1.Objective :

 To define the responsibilities of  Production Department.

2. Scope:

This procedure is applicable to all personnel working in Production Department.

3. Responsibilities :

Microbiology Person / Designee, Microbiology Head

4. Procedure :

  • Strict adherence to approved procedures.
  • To ensure Good Manufacturing Practices.
  • To follow good documentation practices while making entries in Documents & records.
  • To ensure data integrity throughout the whole process.
  • To ensure proper sanitation, cleaning and housekeeping in chemical area & powder processing area.
  • Making sure that production facilities are clean and when appropriate disinfected.
  • To follow entry-exit procedure for powder processing area to avoid contamination.
  • Preparation of SOPs, Protocols & Reports for validation, Batch records, equipment cleaning records.
  • Making sure that validation protocols and reports are reviewed and approved.
  • Preparing, reviewing, approving and distributing the instructions for the production of drug substances &/or drug products according to written procedures.
  • Producing drug substances &/or drug products and, when appropriate, according to preapproved instructions.
  •  Reviewing all production batch records and ensuring that these are completed and signed.
  • Making sure that all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions are recorded;
  • Making sure that the necessary calibrations are performed and records kept.
  • Making sure that preventive maintenance of all equipments has been performed as per their schedule in co-ordination with engineering department.
  • To ensure that all the status & tags are available at their respective positions.
  • To ensure the availability of the all utilities, raw materials, packaging materials, solvents before proceeding for the batch.
  • Making sure that the premises and equipment are maintained and records kept.
  • Evaluating proposed changes in product, process or equipment.
  • Making sure that new and, when appropriate, modified facilities and equipment are qualified.
  • In case of any non-conformance, immediately reporting to head / designee for the necessary actions.

5. Abbreviations :


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