To define the responsibilities of Production Department.
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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