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© 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.
© 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
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:
© 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 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
© 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 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
© 2007 Center for Pharmaceutical Learning
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:
© 2007 Center for Pharmaceutical Learning
(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
© 2007 Center for Pharmaceutical Learning
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
© 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:
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:
© 2007 Center for Pharmaceutical Learning
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:
© 2007 Center for Pharmaceutical Learning
(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 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
© 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 :
© 2007 Center for Pharmaceutical Learning
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
© 2007 Center for Pharmaceutical Learning
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
© 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:
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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):
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(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:
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(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:
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(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
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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
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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
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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:
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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:
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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:
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(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)
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REMARKS: