Wednesday, October 31, 2012

Quality Assurance(QA) role In Pharma Industry

Technology Transfer :
  • 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.

1 comment:

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