© 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.
© 2007 Center for Pharmaceutical Learning

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:
© 2007 Center for Pharmaceutical Learning

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

© 2007 Center for Pharmaceutical Learning

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
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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
© 2007 Center for Pharmaceutical Learning

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:
© 2007 Center for Pharmaceutical Learning

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:
© 2007 Center for Pharmaceutical Learning

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

© 2007 Center for Pharmaceutical Learning

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:
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(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
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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
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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:
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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:
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(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
© 2007 Center for Pharmaceutical Learning

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
© 2007 Center for Pharmaceutical Learning

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
© 2007 Center for Pharmaceutical Learning

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
© 2007 Center for Pharmaceutical Learning

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:
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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

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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
© 2007 Center for Pharmaceutical Learning

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:
© 2007 Center for Pharmaceutical Learning

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:
© 2007 Center for Pharmaceutical Learning

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):
© 2007 Center for Pharmaceutical Learning

(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:
© 2007 Center for Pharmaceutical Learning

(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:
© 2007 Center for Pharmaceutical Learning

(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
© 2007 Center for Pharmaceutical Learning

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
© 2007 Center for Pharmaceutical Learning

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
© 2007 Center for Pharmaceutical Learning

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:
© 2007 Center for Pharmaceutical Learning

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:

© 2007 Center for Pharmaceutical Learning

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:
© 2007 Center for Pharmaceutical Learning

(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)
© 2007 Center for Pharmaceutical Learning

REMARKS: