or
designation and finally professional attire in our part.
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Thank you very much for the attention and
for your valuable time……!!!!for your valuable time……!!!!
Thank you very much for the attention and
for your valuable time……!!!!for your valuable time……!!!!
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38

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Common ways to avoid frequent gmp errors

  • 1. COMMON WAYS TO AVOID THECOMMON WAYS TO AVOID THE MOST FREQUENT GMP ERRORS COMMON WAYS TO AVOID THE 2 March 2016 COMMON WAYS TO AVOID THE MOST FREQUENT GMP ERRORS Page 1
  • 2. Intro….. "Most of the 483s and warning of the common GMP errors.of the common GMP errors. mistakes (and ways to avoid based on the historical data common good manufacturing pharmaceuticals can be easily simple rules. " warning letters are issued because . I have described common. I have described common them) in the following slides data and experience. Many manufacturing practice errors in easily avoided by following a few Page 2
  • 3. Intro….. “Safety - First, Last, and Always” "We all must observe safety rules,"We all must observe safety rules, to protect the product from contamination ultramodern equipments, in our that cost millions of dollars, and nevertheless, some of the products with are potently bio hazardouswith are potently bio hazardous through some pieces of equipment First, Last, and Always” rules, for our own safety andrules, for our own safety and contamination. We work with our laboratories and facilities and with exciting technology, products and materials we work hazardous. Electricity running Page 3 hazardous. Electricity running equipment also presents a risk. “
  • 4. Intro….. "Guards, such as on packaging reason. Locating eyewashes, equipment "emergency stop"equipment "emergency stop" company's evacuation procedures maintenance on vessels, lyophilizers, learn the appropriate follow them thoroughly without deviations. That includes companydeviations. That includes company orders and lockout and tag out the equipment is not in use before " packaging equipment, are there for a eyewashes, fire extinguishers, and stop" buttons, learn yourstop" buttons, learn your procedures. If you clean or do tanks, steam lines, or appropriate safety precautions and without any shortcuts and company policy regarding work Page 4 company policy regarding work out procedures to ensure that before you begin maintenance.
  • 5. Check points: 1. Personal & Product Safety not wearing your safety glasses. have to protect them. Always wearhave to protect them. Always wear shoes, respirators, and other personal Take the time to think things thoroughly your instinct. Avoid situations that and let your supervisors or others Material Safety Data Sheets (MSDS)Material Safety Data Sheets (MSDS) you work in your work place. Safety: One common GMP mistake is . Your eyes are too precious, we wear your safety glasses, safetywear your safety glasses, safety personal protective equipment. thoroughly. Stay alert, and trust that look potentially dangerous, others know about it. Read the (MSDS) for all the materials that Page 5 (MSDS) for all the materials that
  • 6. Check points: 2. Labelling Instructions: Identifying vendor had changed the process manufacturing due the change "looked different from our routine and signs carefully. Check for "released" material has not expired and Caution and warning signs in your local language spoken in the plant Identifying and suspecting that a process in a raw material change in label instructions routine supplies" Read all the labels "released" labels. Ensure that the that it’s the correct material. your plant should be printed in the Page 6 plant.
  • 7. Check points: 3. Alertness in Work: Be especially when you are tired, called away, safety violations occur most oftensafety violations occur most often before lunch, before your shift home, when someone interrupts thought, and so on. Be especially The most common injuries in our back injuries, so use proper liftingback injuries, so use proper lifting think about what you are about to or back at risk. especially careful around breaks, away, and so on. GMP regulation and often right before break times,often right before break times, is over, when it's time to go interrupts you or breaks your train of especially vigilant during those times. our business seem to be hand and lifting techniques, slow down, and Page 7 lifting techniques, slow down, and to do before putting your hands
  • 8. Check points: 4. Gowning Practice: Wear only appropriate clothing. Supervisors are responsible for providing on (including training in proper attire, such as sterile then monitoring employees to make sure that they are wearing appropriate clothing. One common GMP error is not wearing your lab coat while you are in the laboratory (or visitors or contractors not wearing hair coverings, shoe coverings, lab coats, and so on). Splashes can be dangerous and can ruin your clothes. While visiting bulk drug plants, don't wear designer suits or shoes. Wear only appropriate clothing. Supervisors are responsible for providing on-the-job training (including training in proper attire, such as sterile gowning) and then monitoring employees to make sure that they are wearing One common GMP error is not wearing your lab coat while you are in the laboratory (or visitors or contractors not wearing hair Page 8 coverings, shoe coverings, lab coats, and so on). Splashes can be dangerous and can ruin your clothes. While visiting bulk drug plants, don't wear designer suits or shoes.
  • 9. Check points: 4. Gowning Practice: Another common error is wearing your lab coat or plant uniform outside the building and also proceeding to wash room with theoutside the building and also proceeding to wash room with the same. Some 483 observations noted that employees were smoking outside of buildings while wearing their plant uniforms. Jewellery is not allowed in certain areas. Check with your supervisor if you're not sure.. Another common error is wearing your lab coat or plant uniform outside the building and also proceeding to wash room with theoutside the building and also proceeding to wash room with the same. Some 483 observations noted that employees were smoking outside of buildings while wearing their plant uniforms. is not allowed in certain areas. Check with your Page 9
  • 10. Check points: 5. Cleanliness: Keep surfaces and equipment clean. Follow approved cleaning procedures, and use approved cleaning solutions, People may become sick and in the most serious casesolutions, People may become sick and in the most serious case due to cleaning was inadequate, and the cleaning process had never been validated. One of the first things that investigators or visitors notice while they visit your plant is the facility's general cleanliness. Ensure that each equipment was cleaned by checking the "Cleaned Equipment" status tag and equipmentchecking the "Cleaned Equipment" status tag and equipment logbook. If possible, open the equipment and look inside to make sure that no rinse solvent was accidentally left behind. Keep surfaces and equipment clean. Follow approved cleaning procedures, and use approved cleaning solutions, People may become sick and in the most serious casesolutions, People may become sick and in the most serious case due to cleaning was inadequate, and the cleaning process had never been validated. One of the first things that investigators or visitors notice while they visit your plant is the facility's general cleanliness. Ensure that each equipment was cleaned by checking the "Cleaned Equipment" status tag and equipment Page 10 checking the "Cleaned Equipment" status tag and equipment logbook. If possible, open the equipment and look inside to make sure that no rinse solvent was accidentally left behind.
  • 11. Check points: 6. Health & Hygiene: Wash your hands. Most pharmaceutical plants have signs in the bathrooms reminding employees to wash their hands before returning to the plant or work area. Ifwash their hands before returning to the plant or work area. If you've ever put your hand on a plate and cultured the bacteria present, you know that bacteria are everywhere, in large quantities, although omnipresent in life, they are not something that any one of us wants in our medicines or injectables. Wash your hands. Most pharmaceutical plants have signs in the bathrooms reminding employees to wash their hands before returning to the plant or work area. Ifwash their hands before returning to the plant or work area. If you've ever put your hand on a plate and cultured the bacteria present, you know that bacteria are everywhere, in large quantities, although omnipresent in life, they are not something that any one of us wants in our medicines or injectables. Page 11
  • 12. Check points: 7. Report an Illness: Working personnel should notify their supervisors when they have a cold or any viral infections. It is a GMP requirement that employees and temporary employees doGMP requirement that employees and temporary employees do this. On those days when you're not feeling be assigned to attend GMP classes, revise SOPs, or catch up your scintillating GMP reading, such has articles like this one. Working personnel should notify their supervisors when they have a cold or any viral infections. It is a GMP requirement that employees and temporary employees doGMP requirement that employees and temporary employees do this. On those days when you're not feeling up to par, you can be assigned to attend GMP classes, revise SOPs, or catch up on your scintillating GMP reading, such has articles like this one. Page 12
  • 13. Check points: 8. Use of Approved Material: Use only Approved & Released raw materials, packaging components, and labels. Use no expired materials. Under cGMPs, only released materials can be used in all clinical and commercial lots of product. A common error is to store expired materials with current materials. Proper segregation is required and Remove and/or destroy all expired materials. Use only Approved & Released raw materials, packaging components, and labels. Use no , only released materials can be used in all clinical and commercial lots of product. A common error is to store expired materials with current materials. Proper segregation is required and Remove and/or destroy all expired Page 13
  • 14. Check points: 9. Committing Mistakes due to shortfall of TIME: though the pace of our industry is fast, and everyone has more to do than they can possibly get done, everyone deserves the time to think things through. Hence, think before plan and plan before doing the work or committing the time lines... All the time, everybody will be rushed in their work area, where there is greatest possibility of committing the critical mistakes in work area which hampers the GMP status of the product / activity. Committing Mistakes due to shortfall of TIME: Even though the pace of our industry is fast, and everyone has more to do than they can possibly get done, everyone deserves the time to think things through. Hence, think before plan and plan before doing the work or committing the time lines... All the time, everybody will be rushed in their work area, where there is greatest possibility of committing the critical mistakes in Page 14 work area which hampers the GMP status of the product /
  • 15. Check points: 9. Committing Mistakes due to shortfall of TIME: There is no such thing as a dumb question. Better to ask and get an answer than to assume and risk a batch, It's critical thatget an answer than to assume and risk a batch, It's critical that supervisors make sure their people feel comfortable asking those questions and admitting their mistakes. Committing Mistakes due to shortfall of TIME: There is no such thing as a dumb question. Better to ask and get an answer than to assume and risk a batch, It's critical thatget an answer than to assume and risk a batch, It's critical that supervisors make sure their people feel comfortable asking those questions and admitting their mistakes. Page 15
  • 16. Check points: 10. Documentation: Always fill in the blanks. Record all requested information. If it’s truly not applicable, write N/A; your initials, and the date. If pages or sections of forms are not applicable, line through them, write N/A, your initials, and the date. The correct information must be entered on batch records, equipment logbooks, and test result forms, otherwise, your QA / Regulatory Inspector will find out with you soon why you didn't complete the work and sometimes it leads to in complete documentation for the activity is been done. Always fill in the blanks. Record all requested information. If it’s truly not applicable, write N/A; your initials, and the date. If pages or sections of forms are not applicable, line through them, write N/A, your initials, and the date. The correct information must be entered on batch records, equipment logbooks, and test result forms, otherwise, your QA / Regulatory Inspector will find out with you soon why you didn't Page 16 complete the work and sometimes it leads to in complete documentation for the activity is been done.
  • 17. Check points: 11. Online Entries: Record results as you get them. One common GMP error is to speed through documents at the end of the day or at the end ofspeed through documents at the end of the day or at the end of your shift, filling in all the blanks at one time. But we all know that it is impossible to remember what we did five minutes ago, much less eight hours ago. You have to train yourself and your people to record results and information as you get it records, lab notebooks, and test result forms.records, lab notebooks, and test result forms. Record results as you get them. One common GMP error is to speed through documents at the end of the day or at the end ofspeed through documents at the end of the day or at the end of your shift, filling in all the blanks at one time. But we all know that it is impossible to remember what we did five minutes ago, much less eight hours ago. You have to train yourself and your people to record results and information as you get it - on batch records, lab notebooks, and test result forms. Page 17 records, lab notebooks, and test result forms.
  • 18. Check points: 11. Online Entries: Print clearly in logs, and fill them out completely. Fill out all logs and other documents completely. Your handwriting must beand other documents completely. Your handwriting must be clear and legible. If your handwriting, like mine, is difficult to read, then print. Print clearly in logs, and fill them out completely. Fill out all logs and other documents completely. Your handwriting must beand other documents completely. Your handwriting must be clear and legible. If your handwriting, like mine, is difficult to Page 18
  • 19. Check points: 12. Use Indelible Ink: The industry standard is black / blue indelible ink because it photocopies well and does not smear. Pencil is unacceptablephotocopies well and does not smear. Pencil is unacceptable because it smears easily and can be erased and also it releases graphite particles which cannot be controlled in clean rooms especially. The industry standard is black / blue indelible ink because it photocopies well and does not smear. Pencil is unacceptablephotocopies well and does not smear. Pencil is unacceptable because it smears easily and can be erased and also it releases graphite particles which cannot be controlled in clean rooms Page 19
  • 20. Check points: 13. Banish the correction fluid: prohibited. 14. Line through, Initial, and date all changes: way to make a change is to line through the error once using your indelible ink pen, clearly write the correction above or beside it, and initial and date the correction. 13. Banish the correction fluid: Using correction fluid is Line through, Initial, and date all changes: The correct way to make a change is to line through the error once using your indelible ink pen, clearly write the correction above or beside it, and initial and date the correction. Page 20
  • 21. Check points: 15. Data Falsification: Never backdate or falsify the records. Always use today's date when documenting your work. If you do not, you are falsifying records.not, you are falsifying records. For example, if One has manufactured a batch of a product today, and did not fill out a line on a batch record, a QA employee would stop by as part of his online review and ask the person whether he had completed that step or not. If the chemist did remember completing it, He would write in thechemist did remember completing it, He would write in the Comments section of the document that QA had noticed that he had failed to document the step and that he had in fact completed it. Never backdate or falsify the records. Always use today's date when documenting your work. If you do For example, if One has manufactured a batch of a product today, and did not fill out a line on a batch record, a QA employee would stop by as part of his online review and ask the person whether he had completed that step or not. If the chemist did remember completing it, He would write in the Page 21 chemist did remember completing it, He would write in the Comments section of the document that QA had noticed that he had failed to document the step and that he had in fact
  • 22. Check points: 15. Data Falsification: He would initial and date the comment the day that he was writing it.writing it. Preferably, to raise the deviation in those situations and re the personnel whoever involved in that activity. He would initial and date the comment the day that he was Preferably, to raise the deviation in those situations and re-train the personnel whoever involved in that activity. Page 22
  • 23. Check points: 16. Constructive Thoughts /Actions: Take action to make things better. we may reach a conclusion faster than someone else. Have the courage to bring up things that need to be improved. Be the responsible employee who picks the piece of paper from the floor rather than steps over it. As your move up in your career, people are going to trust you with information that is confidential and sensitive. You must honour their confidences but also take action. Constructive Thoughts /Actions: action to make things better. we may reach a conclusion faster than someone else. Have the courage to bring up things that need to be improved. Be the responsible employee who picks the piece of paper from the floor rather than steps over it. As your move up in your career, people are going to trust you with information that is confidential and sensitive. You Page 23 their confidences but also take action.
  • 24. Check points: 17. Calibration Status: Ensure that equipment is calibrated before using it. Equipment that must be calibrated in a manufacturing or laboratory environment typically has anmanufacturing or laboratory environment typically has an equipment calibration tag on it which indicates the date the equipment was last calibrated, who did the calibration, and next calibration due date. Check to make sure that your equipment is within calibration before you use it. Otherwise, your results or measurements could be inaccurate.your results or measurements could be inaccurate. Ensure that equipment is calibrated before using it. Equipment that must be calibrated in a manufacturing or laboratory environment typically has anmanufacturing or laboratory environment typically has an equipment calibration tag on it which indicates the date equipment was last calibrated, who did the calibration, and next calibration due date. Check to make sure that your equipment is within calibration before you use it. Otherwise, your results or measurements could be inaccurate. Page 24 your results or measurements could be inaccurate.
  • 25. Check points: 18. Numbering System: Record ID, part, lot, document, revision, and other control numbers. When something goes wrong with a product lot, trying to determine the true source ofwrong with a product lot, trying to determine the true source of the problem is often like solving a mystery. The GMPs require that you assign and use unique numbers on each lot of your raw materials, reagents, documents, and all lots of produced product to permit traceability should there ever be a problem. While, filling out a batch record or recording your results, recordWhile, filling out a batch record or recording your results, record equipment, lot, sample, reference sample, and document and revision numbers. Record ID, part, lot, document, revision, and other control numbers. When something goes wrong with a product lot, trying to determine the true source ofwrong with a product lot, trying to determine the true source of the problem is often like solving a mystery. The GMPs require and use unique numbers on each lot of your raw materials, reagents, documents, and all lots of produced product to permit traceability should there ever be a problem. While, filling out a batch record or recording your results, record Page 25 While, filling out a batch record or recording your results, record equipment, lot, sample, reference sample, and document and
  • 26. Check points: 19. Eatables are Prohibited in Work area: food, gum, tobacco, or house plants into production and laboratory areas. A common GMP error is bringing drinks into a laboratory. Smoking, eating, and drinking are prohibited in a GMP facility. You do not want to have food inside a GMP facility because rodents and other pests will try to enter the area to get the food. A beetle can bore through 0.125 inch of solid plastic to get to food or the glucose or sucrose stored on pallets in your warehouse. Houseplants may have insects on their soil and leaves. Eatables are Prohibited in Work area: Do not bring food, gum, tobacco, or house plants into production and laboratory areas. A common GMP error is bringing drinks into a laboratory. Smoking, eating, and drinking are prohibited in a GMP facility. You do not want to have food inside a GMP facility because rodents and other pests will try to enter the area to get the food. A beetle can bore through 0.125 inch of solid plastic to Page 26 get to food or the glucose or sucrose stored on pallets in your warehouse. Houseplants may have insects on their soil and
  • 27. Check points: 20. Pest & Rodent Control: Check your pest control devices frequently with the ID no and location of it. If you use an outside pest control service, test it by placing a plastic mouse inoutside pest control service, test it by placing a plastic mouse in one of the traps. If the service doesn't find it, it's not doing a thorough job inspecting and cleaning the traps. Because rats like to run along walls - they do not see well, and they feel safer against a wall - rodent traps should be placed along walls. Antidotes should be available in the site in case of any situationAntidotes should be available in the site in case of any situation of inhaling or taking it inside. Check your pest control devices frequently with the ID no and location of it. If you use an outside pest control service, test it by placing a plastic mouse inoutside pest control service, test it by placing a plastic mouse in one of the traps. If the service doesn't find it, it's not doing a thorough job inspecting and cleaning the traps. Because rats like they do not see well, and they feel safer rodent traps should be placed along walls. Antidotes should be available in the site in case of any situation Page 27 Antidotes should be available in the site in case of any situation
  • 28. Check points: 21. Thorough Review of Document: document / record, check for data accuracy, for completeness, and correct calculations. In our industry, a signature is a legal and an ethical responsibility. If you have signature authority and are asked to sign on something, you must do to the best of your ability, review it thoroughly and completely, make sure that everything that needs to be attached is attached, and make sure that all calculations are correct. Never sign something without thoroughly reviewing it first. Never sign something that you know to be wrong. Get it corrected and then sign it. 21. Thorough Review of Document: Before signing on any document / record, check for data accuracy, for completeness, and correct calculations. In our industry, a signature is a legal and an ethical responsibility. If you have signature authority and are asked to sign on something, you must do to the best of your ability, review it thoroughly and completely, make sure that everything that needs to be attached is attached, and make Page 28 sure that all calculations are correct. Never sign something without thoroughly reviewing it first. Never sign something that you know to be wrong. Get it corrected and then sign it.
  • 29. Check points: 22. Duplication of Data is Prohibited: Record data directly on the appropriate form or notebook. Do not write original data on scrap paper, napkins, or paper towels and then transfer the information to the appropriate form or notebook. If you accidentally record your data on a piece of scrap paper, staple it to the form or notebook, because it is original data. Always attach printouts and labels where indicated. Never throw away original data. Duplication of Data is Prohibited: Record data directly on the appropriate form or notebook. Do not write original data on scrap paper, napkins, or paper towels and then transfer the information to the appropriate form or notebook. If you accidentally record your data on a piece of scrap paper, staple it to the form or notebook, because it is original data. Always attach printouts and labels where Page 29 indicated. Never throw away original data.
  • 30. Check points: 23. OOS Handling: Never simply average Out-of-Specification passing result do not continue testing samples until you get enough that pass. As a result of the Barr case, there has been a lot of scrutiny in this area. Every company should have an SOP that discusses how to handle out how to handle failure investigations. Encourage your people to tell you that what went wrong during the analysis / batch handling when OOS result has obtained. Specification results to obtain a passing result do not continue testing samples until you get enough that pass. As a result of the Barr case, there has been a lot of scrutiny in this area. Every company should have an SOP that discusses how to handle out-of- specification results and how to handle failure investigations. Encourage your people to Page 30 tell you that what went wrong during the analysis / batch handling when OOS result has obtained.
  • 31. Check points: 24. Secondary Check: Have another person perform double / secondary check as Indicated in the batch record / Document / Record. Double checks are mandatory for critical steps, like weighing and adding raw materials, because people have discovered that historically those are problematic areas. Secondary check means that one person performs the work while another person observes and makes any suggestions or corrections. Individuals then sign or where indicated. GMPs require that you have sufficient staff to do this. Have another person perform double / secondary check as Indicated in the batch record / Document / Record. Double checks are mandatory for critical steps, like weighing and adding raw materials, because people have discovered that historically those are problematic areas. Secondary check means that one person performs the work while another person observes and makes any suggestions or Page 31 corrections. Individuals then sign or initial the batch record where indicated. GMPs require that you have sufficient staff to
  • 32. Check points: 25. Proper closing of inter linked receiving, and other doors closed. A common error is to leave shipping and receiving doors open after a delivery has arrived an open invitation for pests of all kinds. Owls, snakes, rats, and mice have been found in warehouses looking for food, water, and shelter. A field mouse only needs 0.25 inch to get under a door, so check the bottom of your outside doors. If there is a gap, you could be inviting a rodent problem. The that you have an effective pest control program; keeping your receiving doors closed will help. Proper closing of inter linked Doors: Keep shipping, receiving, and other doors closed. A common error is to leave shipping and receiving doors open after a delivery has arrived - an open invitation for pests of all kinds. Owls, snakes, rats, and mice have been found in warehouses looking for food, water, and shelter. A field mouse only needs 0.25 inch to get under a door, so check the bottom of your outside doors. If there is a Page 32 gap, you could be inviting a rodent problem. The cGMPs require have an effective pest control program; keeping your
  • 33. Check points: 26. Auditee Attitude: During an Inspection, answer all questions honestly and directly. Do not guess or speculate. Do not volunteer information. Refer questions that you cannot answer to your supervisor. FDA and other regulatory agencies know that this is how employees are trained. Don't be evasive, and don’t try to hide the truth. Don't guess, and don't state your opinion. "If you think we're bad, you should see those guys down the hall!" During an Inspection, answer all questions honestly and directly. Do not guess or speculate. Do not volunteer information. Refer questions that you cannot answer to your supervisor. FDA and other regulatory agencies know that this is how employees are trained. Don't be evasive, and don’t try to hide the truth. Don't guess, and don't state your opinion. "If you think we're bad, you should see those guys Page 33
  • 34. Check points: 27. Highlighting the Mistakes: Report mistakes - or suspected mistakes to your supervisor after the identification of it. Management will hate making mistakes by employees, rather be perfect. But the truth is that we're all human, and human beings make mistakes. As a supervisor, encourage your people to tell you things. Don’t jump all over them when they do so they never do it again. And don't go looking for scapegoats. Highlighting the Mistakes: or suspected mistakes - as soon as possible to your supervisor after the identification of it. Management will hate making mistakes by employees, rather be perfect. But the truth is that we're all human, and human beings make mistakes. As a supervisor, encourage your people to tell you things. Don’t jump all over them when they do so they never do it again. And Page 34
  • 35. Check points: 27. Highlighting the Mistakes: If something goes wrong in your group, you as a supervisor or manager must accept responsibility for the mistake see what you can reconstruct or recover, and figure out how you can prevent the mistake from happening it again and train your personnel on such cases not to repeat the same or occur the same in future. Highlighting the Mistakes: If something goes wrong in your group, you as a supervisor or manager must accept responsibility for the mistake see what you can reconstruct or recover, and figure out how you can prevent the mistake from happening it again and train your personnel on such cases not to repeat the same or occur the Page 35
  • 36. Check points: 28. Continues reading / reviewing of SOP’s: Read and become familiar with all SOPs and other documents that relate to your work. You must know your SOP’s. A commonthat relate to your work. You must know your SOP’s. A common 483 observation continues to be "Firm failed to follow its own SOP." If an SOP needs to be revised, tell your supervisor and offer to help revise it and get it approved. Continues reading / reviewing of SOP’s: Read and become familiar with all SOPs and other documents that relate to your work. You must know your SOP’s. A commonthat relate to your work. You must know your SOP’s. A common continues to be "Firm failed to follow its own SOP." If an SOP needs to be revised, tell your supervisor and offer to help revise it and get it approved. Page 36
  • 37. Conclusion: Apart from the above mentioned, following also to be required to ensure avoiding the discipline, Attitude in work area, Co Cordial relations in work area with supervisors and with sub-ordinates, loyal to the company / position or designation and finally professional attire in our part. Apart from the above mentioned, following also to be required to ensure avoiding the GMP Errors like Self discipline, Attitude in work area, Co-operation, Team work, Cordial relations in work area with supervisors and with ordinates, loyal to the company / position or designation and finally professional attire in our part. Page 37
  • 38. Thank you very much for the attention and for your valuable time……!!!!for your valuable time……!!!! Thank you very much for the attention and for your valuable time……!!!!for your valuable time……!!!! Page 38