SOP on Master Packaging Records
1.0 Purpose: The purpose of this document is to laid down requirements for packaging records in manufacture of a drug batch.
2.0 Scope: This SOP applies to Production Staff.
3.0 Responsibility: Production Chemist to ensure that procedure is followed.
4.0 Materials and Equipment: As required.
5.0 Procedure: Master packaging records are prepared for each product. The information in master packaging records includes –
1. Name of product.
2. Description of product’s pharmaceuticals form and strength.
3. Batch size.
4. Complete list of pack, sizes expressed in appropriate unit and with types of all packaging materials associated with them.
5. Copy of relevant printed packaging materials (e.g. labels,foils, cartons)
6. Special precautions to be observed (e.g. room temperature, relative humidity).
7. Permissible limits of packaging loss / gain for reconciliation of total packaged yield Vs actual manufacturing yield.