Friday, September 5, 2014

Why Validation is important in Pharma Industry

Why Validation is important in Pharma Industry

Why Validation is important in Pharma Industry ?
In pharmaceutical manufacturing company validation is very important, it is a part of good manufacturing practice guidelines and must be complied by a pharma manufacturing facility, in event of failure to comply with requirement of validation of a drug or pharmaceutical manufactured in pharma industry product is deemed as of substandard.

What is Validation?
Validation is process of assuring that a process under taken in manufacturing of pharmaceutical delivers assigned result, or the product being manufactured with the adapted process complies with all its set standards.

Why validation given so much importance in pharma industry. Just consider manufacturing of sterile dosage form, all units of sterile dosage form be it injectable, and parenteral drugs are required to be free from microorganism and their spores, and extraneous particulate matter. All units of sterile injection cannot be opened and tested, but few samples representing the batch are tested for compliance of sterility test. Up on the result of these tested representative samples batch of injection is released. Now in this case it is very important to have complete assurance of the all process undertaken in injection manufacturing so that one can reliably say that all units are of similar quality which are tested and found compliance with standard and are passing test for sterility. Therefore Validation is an important activity for Pharma Industry : If a injectable dosage form manufacturing firm provides all documentary evidence that the process adapted in manufacturing of injection is capable of producing consistent reproducible and reliable quality injections by virtue of validation of injection exhibit or validation batches and midia fill test.

​What is important in assuring that a validation is successful? A validation is successful when the final results obtained are constantly reproducible. Documents proving that the process undertaken is reliable and can provide product of desired quality. Process of validation is just not adhered to manufacturing process of a drug, but the process is also applied over all the steps, machineries, equipments and processes, testing procedures and testing equipments too are validated. There is step by step proper approach for the same.

​1) Process validation:- Manufacturing processes Example : Validation of Granulation process, and compression process, blister packaging process, tablet inspection process, injection compounding, blending, filtration, and aseptic filling ect.

2) Equipment Validation: Filling machines, Tablet compression machines, blender, and all compounding, mixing tanks and filling packaging and equipments used in Pharma Manufacturing.

3) Unit operation Validation/ System Validation Water system validation, AHU HVAC system validation, laminar air flow bench validation, HEPA filters validation. Clean room validation.

4)Analytical method validation: Method used in testing of Drug product being produced. High performance liquid chromatography (HPLC) Gas chromatography, spectrophotometer validation, and all equipments used in testing of drug products and their intermediates and starting raw material and packaging material.

5)Personal skill validation: Validation of a person’s ability to perform taste like reading of end point of a test or a process. For example a person working in sorting of tablets or capsule or inspection of injecteble dosage form should have ability to sort out a defective unit, or tablet or capsule. A analysts must have skill to produce reproducible readings.

6) Microbial tests procedure Validation.

7) Computer system validation.: Computer systems are very important in pharma industry, thy have to comply with gmp guidelines of US FDA 21 cfr part 11 A SYSTEMATIC APPROAC IS ADAPTED VALIDATION OF MACHINARY
1) Design Qualification
2) Installation Qualification
3) Process Qualification
4)Process Validation on machine.

What is validation master plan
A validation master plan is prepared it is a road map for going ahead with validation. It lists out all details like, persons responsible for under taking each and every test of validation, (Validation team), Documentation for process, Process steps, Sampling, and Testing procedure. Validation master plan finally also lists how to draw inference out of data collected from validation activity. Reproducibility of data: In order to verify that the process meets desired standard and compliance at any given time, all process is studies in continuation until a satisfactory data is not gained as evidence of constancy.

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