1. Good Manufacturing
Practices (GMP) Guidelines
FOR EQUIPMENTS
Prepared By: Modi Nirav
M.Pharm (Q.A.), Semester-1
Guided By: Vishnubhai M. Patel
 A.P.M.C.COLLEGE OF PHARMACY,
HIMMATNAGAR.

2. GMP
GMP
CONTENT: For
For
Equipment
Equipment
ss
 Introduction
 Selection criteria
 Design and Construction
 Installation
 Cleaning and maintenance
 Documentation
 Automatic, mechanical and electronic
equipments.

4. GMP
GMP
Introduction: For
For
Equipment
Equipment
ss
 Equipments is important factor which can affect
the quality of drug to great extent.
 Equipment used in the manufacture, processing,
packing of a drug product shall be of appropriate
design, adequate size, and suitably located to
facilitate operations for its intended use and for
its cleaning and maintenance.
 The effectiveness of equipment, like the quality
of a product, starts at the design stage.

5. GMP
GMP
Selection criteria: For
For
Equipment
Equipment
ss
1. Operating criteria (size, speed, effectiveness)
2. Availability of spares and servicing
3. Maintenance
4. Easy accessibility and cleanability
5. Environmental issues
6. Construction materials and design.
7. Availability of process controls
8. Cost
9. Availability of design and maintenance manuals
from the supplier

6. GMP
GMP
For
For
Equipment
Equipment
ss
• New equipment should not be used for
commercial production until it has been qualified
and the process in which it is to be used has been
validated; this applies equally to laboratory and
other test equipment.

7. GMP
GMP
Design and construction: For
For
Equipment
Equipment
ss
Equipment used in manufacturing process,
handling or storage should be of suitable design and
of adequate capacity to facilitate the operations for
which it is intended.
 Not allow to contact any in process material.
 do not affect the product adversely in case of leakage.
 Those parts of equipment which come into contact
with any material should be made of material which
would not be reactive, additive or absorptive.

8. GMP
GMP
For
For
Equipment
Equipment
ss
 Equipment for processing inflammable
materials should be equipped with explosion
proof electrical parts.
 Equipment used for critical steps should have,
as far as recording devices. If it is not possible,
other measuring devices like pressure gauge
should be fixed at easily accessible location.

9. Appropiate design :
• Easily clened on a schedule basis.
• FOR THE SAFETY OF PRODUCT
• The equipment effect should be
• * Non additive
• * Non adsorptive

10. GMP
GMP
Installation: For
For
Equipment
Equipment
ss
While installing equipment points mentioned
below should be considered:
Equipment should be located in such a way that
contamination of sub. By other materials is
minimized.
One equipment should be located at sufficient
distance from the other so do not get admixed
with each other.
 All open mechanical belts and pulleys should be
covered with safety belts.

11. GMP
GMP
For
For
Equipment
Equipment
ss
Water and other utility service lines should be
so installed as to be easily accessible during all
phases of operation.
All pipes, tanks and jackets which handle
steam or coolants should be properly
insulated.

12. GMP
GMP
Cleaning and maintenance: For
For
Equipment
Equipment
ss
Purpose:
To remove product residue of previous product or
batch and to clean and sanitize the equipment for next
batch.
 Equipment should be cleaned regardless of their size.
 Larger equipment which are fixed or too heavy to
move should be cleaned on location.
 Detachable parts and small equipments should be
taken to cleaning area assigned for the purpose.

13. GMP
GMP
For
For
Equipment
Equipment
ss
 Written cleaning procedures or SOP should be
prepared for all the equipments.
 These should be in the language that is understood by
the workers and be available in the section.
 Cleaning procedures are different for dry product and
liquid tanks.
 Tags with words like ‘equipment cleaned’, ‘cleaned’ or
‘ready for use’ can be used for clean equipment. Clean
equipment should be covered to protect from
contamination.

14. GMP
GMP
For
For
Equipment
Equipment
ss
Cleaning implements:
• scrubber, brush..
 Washed with water
 Antiseptic solution(0.5% cetrimide sol.)
 Sterilize-70% IPA
 Sanitizing agent(sodium hypochlorite, IPA)
Cover ends of clean tubing with polyethylene sheet

15. GMP
GMP
For
For
Equipment
Equipment
ss
A format which can be used as a guide for log
book is printed below:
M/s
Log book for cleaning and sanitization of
Date Time SOP no. Cleaned By Checked By

17. GMP
GMP
Maintenance program: For
For
Equipment
Equipment
ss
 Systematic and routine cleaning, adjustment, or
replacement of instrument and equipment parts
 Performed periodically, daily, weekly, monthly
Example:
 Cleaning optical lenses
 Thermostat adjustments
 Changing motor brushes

18. GMP
GMP
Function checks: For
For
Equipment
Equipment
ss
 Monitoring of instrument to verify that your
equipment is working according to the
manufacturer’s specification
 Performed periodically- daily, weekly, monthly
 Performed after major instrument repair
Example:
 Daily monitoring of temperatures
 Checking wavelength calibration
 Checking autoclave indicator paper

19. GMP
GMP
Weekly sterilization checks: For
For
Equipment
Equipment
The laboratory should develop a procedure for ss
the
weekly sterilization check using a biological
indicator
and keep detailed records of each check.
Weekly Sterilization Record
Sterilizer Date of Mfg. Mfg. Date Date Tester’s Sterilized Vial Control Vial Result
Location & Lot # plus 2 yrs. of Test initials Expected Expected Okay
expiration Results Results
(purple = neg) (yellow = gr)

20. GMP
GMP
For
For
Equipment
Equipment
ss
For the proper maintenance implementation
of maintenance program are necessary.
• Assign responsibility
– Oversight of all laboratory equipment
– Individual responsibilities
• Develop written policies and procedures
• Train staff
• Keep records

21. GMP
GMP
For
For
Equipment
Equipment
ss
 Create a record for equipment inventory
 Name, Model #, Serial #
 Location in lab
 Date purchased
 Manufacturer and vendor contact information
 Warranty, expiration date
 Spare parts
 For each piece of equipment:
 Establish routine maintenance plan
 Establish required function checks
 Develop a list of spare parts

22. GMP
GMP
Documentation:
For
For
Equipment
Equipment
ss
 A maintenance protocol that outlines
function verification and maintenance
activities
 Develop a problem log record for each piece
of equipment (Important for future selection)
 Date problem occurred, removed from service
 Reason for breakdown or failure
 Corrective action taken
 Date returned to use
 Change in maintenance or function checks

23. Electronic, mechanical and electronic GMP
GMP
For
For
equipments: Equipment
Equipment
s s
 Automatic, mechanical, or electronic equipment or
other types of equipment, including computers, or
related systems that will perform a function used in
the manufacture, processing, packing, and holding of a
drug product.
 If such equipment is so used, it shall be routinely
calibrated, inspected or checked according to a
written program designed to assure proper
performance. Written records of those calibration
checks and inspections shall be maintained.

24. GMP
GMP
For
For
Equipment
Equipment
ss
 Appropriate controls shall be exercised over
computer or related systems to assure that
changes in master production and control
records or other records are instituted only by
authorized personnel.
 Input to and output from the computer or
related system of formulas or other records or
data shall be checked for accuracy.
 The degree and frequency of input/output
verification all be based on the complexity and
reliability of the computer or related system.

25. GMP
GMP
For
For
Equipment
Equipment
ss
 A backup file of data entered into the computer or
related system shall be maintained except where
certain data such as calculations performed in
connection with laboratory analysis, are eliminated by
computerization or their automated processes.
 Hard copy or alternative systems, such as duplicates,
tapes, or microfilm, designed to assure that backup
data are exact and complete and that it is secure from
alteration, inadvertent erasures, or loss shall be
maintained.

26. Stages: GMP
GMP
For
For
Equipment
Equipment
ss
Design and
Installation
specification
Ongoing operation Operation

27. GMP
GMP
For
For
Equipment
Equipment
ss
 These four stages have been integrated into the
‘‘life cycle approach’’ which starts with the
identification of user requirements, continues
through the stages of development, installation,
validation, operation, and maintenance, and
ends only when the use of the system is
discontinued.
 Revalidation should ideally only need to be
considered when there have been approved
changes to the system.

28. GMP
GMP
Reference: For
For
Equipment
Equipment
ss
 Sidney H. Willig, “Good manufacturing Practices
for Pharmaceutical”, volume-109, Marcel Dekker
N.Y. Page No.65-75.
 P.P.Sharma, “How to practice GMP’s”, 3rd edition,
Vandana Publication. Page no.152-155.
 www.cde.gov/dls/ilq/cd/../module.ppt
 www.pacificbiolabs.com

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