deviation in pharmaceutical industry QA

1. Presented by
PRASHIK SUDHIR SHIMPI
M.PHARM ( QA)

2.  DEFINATION:
DEVIATION:
Deviation is an unexpected event that occurs during the on-going operation
/ Activity /
Documentation / Entries at any stage of Receipt, Storage and Manufacturing,
Analysis and Distribution of Drug Products / Intermediates / Raw Materials /
Packing materials. Deviations are
to be reported as and when they occur and to be investigated for impact
assessment.
Critical Deviation: Deviation that could have significant impact on the
product quality or GMP
system. Examples of critical deviations are given below but not limited to:
Cross contamination or product mix up in a product.
Failure to process step during manufacturing.
Use of obsolete batch document / test method.
Filter integrity failure.
Major Deviations: Deviation that could have a moderate to considerable
impact on the product quality
or GMP system. Examples of major deviations are given below but not limited
to:
Machine breakdown during processing
Mix ups of cartons of same product with different strength.
Minor Deviations: Deviation unlikely to have a detectable impact on product
quality or GMP system.
Examples of minor deviations are given below but not limited to:
Minor errors in batch records or document that not affecting the integrity
of data.
Spillage of material during dispensing.
Failure to meet environmental condition during batch processing.

3.  PROCEDURE:
All deviation shall be documented, investigated,
tracked and trended. All deviation shall be reported
as
when they occur.
The person who observes the deviation shall inform
the immediate supervisor or concern department
head/designee and to Quality Assurance.
As per the severity of deviation and stage of process,
the process may be stopped for initial
assessment.
QA shall issue the “Deviation Control Form “on the
request of initiator (Concerned department) by
assigning deviation number
The initiator shall fill the details (like Product /
Material / Equipment / Document / Other If any and
Batch No. / A.R.No. If applicable) in deviation control
form.

4.  Initiator shall do the initial assessment and shall take suitable
immediate action according to the nature of deviation and inform to
department head and concern QA person.
Initial impact assessment shall be done by the observing department
head / designee and designated person QA. Recommendation for
continuation of process / discontinue the process shall be given by
head of department and Head QA or designee.
Based on nature of deviation, initial assessment and immediate action
taken, Head of initiating department shall approve the deviation for
further evaluation of QA.
After approval of deviation from head of initiating department
deviation form shall be forwarded to QA for evaluation.
During evaluation, designated QA person shall verify whether the
deviation is quality relevance or not and whether deviation is a repeat
occurrence or not.
If it is quality relevance, impact shall be assessed on other
areas/departments.
And if it is a repeat occurrence, impact assessment shall extend to
verify the effectiveness of previous
CAPA taken. After evaluation categorizes deviation into critical, major
or minor based on the evaluation of impacted areas and product
quality impact.
If deviation is categorized as Critical or Major, Cross Functional Team
comprising of technical experts
from different department (as per the nature of deviation) shall be
form to investigate the root cause of deviation.

5.  If deviation is minor, investigation shall be carried out jointly by
designated QA person along with a
person from department where deviation happened.
Failure Investigation and Root Cause identifications shall be
carried out by the investigation team using investigational
methodologies. Upon identification of root cause of failure, the
probable root cause of failure shall be documented. Corrective
actions and preventive actions shall be recommended to prevent
the reoccurrence of the
same. The deviation including investigation report (wherever
applicable) shall be closed within 30 working
days of the initiation date. The initiation date is the date of
observation of deviation. If deviation is not closed within
specified timeline, initiator shall raise “Period Extension Request”
as
per SOP No. QAD 098. Initiating department Head shall review the
extension request and write justification for delay with impact
assessment. QA shall assess the impact of delay in action
completion
and approve / reject the Period extension request.
Deviations shall be closed only when all relevant actions in the
CAPA log are completed.

6.  Continuous trending of deviations shall be
carried out on monthly basis
QA shall carry out trend analysis for all the
deviation in the whole year at the beginning of
the next year
by using monthly trend data. A copy of trend
analysis shall be forwarded to Head CQA.
The record retention for all closed deviation and
investigation reports shall be not less than 7
years or as
otherwise agreed with concerned regulatory
body.
All deviation and investigation reports shall be
kept in custody of QA and QA shall maintain the
Deviation register.

7.  DEFINATION:
MARKET COMPLAINTS
A complaint is any expression of dissatisfaction with a product or service marketed.
Any written/ genuine verbal communication received directly from any customer, retailer,
distributor, healthcare professional, regulatory agency, patient (Consumer) or field staff,
regarding the safety, identity, strength, purity, efficacy, quality, shortages or any other
such complaints shall be considered as a Market Complaint.
PROCEDURE:
All the market complaints shall be received by marketing department
(Domestic/International) at Head Office. Concern marketing person shall record all the
details of complaint product, name and address of complainant and nature of complaint in
"Market Complaint Form and forward the same to Head-CQA. Head-CQA/Designee shall
ensure that all information available in the "Market Complaint Form“ concerning the
particular complaint. Ensure that all required information is entered and all required
information for complaint investigation is received and if not, then Head-CQA shall ask to
send required information to marketing department.
In case of quality/efficacy related complaint, Head-CQA/Designee shall request the
complainant/marketing department for complaint sample. Head-CQA/Designee shall
follow up for
complaint sample up to 15 days from the date of complaint.
If marketing department is unable to provide the required information (Details of
complaint) and
complaint sample to Head-CQA then the same complaint shall treated as non-justified
complaint and closed.If the required information provided by marketing
department/complainant, Head - CQA shall acknowledge the “Market Complaint Form” by
signing on received by column with date and the same shall be forwarded to Head-
QA/Designee at site.
Head-QA/Designee shall enter the complaint details in market complaint log
After logging of complaint, Head-QA/Designee shall start the investigation of compliant
based on
guideline provided

8.  Head-QA/Designee shall write the complaint product details and categorize the
complaint as
Critical/Major/Minor in "Market Complaint Investigation Form
Critical Complaint:
A complaint that strongly indicates the purity, identity, safety or efficacy of a
product may have
been compromised and has the potential to cause a life threatening or serious
health situation.
Major Complaint:
A complaint that indicates the purity, identity, safety or efficacy of a product may
have been
compromised, but does not present as a life threatening or serious health risk.
Minor Complaint:
A complaint that is neither critical nor serious
If complaint is categorized as critical, Head-QA shall intimate (within 24 hours from
the receipt of the
complaint) to Head - Marketing/Distribution for the immediately stoppage of the
further sale and
distribution of the batch till the completion of investigation
Head-CQA / QA shall communicate to FDA / Regulatory Affairs / Customer / MA
holder / QP /
Customer regarding market complaint based on nature of market complaint
The investigation shall be carried out by a team of representatives from QC, QA,
Production, Engineering,
R&D, ADL, Marketing, RA and etc. (as per nature of complaint).
The investigation shall involve, but not restricted to, examining reserve samples,
complaint samples and other samples, review of batches of complaint product,
review of batch documents and other related logbooks and documents etc.