GOODMORNING TO ALL…Shailendra Jadiya (M.Pharm-QA 2013)
Introduction ofPharmaceutical Validation“A Documented programme , whichprovides a high degree of assurancethat a specific process will consistentlyproduce, a product meeting its pre-determined specifications and qualityattributes.”Shailendra Jadiya (M.Pharm-QA 2013)
Scope Of Validation• Analytical Test Methods• Instrument Calibration• Process Utility Services• Raw Material• Packaging Material• Equipment• Facilities• Manufacturing Operations• Product Design• Cleaning• Operations Shailendra Jadiya (M.Pharm-QA 2013)
Importance(Advantages) ofValidation ImportantImportantInfoInfoShailendra Jadiya (M.Pharm-QA 2013)According to Dr. Robert G. Kieflerof Sterling International Group,Sterling Drug Inc. New York USA:1.Reduction of Quality Costs2.Process Optimization3.Assurance of Quality &4.Safety
Shailendra Jadiya (M.Pharm-QA 2013)A.Preventive Costs: are costs incurredin order to prevent failures• Quality Planning• Vender Approval System• Training• Documentation, SOPs, Monographs• Preventive Maintenance• Calibration & Sanitation• Process Validation• QA Auditing & self inspection• Annual review of data or trend analysis
Shailendra Jadiya (M.Pharm-QA 2013)B. Appraisal Costs:are costs of inspection, testing &quality evaluation•Inspection/Testing of raw &packaging materials•Inspection/testing of in process materials•Inspection/testing of finished products•Stability testing
Shailendra Jadiya (M.Pharm-QA 2013)C. Internal Failure Costs:are costs associated with nonconfirming materials that does notmeet quality standards•Rejects•Reworks•Re-inspection•Retests•Wastage/ Scrap•Sorting substandard materials
.Shailendra Jadiya (M.Pharm-QA 2013)D. External Failure Costs:are costs associated with a nonconformance condition after theproduct has left the company’sownership•Recalls•Complaints•Returns due to quality relatedproblems
Shailendra Jadiya (M.Pharm-QA 2013)2. Process Optimization• Means make the process effective,efficient, perfect or useful as possibleat the minimum cost.• Trained & Qualified people are keyelement- Impact in improving efficiency& productivitySome areas where experience shows thatOptimization is possible as a result ofvalidation studies are the following:
Shailendra Jadiya (M.Pharm-QA 2013)• Optimum batch sizes- availability ofequipment, personnel & size of facility.• Reduced sterilization times due to studiesof bio burden validation & control ofautoclave.• Reduced mixing time.• Reduced overfilling of liquids• Faster & more accurate analytical testprocedure• Development of standards for the process,labor, equipment etc.• Better product & component specifications• Reduced energy costs
Shailendra Jadiya (M.Pharm-QA 2013)3.Assurance Of Quality• Validation is an extension of QA, It isnot possible to control a processwithout validation.• Validation & process control are at theheart of GMPs.• Without validated & controlled process,it is impossible to produce qualityproducts.
ImportantImportantInfoInfoShailendra Jadiya (M.Pharm-QA 2013)4.Safety• Validation can also result inincreased operation safety.
Shailendra Jadiya (M.Pharm-QA 2013)School Of Pharmaceutical Sciences, UIT, RGPV, BhopalImportance of Validation1. Assurance of quality2. Time bound3. Process optimization4. Reduction of quality cost.5. Nominal mix-ups, and bottle necks6. Minimal batch failures, improvedefficiently and productivity.7. Reduction in rejections.8. Increased output.9. Avoidance of capital expenditures10. Fewer complaints about process relatedfailures.
Shailendra Jadiya (M.Pharm-QA 2013)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal11. Reduced testing in process and infinished goods.12. More rapid and reliable start-up of newequipment.13. Easier scale-up form development work.14. Easier maintenance of equipment.15. Improved employee awareness ofprocesses.16. More rapid automation.17. Government regulation (Compliance withvalidation requirements is necessary forobtaining approval to manufacture and tointroduce new products)
Shailendra Jadiya (M.Pharm-QA 2013)School Of Pharmaceutical Sciences, UIT, RGPV, BhopalORGANIZATION FOR VALIDATIONValidation activity is not the responsibility of anyone single department in n organization. Theorganization must have a group of people pulledfrom various departments & convert it into agood homogeneous team.The team member may be taken from- R&D,Quality, Production & Engineering.Validation activity is a highly challenging job.Team spirit & maturity is necessary for improvequality.
Shailendra Jadiya (M.Pharm-QA 2013)School Of Pharmaceutical Sciences, UIT, RGPV, BhopalORGANIZATION FOR VALIDATIONValidation organization can be dividedinto three basic areas;1. Establishing the organization.2. Operating it from a quality and costeffectiveness basis.3. Maintaining a functioningorganization.
Shailendra Jadiya (M.Pharm-QA 2013)School Of Pharmaceutical Sciences, UIT, RGPV, BhopalEstablishing the organizationFormulating a department mission is necessary so that,not only process validation staff members understandthe breadth of their job, but also the other corporategroups with whom there is interaction, can alsounderstand.1In some organization senior staff members representingthe process validation, R&D, Quality Assurance,Production and Engineering functions combine to formadvisory or steering committees for the validationprogramme. This committee can prove extremely valuableto the validation program by defining the mission, as wellas by making decisions on specific issues of concern;validation professionals provide sufficient technicalinformation to this committee.
Shailendra Jadiya (M.Pharm-QA 2013)Quality Assurance Committee(Head of quality control/quality assurance,Production, Engineering and GMP section)Validation Steering Committee(Members represent the above departments)Validation Team (Those responsible from Qualitycontrol, production and engineering)
Shailendra Jadiya (M.Pharm-QA 2013)School Of Pharmaceutical Sciences, UIT, RGPV, BhopalDepartments responsible Site validation committee: - Develop site mastervalidation plan. Manufacturing department: - Prepares the batches asthough their routine production batches. Quality assurance: - Ensure compliance and thatdocumentation, procedures are in place. Approvesprotocols and reports. Quality controls: - Perform testing contracts validationtesting and reviews protocol and report as needed. Research and development: - Deals with productdesign. Engineering department: - Installation, quality andcertify plant, facilities, equipment and support systems.
Shailendra Jadiya (M.Pharm-QA 2013)Validation teamA multidisciplinary team is primarilyresponsible for conducting andsupervising validation studies. Personnelqualified by training and experience in arelevant discipline may conduct suchstudies.
Shailendra Jadiya (M.Pharm-QA 2013)School Of Pharmaceutical Sciences, UIT, RGPV, BhopalResponsibilities of validation team Creates updates and reviews/approves individualproject validation plans and validation deliverables. Ensures validation compliance with the companyvalidation master plan and project validation plan.As mentioned in fig No:2 Coordinates, implements, verify elements of VMP. Consults on, evaluates and approves changes. Reviews and approves IQ/OQ/PQ procedures andplans. Reviews test results and makesrecommendations regarding release. Assess risks and develops contingency plan.
References:Shailendra Jadiya (M.Pharm-QA 2013)1. M.A.Potdar- Pharmaceutical Quality Assurance Book-Nirali Prakashan2. AN OVERVIEW OF PHARMACEUTICAL VALIDATION: QUALITYASSURANCE VIEW POINT- L. Nandhakumar*, G. Dharmamoorthy, S.Rameshkumar and S. Chandrasekaran (Review Article in IJRPC 2011)3. Qualification & Validation- Ravi R. Udhan- M.Pharm-QAPPT on http://www.authorstream.com4. Validation regulatory view- T.R. Saraswathi-M.Pharm-P’ceutics PPT on http://www.authorstream.com