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Packing Records

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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