introduction to validation
- 1. Introduction to validation Presented By: Facilitated To: Sachin.J.Gaddimath Mr. Avinash.S.G M.Pharm 1st year Asst. Professor Dept. of Pharmaceutics Dept. of Pharmaceutics HSKCOP, BAGALKOT. HSKCOP, BAGALKOT.
- 2. Contents 1) Definition 2) Introduction to validation 3) Need for validation 4) Scope 5) Merits
- 3. Definition: • Validation is the documented act of proving that any procedure, process, equipment, material, activity or system actually leads to the expected result. According to ISO, • It is confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. According to FDA, • “The establish documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”
- 4. Introduction to Validation: • The concept of validation was first proposed by two FDA, Ted Byers and Bud Loftus, in 1979 in USA, in order to improve the quality of pharmaceuticals. And later on it became an important part of cGMP. It was proposed in direct response to several problems in the sterility of large volume parenteral market. • Validation is an integral part of QC; it involves the systemic study of systems, facilities & processes aimed at determining whether they perform their intended functions adequately & consistently as specified. • This is to maintain and assure a higher degree of quality of food and drug products.
- 5. • Validation itself does not improve processes but confirms that the processes has been properly developed and are under control. • The 1st validation activates were focused on the processes involved in making these products, but quickly spread to associated processes including environmental control, media fill, equipment sanitization and purified water production. • In pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
- 6. There are 3 key points from validation: • The evidence must be documented. • Validation applies to several aspects of manufacturing, including process development, materials, personal and equipment. • It should demonstrate that the system does what is expected of it.
- 7. Need for Validation: • Customer satisfaction. • Customer mandated. • Product liability. • Control production cost. • Development of new generation. • Safety.
- 8. Purposes of validation: • To accept an individual sample as a member of population under study. • To admit samples to the measurement process. • To minimize later questions on sample authenticity. • To provide an opportunity for resampling when needed.
- 9. Reason for validation: • It is regulated requirement stipulated in cGMP. • Greater impart on product development process. • Cost reduction. • To produce zero defect product. • End result of validation will be higher quality more uniform & reproducible product. • Makes a good business source, decrease batch reject & retails.
- 10. Scope of Validation: • Validation requires an appropriate & sufficient infrastructure including: 1) Organization 2) Documentation 3) Personnel 4) Finances • Involvement of management and QA personnel. • Personnel with appropriate qualifications and experience. • Extensive preparation and planning before validation is performed.
- 11. • A specific programme for validation activities in place. • Validation can be done in a structured way according to documentation including procedures and protocols. • Validation should be performed by a) For new premises, equipments, utilities, systems, processes and procedures b) At periodic intervals c) When major changes have been made • Validation in accordance with written protocols. • A written report on the outcome to be produced.
- 12. • Validation over a period of time. Example: 1. At least 3 consecutive batches (full production scale) to demonstrate consistency. (worst case situations should be considered) 2. Demonstrate suitability for new manufacturing formula or method • Process, materials and equipment to prove consistent yield of a product of the required quality. • Manufacturers to identify what validation work are needed. • Significant changes (facilities, equipment, and processes) should be validated. • Risk assessment approach used to determine the scope and extent of validation needed.
- 13. Merits of Validation: • During the process the knowledge of process will be increases. • It assures the repeatability of the process. • It assures the fluency of production. • It assures that the product is continuously according to the marketing authorization. • Decreases the risk of the manufacturing problems. • Decreases the expenses caused by the failures in the production. • Decreases the risk of failing in GMP.
- 14. • Decreases the expenses of the everyday production even though the validation itself will create expenses. • Reduces the chances of product recall from the market. • Eliminates the scrap and reduces defect cost. • May require less in process control and end product testing. • Make process better understood and reduces the risk of regulatory non compliance. • It is a practice that must be followed for manufacturing, distribution, selling or licence.
- 15. References: • Pharmaceutical Quality Assurance..by Manohar Potdar, Second editionDec 2007,Nirali Prakashan. • IJRPC 2011 ‘An overview of pharmaceutical validation:quality • The Theory and Practice of Pharmacy by Leon Lachmann.
- 16. Thank you