Quality Assurance

Onesta Lifecare one of the top PCD pharma companies in India has a modern and well-equipped Quality Control (QC) laboratory, which ensures that our products are pure, safe and effective and are released only after thorough analysis as per stringent specifications, methods and procedures developed according to international guidelines viz. cGMP, WHO – GMP, EU-cGMP and PIC/S etc.

Quality Assurance Departmenthandles the following activities :

  • Quality Assurance is independence of Manufacturing.
  • In-Process quality is checked during manufacturing.
  • Validation of facilities, equipments, process, products & cleaning as per Master Plan.
  • Consectetur consequat.
  • Storage of quality record and control samples.
  • Stability Studies.
  • Registration Documents (DMF)
  • 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
  • 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.
  • Controlled distribution and archiving of documents.
  • Control of changes made by proper change control procedure.
  • Approval of all documents
  • CGMP training
  • SOP complianceprocedure.
  • 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
  • Feedback received from the compliance team
  • Proposals for corrective & preventive actions
  • Annual products review
  • Trend Analysis of various quality parameters for products, environment & water.