location and the principal equipment to be used. (f) the methods, or reference to the methods, to be used for preparing the critical equipments including cleaning, assembling, calibrating, sterilizing; (g) detailed stepwise processing instructions and the time taken for each step; (h) the instructions for in-process control with their limits; (i) the requirements for storage conditions of the products, including the container, labeling and special storage conditions where applicable; (j) any special precautions to be observed; (k) packing details and specimen labels. 21 Packaging Records: - 21.1 Whether authorized packaging instructions for each products, pack size and type are maintained and complied with. Whether following are included in the packaging instructions. (a) Name of the product; (b) the pack size expressed in terms of the weight or volume of the product in the final container; (d) 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.; (e) reproduction of the relevant printed packaging materials and specimens indicating where batch number and expiry date of the product have been applied; (f) 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. (g) description of the packaging operation, including any significant subsidiary operations and equipment to be used;
location and the principal equipment to be used. (f) the methods, or reference to the methods, to be used for preparing the critical equipments including cleaning, assembling, calibrating, sterilizing; (g) detailed stepwise processing instructions and the time taken for each step; (h) the instructions for in-process control with their limits; (i) the requirements for storage conditions of the products, including the container, labeling and special storage conditions where applicable; (j) any special precautions to be observed; (k) packing details and specimen labels. 21 Packaging Records: - 21.1 Whether authorized packaging instructions for each products, pack size and type are maintained and complied with. Whether following are included in the packaging instructions. (a) Name of the product; (b) the pack size expressed in terms of the weight or volume of the product in the final container; (d) 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.; (e) reproduction of the relevant printed packaging materials and specimens indicating where batch number and expiry date of the product have been applied; (f) 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. (g) description of the packaging operation, including any significant subsidiary operations and equipment to be used;