I. Particulars to be shown in the manufacturing records: (1) Serial number. (2) Name of the product. (3) Lot or Batch size. (4) Lot or Batch number. (5) Date of commencement of manufacture and date when manufacture was completed. (6) Names of all ingredients, quantities required for the lot/batch size, quantities actually used. (7) Control reference numbers in respect of raw materials used in formulation. (8) Reference to analytical report numbers or unique code. (9) Actual production and packing particulars indicating the size and quantity of finished packings. (10) Date of release of finished packing for distribution or sale. (11) Signature of the expert staff responsible for the manufacture. II. Records of raw materials: Records in respect of each raw material shall be maintained indicating the quantity received, control reference number, the quantity issued from time to time, the names and batch numbers of the products for the manufacture of which the said quantity of r
There shall be authorised packaging instructions for each product, pack size and type. These shall include or have a reference to the following: -
- Name of the product;
- Description of the dosage form, strength and composition;
- The pack size expressed in terms of the number of doses, weight or volume of the product in the final container;
- Complete list of all the packaging materials required for a standard batch size, including quantities, sizes and types with the code or reference number relating to the specifications of each packaging material.;
- Reproduction of the relevant printed packaging materials and specimens indicating where batch number and expiry date of the product have been applied;
- Special precautions to be observed, including a careful examination of the area and equipment in order to ascertain the line clearance before the operations begin.
- Description of the packaging operation, including any significant subsidiary operations and equipment to be used;
- Details of in-process controls with instructions for sampling and acceptance; and
- Upon completion of the packing and labelling operation, a reconciliation shall be made between number of labelling and packaging units issued, number of units labelled, packed and excess returned or destroyed. Any significant or unusual discrepancy in the numbers shall be carefully investigated before releasing the final batch.
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