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PROCESS VALIDATION

Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.

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QUALITY SQUARE INDUSTRY


  Process Validation

     Mr. Hardik Mistry




       Quality Square Industry
Hester
               Biosciences
                   Ltd

                 Business
                  Profit
                 Prestige




GMP
                                        QUALITY SYSTEM
                                         - VALIDATION




 Customer
satisfaction
                             Customer


                                                   2
 Introduction

 Objectives

 Benefits

 Types of Validation

 Phases of Validation

 Process Validation




                         Quality Square Industry   3
Validation

 “Validation is establishing documented evidence which provides a
  high degree of assurance that a specific process or equipment will
  consistently produce a product or result meeting its pre-determined
  specification and quality attributes .”

 Validation is a key process for effective Quality Assurance.

 QA is the heart and soul of Quality control

   QA = QC + GMP

 Quality Control is incomplete without coordination of Production.


                           Quality Square Industry                    4
 An exercise to create as much paper as possible

 Another unnecessarily burdensome regulatory requirement




                        Quality Square Industry         5
 Confirmation by examination and provision of objective
  evidence that the specified requirements have been
  fulfilled.




                     Quality Square Industry           6

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PROCESS VALIDATION

  • 1. QUALITY SQUARE INDUSTRY Process Validation Mr. Hardik Mistry Quality Square Industry
  • 2. Hester Biosciences Ltd Business Profit Prestige GMP QUALITY SYSTEM - VALIDATION Customer satisfaction Customer 2
  • 3.  Introduction  Objectives  Benefits  Types of Validation  Phases of Validation  Process Validation Quality Square Industry 3
  • 4. Validation  “Validation is establishing documented evidence which provides a high degree of assurance that a specific process or equipment will consistently produce a product or result meeting its pre-determined specification and quality attributes .”  Validation is a key process for effective Quality Assurance.  QA is the heart and soul of Quality control QA = QC + GMP  Quality Control is incomplete without coordination of Production. Quality Square Industry 4
  • 5.  An exercise to create as much paper as possible  Another unnecessarily burdensome regulatory requirement Quality Square Industry 5
  • 6.  Confirmation by examination and provision of objective evidence that the specified requirements have been fulfilled. Quality Square Industry 6
  • 7.  To form basis for written procedures for production and process control which are designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.  To determine that process consistently performs as intended by repeatedly running the system on its intended schedules and reporting all relevant information and data. Results must demonstrate that the process meets pre-determined specifications under normal conditions. Quality Square Industry 7
  • 8.  Quality : - Customer satisfaction : Non-conforming product can lead to lost customers. - Customer mandated: Provision for securing good business  Product liability: Conformance to product specifications must be maintained.  Understanding Equipment, System, Processes : - Process improvement, technology transfer, related product validation, rapid failure investigations, increased employee awareness Quality Square Industry 8
  • 9.  Cost reduction : - Increased efficiency, shortening lead-time resulting in lower inventories. - Fewer rejects and reworks - Longer equipment life by operating the equipment as per manufacturer’s specification and establishment of cost effective preventive maintenance schedules. - Possible reduced testing of raw materials, bulk formulations and finished products.  Regulatory requirement o Successful inspections o Approved products o For export Quality Square Industry 9
  • 12. Prospective Validation  This if performed for all new equipment, products and processes.  It is a proactive approach of documenting the design, specifications and performances before the system is operational.  This is the most defendable type of validation. Quality Square Industry 12
  • 13. Concurrent Validation  This if performed in two instances i.e. for existing equipment, verification of proper installation along with specific operational test is done.  In case of existing, infrequently made product, data is gathered from at least three successful trials. Quality Square Industry 13
  • 14. Retrospective Validation  This is established documented evidence that the process has performed satisfactorily and consistently over time, based on review and analysis of historical data.  The source of such data is production and QA/QC records. Retrospective validation generally not accepted Because…..  The issues to be addressed here are changes to equipment, process, specification and other relevant changes in the past.  Lack of validation protocols usually indicates a lack of documentation, and often data is reported as only pass or fail which does not permit statistical analysis which can only be performed on numeric data. Quality Square Industry 14
  • 15. Revalidation  Consider periodic revalidation where cumulative minor changes to process and raw materials may eventually affect process.  Sterilization processes typically are revalidated periodically (once a year or as needed). Quality Square Industry 15
  • 16. Some reasons for revalidation  Change in process that may affect quality or validation status  Negative trend in quality indicators  Change in the product design that affects the process  Process is moved within facility or transferred from one facility to another  Change in the application of the process Quality Square Industry 16
  • 17. Design Qualification (DQ) Documented verification of the design of equipment and manufacturing facilities.  Installation Qualification (IQ) Documented verification that equipment is installed and operating properly.  Operational Qualification (OQ) Documented verification of equipment or system performance in the target operating range.  Process Performance Qualification (PQ) Documented verification that equipment or systems operate as expected under routine production conditions. The operation is reproducible, reliable and in a state of control.  Process / Product Validation Quality Square Industry 17
  • 18. Document stating how validation will be conducted, including test parameters, product characteristics, manufacturing equipment, and decision points on what constitutes acceptable test results. o General information o Objective o Background/ Pre validation Activities Summary of development and technology transfer (from R&D or another site) activities to justify in-process testing and controls; any previous validations. o List of equipment and their qualification status o Facilities qualification o Process flow chart o Manufacturing procedure narrative o List of critical processing parameters and critical excipients o Sampling, tests and specifications o Acceptance criteria Quality Square Industry 18
  • 20.  Dr. U. K. Jani  Mr. Kaushal Parekh Quality Square Industry 20