Hong Kong Guide to Good Manufacturing Practice for the Secondary ...

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8. STOCK HANDLING AND STOCK CONTROL Stock Rotation and Control 8.1 Comprehensive records should be maintained showing all receipt and issue of products (for secondary packaging) according to batch number. 8.2 Periodic stock reconciliation should be performed comparing the actual and recorded stocks. In any event, this should be performed when each batch is totally used up. All significant stock discrepancies should be subjected to investigation as a check against inadvertent mix-ups and wrong issues. 8.3 The issue of products for secondary packaging should normally observe the principle of stock rotation, i.e. first-in-first-out. 8.4 Products with broken seals, damaged packaging or suspected of possible contamination must not be sold or supplied. 8.5 Goods bearing an expiry date must not be received or supplied after their expiry date or so close to their expiry date that this date is likely to occur before the goods are used by the customer. 8.6 All labels and containers of products should not be altered, tampered or changed. The legislative requirements relating to labels and containers for pharmaceutical products should be complied with at all times. Delivery of Finished Products 8.7 Before delivery, each consignment should be checked against the relevant documentation and physically verified by label description, type and quantity, against the order. 8.8 Records should be maintained of the distribution of each batch of the product packaged in order to facilitate the recall of the batch if necessary. 9. REJECTED AND RETURNED GOODS Rejected Goods 9.1 Rejected materials and products should be clearly marked as being rejected and stored separately in a locked area with restricted access. They should be either returned to the suppliers or destroyed. Whatever action is taken should be recorded and approved by the Quality Assurance Officer. 9.2 All pharmaceutical products must be destroyed or disposed of in accordance with the provisions of the relevant legislative requirements. Returned Goods 9.3 There should be a Standard Operating Procedure (SOP) for the handling of returned products. Records of all returns goods should be kept. 9.4 All returned products should be kept apart from saleable stock until a decision has been reached regarding their disposal. 9.5 Products should only be returned to saleable stock if: a. The goods are in their original unopened containers and in good condition; b. It is known that the goods have been stored and handled under proper conditions; c. The remaining shelf life period is acceptable; and Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 12
d. The goods have been examined and assessed by the Quality Assurance Officer. This assessment should take into account the nature of the product, any special storage conditions required, and the time which had elapsed since it was distributed. Special attention should be given to thermo-labile products. 9.6 The returned products should be formally released to the saleable stock by the Quality Assurance Officer. 10. PRODUCT COMPLAINTS 10.1 An SOP describing the actions to be taken for the handling of all written and oral complaints regarding a product should be available. The SOP should ensure that the complaints received are investigated and followed through, that corrective actions are taken to prevent repeated complaints, and, where a decision is made to recall the product, the details of the recall. 10.2 There should be a record for each individual complaint. Investigations 10.3 The Quality Assurance Officer should initiate the investigation immediately and all investigation should be documented in writing. The investigation should take into consideration the condition and circumstances under which the product was distributed, stored and used. 10.4 If a product defect is discovered or suspected in a batch, consideration should be given to determine whether other batches are also affected. 10.5 An investigation report should be prepared with all corrective/preventive actions clearly stated. 11. PRODUCT RECALL 11.1 There should be an SOP for all urgent and non-urgent product recalls. 11.2 In the event of a recall, all customers to whom the product has been distributed should be informed with the appropriate degree of urgency. 11.3 The recall message should indicate whether the recall needs to be carried out at the retail level, and whether there is a need to remove all recalled products immediately from the shelves, and prevent their mixing with other saleable stocks. 11.4 If the product is exported, the overseas counterparts and/or regulatory authorities must be informed of the recall. 11.5 All actions taken in connection with the recall must be approved by the company and/or regulatory authorities, and recorded. Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 13
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