Process validation

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Process Validation: 

Process Validation Presented by Kishan singh M. Pharm. 2 nd sem. G.I.S.I.P.S. Dehradun Aug 16, 2012

Validation – : 

Validation – Acc. to GMP- “ Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting it’s pre-determined specification and quality attributes.” 2

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Types Of Process Validation 3

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A) Prospective validation Also called as premarket validation. Done during the product development stage. Carried out prior to distribution of new product or existing product made under a revised manufacturing processes where such revision may affect product specification or quality characteristic. 4

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B) Concurrent validation Study is carried out under a protocol during a course of normal production. The IPQC (In Process Quality Control ) parameters are also decides & monitor for use of regular production , final control & stability. 5

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C) Retrospective validation Conducted for a product already being marketed, Historic data taken from the records of completed production batches(20-30). 6

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D) Revalidation All or a portion of validation that is required to be repeated when changes that affect original validation are made. Examples of changes requiring revalidation Changes to product specifications Process parameters Equipment (type, function, location, control system, major repairs) Raw materials Manufacturing materials Packaging material 7

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Qualifications Design Qualification (DQ) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) 8

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Design Qualification (DQ) - Define the functional & operational specification of instrument, program or equipment . (B) Installation Qualification (IQ) -IQ provides documented evidence that the equipment or system has been developed or installed accordance with design drawings and in-house requirement. 9

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(C) Operational Qualification (OQ) - to provide a high degree of assurance that the equipment functions as intended. (D) Performance Qualification (PQ) - Demonstrates that the process or equipment performs as intended in a consistent manner over time. - Done after IQ & OQ has been completed. 10

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SECTION Deal with 21 CFR Parts 210 and 211. Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals, Section 211.110 Sampling and testing of in-process materials and drug products. 21 CFR Part 820. Current Good Manufacturing Practice Regulations for medical device Section 211.113 Control of Microbiological Contamination. Regulatory Requirements For Validation 11

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Priority for Process Validation A . Sterile Products and Their Processes 1. Large-volume parenterals (LVPs) 2. Small-volume parenterals (SVPs) 3. Ophthalmic, other sterile products, and medical devices B. Nonsterile Products and Their Processes 1. Low-dose/high-potency tablets and capsules/transdermal delivery systems (TDDs) 2. Drugs with stability problems 3. Other tablets and capsules 4. Oral liquids, topical, and diagnostic aids 12

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Validation Master Plan (VMP ) Validation protocols (VP ) Validation reports(VR ) Standard Operating Procedures (SOPs) Types of Documentation 13

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Validation Master Plan (VMP) Is a document provide whole facility that describes which EQ, systems, methods, will be validated & when they will validate. Provide format requirements for each particular validation document . Also describes how to deal with deviations. 14

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Validation protocols (VP) Object of the validation and qualification Responsible persons and standards. Validation reports(VR) Title Objective of the study Details of the materials Details of procedures and test methods Standard Operating Procedures (SOPs) written documented evidence how to operate an instrument equipment or system. 15

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16 Improves quality assurance. Reduces manufacturing cost. Enables more effective and rapid trouble shooting. Enables better system control and maintenance. Empowers all employees to control their processes and to improve them . Benefits of validation-

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references Leon lachman , lieberman,and kanig the theory and practice of industrial pharmacy.ed.III.;1990. varghese publication house pg.832-833. Jain NK, Pharmaceutical Product Development;2010. cbs publication pg.524-548. Guideline on General Principles of Process Validation (www.fda.gov/cder/guidance/pv.htm.; May 1987) accessed on 30 july 2012. 17

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Thank you Kishan singh M. Pharm. 2 nd sem . Email – kishanbisht79@gmail.com 18