A 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 limits. 4.20 A Batch Processing Record should be kept for each 4.17 A Batch Processing Record should be kept for each batch Moved the Nil batch processed. It should be based on the relevant processed. It should be based on the relevant parts of the second parts of the currently approved Manufacturing Formula currently approved Manufacturing Formula and Processing paragraph of PE and Processing Instructions, and should contain the Instructions. The method of preparation of such records 009-8 clause following information: should be designed to avoid transcription errors. The record 4.17 to PE should carry the number of the batch being manufactured. clause 4.18 as The name and batch number of the product; a new entry f), as Before any processing begins, there should be recorded checks this is a more Dates and times of commencement, of that the equipment and work station are clear of previous logical place significant intermediate stages and of products, documents or materials not required for the planned completion of production; process, and that equipment is clean and suitable for use. Minor rewrite Identification (initials) of the operator(s) replacing PE During processing, the following information should be who performed each significant step of the 009-8 clause recorded at the time each action is taken and, after process and, where appropriate, the name 4.17 entry c) by completion, the record should be dated and signed in of any person who checked these PE 009-10clause agreement by the person responsible for the processing operations; 4.20 entry i). operations: That is, replacing The batch number and/or analytical control names of number as well as the quantities of each the name of the product; responsible starting material actually weighed dates and times of commencement, of significant persons per (including the batch number and amount of intermediate stages and of completion of stage of any recovered or reprocessed material production; production with added); one name of the name of the person responsible for each stage of Any relevant processing operation or event person production; and major equipment used;
A 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 limits. 4.20 A Batch Processing Record should be kept for each batch processed. It should be based on the relevant parts of the currently approved Manufacturing Formula and Processing Instructions, and should contain the following information: The name and batch number of the product; Dates and times of commencement, of significant intermediate stages and of completion of production; Identification (initials) of the operator(s) who performed each significant step of the process and, where appropriate, the name of any person who checked these operations; The batch number and/or analytical control number as well as the quantities of each starting material actually weighed (including the batch number and amount of any recovered or reprocessed material added); Any relevant processing operation or event and major equipment used; 4.17 A Batch Processing Record should be kept for each batch processed. It should be based on the relevant parts of the currently approved Manufacturing Formula and Processing Instructions. The method of preparation of such records should be designed to avoid transcription errors. The record should carry the number of the batch being manufactured. Before any processing begins, there should be recorded checks that the equipment and work station are clear of previous products, documents or materials not required for the planned process, and that equipment is clean and suitable for use. During processing, the following information should be recorded at the time each action is taken and, after completion, the record should be dated and signed in agreement by the person responsible for the processing operations: the name of the product; dates and times of commencement, of significant intermediate stages and of completion of production; name of the person responsible for each stage of production; Moved the second paragraph of PE 009-8 clause 4.17 to PE clause 4.18 as a new entry f), as this is a more logical place Minor rewrite replacing PE 009-8 clause 4.17 entry c) by PE 009-10clause 4.20 entry i). That is, replacing names of responsible persons per stage of production with one name of the person Nil
consult-manuf-automatic-adoption-pics-130529-comparison.docx