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Assuring a higher degree of quality of drug products.
Validation is a process of establishing documentary evidence demonstrating that procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages. In Pharma Industry it is imperative apart from final examination and respect of the product with the standard that the process adapted to produce itself must assure that process will consistently produce the expected results. Here the desired results are established regarding specifications for the outcome of the process.
Qualification of systems and equipment is, therefore, a part of the process of validation. It is a requirement of food and drug, pharmaceutical regulating agencies like FDA's proper manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation comprises the following subsections.
HVAC System Validation
Analytical Method Validation
Computer System Validation
Cold Chain Validation
Similarly, the activity of qualifying systems and equipment comprises the following subsections:
Design Qualification (DQ)
Component Qualification (CQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)