Pharmaceutical Validation_Sachin Kumbhoje

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Century Gothic:

Pharmaceutical Validation Presentation by: Sachin R. Kumbhoje , M. Pharm. Assistant Professor, Department of Pharmaceutical Chemistry

Wingdings 2:

Presentation Outline

Verdana:

C oncept, & C onsiderations Definition Prospective Validation Concurrent Validation Retrospective Validation Revalidation 3

Comic Sans MS:

How the term ‘Validation’ is officially defined? Establishing documented evidence which provides a high degree of assurance that a specific system, process or facility will consistently produce a product meeting its pre-determined specifications and quality attributes. 4

Agency FB:

How the term ‘Validation’ is officially defined? Establishing documented evidence which provides a high degree of assurance that a specific system, process or facility will consistently produce a product meeting its pre-determined specifications and quality attributes. 5

Wingdings:

Why? When does a Medicine is fit for its intended use ? How should we check Safety and Efficacy ? Does the end product testing provides the guarantee of the Quality ? … to ensure that the output is consistent; first time, every time!! 6

Monotype Sorts:

Process Validation “Organized, documented common sense !”

Times New Roman:

T ypes of Process Validation Experimental approach Prospective validation (Pre-market validation) Concurrent validation (For Ongoing Commercial batches) Analysis of historical data Retrospective validation (For any change in RM/PM) Revalidation Periodical revalidation Revalidation after change 8

Verve:

Define Critical Process Parameters, Critical Quality Attributes Develop protocol describing validation studies Execute studies Address planned and unplanned deviations Compile a report Review & Approval of report GMP Documentation all the way…. This process applies to all validation How do we Validate ? 9

Microsoft Photo Editor 3.0 Photo:

Equipment Validation “Validation requires Qualified Equipments”

Pharmaceutical Validation:

T ypes of Equipment Qualification 11

Presentation Outline:

Q ualification of all the Inputs of the process Area/Facility qualification HVAC qualification Environmental qualification Equipment qualification Utilities qualification Cleaning Procedure Validation Analytical Method Validation RM/PM qualification (Vendor Qualification) Personnel qualification 12

Concept, & Considerations:

Cleaning Validation 21 CFR 211.67 “Equipment Cleaning and Maintenance ”

How the term ‘Validation’ is officially defined?:

1/3 rd Recent Drug GMP Warning Letters Cite Cleaning Practices (2002 survey) Year # of Warning Letters # of Warning Letters related to Cleaning % Related to Cleaning 1999 65 23 35% 2000 71 20 41% 2001 71 20 28% 14

How the term ‘Validation’ is officially defined?:

Where Do I start Cleaning Validation? Obtain a Process Flow Diagram All Equipments/Systems IQ/OQ’d ? Cleaning SOP available ? Type A and Type B Cleaning? Test Methods and Sampling Plan Define Applicable Hold Times Dirty: End of Process to Start of Cleaning Clean: End of Cleaning to Next Process Use What “Residuals” Need to Be Cleaned by the CIP ? Product (includes degradates, excipients, raw materials, etc.) Cleaning Agents Are the “Residuals” Representative of the Process ? 15

Why?:

Validation Master Plan “If you have not written, you have not done it” -FDA

Process Validation:

Validation Master Plan Produce documental evidence that it was done in accordance with ‘ How’ Demonstrate that it remains in a state of control 17

Types of Process Validation:

Validation Master Plan Contents of PVP: Approval page, and table of contents Introduction, and objectives Qualification Personnel, planning and scheduling Responsibilities of personal Preventive measures Documentation e.g. validation protocols and reports SOPs Change Controls Training requirements 18

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Validation Master Plan Contents of PVR Approval page, & Table of contents Title, & Objective of the study Reference to the protocol Details of material (RM/PM) Equipment (ID & Cal Status) Summary of Process Details of procedure and test methods Summary of analytical results Summary and Conclusion Recommendations 19

Equipment Validation:

Guidelines FDA guidance documents Validation http://www.fda.gov/cber/gdlns/sterval.pdf Process Validation http:// www.fda.gov/cder/guidance/pv.htm Supplementary Training Modules on Good Manufacturing Practices by WHO 20

Types of Equipment Qualification:

queries? you are free to ask your doubts, if any sachin.kumbhoje@rediffmail.com 2012 C

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