process validation-Amol Yadav

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Welcome 1

PROCESS VALIDATION : 

PROCESS VALIDATION Presented by:- Mr. Amol M Yadav M.Pharm (pharmaceutics) Seminar on ARVIND GAVALI COLLEGE OF PHARMACY,JAITAPUR SATARA

Content: 

Content Definition Introduction of validation Types of validation Scope of validation Importance of validation Process validation Validation protocol Types of process validation Conclusion Bibliography

Introduction : 

Introduction The proof of validation is obtained through the collection and evaluation of data . Beginning from the process development phase and continued through in to the production phase. Validation is necessarily includes process qualification, material, equipment , system, personnel.

VALIDATION: 

VALIDATION quoted as……………….. “Validation is not a destination, It is a never Ending Journey………….. Life is like a process, If u don’t validate it , U can’t become a good person.

Definition : 

Definition “ Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting it’s pre-determined specification and quality attributes.”

Scope of validation: 

Scope of validation Pharmaceutical validation is vast area of work and it practically covers every aspect of pharmaceutical process activities. Following area or operation will point out for pharmaceutical validation.

Scope of validation: 

Scope of validation

Scope of validation: 

Scope of validation

Importance of validation: 

Importance of validation Every activity in any business unit is done to get some benefit from that. Validation activity must give the industry some advantages , some benefit & some added value .

Reduction Of Quality Cost: 

Reduction Of Quality Cost Preventive cost : To prevent failure or reduce the appraisal cost. 1. Quality planning. 5.Process validation . 2. Training. 6.Self inspection. 3. Calibration. 7.Documentation . 4. Sanitation. 8. Review of data. Internal failure cost : Non-confirming material. 1. Reject. 3. Re-inspection. 2. Rework. 4. Re-test. External failure cost : Non- confirming condition after the product left the company ownership. 1.Recall. 2 . Complaints. 3.Return due to Quality problem

Process Optimization : 

Process Optimization Make the process effective, efficient, perfect or useful as possible at the minimum cost. Trained qualified people are the key element in any process, thus greatest impact on improving efficiency and productivity . In this content, GMP training program that include how to do the job correctly, easily and repeatedly. Ex- reduce mixing time, R educe overfilling of liquid, Development of std process, labor, equipment that result in better production

When validation is done: 

When validation is done Totally new processes New equipment Processes and equipment, which have been altered to suit changing priorities. Processes where end product test is poor

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Validation of new processes

: 

Validation of existing processes

Assembling of validation protocol : 

Assembling of validation protocol Purpose Principle Testing procedure Table of content Approval pages Description SOP Calibration Utilities

Validation protocol : 

Validation protocol

Process Validation : 

Definition:- “The collection and evaluation of data from the process design stage throughout production which establishes evidence that a process is capable of consistently delivering quality product.” Process validation involves a series of activities taking place over the lifecycle of the product and process . It start after only after the complete qualification program(DQ,IQ,OQ,PQ) of facilities and equipment is over. Process Validation

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Prospective Validation Retrospective validation Types of Process validation Revalidation Concurrent Validation

Prospective Validation : : 

Prospective validation is done during the Product development stage . When we developed a new mfg process and formula each step will be validated to achieve desire result . Input and output parameter is defined. (material specification, process, operator condition) Prospective Validation :

Contd… : 

Contd … Unsatisfactory process must be modified & improve until the validation exercise prove them to be satisfactory. Essential in order to limit the risk of error occurring on the production scale. Every aspect from laboratory scale to commercial scale is documented on record of Process validation.

Concurrent Validation : : 

Concurrent Validation : Concurrent validation is carried out during production . This time the in-process quality control parameter are also decides & monitor for use of regular production, final control & stability. If initial batches use same type of equipment then revalidation may not be required only IPQC test are enough. IPQC test should be carried out for every batch to see the process is moving forward in the excepted direction.

Contd… : 

Contd … Process & procedure should undergoes periodic critical revalidation to ensure that achieving the desire result. The verification of process parameter are evaluated for the mfg . facilities batch after batch if any changes is required. The premises and equipment to be used have been validated previously and then decision to carry out concurrent validation

Revalidation : : 

Revalidation : “Revalidation is needed to ensure that changes in the process and in process environment whether intentional or unintentional do not adversely affect process characteristics and product quality” e.g . Change in : Formula. Equipment . Procedure . Quality of raw material. Physical variation. May required revalidation process

Types Of Revalidation : : 

Types Of Revalidation : Periodic revalidation carried out at schedule interval Revalidation after any changes bearing on product quality.

Revalidation After Any Changes Bearing On Product Quality. : 

Revalidation After Any Changes Bearing On Product Quality. Change in Packaging material. Replacing plastic by a glass. Change in Process. Mixing time Drying temp. Cooling regimen. Change in Eq uip ment. Conventional granulator Replaced by Rapid mixer granulator or Fluid bed processor. Change in Starting material. Density Viscosity. Particle size. Crystal type. Modification of active ingredients.

Periodic Revalidation Carried Out At Schedule Interval. : 

Periodic Revalidation Carried Out At Schedule Interval. It is well known that the process changes may occur gradually even if experienced operator works correctly, similaraly equipment may also causes gradually changes . Periodic revalidation is based on review of historical data. i.e . data generated during in process & finished product testing.

Retrospective Validation: : 

Establishing documented evidence that a system does what if purpose to do based on a review and analysis of historical data and information obtained during production of marketable products. This validation includes : Batch documents. Process control chart. Maintenance log book. Record of personnel changes. Finished product data. Storage stability result. Retrospective Validation:

Conclusion. : 

Conclusion. Validation is obtained through beginning from the process development phase and continued through into production phase,which provides high degree of assurance that will consistently produce a product meeting its predetermined specification and quality attributes. It is used to achieve reduction of cost, process optimization, assurance of quality and safety. Process validation involves series of activity taking place over the Lifecycle of the product and process.

Bibliography : 

D.G.Watson, ‘Pharmaceutical Analysis ’,, Harcourt publishers , Second Edition 2005,1-21. Y.Anjaaneyulu, R.Marayya, ‘Quality Assurance and Quality management in Pharmaceutical Industry’,, Pharmamed publication, First Edition, 2009, 79-82. P.D.Sethi,Quantitave Analysis of Drugs in Pharmaceutical formulations, CBS Publishers, Third Edition, 2005, 51-64. M.A.Potdar, Pharmaceutical Quality assurance, Nirali Prakashan Second Edition,Dec.2007,8.1-8.108. Bibliography

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