List of important documents (SOP’S)
QUALITY ASSURANCE
S/N
1
TITLE
Good Laboratory Practice
2.
Document Signatory in the Laboratory
3.
Cleaning in the Laboratory and Glassware used in the Laboratory
area
4.
Workbook Procedure and Validation
5.
Air and Environmental Contamination
6.
Contract Manufacturing and Analysis
7
Product Complaints
8.
Batch Review
9.
Product Recall
10.
Handling of Returned Drug Product
11.
Preparation of Bench Solutions and Reagents
12.
Preparation and Standardization of Volumetric Solutions and
Reagents
13.
Preparation of Media for Microbiological Use
14.
Disposal of Reagents in the Laboratory
15.
Receiving Manufacturing and Testing Instructions For New Process
from Overseas
16.
Documentation
17.
Batch Documentation
18.
Retesting and Re-sampling of Materials
19.
Handling of Retention Samples
20.
In-Process Inspection of Area
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21.
Identification of Raw Materials Before Weighing
22.
In-process Control (General)
23.
In-Process Control (Weighing)
24.
In-Process Control (Mixing and Blending)
25.
In- Process Control (Compression)
26.
In-Process Control (Packaging)
27.
Care of Instrument Room
28.
Maintenance, Operation and Calibration of
Weighing Balances
29.
Calibration of Weighing Scales in the Plant
30.
Maintenance and Calibration of Equipment and
Laboratory Instruments
31.
Maintenance, Calibration and Operation of
Dissolution Rate Tester (Type DT6)
32.
Operation and Maintenance of Tablet Hardness
Tester
33.
Validation Exercise
34.
Validation Committee
35.
Analytical Validation
36.
Cleaning Validation
37.
Retrospective Validation
38.
Monitoring of Relative Humidity and Temperature
(Procedure/Validation)
39.
Stability Testing
40.
Audit Check (Packaging)
41.
Evaluating Out-of- Specification (OOS) Laboratory Results
42.
Microbiological Control of Manufacturing
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Environment
43.
Microbial Analysis of Water Samples
44.
Disinfection of the Floors and Surfaces in the
Manufacturing Areas
45.
Operating Instruction for various lab equipment
45.
Validation Procedure for Autoclave
46.
Tube Coagulase Test
47.
Use and Care of Microscope
48.
Keeping Reference Samples and Standard Cultures
49.
Microbiological Examination of Washed Securitainers
50.
Microbiological Tests for Sterility of Bottles
51.
Sampling of Products for Microbiological Tests
52.
Regulations of the Microbiology Laboratory
53.
Use and Care of various lab equipments
54.
Sampling Plan for Raw Materials & Auxiliaries
55.
In-Process Control (Liquid Packaging)
56.
Annual Product Review
57.
Monitoring and Fumigation of the Manufacturing Areas
58.
in-Process Control (Water)
59.
Sanitization of Water Pipe lines & Storage Vessels
60.
Release of Finished Products for Sale
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WAREHOUSE
S/N
TITLE
1.
Cleaning Procedure in Warehouse
2.
Storage and Warehousing Conditions
3.
Material and Equipment Handling Procedures
4.
Receiving and Handling of Raw and Packaging Materials
5.
Supply of Raw Materials to Other Party
6.
Collection of Finished Goods
7.
Dispatches of Finished Goods
8.
Safety In Warehouse
9.
Materials Returns Procedure
10.
Storage and Materials Movement ( FIFO Principle )
11.
Air control sampling room
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PRODUCTION AND PACKAGING
S/N
1.
TITLE
Facilities in the Locker Room
2.
Cleaning of the Changing Room
3.
Painting of Facilities in the Factory (Production Areas)
4.
Entry into Manufacturing Area
5.
Preventing Contamination
6.
Maintenance of Equipment
7.
Fixing Manufacturing Parameter
8.
Batch Identification
9.
Manufacturing and Packaging Protocols
10.
Yield
11.
Coating Operations
12.
Process Validation
13.
Process Change
14.
Re-processing
15.
Retrospective Batch Review
16.
Product Change
17.
Recovered Materials/ Reprocessing
18.
Removal of Waste from Production Department
19.
Weighing Process
20.
Material Flow
21.
Manufacturing Procedures for Various Stages of Production
22.
Manufacturing of New Drug products
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23.
Cleaning of oven
24.
Transfer of Raw Materials
25.
Cleaning of Manufacturing Utensils and other containers (each)
26.
Cleaning of Stainless Steel containers
27
Cleaning of Floor Drainage Sinks
28
Cleaning Procedure for Different processing areas
29
Cleaning of Aluminium Pallets
30
Line Clearance and Line Release
31
Line Release for Production
32
Written Instructions for Packaging
33
General Hygiene For Packaging Staff
34
Removal of Packaging Waste
35
Packaging Plan
36
Operation of various Machines (individually)
37
Validation of various packaging machines
38
Mistake/Mix-Up/Contamination
39
Printing Exercise
40
Transfer of Finished Products
41
Line Release for Packaging Operations
42
Manual Packaging Line Operation
43
Batch Identification in Packaging
44
Yield Determination in Packaging
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GENERAL
S/N
1.
TITLE
Guidelines for Writing Standard Operating Procedure
2.
G.M.P Committee
3.
Working Conditions of Personnel
4.
Training
5.
Qualification of Newly Recruited Employees
6.
Follow-up/Refresher Courses
7.
Staff Clinic / first aid
8.
Drug Safety
9.
Guidelines for Self Inspection
10.
Removal of Detergent Residue after Cleaning
11.
Clearing of Septic Tanks
12.
Control Procedure for Pest Control and Fumigation Materials
13.
Pest Control and Fumigation Exercise
14.
Destruction of Materials
15.
Installation and Qualification of Equipment
16.
Manufacturing Prescription
17.
Suppliers’ Audit
18.
General Principles: Change Handling Procedures
19.
SOP Actualization Programme
20.
Time Limits For Various Processes
21.
Document Change Control & Actualization
22.
Documentation: General Principles
23.
Handling Deviations
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24.
Treatment of Personnel with Infectious Diseases
25.
Returned Goods
26.
Training on SOP
27.
Protective Clothing Guidelines
28.
Product Recall
29.
Product Complaints
30.
Maintenance and Calibration of Equipment
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ENGINEERING
S/N
TITLE
1.
Engineering Maintenance Programme
2.
Preventive Maintenance
3.
Preventive Maintenance Programme for the Plant Building
4.
Lubrication
5.
Cleaning and Maintenance of Air Filters in the Manufacturing area
6.
Cleaning of the Generator Plant and the Room
7.
Air Handling Units
8.
Changes/Modification in the Air Handling Unit
9.
Water Treatment Process and Plant Maintenance
10.
Cold room Cleaning, Maintenance and Validation
11.
Maintenance equipments
12.
Boiler Operations
13.
Cleaning of Drainage within Production & Packaging Area
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LIST OF REQUIREMENTS
1.
Personnel Details
2.
Organogram
3.
List of Products
4.
List of Equipment for Production
5.
List of Equipment for Quality Assurance/Control
6.
Quality Policy
7.
Sample Batch Manufacturing Records (BMR)
8.
Evidence of Training
9.
Evidence of Medical/Clinic Services
10.
Evidence of Medical Check-up
11.
Evidence of Fumigation & Pest Control
12.
Evidence of Food Handling Certification
13.
Evidence of Environment, Health and Safety (EHS) Policy
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QUALITY AUDIT – CHECKLIST
INSPECTION OF MANUFACTURING PLANT
INTRODUCTION:
This Quality Audit is performed on behalf of the Pharmaceutical Manufacturers Group of
the Manufacturers Association of Nigeria (PMG-MAN). As an active member of the
Group, we believe that every member company will maintain at least the minimum
standard of the requirements of current Good Manufacturing Practices (GMP) and Good
Laboratory Practices (GLP).
The planning and effective performance of this audit is aimed at ensuring these minimum
standards.
The non-conformities detected during this audit must be corrected within the agreed time
frame.
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QUALITY AUDIT – CHECKLIST
INSPECTION OF MANUFACTURING PLANT
Name /Address of Factory:
Product Lines:
Date of Audit:
Auditors:
Audited Persons/Units:
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QUALITY AUDIT – CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GENERAL IMPRESSION
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QUALITY AUDIT – CHECKLIST
INSPECTION OF MANUFACTURING PLANT
PRIORITY ACTIONS
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QUALITY AUDIT – CHECKLIST
INSPECTION OF MANUFACTURING PLANT
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PMG-MAN STANDARD QUALITY AUDIT
QUALITY RATING SYSTEM
RATING
MEANING
INTERPRETATION
3
Excellent
Item/Area/System/Knowledge is Superior
2
Adequate
Item/Area/System/Knowledge Meets
Basic Minimum Requirements
1
Poor
Item/Area/System/Knowledge is weak
and not up to Acceptable Standard
0
Unacceptable
Item/Area/System/Knowledge is
Missing or of such Nature to Warrant
Serious Quality/Compliance Concerns
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AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
SECURITY
1.
Is the environment very clean?
2.
Are the toilets and changing rooms clean and
devoid of offensive odour?
3.
Do the personnel appear neat and properly
dressed?
4.
Is there evidence of regular disposal of waste in
the refuse drum?
5.
Are the windows, walls and floors clean and
properly maintained?
6.
Is there evidence of growth of mould and fungi or
presence of rodents in the area?
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REMARKS
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AUDIT - CHECKLIST
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RAW AND PACKAGING MATERIALS
WAREHOUSE
1.
When was the last inspection conducted?
2.
Are the walls, floors and shelves cleans?
Is there absence of rodents, vermin fungi and
mould?
Are there physically separated areas for:
- Raw materials
- Semi finished products
- Packaging materials?
Is there a quarantine area for raw materials and
active ingredients under test?
Is there a separated area for rejected materials?
3.
4.
5.
6.
7.
Are there identification labels on all containers that
have materials in them?
8.
Are the warehouse lightning and ventilation
adequate?
9.
Is there any programme for pest control and is
such documented?
10.
Are there warehouse operating instructions and
procedures and are they followed?
11.
Are untested drug components, drug product
containers and closures separated from the tested
and certified ones?
12.
Is the arrangement of materials in the warehouse
adequate?
13.
Is there evidence of safety consciousness in the
personnel working in this area?
14.
Is incoming materials “Quarantined” until it is
checked, analysed and released? Is it properly
stored?
Is there sufficient accountability system for labels?
15.
16.
Are there written procedures on inventory control
and reconciliation and are these followed?
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AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
17.
18.
19.
20.
21.
22.
23.
24.
25.
TITLE
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RAW AND PACKAGING MATERIALS
WAREHOUSE
Is there a written procedure describing the
scheduled for retesting of materials in the
inventory and is it followed?
Are the records of retesting available?
Is a separate sampling room available?
Is the sampling room designed to prevent
microbial and/or product contamination?
Is a returned material store available?
Is a cold store available?
Is an area available for storing of reference
samples?
Is a separate room available for explosive
substances?
Is it ensured that for all materials a “First in First
out” system is followed?
26.
Are all containers legibly and completely labeled?
27.
Are there SOPs describing in detail the receipt,
identification and handling of starting materials,
packaging and auxiliary materials as well as the
status of the material after testing?
28.
Is rejected materials adequately controlled?
29.
Are SOPs available for the general storage and
handling procedures and are these followed?
30.
Are there material storage and handling procedures
documented?
31.
Are SOPs available describing the material flow to
manufacturing areas and vice-versa and are these
followed?
32.
Are obsolete and outdated materials destroyed?
Any record of such destructions?
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AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
FINISHED GOODS WAREHOUSE
1.
When was the last inspection conducted?
2.
Are the walls, floors and shelves cleans?
Is there absence of rodents, vermin’s, fungi and
mould?
Are there physically separated areas for:
- Finished goods
- Returned items?
Is there a separated area for rejected materials?
Are there identification labels on all containers that
have materials in them?
3.
4.
5.
6.
7.
Is there any programme for past control and is
such documented?
8.
Is the arrangement of materials in the warehouse
adequate?
9.
Is there evidence of safety consciousness in the
personnel working in this area?
10.
Do distribution records indicate the:
- Name and address of the consignee
- Loading date
- Name, quality and control number of the item?
Is the establishment system sufficient to facilitate
the recall of the finished product, if necessary?
11.
12.
Is there materials nearing expiry?
13.
Are such materials reported for necessary action?
Any written evidence?
14.
15.
16.
Has a positive action been taken?
Are warehouse lighting and ventilation adequate?
Are different batches of finished products
separated physically?
17.
Is there a system to ensure that only products
released for sale are distributed?
18.
Are the trucks conveying the goods to their
destinations able to project the goods from rain
and sunshine?
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AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
PRODUCTION AREA - LIQUIDS
WEIGHING
1.
Are raw materials properly identified during
weighing?
2.
Is the weighing area clear of other materials that
are not necessary for this operation?
3.
Are materials for weighing checked physically
before and after? Are such checks confirmed by
a second person and such record weighed?
4.
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Is the balance for the weighing the appropriate
one for the material(s) being weighed?
5.
Are there records for the periodic calibration of
the balances in the weighing room?
6.
Where measurement instead of weighing is
involved are the appropriate containers used?
Are there such containers well calibrated?
7.
Are the personnel wearing appropriate uniforms
for the operation - Nose masks, Hand gloves,
Safety-shoes etc?
8.
Is there any personnel in the weighing area that has
open sore or lesion that may pose problem to the
product under processing?
9.
Is there any material in the weighing area that can
shed fiber or other contaminations or wooden
pallets and are such close to clean containers?
MIXING
10.
Is the production area effectively ventilated with
filtered air?
11.
Are there systems for processing and transfer that
can protect the products from contamination?
12.
Are Tanks, Containers, Pipe works and Pumps
designed and installed to facilitate easy cleaning
and sanitation if necessary?
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AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
MIXING
13.
Any device to ensure that materials transferred
through pipes are delivered to their correct
destination?
14.
Are there presence of materials likely to shed
fibers into the mixing tank(s) in the preparation
area?
15.
Are all processes documented at the time of
performance?
16.
Is there a step-by-step procedure for this operation
and is such a protocol followed?
17.
Where procedures are altered, are such alterations
recorded and reasons adduced for the alterations?
18.
Are there records of unplanned deviations from
manufacturing specifications? Are such brought to
the attention of the head of Quality and
Production?
19.
Are laid down criteria for acceptance of such
deviations devised by the Quality Control?
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FILLING
20.
Are the glass bottles maintaining an appropriate
degree of cleanliness at the time of filling?
21.
Any device to detects presence of particulate
matter in the bottle before and after filling and is
such a device effected? If bright background
illumination is used, are observers changed
frequently?
22.
Is the working area where liquids are prepared
disinfected periodically and records of such kept?
Is efficacy of such disinfectant assured?
23.
Are the filling constantly monitored to assure
uniformity of volume?
24.
Are there constant physical inspections of closures
for firmness or otherwise?
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AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
LABELLING AND PACKAGING
25.
Is the labeling constantly monitored and rough
and squeezed ones on the containers replaced
manually?
26.
If labeling is not automated, are the filled bottles
properly stored and identified awaiting manual
labeling?
27.
Is the Batch Packaging Record employed at the
time of exercise and are appropriate
documentation made?
28.
Are any deviations from the standard operating
procedures for packaging documented?
29.
Is there adequate separation of packaging lines to
avoid mix-up?
30.
Is Batch identity maintained throughout the
packaging operation?
31.
Are there records of reconciliation for quantity of
packaging material issued, used, destroyed and
returned?
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AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
GUIDE
LINE
No.
TITLE
PRODUCTION AREA - TABLETTING
1.
2.
Is dust extraction device available at an
appropriate area and is it functional?
4.
Do the personnel use the protective clothing
(gloves, caps, nose masks, etc) in these working
areas?
5.
Are the personnel clothing clean?
6.
Is there absence of other materials not necessary
for operation in?
- Weighing
- Mixing
- Granulation and
- Tableting rooms
7.
8.
Are the utensils in-use clean?
Are these utensils kept in an adequate place free
from contamination?
9.
If weighing was carried out during the
inspections, are the containers of raw materials to
be weighed cleaned before being opened?
During weighing, are weights and raw materials
double-checked and is the in-process inspector
present?
Are raw materials and components for each batch
segregated after weighing?
11.
12.
13.
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Are the following areas clean?
-Weighing room
- Mixing room
- Granulation
-Tableting room
-Washing room
Are lighting and ventilation adequate in:
- Weighing
- Mixing
- Granulation and
- Tableting areas
3.
10.
R
Does these identification include
- the name of raw materials
- the batch number of the raw material
- the quantity that was weighed
Are weighing record sheets filled and duly signed
during weighing?
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AUDIT - CHECKLIST
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No.
TITLE
PRODUCTION AREA
14.
Are processing areas clean and properly
maintained according to standard operating
procedures?
15.
Is the air supply system for all processing areas
adequate to eliminate cross-contamination of drug
products?
Are equipment identified as to their status (clean,
duty, batch contents)?
16.
17.
18.
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Are written operating procedures for equipment
readily available to operators and are they in-use?
Are written procedures available for cleaning,
maintenance and sanitizing of equipment?
Are they followed?
19.
In mixing and granulation rooms is the adding of
raw materials components verified separately by
two individuals? Is it documented at the time of
performance? Any records?
20.
Are there physical separation or other measures to
avoid cross-contamination during production of
different batches and different products?
Is there any lesion or wound on any operator
handling materials which can affect the product
adversely?
Are correct documentations done in the batch
manufacturing protocols at the time of
performance of operations?
21.
22.
23.
24.
25.
26.
27.
Are there adequate areas for the orderly storage of
semi-finished and bulk products?
Do SOPs exist for the cleaning of the various
equipment and machines used in the production
area? Are they followed?
Does SOP exist for reprocessing of production?
Are frequent calibration and servicing of balances
performed and documented?
Are BMPRs kept at the work stations during the
entire operation?
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AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
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LINE
No.
TITLE
PRODUCTION AREA
28.
Are Master and BMPRs properly assembled?
29.
Are process parameters for each step laid down in
writing?
30.
Are yield limits established at each significant step
of production?
31.
Are all yield calculations and reconciliation’s
documented in the BMPRs?
Are adequate procedures utilized to reconcile the
quantities of starting materials issues, used and
returned, are these followed?
32.
33.
34.
35.
36.
37.
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Are written product related in-process control
procedures available?
Is the processing procedure approved by Quality
Control/Quality Assurance?
Is change control performed in the case of:-Changes in starting Materials?
- changes in packaging materials?
- changes in processes?
- changes in equipment
- change of standard batch size?
- changes in production area and support
system?
- changes in environmental conditions
- changes in suppliers
Unexpected changes
Are products quarantine between their
manufacture and packaging
Are products quarantine between their
manufacture and release
Do these manufacture/Packaging protocols include
the followings: - and control records include also
the followings: - Name and strength of the product?
- Description of the dosage form?
- Batch product number and pack size?
- Name/weight (measure) of each ingredient
per dosage form?
- Total weight (measure) of each dosage unit?
- Standard batch size?
Specifications and compendia reference of
ingredients?
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AUDIT - CHECKLIST
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GUIDE
LINE
No.
TITLE
PRODUCTION AREA
38.
Any calculated excess ingredient and packaging
materials?
- Statement of theoretical weight (measure)
quantity at appropriate phases of
manufacturing?
- Statement of theoretical yield at appropriate
phases of manufacturing, including the
minimum and maximum allowed limits?
39
Date of preparation (initiation of operation) of the
updated Master Formular edition number?
- Date and edition number of updated, original
product
and manufacturing prescriptions?
- Product related procedures?
- Statement of important steps to be signed during
manufacturing?
- Product related precautions to be followed
- Process – related precautions to be followed
- Product environmental specifications, where
applicable?
-Procedure for handling equipment and machines?
- Cleaning Procedures?
- In-process control procedures?
- In-process bulk and drug product specifications?
- Specification of primary and other packaging
materials?
- Quantity (weight) of packaging materials per
dosage form?
- Total quantity (weight) of packaging materials
per batch?
- Packaging and labeling procedures?
- Quality Assurance/Quality Control approved
specifications?
- Quality Assurance/Quality Control approved and
testing procedures? sampling
- Storage conditions?
- Shelf life information?
40.
Are the manufacturing/Packaging Protocols, dated
and signed by responsible person?
41.
Are all the signatures full and hand written?
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AUDIT - CHECKLIST
INSPECTION OF MANUFACTURING PLANT
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No.
TITLE
PACKAGING - BLISTERING
1.
Is the blistering hall clean and orderly managed?
2.
Is the blistering hall having adequate lighting and
ventilation?
3.
Are the batch packaging records kept at the work
stations during the entire operation?
5.
Is the printing room clean and well arranged?
6.
Is one product printed at a time?
7.
Is there line identified for such a product?
8.
Is there risk of labels/inserts mix-up?
9.
Are the personnel wearing appropriate uniforms in
performing their duties?
10.
Are the personnel in packaging hall wearing neat
uniforms?
Is each packaging line identified with product
name, packaging size and batch number?
Is there only one product, batch and packing size
on a line at any given time?
12.
13.
Is there presence of previous during product and
labeling materials?
14.
For container that have been used previously for a
certain materials and now been used for another
materials, are old labels removed before using
them?
Are drums containing blisters for packaging
properly
labeled at all times until the blisters in the drum
are exhausted?
Are blisters being left on the floor?
Is the number of blisters in a pack size correct as
declared?
Is the number of pack size in outer carton correct
as declared?
15.
16.
17.
18.
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Is each blistering line identified with product
name and batch number?
4.
11.
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No.
TITLE
PRODUCTION AREA
19.
20.
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Do SOPs exist for the cleaning of the various
equipment and machines used in the production
area? Are they followed
Does SOP exist for reprocessing of products?
21.
Are frequent calibrations and servicing of balances
performed and documented?
22.
Are validation procedures available for:
- Procedures
- Process
- Machines and equipment in
- Production and packaging areas?
23.
Is there SOP for pre-clearance procedures
employed in order to assure that any packaging
material from the previous hatch has been removed
and are these followed?
24.
Are master and packaging records properly
assembled?
25.
Are batch packaging records kept at the work
station during the entire operation?
26.
Are process parameters laid down for every step in
writing?
27.
Are in-process control results available?
28.
Is there a documented label instructions prior to
use?
29.
Are all containers, machines, installation and
equipment used during and after packaging
properly identified?
30.
Are yield limit established at each significant step
of packaging?
31.
Are adequate procedures to reconcile the quantities
of packaging materials issued, used and returned
and are these followed?
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TITLE
ENGINEERING (WORKSHOP)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
R
A
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3
2
1
N
0
G
REMARKS
N/A
Does a written preventive maintenance
programme exist for machine and equipment in
production, packaging and laboratory as well as in
Engineering?
In all the Engineering sections, are risk of
accidents due to carelessly placed wire, equipment
and other obstacle?
Are the sinks, toilets and bathrooms clean?
Are these areas habouring cobwebs, insects and
vermin’s?
Are appropriate uniforms used for the performance
of function?
Are lubrication records available based on a
lubrication manual for major machines and
equipment?
Are written records or log books maintained of
maintenance and repairs?
Do standard operating procedures exist for
cleaning/ sterilizing of filters?
Do records exist for cleaning/sterilizing of filters?
Are all structural materials in the various sections
of Engineering properly arranged?
Is the entire environment generally clean and well
arranged?
Is there evidence that the personnel are safety
conscious?
Do updated schemes (drawings) of the air
handling and distribution system exist, meeting
current requirements?
Is there an adequate system for dust extraction?
Are air filtration systems (which include pre-filters
and particulate filter) used on air supplied to the
manufacturing areas?
Is there an adequate system for dust extraction?
Are updated SOPs available for all
controls/monitoring, calibrations and validations
performed and are these followed?
Are adequately constructed waste containers
located in appropriate areas?
Does a preventive maintenance programme exist
for the whole buildings in the plant? Are written
records available?
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REMARKS
N/A
GENERAL SERVICE
1.
2.
Are the changing rooms for production personnel
clean?
Are the doors closed always to prevent entry or
exit of dust to other area?
3.
Is the tearoom clean and well arranged?
4.
Are precautions taken to prevent microbiological
contamination where necessary?
5.
Do SOP exist regarding the policy for the entry of
visitors to the different areas and are they
followed?
6.
Are measures taken to ensure that visitors do not
jeopardise the quality of the products in any way?
Are SOPs for good personal hygiene practices
available and are these followed?
7.
8.
9.
10.
Do SOP exist regarding the policy for the entry of
visitors to the different areas and are they
followed?
Are measures taken to ensure that visitors do not
jeopardize the quality of the products in any way?
Are SOPs for good personal hygiene practices
available and are these followed?
11.
Are building and surrounding areas free from all
and other unwanted materials?
12.
Are waste and trash stored in an orderly manner?
13.
Are the grounds attractively landscape and parking
lots, fences and drive ways in a good state of
repair?
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REMARKS
N/A
CANTEEN
1.
Is the store well arranged and is it clean?
2.
Is the evidence of safety consciousness in the
personnel working in this area?
3.
Are the cooking utensils not in use properly kept?
4.
Is there water/oil spillage on the floor that can
cause accident?
5.
Are the changing rooms and bathrooms clean?
6.
Are the personnel wearing clean clothes and
headgears?
7.
Is the working environment kept clean?
8.
Is regular waste disposal carried out in the
canteen?
9.
Are the waste containers kept far away from the
cooking area?
10.
If washing is being carried out during this
inspection, are the utensils washed rinsed with
copious clean pure water?
11.
On inspection of the cleaned utensils, are they
really clean?
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QUALITY CONTROL DEPT.
3
2
1
1.
Are there master control procedures?
- Approved by Quality Control?
Signed and dated by a responsible person?
2.
Do established procedures include specifications,
standard test procedures or other control
procedures for:
Raw materials and components
- In-processing materials (semi-finished
products)?
Packaging and labeling materials?
Finished products? - Test materials
(reagents, media etc)
3.
Are all procedures in written form and available to
all Quality Control personnel?
4.
Do test methods describe the sources such as
pharmacopoeias?
5.
Is each finished batch checked for compliance
before being released?
Does this final release include:
- Identity and strength of active ingredient?
- Identity and strength of effective and
auxiliary raw materials?
Acceptance and rejection levels?
6.
7.
8.
9.
10.
11.
12.
13.
N
0
G
REMARKS
N/A
Are any deviation from established procedures and
specifications justified and recorded?
Are test methods validated for accuracy and
responsibility?
Are all drug products failing to meet established
standard and specifications rejected?
Are there procedures and specifications for
accepting reprocessed materials?
Does Quality Control maintain written records of
all tests conducted?
Does these include:
- Graph, charts, spectra, chromatograms etc?
- Record of all calculations
Are these established sampling procedures for:
Raw materials
- In-process materials
- Packaging and labeling materials
- Finished products?
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14.
15.
TITLE
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QUALITY CONTROL DEPT.
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1
In the room for sensitive instruments
- Are temperature and humidity controlled?
- Is there any vibration - proof bench for
analytical balance?
17.
Is there a programme for calibration of laboratory
instruments?
18.
Are instruments properly maintained?
19.
20.
Are the calibration documented?
Does Quality Control review and approve all
production and control records to assure
compliance with established written procedures
before a batch is released?
21.
Do retention samples meet the following criteria?
- A representative sample of the batch
- A quantity, at least two times the amount
required for all tests
22.
Is a written programme available for stability
studies?
Are containers of raw materials opened for
sampling, securely closed after and marked after
sampling?
Are printer’s proofs checked and approved before
mass production?
Does a documented water testing/monitoring
programme exist, indicating sampling schedule,
microbiological, chemical, filter changes,
regeneration, cleaning and distribution?
Are SOPs available for all controls and validation
of such controls on water supplied to plant?
24.
25.
26.
27.
28.
0
G
REMARKS
N/A
Do sampling procedure for finished products
include numbers of units per batch to be tested?
Are sample collected by Quality Control?
- For testing
- For retention?
16.
23.
N
Are there SOPs for in process control checks for
Production and Packaging?
Are in-process checks validated?
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N
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REMARKS
N/A
QUALITY CONTROL DEPT.
29.
30.
31.
32.
33.
Are in-process results included in the batch
record?
How are in-process check results, which do not
conform, dealt with?
Do written procedures exist governing a
document change control system to ensure that
only updated documents are used and are these
followed?
Are written specifications for all starting,
packaging and auxiliary materials available
including updated acceptance criteria?
Are SOPs available for handling of rejected raw
materials auxiliaries and packaging materials and
are they followed?
34.
Does SOPs exist for handling of raw materials,
auxiliaries and packaging materials and are they
followed?
35.
Are all manufacturing Protocols and Packaging
Protocols approved by the Quality Assurance?
36.
Are SOPs available for signatory to any document
and are they followed?
Does Quality Control department have enough
qualified personnel for the jobs?
Does documentation of written and oral
complaints exist?
Do SOPs exist for testing, reprocessing and
destroying
of returned drug products and are these followed?
Do SOPs exist for operation of laboratory
equipment and are these followed?
Does an updated list of Laboratory equipment
exist?
Does SOP exist for discarding Laboratory
reagents that are prepared in the Laboratory and
are they followed?
Are all Laboratory solvents/reagents properly
labeled and stored?
Do SOPs exist for preparation and standardization
and expiry of volumetric solution and are these
followed?
37.
38.
39.
40.
41.
42.
43.
44.
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45.
Does the Quality Control monitor the handling of
approved materials in the warehouse (FIFO)?
46.
Are the following documents available?
- Sampling plan
- Specifications
- Analytical records including worksheets
- Certificate of analysis
- Data form environmental monitoring
Records of calibration, maintenance and
repair of instruments and equipment
Are raw data retained to support results in the
certificate of analysis?
47.
48.
49.
Are these SOPs for general inspection of
manufacturing areas for the in-process inspector?
51.
Does a SOP exist for each of the processing steps
for the in-process control inspector and are such
followed?
Do SOP exist for writing report of analysis in a
work book and are they followed?
53.
Is there SOP for batch review before a batch is
finally released?
54.
Is there SOP for regular microbiological testing
and documentation with respect to airborne and
surface contamination and is it followed?
Does an approved sampling plan exist indicating
the sampling procedure, sampling area,
identification of sampled container,
responsibilities and quantities, which have to be
taken?
Are there written procedures describing in detail
testing, approval and rejection of starting and
packaging materials?
Is each material tested for conformity with the
specification?
55.
56.
57.
0
G
REMARKS
N/A
Are SOPs for investigation of out of specification
laboratory results available and are these
followed?
Does SOP exist defining retesting/re-sampling
conditions and responsibilities in case of out of
specification results and is it followed?
50.
52.
N
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58.
Is the material “released” in writing and are the
containers marked accordingly and physically
separated?
59.
In case of specification discrepancies, is there a
written procedure on how to handle it?
Is the whole batch documentation including
Laboratory data kept in one safe place accessible
at all times? Who is responsible for that?
60.
61.
62.
63.
64.
Are record sheets dated and signed by a
responsible person?
66.
In the case of using person dedicated
notebook/logbook, how is dating and signing dealt
with? How are exhausted person - dedicated
notebooks handled?
67.
Are corrections of raw data not caused by writing
error justified, dated and signed by the analyst or
responsible of the Laboratory?
68.
Are corrections performed so that the previous
data can be clearly identified?
Are reading reported at the time of their
performance?
Is it assured that chromatograms, charts and
printouts can be clearly related to the
corresponding Laboratory equipment?
70.
71.
72.
73.
0
G
REMARKS
N/A
Are the batch data reviewed on periodic basis?
In Laboratory documentation, are raw data
documented in adequate record sheets, notebooks,
logbooks, print outs or drafts?
If record sheets are used, are these updated and
numbered consecutively by means of a paginating
stamp in order to ensure their completeness?
Are raw data reported and documented manually
or by means of computerized system?
65.
69.
N
Is the completeness of the run assured?
Is it assured that equipment functions properly
during runs?
Are system suitability performed?
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74.
Are measures taken to ensure that manual raw data
calculations are double checked by the responsible
for final batch release?
75.
Are test results transferred adequately on to the
certificate of analysis?
76.
Does the Certificate of Analysis include the
followings? Name of product?
- Dosage form?
Batch number?
Manufacturer?
- Date of manufacturing?
- Test results?
- Date of testing?
- Expiry date?
- Clear statement of release or rejection?
- Signature of responsible(s)?
77.
Does the water used for production meet chemical
and microbiological quality specified. Any
record to show quality control approval of its use?
78
Is there a formal change control system that
addresses changes to validation system including
Quality Assurance/Quality control review and
approval
79
Does validation team exist? Who are in the team
and job titles?
80
Who is responsible for the validations?
81
Are validation procedures available for:
- Procedures
82.
83.
N
0
G
REMARKS
N/A
- Process
- Machines and equipment?
Is a retrospective validation carried out on a
periodic basis on a particular product?
Does retrospective validation include trend
analysis?
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TITLE
MICROBIOLOGICAL TESTING
84.
85.
86.
87.
88.
89.
90.
91.
R
A
T I
3
2
1
N
0
G
REMARKS
N/A
Are the following microbiological tests performed:
- Microbiological testing of non-sterile
products?
- Microbiological testing of effectiveness of
cleaning procedures?
- Microbiological testing of effectiveness of
disinfectant?
- Microbiological testing of starting materials
(bioburden)?
Is the microbiological testing performed
according to the updated procedure?
Is special emphasis put on microbiological testing
of sterile, topical, nasal and inhalation products, if
applicable?
Are total counts and identification of contaminants
included?
Are autoclaves, hot air sterilizers and incubators
calibrated?
Are facilitaties for sterility testing similar to
facilities for sterile production?
Does an SOP exist defining retesting conditions in
the case of positive testing results and is it
followed?
Are incubation times in accordance with
specifications?
92.
Are microbiological testing procedures including
identification of contaminants validated?
93.
Do SOPs for preparation of media include expiry
dating? Is growth promotion testing included?
94.
Does the hygiene programme for the cleaning and
disinfectation of the sterility-testing laboratory
include personnel and is it followed?
95.
Are microbiological testing results entered in lobook or analytical sheets?
MICROBIOLOGICAL AND PARTICLE
MONITORING
96.
Is there a written microbial monitoring
programme for the manufacture of sterile and nonsterile products (see section 2:5)?
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TITLE
97
Does this monitoring programme include:
- Air?
- - Surface?
- - Personnel?
- - Machine and equipment?
- - Disinfectant/cleaning?
- Material?
- Water?
98.
Are the procedures for microbiological monitoring
validated?
99.
Is there a periodic identification of contaminants
isolated in air, water, surfaces and personnel?
100.
Is there a written particles monitoring programme
for the manufacture of sterile and non-sterile
products and is it followed?
101.
Does the monitoring programme include: - Air?
- Energy (water, steam, etc)?
102
Does alert/action limits exist for all these
controls?
103
Does a statistical data register exist?
104
Is there a periodic analysis of data and trends?
105
Is corrective action documented?
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REMARKS
N/A
MANAGEMENT
1.
Are the responsibilities of the person who is
responsible to the government clearly stated?
2.
Is an updated organizational chart available?
3.
Does the organizational chart include key
personnel and their respective deputies?
4.
Do the key personnel have the education, training
and experience to perform their assigned
functions?
5.
Are the competent personnel available in sufficient
number to supervise all stages of manufacture?
6.
Are the deputies able to perform key personnel
functions?
7.
Does a Quality Control unit exist?
8.
Does a Quality Assurance unit exist?
9.
Is there a person responsible for GMP related
aspects?
10.
Do updated written job description exist for the
key personnel?
11.
Are areas of competence and responsibilities of the
key personnel clearly stated and laid down in
writing with special regard to Quality Assurance?
12.
Are the procedures indicating clearly the
responsible person for quality relevant activities
who demonstrates them by checking and signing
quality relevant documents?
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REMARKS
N/A
42
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N
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REMARKS
N/A
43