Small and Medium Pharmaceutical Industry Centre (SMPIC) NIPER-SAS Nagar will organise a one-day interactive seminar on validation between industry, government, academia and individuals on April 30 at NIPER compound, Mohali, Chandigarh.
The main objective of the seminar is to describe how the validation programme will be executed in a facility. It is the document that outlines the principles involved in the qualification of a facility that defines the areas and systems to be validated and provides a written programme for achieving and maintaining a qualified facility with validated processes. It is the foundation for the validation programme and should include process validation, facility and utility qualification and validation, equipment qualification cleaning and computer validation.
Dr D Roy, Deputy Drugs Controller, CDSCO (NZ), Ghaziabad, Dr Ajaya Prakash, general manager (QA), Winmedicare, Meerut, Ravi Saxena, director, cGMP Pharma 'n' Plans Pvt Ltd., Neeti Bharadwaj, director (Validation and QA), cGMP Pharma 'n' Plans Pvt Ltd., Bhavin Mehta, director, Kilitch Drugs (India) Ltd., Aprajita Takiar, MD, Lark Laboratories will put forth the importance and the requirement of validation.
According to GMP definition validation is an establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.
In pharma industry, validation is a small but an important part of GMP compliance. It is a documented act of demonstrating a wide variety of procedures, processes and activities that needs to be validated and includes process validation, analytical method validation, cleaning validation and computer system validation which leads to the consistent and expected outcome.
The activity of qualifying systems and equipments is divided into sub-sections which includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Standard Operating Procedures (SOPs), manufacturing formulae, detailed batch documentation, change control systems, investigational reporting systems, analytical documentation, development reports, validation protocols and reports, are integral components of the validation philosophy.
A validation documentation provides a source of information for the ongoing operation of the facility and is a resource that is used in subsequent process development and modification activities.