Packaginginstructions包装材料.docx

Packaging instructions15.24 Formally authorized packaging instructions should exist foreach product, pack size and type. These should normally include, or makereference to: (a) the name of the product;(b) a description of its pharmaceutical form, strength and, where applicable,method of application;(c) the pack size expressed in terms of the number, weight or volume of theproduct in the final container;(d) a complete list of all the packaging materials required for a standard batchsize, including quantities, sizes and types, with the code or referencenumber relating to the specifications for each packaging material;(e) where appropriate, an example or reproduction of the relevant printedpackaging materials and specimens, indicating where the batch numberand expiry date of the product have been marked;(f ) special precautions to be observed, including a careful examination of thepackaging area and equipment in order to ascertain the line clearancebefore and after packaging operations;(g) a description of the packaging operation, including any significant subsidiaryoperations, and equipment to be used;(h) details of in-process controls with instructions for sampling and acceptancelimits.Batch processing records15.25 A batch processing record should be kept for each batch processed. Itshould be based on the relevant parts of the currently approved specificationson the record. The method of preparation of such records should be designedto avoid errors. (Copying or validated computer programmes are recommended.Transcribing from approved documents should be avoided.)15.26 Before any processing begins, a check should be made that the equipmentand work station are clear of previous products, documents, or materialsnot required for the planned process, and that the equipment is clean and suitablefor use. This check should be recorded.15.27 During processing, the following information should be recorded at thetime each action is taken, and after completion the record should b