Gmp checklist

© 2007 Center for Pharmaceutical Learning
W.H.O. G.M.P. INSPECTION PERFORMA
DATE OF INSPECTING FIRM’S
REPRESENTATIVES
INSPECTION OFFICERS: PRESENT DURING
INSPECTION
FIRM’S NAME: PHONE NO. :
ADDRESS:
LICENCE NO.:
CATEGORIES OF DRUGS MANUFACTURED
AND PRODUCTION CAPACITY:
DETAILS OF EXPORT, IF UNDERTAKEN
ALREADY:
TECHNICAL PERSONNEL:
MANUFACTURING:
QUALITY CONTROL:
PRODUCTS TO BE CERTIFIED:
PRODUCTS LICENSED:
WHETHER SITEMASTER FILE SUBMITTED
IF YES, COMMENTS OF INSPECTING
OFFICER ON SITE MASTER FILE.

Complaint Yes/No Remark if non
complaint
1. PERSONNEL:
1.1 IS ORGANISATION CHART AVAILABLE:
1.2 ARE NO. OF PERSONNEL ADEQUATE:
1.3 NAME ,QUALIFICATION AND EXPERIENCE OF KEY
PERSONNEL(CHECK WITH SMF):
1.4 IS QUALIFICATION AND EXPERIENCE OF
PERSONNEL COMMENSURATE WITH JOB
DESCRIPTION:
1.5 IS MANAGERIAL RESPONCIBILITIES OF EACH
TECHNICAL PERSONNEL SPECIFIED IN WRITTING
WITH JOB DESCRIPTION:
1.6 CHECK WHETHER THERE ARE GAPS OR
UNEXPLAINED OVERLAP OF RESPONSIBILITIES
OF THE CONCERNED PERSONNEL:
2. TRAINING OF PERSONNEL:
2.1 IS WRITTEN PROGRAMME FOR TRAINING
AVAILABLE:
2.2 ARE ALL PERSONNEL TRAINED INITIALLY:
2.3 ARE PERIODICAL ASSESMENT RECORDS
AVAILABLE
2.4 IS SPECIAL PROGRAMME AVAILABLE FOR
PERSONNEL WORKING IN CLEAN AREAS AND
AREAS WHERE HIGHLY ACTIVE AND TOXIC
MATERIAL & HANDLED:
2.5 IS SOPs FOR TRAINING OF PERSONNEL
AVAILABLE:
3. PERSONNEL HYGIENE OF PERSONNEL:
3.1 ARE ALL PERSONNEL MEDICALLY EXAMINED
PRIOR TO = AND DURING EMPLOYMENT:
3.2 ARE THEY RESTRICTED , IF MEDICAL REASONS
DICTATE:
3.3 IS SOPs FOR CLOTHING AND HYGIENE
AVAILABLE:

3.4 ARE CLEAN UNIFORMS AND HAIR COVERING
CAPS USED:
3.5 CHECK NO. OF UNIFORMS PROVIDED. ARE
THEY ADEQUATE:
3.6 WHAT PROTECTIVE CLOTHING ARE PROVIDED
FOR VISITORS / OUTSIDE PERSONNEL
ENTERING IN PRODUCTION AREAS. ARE THEY
ADEQUATE:
4. PREMISES :
4.1 BRIEF DESCRIPTION OF BUILDING
4.2 IS DESIGNS AND CONSTRUCTED:
4.3 IS THE PREMISES COMPLY WITH SMF AND
SITUATED IN AN ENVIRONMENT WHICH CAUSED
MINIMUM RISK OF CONTAMINATION TO
MATERIALS OR PRODUCTS:
4.4 IS AREA PROVIDED COMMENSURATE WITH
PRODUCTION:
4.5 ARE NON MEDICAL PRODUCTS MANUFACTURED
IN THE PREMISES. IF YES, GIVE DETAILS:
4.6 ARE SOPs AVAILABLE FOR MAINTENANCE,
CLEANING AND SANITATION OF BUILDINGS,
PREMISES AND SURROUNDING
4.7 CHECK WHETHER THE AREA IS CLEANED AND
VALIDATED BEFORE STARTING STORING
/PROCESING /PACKING OPERATIONS:
4.8 IS ELECTRICAL SUPPLY,
LIGHTING,TEMPERATURE,HUMIDITY,AND
VENTILATION APPROPRIATE:
4.9 ARE ARRANGEMENT MADE FOR CONTROL OF
ENTRY OF RODENTS& BIRD
4.10 ARE FOLLOWING AREAS PROVIDED:
(A) SEPARATE REST ROOMS AND REFRESHMENT
ROOMS:
(B) SEPARATE CHANGING ROOMS AND TOILETS
FOR MALE AND FEMALE WORKERS:
(C) WORKSHOP IN A SEPARATE PLACE:
(D) ANIMAL HOUSES WITH SEPARATE ENTRY AND
AIR HANDLING UNIT:
5. STORAGE AREAS:
5.1 IS AREA SUFFICIENT FOR ORDERLY STORAGE

OF MATERIALS:
5.2 INDICATE AREAS FOR EACH CATEGORY AND
WHETHER BARRIERS ARE PROVIDED IF NOT,
EXPLAIN MODE OF SEGREGATION:
RAW MATERIALS:
QUARANTINE:
APPROVED:
REJECTED:
PACKING MATERIALS:
IS ACCESS TO QUARANTINE AREA
RESTRICTED:
5.4 ARE REJECTED GOODS MARKED AND STORED
SEPARATELY IN A SECURED AREA:
5.5 ARE RECORDS FOR ACTION TAKEN ON
REJECTED GOODS AVAILABLE:
5.6 ARE FACILITIES AVAILABLE FOR STORAGE IN
CONTROLLED TEMPERATURE/ HUMIDITY:
5.7 IS RECORD OF TEMPERATURE AND HUMIDITY
MAINTAINED:
5.8 ARE RECEIVING BAYS COVERED
5.9 ARE INCOMING MATERIALS CLEANED BEFORE
ENTRY TO STORAGE AREA:
5.10 IS SEPARATE SAMPLING AREA PROVIDED.IF ,
NOT HOW CONTAMINATION AND CROSS
CONTAMINATION IS PREVENTED:
5.11 ARE SENSITIVE MATERIALS/
HORMONES,BLACTUM, ANTIBIOTICS,
NARCOTICS,INFLAMMABLES, EXPLOSIVES
STORED IN SECURED AREA:
5.12 ARE PRINTED/CODED PACKING MATERIALS AND
CUT LABELS STORED IN SECURED AREA WITH
RESTRICTED ENTRY,AND WHETHER PACKING
MATERIALS LINE LABELS,CARTONS.LEAFLETS
ARE IN PIGEON HOLE, ALMIRAH:
5.13 IS DISPENSING AREA PROVIDED WITH DUST

CONTROL PROVISION:
5.14 DESCRIBE THE PRIMARY PACKING MATERIALS
STORAGE AREA:
6. PRODUCTION AREA:
6.1 ARE PRODUCTION AREAS FOR THE
FOLLOWINGS SEPARATED AND SELF CONTAIN.
DESCRIBE THE NATURE OF SEPARATION:
(A) BETA- LACTUM ANTIBIOTICS:
(B) HORMONES/CORTICOSTEROIDS
(C) OTHER DRUGS.
6.2 WHETHER THE ACCESS TO PRODUCTION AREA
RESTRICTED TO AUTHORISED PERSONNEL:
6.3 ARE WALLS, FLOORS AND CEILING SMOOTH AND
FREE FROM CRACKS:
6.4 IS THE PRODUCTION AREA WELL-LIT:
6.5 HOW CROSS CONTAMINATION OF STARTING
MATERIAL OR OF A PRODUCT BY ANOTHER
MATERIAL OR PRODUCT IS PREVENTED:
6.6 IS THE LAY OUT OF MANUFACTURING DIVISION
OF EACH CATEGORY OF DOSAGE FORM IN
LOGICAL SEQUENCE. IF NOT, GIVE DETAILS
WITH REFERENCE TO FLOOR PLAN:
6.7 IS WORKING SPACE ADEQUATE AND ATLEAST
ONE METER PROVIDED AROUND FOR EACH
EQUIPMENT:
6.8 ARE SERVICE LINES, LIGHT FITTINGS
CONCEALED AND FLUSHED TO THE SURFACE
OR MADE ACCESSIBLE FROM OUTSIDE. LOOK
FOR PROTRUDING SURFACE AND SPECIFY:
6.9 ARE DRAINE PROVIDED WITH TRAPS TO AVOID
BACK FLOW
6.10 ARE DRAINS CLEANED AND DISINFECTED
PERIODICALLY. CHECK RECORDS:
6.11 IS PRODUCTION AREA PROVIDED WITH PROPER
VENTILATION WITH AIRCONTROL FACILITIES
(FILTRATION, TEMPERATURE AND
HUMIDITY).ARE RECORDS MAINTAINED

THEREOF.
6.12 ARE LOCKERS PROVIDED FOR STORAGE OF
TOOLS AND PARTS:
6.13 ARE PACKAGING AND VISUAL INSPECTION
AREAS DESIGNED TO FACILITATE SEGREGATION
FOR EACH WORK LINE:
6.14 ARE EQUIPMENTS:
(A) LOCATED IN LOGICAL SEQUENCE (GIVE
BRIEF DESCRIPTION):
(B) DESIGNED, CONSTRUCTED TO SUIT THE
PURPOSE:
(C) PERMIT EFFECTIVE CLEANING:
(D) CLEANED BETWEEN BATCH OPERATION
AND RECORDED.CHECK RECORDS:
(E) CALLED TO INDICATE THEIR STATUS:
6.15 ARE SERVICE LINES PAINTED TO INDICATE THE
CONTENTS AND FLOW. RECORDS THE ORDER
SCHEME:
6.16 ARE BALANCES AND MEASURING EQUIPMENTS
CALIBRATED PERIODICALLY.CHECK RECORDS
AND PERIODICITY:
6.17 ARE WEIGHING EQUIPMENTS AND MEASURING
EQUIPMENTS OF APPROPRIATE RANGE AND
PRECISION AVAILABLE. CHECK CAPACITY OF
THE EQUIPMENT VIS-À-VIS BATCH SIZES OF
PRODUCTION:
6.18 CHECK THE TYPE OF WASHING AND CLEANING
EQUIPMENTS IN PRODUCTION AREA.(PARTICLE
GENERATING EQUIPMENTS SHOULD NOT BE
USED):
6.19 HOW DEFECTIVE EQUIPMENTS ARE
SEGREGATED:
7. MATERIALS:
7.1 IS SEGREGATION IS LOTWISE AND STOCK
ROTATION BY FIFO ADOPTED:
7.2 DOES PURCHASE DEPARTMENT STAFF
KNOWLEDGEABLE ABOUT THE PRODUCTS AND
MATERIALS:
7.3 HOW SUPPLIERS ARE SELECTED:
7.4 ARE SUPPLIERS EVALUATED AND APPROVED
AND THEIR NAME INCLUDED IN SPECIFICATION:

7.5 ARE PURCHASES MADE DIRECTLY FROM
PRODUCERS:
7.6 ARE MATERIALS CHECKED FOR INTEGRITY AND
CONFORMITY WITH ORDER ON RECEIPT:
7.7 IS DAMAGE RECORDED AND REPORTED TO
QUALITY CONTROL:
7.8 DO THE LABELS SHOW B.NO, NAME, C.R.NO. ,
STATUS,EXPIRY DATE , RETEST DATE
ETC.(COLLECT) SAMPLE OF INHOUSE LABELS):
7.9 IS COLOUR CODING SYSTEM USED TO INDICATE
STATUS:
7.10 ARE SAMPLE CONTAINERS IDENTIFIED AND
RELEASED:
7.11 ARE WRITTEN PRODUCERS FOR SAMPLING AND
DISPENSING AVAILABLE. COMPARE SOPs WITH
ACTUAL PRACTICE:
7.12 IS SAMPLING AND DISPENSING DONE BY
DESIGNATED PERSONS:
7.13 IS EACH DISPENSING CHECKED AND
RECORDED.
7.14 IS ADEQUATE STORAGE AREA FOR FINISHED
GOODS PROVIDED:
7.15 IS ADEQUATE AREA FOR RECALLED/RETURNED
PRODUCTS PROVIDED:
7.16 ARE PACKING MATERIALS CHECKED ON
DELIVERY AND ASSIGNED A SPECIFIC
REFERENCE NUMBER:
7.17 HOW THE WASTE MATERIALS FROM
STORE,PRODUCTION, QUALITYCONTROL
DISPOSED OFF:
7.18 IS THERE ACCUMULATION OF WASTE MATERIAL
AT ANY PART OF THE STORAGE/
PRODUCTION/Q.C.AREA:
8. DOCUMENTATION:
8.1 ARE ALL DOCUMENTS PREPARED AND
REVIEWED BY COMPETENT PERSONNEL
APPROVED AND SIGNED BY AUTHORISED
PERSONNEL:
8.2 ARE ALL DOCUMENTS PERIODICALLY REVISED:
8.3 ARE THE DOCUMENTS UNAMBIGUOUS CLEAR
EASY FOR REPRODUCTION AND EASY TO
CHECK:

8.4 IS THERE ANY ALTERATIONS, IN ENTRY MADE. IF
YES, ARE ALTERATIONS CLEAR, LEGIBLE AND
INITIALLED(OVER WRITING IS NOT PERMITTED):
8.5 ARE THE FOLLOWING DOCUMENTS AVAILABLE
WITH NECESSARY DETAILS:
(A) TESTING PROCEDURES FOR STARTING
MATERIALS, INTERMEDIATE PRODUCTS
AND FINISHED PRODUCTS,PACKING
MATERIALS:
(B) VALIDATION OF TESTING PROCEDURE:
(C) MASTER FORMULA CARD(COLLECT
SPECIMEN):
(D) PACKAGING INSTRUCTION (COLLECT
SPECIMEN):
(E) BATCH PROCESSING CARDS INCLUDING
INPROCESS CONTROLS.(COLLECT
SPECIMEN):
(F) BATCH PACKAGING CARD (COLLECT
SPECIMEN):
(G) REFERENCE STANDARDS:
(H) DISPOSAL RECORD OF OUTDATED
PRIMARY AND PRINTED PACKING
MATERIALS:
(I) RELEASE RECORDS:
(J) DISTRIBUTION RECORDS.(WITH WHAT
LEVEL):
(K) COMPARE MASTER FORMULA CARD WITH

ACTUAL PRACTICE:
8.6 ARE ALL RECORDS AND ASSOCIATED SOPs
RETAINED UPTO ONE YEAR AFTER EXPIRY OF
FINISHED PRODUCT:
8.7 ARE STANDARD OPERATING PROCEDURES FOR
THE FOLLOWING OPERATIONS AVAILABLE:
(A) RECEIPT MATERIALS:
(B) ENVIRONMENTAL MONITORING:
(C) INTERNAL LABELLING , QUARANTINE AND
STORAGE OF MATERIALS:
(D) EACH INSTRUMENT AND EQUIPMENT IN
THEIR PREXIMITY:
(E) EQUIPMENT ASSEMBLY AND VALIDATION:
(F) SAMPLING(RAW MATERIALS AND FINISHED
PRODUCTS):
(G) DISPENSING (RAW MATERIALS AND
PACKING MATERIALS):
(H) BATCH NUMBERING SYSTEM:
(I) RELEASE OR REJECTION:
(J) LOG BOOK FOR EACH EQUOPMENT AND
INSTRUMENT:
(K) SANITATION AND CLEANING OF PREMISES
AND EQUIPMENT:
(L) SANITATION OF PIPES CARRYING
DISTILLED/DEIONISED WATER:

(M)RECOVERY FROM REJECTED PRODUCTS:
(N) DISPOSAL/REUSE OF RETURNED GOODS:
(O) PEST CONTROL:
(P) ANALYTICAL APPARATUS AND
CALIBRATION:
(Q) COMPLAINTS,RECALLS AND RETURNS:
(R) COMPARE SOPs WITH ACTUAL PRACTICE:
9. PRODUCTION:
9.1 IS THERE ANY DEVIATION FROM SOPs
MANUFACTURING PROCEDURES:
9.2 IS YIELD CHECKED AT EACH STAGE:
9.3 IS MORE THAN ONE PRODUCT PROCESSED IN
THE SAME ROOM:
9.4 ARE EQUIPMENTS AND ROOMS LABELLED TO
INDICATE THE OPERATION IN PROGRESS:
9.5 IS ANY NON MEDICAL PRODUCT PRODUCED.
SPECIFY THE DETAILS:
9.6 IS THERE PROVISION FOR INPROCESS
CONTROLS IN THE PRODUCTION AREA(MUST
NOT EFFECT THE QUALITY OF THE PRIODUCTS
MANUFACTURED):
9.7 IS THERE PROVISION FOR DUST COLLECTION
WHERE DRY MATERIALS ARE HANDLED:
9.8 IS PERIODICAL MICROBIAL MONITORING OF
PRODUCTION AREAS OF SUCEPTIBLE PRODUCTS
CONDUCTED:
9.9 WAS THE AREA BEING CLEANED BEFORE
STARTING EVERY BATCH:
9.10 ARE PIPES CARRYING DISTILLED/DEIONISED
WATER SANITIZED ACCORDING TO PROCEDURE
WHICH INDICATE LIMITS FOR MICROBIAL
CONTAMINATION AND MEASURES TO BE TAKEN:
9.11 WAS ANY BATCH REPROCESSED FROM

REJECTED PRODUCTS:
9.12 WAS ANY BATCH RETURNED HAS BEEN
CONVERTED FOR RESALE , RELABELLING OR
BULKING:
10. PACKAGING:
10.1 IS THERE ADEQUATE SEPARATION OF PACKING
LINES TO PREVENT ANY MIX-UP:
10.2 IS EACH PACKAGING LINE IDENTIFIED WITH
PRODUCT NAME, BATCH NO. AND PACKAGING
SIZE:
10.3 IS ONLY ONE PRODUCT, BATCH AND PACKAGING
SIZE ON A LINE AT ANY GIVEN TIME:
10.4 IS LINE CLEARED BEFORE EACH BATCH
OPERATION,CERTIFIED AND RECORDED:
10.5 DOES PACKING QUICKLY FOLLOWS THE FILLING
AND SEALING:
10.6 ARE ALL CODED PACKING MATERIALS VERIFIED
BEFORE USE.
10.7 IS RECONCILATION OF PACKING MATERIALS
USED VIS-À-VIS PRODUCT RECORDED:
10.8 IS ON LINE COTROL PROCEDURE DURING
PACKING AVAILABLE:
11. QUALITY CONTROL:
11.1 HOW FAR THE HEAD OF QUALITY CONTROL
AND PRODUCTION ARE INDEPENDENT OF EACH
OTHER:
11.2 ARE ALL THE PROCEDURES OF
DOCUMEBNTED:
11.3 IS SAMPLING PROCEDURE ADEQUATE:
11.4 DO THE LABEL ON SAMPLE CONTAINER, SHOW
BATCH NO. , NAME,CONTAINER NO., DATE OF
SAMPLING AND PERSON WHO SAMPLED:
11.5 IS IDENTIFY TEST DONE ON EACH CONTAINER
OF STARTING MATERIALS:
11.6 ARE ANALYTICAL RECORDS OF EACH BATCH
OF THE RAW MATERIALS,INTERMEDIATES AND
FINISHED PRODUCTS AVAILABLE WITH WORK
SHEETS:
11.7 ARE PRODUCTION RECORDS REVIEWED:
11.8 ARE ALL RETENTION SAMPLES KEPT FOR ONE
YEAR AFTER EXPIRY DATE AND OTHER

STARTING MATERIALS FOR A MINIMUM OF TWO
YEARS:
11.9 IS PROGRAMME FOR STABILITY TESTING OF
STARTING MATERIALS AND FINISHED
PRODUCTS AVAILABLE:
11.10 IS STABILITY TESTING CONDUCTED PRIOR TO
MARKETING AND AFTER CHANGE OF PROCESS
EQUIPMENT,PACKING MATERIALS:
11.11 IS QUALITY CONTROL LAB SEPARATE FROM
PRODUCTION AREA:
11.12 ARE BIOLOGICAL AND MICROBIOLOGICAL
TESTING AREAS SEPARATE FROM EACH
OTHER,AND DO THEY HAVE SEPARATE AIR
HANDLING FACILITIES:
11.13 IS INSTRUMENT ROOM SEPARATE:
11.14 IS DESIGN OF LAB SUITABLE WITH ADEQUATE
SPACE,VENTILATION AND FOR PREVENTION OF
FUMES:
11.15 ARE RECORDS OF SERVICE AND CALIBRATION
OF INSTRUMENT AVAILABLE:
11.16 ARE APPROPRIATE SAMPLING EQUIPMENT
AVAILABLE AND STARTED SEPARATELY:
11.17 ARE INSTRUMENTS CHECKED DAILY OR PRIOR
TO USE:
11.18 ARE DATE OF CALIBRATION , SERVICE ,AND
DATE WHEN RECALIBRATION DUE INDICATED:
11.19 ARE THE REAGENTS PREPARED ACCORDING
TO WRITTEN PROCEDURES AND LABELLED
APPROPRIATELY:
11.20 ARE REFERENCE STANDARDS AVAILABLE
CORRESPOND TO THE MATERIALS ANALYSED:
11.21 IS ADEQUATE STORAGE SPACE (IF NECESSARY
WITH COOLING) AND RECORDS ARE AVAILABLE
FOR REFERENCE STANDARDS AND
REFERENCE SAMPLES. CHECK THE MODE OF
STORAGE OF REFERENCE STANDARDS:
11.22 ARE WORKING STANDARDS CHECKED AT
REGULAR INTERVALS:
11.23 ARE THE LABELS OF REF. STANDARDS
INDICATE NAME, DATE OF MFG. DATE OF
EXPIRY,CONCENTRATION AND DATE OF
CLOSURE IS FIRST OPENED AND STORAGE
CONDITIONS:

11.24 ARE THE LABEL OF REAGENTS PREPARED
SHOW CONCENTRATION , STANDARDISATION
FACTOR, SELF- LIFE,STANDARDISATION DATE
,STORAGE CONDITION AND SIGNATURE OF THE
PERSON PREPARES THE REAGENTS:
11.25 ARE POSITIVE AND NEGATIVE CONTROLS USED
TO TEST SUITABILITY OF CULTURE MEDIA:
11.26 ARE STABILITY STUDIES CONDUCTED BEFORE
ASSIGNING SHELF LIFE AND IS IT PERIODICALL
REVIEWED, AND GIVE DETAILS:
12. SELF INSPECTION:
GIVE DETAILS OF NAMES,
QUALIFICATION AND BACKGROUND
OF THE MEMBERS OF SELF
INSPECTION TEAM:
12.1 INTERVAL PERIOD BETWEEN SELF
INSPECTIONS:
12.2 DOES SELF INSPECTION REPORT CONTAINS
COMMENTS ON:
(A) PERSONNEL:
(B) PREMISES:
(C) MAINTENANCE OF BUILDING AND
EQUIPMENT:
(D) STORAGE:
(E) EQUIPMENT:
(F) PRODUCTION AND INPROCESS
CONTROL:
(G)QUALITY CONTROL:
(H) DOCUMENTATION:

(I) SANITATION AND HYGIENE:
(J) VALIDATION PROCEDURE /
PROGRAMMES:
(K) CALIBRATION OF INSTRUMENTS:
(L) RECALL PROCEDURES:
(M)LABELS CONTROL:
(N) COMPLAINTS:
(O)CORRECTIVE ACTION ON PREVIOUS
REPORTS:
13 RECALL PROCEDURE :
EXPLAIN PROCEDURE ADOPTED FOR RECALL
OF PRODUCTS:
14 QUALITY AUDIT SYSTEM :
(BRIEF RESPONSIBILITIES
REMARKS:
1.1 IS ORGANISATION CHART
AVAILABLE:
1.2 ARE NO. OF PERSONNEL
ADEQUATE:
1.3 NAME ,QUALIFICATION AND
EXPERIENCE OF KEY
PERSONNEL(CHECK WITH SMF):
1.4 IS QUALIFICATION AND
EXPERIENCE OF PERSONNEL
COMMENSURATE WITH JOB
DESCRIPTION:
1.5 IS MANAGERIAL
RESPONCIBILITIES OF EACH

TECHNICAL PERSONNEL
SPECIFIED IN WRITTING WITH
JOB DESCRIPTION:
1.6 CHECK WHETHER THERE ARE
GAPS OR UNEXPLAINED
OVERLAP OF RESPONSIBILITIES
OF THE CONCERNED
PERSONNEL:
2. TRAINING OF PERSONNEL:
2.1 IS WRITTEN PROGRAMME FOR
TRAINING AVAILABLE:
2.2 ARE ALL PERSONNEL TRAINED
INITIALLY:
2.3 ARE PERIODICAL ASSESMENT
RECORDS AVAILABLE
2.4 IS SPECIAL PROGRAMME
AVAILABLE FOR PERSONNEL
WORKING IN CLEAN AREAS
AND AREAS WHERE HIGHLY
ACTIVE AND TOXIC MATERIAL
& HANDLED:
2.5 IS SOPs FOR TRAINING OF
PERSONNEL AVAILABLE:
3. PERSONNEL HYGIENE OF PERSONNEL:
3.1 ARE ALL PERSONNEL
MEDICALLY EXAMINED PRIOR TO
= AND DURING EMPLOYMENT:
3.2 ARE THEY RESTRICTED , IF
MEDICAL REASONS DICTATE:
3.3 IS SOPs FOR CLOTHING AND
HYGIENE AVAILABLE:
3.4 ARE CLEAN UNIFORMS AND HAIR
COVERING CAPS USED:
3.5 CHECK NO. OF UNIFORMS

PROVIDED. ARE THEY
ADEQUATE:
3.6 WHAT PROTECTIVE CLOTHING
ARE PROVIDED FOR VISITORS /
OUTSIDE PERSONNEL ENTERING
IN PRODUCTION AREAS. ARE
THEY ADEQUATE:
6. PREMISES :
4.1 BRIEF DESCRIPTION OF BUILDING
4.2 IS DESIGNS AND CONSTRUCTED:
4.3 IS THE PREMISES COMPLY WITH SMF
AND SITUATED IN AN ENVIRONMENT
WHICH CAUSED MINIMUM RISK OF
CONTAMINATION TO MATERIALS OR
PRODUCTS:
4.4 IS AREA PROVIDED COMMENSURATE
WITH PRODUCTION:
4.5 ARE NON MEDICAL PRODUCTS
MANUFACTURED IN THE PREMISES. IF
YES, GIVE DETAILS:
4.6 ARE SOPs AVAILABLE FOR
MAINTENANCE, CLEANING AND
SANITATION OF BUILDINGS, PREMISES
AND SURROUNDING
4.7 CHECK WHETHER THE AREA IS CLEANED
AND VALIDATED BEFORE STARTING
STORING /PROCESING /PACKING
OPERATIONS:
4.8 IS ELECTRICAL SUPPLY,
LIGHTING,TEMPERATURE,HUMIDITY,AND
VENTILATION APPROPRIATE:
4.9 ARE ARRANGEMENT MADE FOR
CONTROL OF ENTRY OF RODENTS& BIRD
4.10 ARE FOLLOWING AREAS PROVIDED:
(A) SEPARATE REST ROOMS AND
REFRESHMENT ROOMS:
(B) SEPARATE CHANGING ROOMS
AND TOILETS FOR MALE AND

FEMALE WORKERS:
(C) WORKSHOP IN A SEPARATE
PLACE:
(D) ANIMAL HOUSES WITH
SEPARATE ENTRY AND AIR
HANDLING UNIT:
7. STORAGE AREAS:
5.1 IS AREA SUFFICIENT FOR
ORDERLY STORAGE OF
MATERIALS:
5.2 INDICATE AREAS FOR EACH
CATEGORY AND WHETHER
BARRIERS ARE PROVIDED IF
NOT, EXPLAIN MODE OF
SEGREGATION:
RAW MATERIALS:
QUARANTINE:
APPROVED:
REJECTED:
PACKING MATERIALS:
IS ACCESS TO QUARANTINE
AREA RESTRICTED:
5.4 ARE REJECTED GOODS
MARKED AND STORED
SEPARATELY IN A SECURED
AREA:
5.5 ARE RECORDS FOR ACTION
TAKEN ON REJECTED GOODS
AVAILABLE:
5.6 ARE FACILITIES AVAILABLE
FOR STORAGE IN

CONTROLLED TEMPERATURE/
HUMIDITY:
5.7 IS RECORD OF TEMPERATURE
AND HUMIDITY MAINTAINED:
5.8 ARE RECEIVING BAYS
COVERED
5.9 ARE INCOMING MATERIALS
CLEANED BEFORE ENTRY TO
STORAGE AREA:
5.10 IS SEPARATE SAMPLING AREA
PROVIDED.IF , NOT HOW
CONTAMINATION AND CROSS
CONTAMINATION IS
PREVENTED:
5.11 ARE SENSITIVE MATERIALS/
HORMONES,BLACTUM,
ANTIBIOTICS,
NARCOTICS,INFLAMMABLES,
EXPLOSIVES STORED IN
SECURED AREA:
5.12 ARE PRINTED/CODED
PACKING MATERIALS AND
CUT LABELS STORED IN
SECURED AREA WITH
RESTRICTED ENTRY,AND
WHETHER PACKING
MATERIALS LINE
LABELS,CARTONS.LEAFLETS
ARE IN PIGEON HOLE,
ALMIRAH:
5.13 IS DISPENSING AREA
PROVIDED WITH DUST
CONTROL PROVISION:
5.14 DESCRIBE THE PRIMARY
PACKING MATERIALS
STORAGE AREA:
7. PRODUCTION AREA:

6.1 ARE PRODUCTION AREAS FOR THE
FOLLOWINGS SEPARATED AND SELF
CONTAIN. DESCRIBE THE NATURE OF
SEPARATION:
(D) BETA- LACTUM ANTIBIOTICS:
(E) HORMONES/CORTICOSTEROIDS
(F) OTHER DRUGS.
6.2 WHETHER THE ACCESS TO
PRODUCTION AREA RESTRICTED TO
AUTHORISED PERSONNEL:
6.3 ARE WALLS, FLOORS AND CEILING
SMOOTH AND FREE FROM CRACKS:
6.4 IS THE PRODUCTION AREA WELL-LIT:
6.5 HOW CROSS CONTAMINATION
OF STARTING MATERIAL OR
OF A PRODUCT BY ANOTHER
MATERIAL OR PRODUCT IS
PREVENTED:
6.6 IS THE LAY OUT OF
MANUFACTURING DIVISION
OF EACH CATEGORY OF
DOSAGE FORM IN LOGICAL
SEQUENCE. IF NOT, GIVE
DETAILS WITH REFERENCE TO
FLOOR PLAN:
6.7 IS WORKING SPACE
ADEQUATE AND ATLEAST
ONE METER PROVIDED
AROUND FOR EACH
EQUIPMENT:
6.8 ARE SERVICE LINES, LIGHT
FITTINGS CONCEALED AND
FLUSHED TO THE SURFACE OR
MADE ACCESSIBLE FROM
OUTSIDE. LOOK FOR
PROTRUDING SURFACE AND
SPECIFY:
6.9 ARE DRAINE PROVIDED WITH

TRAPS TO AVOID BACK FLOW
6.10 ARE DRAINS CLEANED AND
DISINFECTED PERIODICALLY.
CHECK RECORDS:
6.11 IS PRODUCTION AREA
PROVIDED WITH PROPER
VENTILATION WITH
AIRCONTROL FACILITIES
(FILTRATION, TEMPERATURE
AND HUMIDITY).ARE
RECORDS MAINTAINED
THEREOF.
6.12 ARE LOCKERS PROVIDED FOR
STORAGE OF TOOLS AND
PARTS:
6.13 ARE PACKAGING AND VISUAL
INSPECTION AREAS DESIGNED
TO FACILITATE SEGREGATION
FOR EACH WORK LINE:
6.14 ARE EQUIPMENTS:
(F) LOCATED IN LOGICAL
SEQUENCE (GIVE BRIEF
DESCRIPTION):
(G) DESIGNED,
CONSTRUCTED TO SUIT
THE PURPOSE:
(H) PERMIT EFFECTIVE
CLEANING:
(I) CLEANED BETWEEN
BATCH OPERATION AND
RECORDED.CHECK
RECORDS:
(J) CALLED TO INDICATE
THEIR STATUS:
6.15 ARE SERVICE LINES PAINTED
TO INDICATE THE CONTENTS
AND FLOW. RECORDS THE
ORDER SCHEME:
6.16 ARE BALANCES AND

MEASURING EQUIPMENTS
CALIBRATED
PERIODICALLY.CHECK
RECORDS AND PERIODICITY:
6.17 ARE WEIGHING EQUIPMENTS
AND MEASURING
EQUIPMENTS OF APPROPRIATE
RANGE AND PRECISION
AVAILABLE. CHECK
CAPACITY OF THE EQUIPMENT
VIS-À-VIS BATCH SIZES OF
PRODUCTION:
6.18 CHECK THE TYPE OF WASHING
AND CLEANING EQUIPMENTS
IN PRODUCTION
AREA.(PARTICLE GENERATING
EQUIPMENTS SHOULD NOT BE
USED):
6.19 HOW DEFECTIVE EQUIPMENTS
ARE SEGREGATED:
8. MATERIALS:
7.1 IS SEGREGATION IS LOTWISE
AND STOCK ROTATION BY
FIFO ADOPTED:
7.2 DOES PURCHASE
DEPARTMENT STAFF
KNOWLEDGEABLE ABOUT
THE PRODUCTS AND
MATERIALS:
7.3 HOW SUPPLIERS ARE
SELECTED:
7.4 ARE SUPPLIERS EVALUATED
AND APPROVED AND THEIR
NAME INCLUDED IN
SPECIFICATION:
7.5 ARE PURCHASES MADE
DIRECTLY FROM PRODUCERS:
7.6 ARE MATERIALS CHECKED
FOR INTEGRITY AND
CONFORMITY WITH ORDER ON
RECEIPT:

7.7 IS DAMAGE RECORDED AND
REPORTED TO QUALITY
CONTROL:
7.8 DO THE LABELS SHOW B.NO,
NAME, C.R.NO. ,
STATUS,EXPIRY DATE ,
RETEST DATE ETC.(COLLECT)
SAMPLE OF INHOUSE LABELS):
7.9 IS COLOUR CODING SYSTEM
USED TO INDICATE STATUS:
7.10 ARE SAMPLE CONTAINERS
IDENTIFIED AND RELEASED:
7.11 ARE WRITTEN PRODUCERS
FOR SAMPLING AND
DISPENSING AVAILABLE.
COMPARE SOPs WITH ACTUAL
PRACTICE:
7.12 IS SAMPLING AND DISPENSING
DONE BY DESIGNATED
PERSONS:
7.13 IS EACH DISPENSING
CHECKED AND RECORDED.
7.14 IS ADEQUATE STORAGE AREA
FOR FINISHED GOODS
PROVIDED:
7.15 IS ADEQUATE AREA FOR
RECALLED/RETURNED
PRODUCTS PROVIDED:
7.16 ARE PACKING MATERIALS
CHECKED ON DELIVERY AND
ASSIGNED A SPECIFIC
REFERENCE NUMBER:
7.17 HOW THE WASTE MATERIALS
FROM STORE,PRODUCTION,
QUALITYCONTROL DISPOSED
OFF:
7.18 IS THERE ACCUMULATION OF
WASTE MATERIAL AT ANY
PART OF THE STORAGE/
PRODUCTION/Q.C.AREA:

9. DOCUMENTATION:
8.1 ARE ALL DOCUMENTS
PREPARED AND REVIEWED BY
COMPETENT PERSONNEL
APPROVED AND SIGNED BY
AUTHORISED PERSONNEL:
8.2 ARE ALL DOCUMENTS
PERIODICALLY REVISED:
8.3 ARE THE DOCUMENTS
UNAMBIGUOUS CLEAR EASY
FOR REPRODUCTION AND
EASY TO CHECK:
8.4 IS THERE ANY ALTERATIONS,
IN ENTRY MADE. IF YES, ARE
ALTERATIONS CLEAR,
LEGIBLE AND
INITIALLED(OVER WRITING IS
NOT PERMITTED):
8.5 ARE THE FOLLOWING
DOCUMENTS AVAILABLE WITH
NECESSARY DETAILS:
(L) TESTING PROCEDURES
FOR STARTING
MATERIALS,
INTERMEDIATE PRODUCTS
AND FINISHED
PRODUCTS,PACKING
MATERIALS:
(M)VALIDATION OF TESTING
PROCEDURE:
(N) MASTER FORMULA
CARD(COLLECT
SPECIMEN):
(O) PACKAGING INSTRUCTION
(COLLECT SPECIMEN):

(P) BATCH PROCESSING
CARDS INCLUDING
INPROCESS
CONTROLS.(COLLECT
SPECIMEN):
(Q) BATCH PACKAGING CARD
(COLLECT SPECIMEN):
(R) REFERENCE STANDARDS:
(S) DISPOSAL RECORD OF
OUTDATED PRIMARY AND
PRINTED PACKING
MATERIALS:
(T) RELEASE RECORDS:
(U) DISTRIBUTION
RECORDS.(WITH WHAT
LEVEL):
(V) COMPARE MASTER
FORMULA CARD WITH
ACTUAL PRACTICE:
8.6 ARE ALL RECORDS AND
ASSOCIATED SOPs RETAINED
UPTO ONE YEAR AFTER EXPIRY
OF FINISHED PRODUCT:
8.7 ARE STANDARD OPERATING
PROCEDURES FOR THE
FOLLOWING OPERATIONS
AVAILABLE:
(S) RECEIPT MATERIALS:
(T) ENVIRONMENTAL
MONITORING:

(U) INTERNAL LABELLING ,
QUARANTINE AND
STORAGE OF MATERIALS:
(V) EACH INSTRUMENT AND
EQUIPMENT IN THEIR
PREXIMITY:
(W)EQUIPMENT ASSEMBLY
AND VALIDATION:
(X) SAMPLING(RAW
MATERIALS AND FINISHED
PRODUCTS):
(Y) DISPENSING (RAW
MATERIALS AND PACKING
MATERIALS):
(Z) BATCH NUMBERING
SYSTEM:
(AA)RELEASE OR REJECTION:
(BB)LOG BOOK FOR EACH
EQUOPMENT AND
INSTRUMENT:
(CC)SANITATION AND
CLEANING OF PREMISES
AND EQUIPMENT:
(DD)SANITATION OF PIPES
CARRYING
DISTILLED/DEIONISED
WATER:

(EE)RECOVERY FROM
REJECTED PRODUCTS:
(FF)DISPOSAL/REUSE OF
RETURNED GOODS:
(GG)PEST CONTROL:
(HH)ANALYTICAL APPARATUS
AND CALIBRATION:
(II) COMPLAINTS,RECALLS
AND RETURNS:
(JJ) COMPARE SOPs WITH
ACTUAL PRACTICE:
11. PRODUCTION:
9.1 IS THERE ANY DEVIATION
FROM SOPs MANUFACTURING
PROCEDURES:
9.2 IS YIELD CHECKED AT EACH
STAGE:
9.3 IS MORE THAN ONE PRODUCT
PROCESSED IN THE SAME
ROOM:
9.4 ARE EQUIPMENTS AND ROOMS
LABELLED TO INDICATE THE
OPERATION IN PROGRESS:
9.5 IS ANY NON MEDICAL
PRODUCT PRODUCED. SPECIFY
THE DETAILS:
9.6 IS THERE PROVISION FOR
INPROCESS CONTROLS IN THE
PRODUCTION AREA(MUST NOT
EFFECT THE QUALITY OF THE
PRIODUCTS MANUFACTURED):
9.7 IS THERE PROVISION FOR

DUST COLLECTION WHERE
DRY MATERIALS ARE
HANDLED:
9.8 IS PERIODICAL MICROBIAL
MONITORING OF PRODUCTION
AREAS OF SUCEPTIBLE
PRODUCTS CONDUCTED:
9.9 WAS THE AREA BEING
CLEANED BEFORE STARTING
EVERY BATCH:
9.10 ARE PIPES CARRYING
DISTILLED/DEIONISED WATER
SANITIZED ACCORDING TO
PROCEDURE WHICH INDICATE
LIMITS FOR MICROBIAL
CONTAMINATION AND
MEASURES TO BE TAKEN:
9.11 WAS ANY BATCH
REPROCESSED FROM
REJECTED PRODUCTS:
9.12 WAS ANY BATCH RETURNED
HAS BEEN CONVERTED FOR
RESALE , RELABELLING OR
BULKING:
12. PACKAGING:
10.1 IS THERE ADEQUATE
SEPARATION OF PACKING
LINES TO PREVENT ANY MIX-
UP:
10.2 IS EACH PACKAGING LINE
IDENTIFIED WITH PRODUCT
NAME, BATCH NO. AND
PACKAGING SIZE:
10.3 IS ONLY ONE PRODUCT,
BATCH AND PACKAGING SIZE
ON A LINE AT ANY GIVEN
TIME:
10.4 IS LINE CLEARED BEFORE
EACH BATCH
OPERATION,CERTIFIED AND
RECORDED:
10.5 DOES PACKING QUICKLY

FOLLOWS THE FILLING AND
SEALING:
10.6 ARE ALL CODED PACKING
MATERIALS VERIFIED BEFORE
USE.
10.7 IS RECONCILATION OF
PACKING MATERIALS USED
VIS-À-VIS PRODUCT
RECORDED:
10.8 IS ON LINE COTROL
PROCEDURE DURING PACKING
AVAILABLE:
13. QUALITY CONTROL:
11.1 HOW FAR THE HEAD OF
QUALITY CONTROL AND
PRODUCTION ARE
INDEPENDENT OF EACH OTHER:
11.2 ARE ALL THE PROCEDURES OF
DOCUMEBNTED:
11.3 IS SAMPLING PROCEDURE
ADEQUATE:
11.4 DO THE LABEL ON SAMPLE
CONTAINER, SHOW BATCH NO. ,
NAME,CONTAINER NO., DATE
OF SAMPLING AND PERSON
WHO SAMPLED:
11.5 IS IDENTIFY TEST DONE ON
EACH CONTAINER OF STARTING
MATERIALS:
11.6 ARE ANALYTICAL RECORDS OF
EACH BATCH OF THE RAW
MATERIALS,INTERMEDIATES
AND FINISHED PRODUCTS
AVAILABLE WITH WORK
SHEETS:
11.7 ARE PRODUCTION RECORDS
REVIEWED:
11.8 ARE ALL RETENTION SAMPLES
KEPT FOR ONE YEAR AFTER
EXPIRY DATE AND OTHER

STARTING MATERIALS FOR A
MINIMUM OF TWO YEARS:
11.9 IS PROGRAMME FOR STABILITY
TESTING OF STARTING
MATERIALS AND FINISHED
PRODUCTS AVAILABLE:
11.10 IS STABILITY TESTING
CONDUCTED PRIOR TO
MARKETING AND AFTER
CHANGE OF PROCESS
EQUIPMENT,PACKING
MATERIALS:
11.11 IS QUALITY CONTROL LAB
SEPARATE FROM PRODUCTION
AREA:
11.12 ARE BIOLOGICAL AND
MICROBIOLOGICAL TESTING
AREAS SEPARATE FROM EACH
OTHER,AND DO THEY HAVE
SEPARATE AIR HANDLING
FACILITIES:
11.13 IS INSTRUMENT ROOM
SEPARATE:
11.14 IS DESIGN OF LAB SUITABLE
WITH ADEQUATE
SPACE,VENTILATION AND FOR
PREVENTION OF FUMES:
11.15 ARE RECORDS OF SERVICE AND
CALIBRATION OF INSTRUMENT
AVAILABLE:
11.16 ARE APPROPRIATE SAMPLING
EQUIPMENT AVAILABLE AND
STARTED SEPARATELY:
11.17 ARE INSTRUMENTS CHECKED
DAILY OR PRIOR TO USE:
11.18 ARE DATE OF CALIBRATION ,
SERVICE ,AND DATE WHEN
RECALIBRATION DUE
INDICATED:
11.19 ARE THE REAGENTS PREPARED
ACCORDING TO WRITTEN
PROCEDURES AND LABELLED
APPROPRIATELY:

11.20 ARE REFERENCE STANDARDS
AVAILABLE CORRESPOND TO
THE MATERIALS ANALYSED:
11.21 IS ADEQUATE STORAGE SPACE
(IF NECESSARY WITH COOLING)
AND RECORDS ARE AVAILABLE
FOR REFERENCE STANDARDS
AND REFERENCE SAMPLES.
CHECK THE MODE OF STORAGE
OF REFERENCE STANDARDS:
11.22 ARE WORKING STANDARDS
CHECKED AT REGULAR
INTERVALS:
11.23 ARE THE LABELS OF REF.
STANDARDS INDICATE NAME,
DATE OF MFG. DATE OF
EXPIRY,CONCENTRATION AND
DATE OF CLOSURE IS FIRST
OPENED AND STORAGE
CONDITIONS:
11.24 ARE THE LABEL OF REAGENTS
PREPARED SHOW
CONCENTRATION ,
STANDARDISATION FACTOR,
SELF- LIFE,STANDARDISATION
DATE ,STORAGE CONDITION
AND SIGNATURE OF THE
PERSON PREPARES THE
REAGENTS:
11.25 ARE POSITIVE AND NEGATIVE
CONTROLS USED TO TEST
SUITABILITY OF CULTURE
MEDIA:
11.26 ARE STABILITY STUDIES
CONDUCTED BEFORE
ASSIGNING SHELF LIFE AND IS
IT PERIODICALL REVIEWED,
AND GIVE DETAILS:
14. SELF INSPECTION:

GIVE DETAILS OF NAMES,
QUALIFICATION AND BACKGROUND
OF THE MEMBERS OF SELF
INSPECTION TEAM:
12.1 INTERVAL PERIOD BETWEEN
SELF INSPECTIONS:
12.2 DOES SELF INSPECTION REPORT
CONTAINS COMMENTS ON:
(P) PERSONNEL:
(Q) PREMISES:
(R) MAINTENANCE OF
BUILDING AND
EQUIPMENT:
(S) STORAGE:
(T) EQUIPMENT:
(U) PRODUCTION AND
INPROCESS CONTROL:
(V) QUALITY CONTROL:
(W)DOCUMENTATION:
(X) SANITATION AND
HYGIENE:
(Y) VALIDATION PROCEDURE
/ PROGRAMMES:
(Z) CALIBRATION OF
INSTRUMENTS:

(AA)RECALL PROCEDURES:
(BB)LABELS CONTROL:
(CC)COMPLAINTS:
(DD)CORRECTIVE ACTION
ON PREVIOUS REPORTS:
13. RECALL PROCEDURE :
EXPLAIN PROCEDURE ADOPTED FOR
RECALL OF PRODUCTS:
14. QUALITY AUDIT SYSTEM :
(BRIEF RESPONSIBILITIES)

REMARKS:

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