VALIDATION on pharmaceutical industry.pptx

pharmaceutical validation pharmaceutical engineering validation

1. VALIDATION Introduction to pharmaceutical validation, scope & merits of validation 1

2. CONTENTS: Introduction Definition Why validation is required Documentation of validation Validation master plan Scope of validation Types of validation Advantages Disadvantages Conclusion 2

3. INTRODUCTION : Pharmaceutical validation is the process of establishing documentary evidence to show that a process, system, or equipment consistently produces the expected results and meets predefined quality standards and regulatory requirements.  It ensures drug products are safe, effective, and of high quality , forming a fundamental component of  current Good Manufacturing Practices ( cGMP ) .   3

4. DEFINITION: validation is the documented process of proving that a specific process, system, or equipment consistently produces a product meeting predetermined specifications and quality attributes. 4

5. WHY VALIDATION IS REQUIRED! The pharmaceutical industry uses expensive material , advanced facilities and equipment and highly qualified personals . It would not be feasible to use equipment not knowing if it will produce the product we want, not to employ the people with no assurance that they can do or fail to implement process checks or examination to assure that product meet specification. Customer satisfaction Product liability Control production cost The development of next generation Safety 5

6. DOCUMENTATION OF VALIDATION The validation activity cannot be completed without proper documentation of each and every minute activity with utmost details. Documentation of validation is generally of different types such as : Validation Master Plan(VMP) Validation Protocol(VP) Validation Reports(VR) Standard Operating Procedure(SOP) 6

7. VALIDATION MASTER PLAN A Validation Master Plan is a document that summarizes the firm's overall philosophy, intention and approaches to be used for establishing performance adequacy. A tool to track progress. Assignment of responsibility and team work. It identifies acceptance criteria before the start of validation. V.M.P gives idea about future performance: What activities are to be performed? Who is going to perform these activities? When the activities should start and when they should get over? What documents will be generated? What the policy on revalidation ? 7

8. V.M.P. includes Premises Processes Products Format for protocol and other documentation List of relevant SOPs Planning and scheduling Location Estimation of staffing requirements A time plan of the project 8

9. SCOPE OF VALIDATION: : Selection of raw material i.e. raw materials of desired quality attributes. Product design based on the expected performance. Process design to build the desired quality attributes in the product. Design of control parameters, such as change control, acceptance criteria, tolerance limits, etc. In process quality control parameters and sampling plans Finished product testing or evaluation criteria. Validation of related analytical process , facility and equipment. Personnel training. Validation involves careful determination of criteria variable of the process, such as moisture content of granules, drying temperature of time, etc . 9

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11. URS, FAT and SAT : User Requirement Specifications- Manufacturers should prepare a document that describes, for example, the utility or equipment to be sourced. The requirements and specifications for the utility or equipment should be defined by the user and should be documented in the URS . Factory Acceptance Test and Site Acceptance Test- Where appropriate, FAT and SAT should be performed to verify the suitability of the system at site, prior to the subsequent stages of qualification. This should be appropriately documented . 11

12. TYPES : 12

13. CLEANING VALIDATION: Cleaning validation in the pharmaceutical industry is a documented process that proves a cleaning procedure consistently removes residues of previous products, cleaning agents, and microorganisms to acceptable, safe levels.  It ensures equipment is free from contaminants, thereby preventing cross-contamination and protecting patient safety 13

14. Prospective validation should include the following: Short description of the process 2 . summary of the critical processing steps to be investigated 3 . List of the equipment’s to be used along with their calibration status 4 . Finished product specifications for release 5 . List of analytical methods 6 . Proposed in-process controls with acceptance criteria 7 . Additional testing to be carried out 8.Sampling plan 9.Methods for recording and evaluating results 10.Functions and responsibilities 14

15. B) Concurrent Process Validation: The concurrent process validation establishes documented evidence that the process is in a state of control during the actual execution of the process It is a process where current production batches are used to monitor processing parameters. It gives of the present batch being studied, and offers limited assurance regarding consistency of quality from batch to batch . This time the in-process quality control parameter are also decided and monitored. 15

16. C) Retrospective Process validation : It is defined as established documented evidence that a system does what it supports to do on the review and analysis of historical information. This is achieved through the review of the historical manufacturing testing data to prove that the process has always remained in control It is conducted for a product already being marketed, and is based on extensive data accumulated over several lots and over time . Retrospective Validation is only acceptable for well established detailed processes and will be Inappropriate where there have recent changes in the formulation of the products, operating procedures, equipment and facility. 16

17. The retrospective process validation should contain the following: • Batches manufactured for a defined period (minimum of 10 last consecutive batches) • Number of lots released per year • Batch size/strength/manufacturer/year/period • Master manufacturing/packaging documents • Current specifications for active materials/finished products • List of process deviations, corrective actions and changes to manufacturing documents 17

18. D) Revalidation: Required when there is a change in any of the critical process parameters, formulation, primary packaging components, raw material fabricator, major equipment or premises. Failure to meet product and process specifications in batches would also require process re- validation. Revalidation becomes necessary in certain situations . Changes in raw materials Changes in the source of active raw material manufacturer. • Changes in packaging material Changes in the process 18

19. Types of Equipment Validation: 19

20. A) Design Qualification: It is a documented verification that the proposed design is suitable for intended purpose.” The design qualification outline the key features of the system designed to address the user requirements, regulatory compliance and selection rationale of a particular supplier. Important DQ consideration include: 1.GMP‟s and regulatory requirements. 2.Performance criteria. 3 . Facility air flow, movement flow and pressure regimens. 20

21. B) Installation Qualification: It is a documented verification that all the aspects of a facility, utility or equipment that can affect product quality adhere to approved specifications and are correctly installed . Important IQ consideration include: 1.Installation conditions (wiring, utilities, and functionality ) 2 . Calibration, Preventive maintenance, cleaning schedules . 3 . Safety features. 4 . Supplier documentation, prints, drawings and manuals. 5 . Software documentation 6 . Spare parts list. 21

22. C) Operational Qualification: It is a documented verification that all aspects of a facility, utility or equipment that can affect product quality OQ considerations include: Process control limits (time, temperature, pressure, line speed, and setup conditions). Raw material specification. Process operating procedures Material handling requirements. Process change control Training Short term stability and capability of the process 22

23. D) Performance Qualification: I t is a documented verification that all aspects of a facility, utility or equipment perform as intended in meeting predetermined acceptance criteria. PQ consideration include: 1.Actual product and process parameters and procedures established in OQ. 2 . Acceptability of the product . 3 . Assurance of process capability as established in OQ. 4 . Process repeatability, long term process stability 23

24. Advantages of validation: 1.Consistent through output. 2 . Reduction in rejections and reworks. 3 . Reduction in utility cost. 4 . Avoidance of capital expenditures. 5 . Fewer complaints about process related failure. 6 . Reduced testing process and finished goods. 24

25. Disadvantages of validation: 1.Validation is time consuming process. 2 . The process for manufacture is often complex and costly. 3 . Validation also has practical limit and related cost. 25

26. Reduction of quality cost Process Optimization Assurance of quality Safety Better consumer quality Application of validation 26

27. CONCLUSION: 27 This review gives an idea about the validation in pharmaceutical industry. Validation is an essential component of GMP. Validation helps assure product will meet standard quality, safety, efficacy, purity, effectiveness according to GMP. Validation is commonly used in drug development, manufacturing and specification of final product. Validation is helps in eliminating the chances of batch failure as the product are manufactured under optimizing each manufacturing stage . Validation helps in reduce the cost of quality which gives the best quality of product.

28. 28 REFERENCES: Anju G, Pandey P. Process Validation of Pharmaceutical Dosages Form: A Review. Biomedical Journal of Scientific and Technical Research. 2017;1(5):1467–75. 2 . Ahir KB, Singh KD, Yadav SP, Patel HS, Poyahari CB. Overview of Validation and Basic Concepts of Process Validation. Scholars Academic Journal of Pharmacy (SAJP). 2014;3(2):178–90. 3 . Harpreet K, Gurpreet S, Nimrata S. Pharmaceutical Process validation: A Review. Journal of Drug Delivery and Therapeutics. 2013;3(4):189–94. .Jain K, Agrawal P, Bharkatiya M. A Review on Pharmaceutical Validation and Its Implication. International Journal of Pharmacy and Biological Sciences. 2018;8(2):117–26. Sharma M, Agarwal S, Agarwal S, Sharma M. Prospective Validation: A Review. The Pharma Innovation. 2015;4(3):1–7 . Mead, W. J., Process validation in cosmetic manufacture, Drug Cosmet . Ind., (Sep tember 1981). Chapman , K. G., A history of validation in the United States, Part I, Pharm. Tech., (November 1991). Nash , R. A., The essentials of pharmaceutical validation in Pharmaceutical Dosage Forms: Tablets, Vol. 3, 2nd ed., Lieberman, H. A., Lachman , L. and Schwartz, J. B., eds., Marcel Dekker, New York (1990).

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