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Six system inspection model
- 1. INSTITUTE OF PHARMACEUTICAL SCIENCE KURUKSHETRAUNIVERSITY SUBMITTED TO : MRS.ANJU GOYAL SUBMITTED BY: JYOTI (PROFESSOR). M PHARMA 1 SEM ( QA)
- 2. SIX SYSTEM INSPECTIONMODEL • HELP PHARMACEUTICAL MANUFACTURERS TO FOLLOW CGMP GUIDELINES. • THE SIX SYSTEM INSPECTION MODEL ARE AS QUALITY, PRODUCTION, FACILITIES, EQUIPMENT, LABORATORY CONTROLS, MATERIALS & PACKAGING & LABELLING • APPROACH OF SIX SYSTEM • ASSURE BEST QUALITY SYSTEM MODEL FOR PHARMACEUTICAL PRODUCTS. • ASSURES MORE UNDERSTANDING OF WHOLE OPERATION LEADING TO A MORE POWERFUL SYSTEM WITH CGMP GUIDELINES. • HIGHLIGHT MODEL’S CONSISTENCY WITH CGMP REGULATORY REQUIREMENTS FOR MANUFACTURING HUMAN & VETERINARY DRUGS.
- 3. QUALITY MANAGEMENT SYSTEM •IT IS A SYSTEM IN WHICH DOCUMENTS PROCESSES PROCEDURES, & RESPONSIBILITY FOR ATTAINING APPROACHES & GOALS • LEADERSHIP • HELP TO COMMUNICATE ORGANIZATION ‘S ACTIVITIES. • HELP TO MEET CUSTOMER & REGULATORY REQUIREMENTS. • KEY COMPONENTS OF QMS • QUALITY MEANS EXCELLENCE OF ANYTHING.
- 4. • PLANNING • MAINTAINCUSTOMER CONNECTION. • CUSTOMER SATISFACTION • QUALITY PRINCIPLES • FOCUS ON CUSTOMER • ADMINISTRATION • TO ENGAGE THE PEOPLE • APPROACH TOWARD PROCESS • CONTINUOUS IMPROVEMENT FACT DECISION MAKING • MANAGE RELATIONSHIP
- 5. OBJECTIVE OF QUALITY •LESS DEFECTS • GOOD EFFICACY • EFFECTIVE PHARMACEUTICALS • GIVE CLEAR IDEABTO KNOW ABOUT PROGRESS TOWARDS GOALS , INVOLVING THE TIMELINES TO ACHIEVE IT
- 6. QUALITY MANUAL • DESCRIBES; •SCOPE OF QMS • CLARIFY NEEDS OF OMS STRATEGY • MENTION ANY PART OF QMS • QUALITY STEPS USED IN ORGANIZATION • DESCRIBES ORGANIZATION’S QUALITY GOALS & STRATEGY
- 7. RESPONSIBILITY OF ORGANISATIONS& IT’S STRUCTURE • STRUCTURAL DOCUMENTATION INCLUDES GUIDES SUCH AS FLOWCHARTS • PERSONNEL • INSTRUMENT • KNOW ABOUT STRUCTURE • KEY OF EVALUATION • PROVISIONS • PURCHASING & INVENTORY • MANAGE PROCESS • DOCUMENTS & RECORDS .
- 8. MANAGE THE DATA •DATA IS A KEY APPROACH TO TQM. • GIVE CONTINUOUS IMPROVEMENT • GIVE UP TYPES OF DATA ,SOURCES, COLLECTION METHODS, RESPONSIBILITIES, STORAGE , DISPOSAL & ANALYSIS. • INVOLVES FOLLOWING SOURCES: • SATISFACTION OF CUSTOMER • SUPPLIER PERFORMANCE • PROCESS OBSERVATION • TRENDS • CORRECTIVE ACTION
- 9. PROCESSES • TO CONTROLQUALITY & ASSURANCE • QMS IS APPROACH TOWARD OPERATING PROCESSES • DESCRIBES ALL STEPS TO CHANGE INPUT INTO OUTPUTS • AFTER IDENTICATION OF THE PROCESS ,ORGANIZATION STARTS DEFINES KEY SUCCESS • IDENTIFY ORGANIZATION PROCESSES • DEFINE PROCESS STANDARD • ESTABLISH METHODS FOR MEASURING SUCCESS • DOCUMENTS STANDARDIZATION APPROACH TO ENSURE QUALITY • DRIVE CONTINUAL IMPROVEMENT
- 10. QUALITY OF PRODUCTSDEFINE CUSTOMER SATISFACTION TO MEASURE CUSTOMER ATTITUDE & COMPLAINT IS FIRST STEP TOWARDS MONITORING SATISFACTION OF CUSTOMER • SATISFACTION SURVEYS • COMPLAINTS PROCEDURES • ANALYTICAL APPLICATIONS TO MEASURES SATISFACTION TRENDS • MANAGEMENT REVIEW OF CUSTOMER SATISFACTION
- 11. CONTINUAL ENHANCEMENT • TOMAINTAIN SATISFACTION OF CUSTOMER CONTINUOUS ENHANCEMENT. • CLEAR DOCUMENTATION NEEDED FOR CONTINUOUS ENHANCEMENT FOR PLANNING ORGANIZATIONAL PROCESSES TO ACHIEVE QMS STANDARDS. • ENHANCEMENT OF DOCUMENTATION SHOULD ENCLOSED WITH • QUALITY PLANNING PROCEDURE • COMPLAINCE REQUIREMENTS • SAFETY DESIGN • RISK BASED THINKING • CORRECTIVE ACTION • BREAKTHROUGH IMPROVEMENT • INNOVATION • ASSESSMENT OF QMS
- 12. INSTRUMENTS OF QUALITY •FOR THE SUCCESS OF QMS BASIC THING IS TO CONTROL &CALIBRATE INSTRUMENTS WHICH ARE USED TO MEASURE QUALITY. • INSTRUMENTS ARE CALIBRATED ACCORDING TO STANDARD OF ORGANISATIONS. • MAINTAIN QUALITY OF EQUIPMENT • MAINTAIN CLEAR DOCUMENTATION OF OF CALIBRATION RESULT, SOPS, CALIBRATION RESULTS
- 13. TO CONTROL THEDOCUMENTS • ACCORDING TO ISO TO DEFINE DOCUMENTS IN QUALITY ORGANIZATION INVOLVE RECORDS OF: • COMMUNICATION • EVIDENCE • QMS CONFORMITY • KNOWLEDGE SHARING
- 14. PRODUCTION SYSTEM • INCLUDEPLANNING FOR PRODUCTION • CONTROL OF PRODUCTION • PRODUCTION SYSTEM IS DEFINED AS STRUCTURE OF ACTIVITIES WHERE INPUTS ARE MODIFY INTO VALUE ADDED TO PRODUCT. • PRODUCTION PLANNING OBJECTIVE • TO PRODUCE THE PRODUCT WITHIN TIME PLANNING • ENHANCE PRODUCTIVITY • PLANNING INCREASE SYSTEMATIC WAY IN CASE OF SERIES OF OPERATION
- 15. • TYPES OFPRODUCTION • CONTINUOUS PRODUCTION SYSTEM • INTERMITTENT PRODUCTION SYSTEM • DISPATCHING RECORDS • PRODUCTION CONTROL • FUNCTION OF PRODUCTION CONTROL • PROGRESS CONTROL
- 16. CORRECTIVE ACTIONS • DEPENDSON INTERNAL & EXTERNAL FACTORS ; • INTERNAL FACTORS : CONTROL WITHIN ORGANISATIONS,INTERNAL ISSUES ( LACK OF REQUIRED INSTRUCTIONS, MATERIALS • EXTERNAL FACTORS NOT CONTROL WITHIN ORGANISATIONS (PRODUCT DEMAND, ) • METHODS TO TAKE CORRECTIVE ACTION • MAKE THE PLAN • CHANGING NUMBER OF WORKING HOURS & NUMBER OF WORKERS • MODIFICATION IS DONE • MINIMIZE THE EQUIPMENT HANDLING TIME • WELL PLANNING
- 17. FACILITY & EQUIPMENTSYSTEM • EQUIPMENT SHOULD BE QUALIFIED, CALIBRATED,CLEANED AS TO PREVENT CONTAMINATION. • THIS INVOLVE : • MAINTENANCE OF BUILDINGS & FACILITIES • QUALIFICATIONS OF EQUIPMENT ( INSTALLATION & OPERATIONS, PREVENTIVE MAINTENANCE & CLEANING • 21 CFR 211 SUBPART B , INCLUDING ORGANIZATION & PERSONNEL, C INCLUDES BUILDINGS & FACILITIES,D INCLUDE EQUIPMENTS.
- 18. LABORATORY CONTROL SYSTEM •CONSIST WITH ACTIVITIES REGARDING TO LABORATORY PROCEDURES, EVALUATION, ANALYTICAL METHODS DEVELOPMENT & VALIDATION • CGMP REGULATIONS 21 CFR 211 INCLUDES • SUBPART I HAVING LABORATORY CONTROL RELATED TO GENERAL REQUIREMENTS, TESTING, STABILITY TESTING • SUBPART J HAVING RECORDS & REPORTS RELATED TO GENERAL REQUIREMENTS, EQUIPMENT CLEANING & USE COMPONENTS, LABELLING RECORDING, CLOSURE , BATCH PRODUCTION & CONTROL RECORDS , LABORATORY RECORDS , DISTRIBUTION RECORDS , COMPLAINT FILES • SUBPART K RELATED TO RETURNED DRUG PRODUCTS, DRUG PRODUCT SALAVAGING
- 19. MATERIAL SYSTEM • INCLUDETHE MAJOR ACTIVITIES TO CONTROL FINISHED PRODUCT, CONTAINER & CLOSURE • VALIDATION OF CONTROL PROCESSES • DRUG STORAGE • DISTRIBUTION CONTROL • RECORDS
- 20. PACKAGING & LABELLINGSYSTEM • CONTROL PACKAGING & LABELLING OF DRUG OR DRUG PRODUCT • INCKUDE DOCUMENTATION OF PROCEDURES, LABEL EXAMINATION & USAGE , LABEL STORAGE & ISSUANCE, PACKAGING & LABELLING OPERATION CONTROL & VALIDATION OF THESE OPERATIONS • CGMP REGULATIONS 21 CFR SUBPARTS B,G & J
- 21. CONCEPT OF SELFINSPECTION IS A PROCESS TO ANALYSE SELF PERFORMANCE RELATED TO ANY ASPECT OF QUALITY .IDENTIFY THE PROBLEMS, WHETHER PROBLEM OR DEFECT IS MAJOR , MINOR, OR CRITICAL IN NATURE
- 22. CHANGE MANAGEMENT &CHANGE CONTROL • ASSURES CHANGE TO PRODUCTS WHICH ARE INTRODUCED IN CONTROLLED & COORDINATE MANNER • MAINLY INVOLVE MINIMUM DISTURBANCE TO SYSTEM • DECREASE PREVIOUS STEPS • COST EFFECTIVE USE OF SOURCES
- 23. OUT OF SPECIFICATIONS •DEFINES EVALUATION OF TEST RESULTS WHICH ARE COMES OUT OF SPECIFICATIONS • GIVE UP THE SERVICE FOR THE UPDATE INFORMATION • INCLUDE RESULT OF ALL TEST • FDA GUIDELINES FOR OOS • FINISHED PRODUCT & ACTIVE PHARMACEUTICAL INGREDIENTS • BIOLOGY & BIOTECHNOLOGICAL PRODUCT • HUMAN DRUGS • VETERINARY DRUGS • COMBINATION OF PRODUCT • TYPE MEDICATED ARTICLES • MEDICATED FEED • DIETARY SUPPLEMENT • TRANSPLANTATION OF HUMAN TISSUES UNDER SECTION 361 SECTION
- 24. OUT OF TRENDS •ARE STABILITY RESULT THAT DOES NOT GO WITH PREDICATED PATH • HANDLE LATEST QUALITY SYSTEM • ENCOURAGE INDUSTRY NEW TECHNOLOGIES ADVANCES • GUIDANCE ON QUALITY SYSTEM APPROACH TO PHARMACEUTICAL CGMP REGULATIONS • PRODUCE MORE EFFICIENT & LOW COST DRUG
- 25. COMPLAINTS EVALUATION &HANDLING • TWO PARTS OF COMPLAINTS HANDLING PROCEDURE: • FIRST PART MUST BE APPLICABLE FOR CUSTOMER, EXPLAINING THE PROCESS OF FILLING A COMPLAINT • SECOND PART MUST BE INCLUDE INTERNAL STEPS REQUIRED FOR EMPLOYEES • COMPLAINTS HANDLING PROCEDURE • PROVIDES STEPS THAT HOW TO APPLY COMPLAINT • PROCEDURE PROVIDED BY COMPANY HELP THE CUSTOMER TO FILE THE COMPLAINT
- 26. • INTERNAL COMPLAINTHANDLING PROCEDURE • DEFINE ROLE & RESPONSIBILITY OF EMPLOYEES TO HANDLE COMPLAINTS , STEPS TAKEN FOR COMPLAINT • RESOLVE THE COMPLAINT • APOLOGISE FOR DELAY DELIVERY , REFUND, EXCHANGE OF PRODUCT,ETC
- 27. STEPS TO HANDLECOMPLAINTS • RECORD THE COMPLAINT • COMPLAINT ANALYSIS • COMPLAINTS RESOLUTION • CONPLAINT INVESTIGATION
- 28. INVESTIGATION & DETERMINATIONOF ROOT CAUSE • TYPE OF PROBLEM SOLVING METHOD • AIM TO PREVENT REPETITION OF PROBLEMS • ROOT CAUSE ANALYSIS • WHO SHOULD WORK ON EVALUATING PROBLEM • DEFINE PROBLEM • WHAT IS IT? • WHEN DID IT HAPPEN? • HOW WERE OVERALL GOALS AFFECTED • WHAT WILL BE DONE?
- 29. CORRECTIVE & PREVENTIVEACTION • CORRECTIVE ACTION • LABORATORY CONTROL THE RESULTS OF CORRECTIVE ACTION TO ENSURE IT WAS EFFECTIVE • IF EFFECTIVE: CORRECTIVE ACTION • IF NOT EFFECTIVE: SELECT ANOTHER CORRECTIVE ACTION • PREVENTION ACTION • PROCESS OF CONTINUAL IMPROVEMENT • IMPROVEMENT OF QMS • IMPROVEMENT OF TECHNICAL OPERATIONS
- 30. RETURNS & RECALL •RECALL IS THE STEPS TO PUT SOMETHING BACK TO ITS ORIGINAL PLACE • DEMAND TO RETURNS ,EXCHANGE , REPLACE THE PRODUCT • TO AWARE SAFETY OF CUSTOMER • PRODUCT RECALL • DONE BY VARIOUS SOURCES INCLUDING MANUFACTURERS WHOLESALERS , RETAILERS , CUSTOMER
- 31. APPROACH TO PRODUCTSRECALL TEAM • EXAMPLE IF PRODUCTION OF 15 BATCHES DONE LAST 3 YEAR , THEN TAKE LATEST 19 BATCHES , BUT IF ONLY 8 BATCHES WERE MANUFACTURED OVER LAST 3 YEARS REVIEW THE 8 BATCHES • THE APR INVOLVE COMPARATIVE STUDY OF PREVIOUS YEAR REVIEW REPORT TO EVALUATE YEAR TO YEAR CONSISTENTCY • SIX AREA TO REVIEW OF PRODUCT SPECIFICATIONS • LEGAL: MARKET APPROVAL AS WELL AS REGULATORY NOTICE • EXTERNAL: COMPLAINTS, RECALL ADVERSE EVENTS & RETURNS • PROCESSES: CONTROL, CHANGES, PROCESS VALIDATION • PRODUCT : PRODUCT TESTING, OOS TEST METHODS • QUALITY CONTROL: TEST METHODS • EVENTS : PRODUCT RELATED INCIDENTS
- 32. APR SUMMARY REPORTSFORMAT • CONSIST OF VARIOUS FORMS • APR INCLUDE COVER PAGE , SUBSECTION, SUMMARY, REFRENCES • COVER PAGE INCLUDE TITLE OF APR RODUCT COVERED , SIGNATURE OF APR AUTHORITY • SUBSECTION CONSIST ALL DATA & DOCUMENTATION FOR EACH STEPS • SUMMARY ANNUAL PRODUCT REVIEW SUMMARY , OVERALL APR RATING • REFERENCE CONSIST ALL LIST OF ALL CAPA RAISED AS RESULTS OF APR SUMMARY
- 33. APR CONCLUSION &RATING • SATISFACTORY • ACCEPTABLE • ACCEPTABLE WITH CONDITIONS • UNACCEPTABLE
- 34. APR REPORT APPROVAL •SIGNED OF WITH • QA MANAGER • REGUKATIRY AFFAIRS MANAGER • PRODUCTION MANAGER • OTHER GROUPS WHO MAY BE AFFECTED BY ANY CHANGES
- 35. BATCH REVIEW &BATCH RELEASE • PURPOSE FOR APPROVAL & RELEASE OF FINISHED PRODUCT BATCH ESTABLISH THE PRODUCT • RESPONSIBILITY SOP FOR BATCH RELEASE • QA DEPARTMENT RESPONSIBLE FOR REVIEWING THE BATCH RECORDS • HEAD PRODUCTION RESPONSIBLE FOR COMPLETION & REVIEW OF BMR • HEAD QC OR QM RESPONSIBLE FOR COMPLETION OF ANALYTICAL RECORDS • PROCESS FOR BATCH RELEASE SUBMITTED BY PRODUCTION DEPARTMENT & APPROVED BY PRODUCTION OFFICER & THEN PROCEED TO QA DEPARTMENT REVIEW
- 36. REVIEW OF BATCHRECORDS • AFTER APPROVAL OF CONTRACT THEN THERE WILL BE PLANNED FOR CONDITIONAL TRANSFER • NO PERMISSION TO OTHER PARTY TO SELL PRODUCTS • OFFICER OR EXCEUTIVE OF QA REVIEW THE DOCUMENTS OF BOTH BATCH MANUFACTURING & BATCH PACKAGING RECORDS
- 37. CONCYOF IPQC • STANDSFOR IN PROCESS QUALITY CONTROL • AIM: TO DEVELOP THE TECHNICAL PROCEDURE USED IN MANUFACTURING PROCESS • AT ALL STEPS OF OPERATION NEED TO OBSERVE , CONTROL & ENHANCE EFFICACY OF FINISHED PRODUCT • INVESTIGATION OF RAW MATERIAL, INSTRUMENTS, ENVIRONMENT, PROCESS, EVALUATION & PACKAGING • USFDA GUIDELINES • TO ENSURE UNIFORMITY OF DRUG PRODUCT • ESTABLISHED WRITTEN PROCEDURE & FOLLOWED TO MENTION IN PROCESS & EVALUATION DONE ON PARTICULAR SAMPLE OF IN PROCESS OF EACH BATCH
- 38. IPQC FOR PARENTERALPRODUCTS • TO CHECK THE BULK SOLUTION TO FILL DRUG CONTENT, OH, COLOR, CLARITY OF SOLUTION • TESTING FOR LEAKAGE OF SEALED AMPOULES • EXAMINE FILLED VOLUME OF LIQUID • IPQC FOR SOLID DOSAGE FORM • CHECK VARIATION IN WEIGHT OF TABLET & CAPSULE WITHIN PARTICULAR DURATION • DISSOLUTION TIME , HARDNESS • IPQC FOR SEMI-SOLID • DETERMINE PARTICLE SIZE OF PREPARATION • CHECK APPERANCE, VISCOSITY ,SPECIFIC GRAVITY SEDIMENTATION
- 39. DOCUMENTATION & EVALUATIONOF DATA • IF THERE ANY REQUIRED IN PROCESS CONTROLS AS WELL AS ENVIRONMENTAL CONTROL DONE IT MUST BE RECORDED • IF THERE IS ANY VARIATION THEN SIGNATURE OF PERSON WHO APPROVED THE VARIATION • PRODUCTION HEAD REPONSIBLT FOR VARIATION PROCESS
- 40. AREA CLEARANCE &LINE CLEARANCE • ASSURES THAT PRODUCTION SHOULD BE FREE FORN CONTAMINATION • SOP IS APPLICABLE FOR LINE CLEARANCE OF PRODUCTION, WAREHOUSE AREAS OF FORMULATION PLANT • AUTHORITY • FOR PROPER CLEANING OF INSTRUMENTS & AREA OPERATOR SHALL BE CONSIDERED • CHECK CLEANLINESS OF INSTRUMENTS & PRODUCTION OFFICER SHALL BE RESPONSIBLE • IPQA OFFICEYSHALL BE RESPONSIBLE FOR GIVING LINE CLEARANCE
- 41. PROCEDURE • AFTER AREAIS CHECKED & FOUND APPROPRIATE WAREHOUSE • AFTER RECIEVING INSTRUCTION FORM PRODUCTION, IPQA PERSON SHOULD CHECK THE AREA , EQUIPMENT & DOCUMENTS • IF THERE IS ANY DISSATISFACTION AS PER LINE CLEARANCE GUIDELINES PRODUCTION PERSONNEL COMPARE IT & AGAIN GIVE INSTRUCTIONS TO IOWA PERSONNEL FOR LINE CLEARANCE • WHILE COMPLETING PROPER CLEANING OF INSTRUMENTS OR AREA IF NECESSARY PRODUCTION PERSONNEL GIVE INTIMATION TO IPQA PERSONNEL FOR SLIP OF COLLECTING SAMPLE • IF THERE IS BREAKDOWN OF MORE THAN HALF HR IN BETWEEN ANY PROCESS THEN LINE CLEARANCE SHOULD BE TAKEN AGAIN • NO NEED TO ATTACH ADDITIONAL LINE CLEARANCE SHEET FOR CARRY FORWARD LINE CLEARANCE DUE TO SHIFT OR DATE CHANGE •
- 42. LIST OF ANNEXURE •LINE CLEARANCE CHECK LIST FOR DISPENSING • LINE CLEARANCE CHECK LIST FOR MANUFACTURING • LIBE CLEARANCE CHECK LIST FOR PRIMARY PACAKGING • LIJE CLEARANCE CHECK LIST FOR SECONDARY PACKAGING
- 43.