WHO_GMP_文件管理(中国培训ppt).ppt

World Health Organization * * This is an example of a batch record. The elements to look for here are easy reading, by careful setting out blocks of information so that the reader is able to go through the complicated information easily, and a systematic approach to the sequence of information. World Health Organization * * The batch packaging record is required for every batch or part batch that is packaged. It is developed from the relevant part of the packaging instructions and, once again, its review is an important part of the batch release process. Depending on company practice and the design of the document, it may be specific to a particular batch size or may be used for a variety of sizes. Before the start of the packaging process – checks that equipment and work station are suitable and clean should be provided. It should be checked that there is no previous product that remained on the packaging line. A formal line clearance (opening) should be done in accordance with an SOP and this should be recorded in the BPR or checklist. World Health Organization * * The batch packaging record. The information required for the completed batch packaging record, once again, consists of a combination of pre-printed material and data that are added by the operators during the process: Name of the product, batch number and quantity to be packed Batch number, theoretical quantity and actual quantity of finished product Reconciliation calculations Dates and times of operation Name of person responsible for packaging Initials of operators carrying out each step Checks made and results obtained World Health Organization * * The batch packaging record - continued: Details of packaging operation, including equipment and line used Returns to store Specimen of printed packaging materials, with batch coding Comments on deviations from the process and actions taken Reconciliation of packaging materials, including returns and destruction. If returns to the stores are pe