ADVANCED QUALITY ASSURANCE .

TECHNIQUES II 2ND SEM

PROCESS VALIDATION
INTRODUCTION:A DOCUMENTED PROGRAM WHICH PROVIDES A HIGH DEGREE OF ASSURANCE THAT A SPECIAFIC PROCESS WILL CONSISTENTLY PRODUCE A PRODUCT MEETING PRE-DETERMINED SPECS AND QUALITY ATTRIBUTES.

COMMENCES AFTER THE COMPLETE QUALIFICATION OF FACILITY AND EQUIPMENT

IN SOME CASE PV MAY BE CONCURRENTLY CONDUCTED WITH IQ /PQ

PV:ESSENTIAL IN FOLLOWING SITUATIONS

i. TOTALLY NEW PROCESS

ii.

NEW EWUIPMENT

iii.

PROCESS AND EQUIPMENT ALTERED TO SUIT CHANGES

iv.

PROCESS WHERE THE END PRODUCT TEST IS POOR AND UNRELAIBLE INDICATION OF PRODUCT QUALITY

PV:CATEGORIES
a) PROSPECTIVE

b) CONCURRENT

c)

REVALIDATION

d) RETRPSPECTIVE

PV:PROSPECTIVE VALIDATION
ALL STEPS DOCUMENTED AND RECORDED PERFORMED DURING PD STAGE EACH STEP IS REQUIRED TO BE ESTABLISHED SO THAT DESIRED RESULTS ARE OBTAINED CONSISTENTLY. THIS ENCOMPASSES :DEFINING OF RM SPECS,EQUIPMENT AND PROCESS PARAMETERS,OPERATING CONDITIONS,LEVEL OF TRAINING OF PEOPLE. OUTPUT RESULTS ARE STUDIED AND FINAL SPECS ARE DETERMINED FOR THIS STAGE. LIMITS OF VARIATIONS ARE DETERMINED AND SPECIFIED LAB BATCH CAN BE SCALED UP TEN TIMES FOR THE PILOT BATCH ACTUAL COMMERCIAL BATCH CAN BE TEN TIMES OF THE VALIDETED PILOT BATCH

PV:CONCURRENT VALIDATION (CV)

CV IS PERFORMED DURING COMMERCIAL PRODUCTION FIRST THREE BATCHES ARE VALIDATED AND THEN AFTER THIS THE PROCESS IS TNANSFERRED TO PRODUCTION VARIATIONS ARE RECORRED AND DOCUMENTED IPQC TESTS ARE DECIDED AND MONITORED WORST CASE SITUATION CAN ALSO BE CONSIDERED CHANGE OF EQUIPMENT SHALL REQUIRE FULL SCALE OPERATION.HOWEVER IF THE SAME OR SIMILAR EQUIPMENT ARE USED THEN THE PROTOCOL CAN BE ALTERED ACCORDINGLY. RESULTS OBTAINED ARE PART OF BPCR AND MAY BE USEFUL DURING RETROSPECTIVE VALIDATION NEEDS TO REPEATED IF THERE ARE MAJOR CHANGES IN PROCESS AND EQUIPMENT

PV:RE-VALIDATION
REQUIRED UNDER FOLLOWING CONDITIONS CHANGE OF FORMULA,EQUIPMENT,PROCESS,PM/PM SPECS,PHYSICAL VARIATIONS LIKE:BULK DENSITY,PARTICLE SIZE ETC. CHANGE IN THE EQUIPMENT WITH DIFFERENT PRINCIPLE MAJOR CHANGES IN THE PROCESS PARAMETERS : DRY HEAT STERILISATION IN DHS TO STRILISING TUNNEL CHANGES IN FACILITY AND INSTALLATION ON APPEREANCE OF NEGATIVE QUALITY BONDS EG. INCREASED DT ,CHANGES IN pH, VISCOSITY ON APPREANCE OF NEW FINDINGS ON CURRENT KNOWLEDGE EG: FREQUENCY OF CHECKING DUE TO SOPHISTICATION OF IN-PROCESS METHODOLOGY DEPENDENT ON SIGNIFICANCE OF CHANGES

PV:RETROSPECTIVE VALIDATION (RV)

RV DEFINED AS ESTABLISHED DOCUMENTED EVIDENCE THAT A SYSTEM DOES WHAT IT PROPOSES TO DO BASED ON THE REVIEW AND ANALYSIS OF HISTORICAL DATA AND INFORMATION OBTAINED DURING PRODUCTION OF CLINICAL OR MARKETABLE PRODUCTS USUALLY STATICIAL PAKAGES OR MANUAL REVIEWS ARE USED RV IS SUFFICIENT TO ESTABLISH THE VALIDITY OF PROCESS RV MAY BE ALLOWED WHEN FORMUAL ,PROCEDURE,EQUIPMENT HAVE NOT BEEN ALTERED A CRITICAL EXAMINATION OF THE PROCESS CONTROL DATA AND ANALYTICAL FINDINGS MAY BE PERFORMED AND IF NOT ADEQUATE ADDITIONAL TESTS MAY BE PERFORMED.