Quality Assurance(QA) role In Pharma Industry

• Receipt of product design documents from Research Center.
• Distribution of documents received from Research Center (RC).
• Checking & approval of documents generated based on RC documents i.e. Batch Manufacturing Record.
• Scale-up and validation of product

Validation :

• Preparation of validation plans for facility / equipments / process including cleaning.
• Approval of protocols for validation of facility / equipment / product / process.
• Team member for execution of validation of facility / equipment / product / process.

Documentation Control :

• Controlled distribution and archiving of documents.
• Control of changes made by proper change control procedure.
• Approval of all documents

Assuring Quality of Products :

• cGMP training
• SOP compliance
• Audit of facility for compliance
• Line clearance
• In-process counter checks
• Critical sampling
• Record verification
• Release of batch for marketing
• Investigation of market complaints
• Stability of products

Quality Improvement Plans :

• Feedback received from the compliance team
• Proposals for corrective & preventive actions
• Annual products review
• Trend Analysis of various quality parameters for products, environment & water.