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 MANUFACTUREDAND PRODUCTION CAPACITY:

DETAILS OF EXPORT, IF UNDERTAKENALREADY:

TECHNICAL PERSONNEL:

MANUFACTURING:

QUALITY CONTROL:

PRODUCTS TO BE CERTIFIED:

PRODUCTS LICENSED:

WHETHER SITEMASTER FILE SUBMITTEDIF YES, COMMENTS OF INSPECTINGOFFICER 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

AVAILABLE2.4 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 BUILDING4.2 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 COVERED5.9 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 SELFINSPECTION 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 BUILDING4.2 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 FLOW6.10 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 SELFINSPECTION 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:

gmp checklist

Education

personnel hygiene of

personnel adequate

secured area

technical personnel

personnel working

area sufficient

dispensing area

authorised personnel