Quality Assurance

Fitwel's quality policy is mandated and supported by the Executive Management and coordinated by an independent Corporate Quality Assurance (CQA) Department.

Highlights :

  • Quality Assurance is independence of Manufacturing.
  • In-Process quality is checked during manufacturing.
  • Validation of facilities, equipments, process, products & cleaning as per Master Plan.
  • Complaint Handling.
  • Storage of quality record and control samples.
  • Stability Studies.
  • Registration Documents (DMF)

Quality Assurance Departmenthandles the following activities :

Technology Transfer :

  • Receipt of product design documents from Fitwel Research Centre (FRC).
  • Distribution of documents received from FRC.
  • Checking & approval of documents generated based on FRC 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.