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Gmp checklist

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Gmp checklist

  1. 1. © 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.
  2. 2. © 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:
  3. 3. © 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
  4. 4. © 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
  5. 5. © 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
  6. 6. © 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:
  7. 7. © 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:
  8. 8. © 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
  9. 9. © 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:
  10. 10. © 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
  11. 11. © 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
  12. 12. © 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:
  13. 13. © 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 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:
  14. 14. © 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
  15. 15. © 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
  16. 16. © 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
  17. 17. © 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
  18. 18. © 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:
  19. 19. © 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
  20. 20. © 2007 Center for Pharmaceutical Learning 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
  21. 21. © 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:
  22. 22. © 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:
  23. 23. © 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):
  24. 24. © 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:
  25. 25. © 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:
  26. 26. © 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
  27. 27. © 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
  28. 28. © 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
  29. 29. © 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:
  30. 30. © 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:
  31. 31. © 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:
  32. 32. © 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)
  33. 33. © 2007 Center for Pharmaceutical Learning REMARKS:

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