A record of the in-process controls and the initials of the operator of different significant responsible for initials of the person(s) carrying them out, steps of production and, where appropriate, of the the operations and the results obtained; person who checked each of these operations (e.g. Inclusion of a weighing); The product yield obtained at different and provision for pertinent stages of manufacture; the trial number and/or analytical control number automated as well as the quantities of each starting material reporting Notes on special problems including details, actually weighed (including the batch number and systems with signed authorisation for any deviation amount of any recovered or reprocessed material from the Manufacturing Formula and added); Processing Instructions; any relevant processing operation or and Approval by the person responsible for the major equipment used; processing operations. a record of the in-process controls and the initials Note: Where a validated process is continuously of the person(s) carrying them out, and the results monitored and controlled, then automatically obtained; generated reports may be limited to compliance the amount of product yield obtained at different summaries and exception / out-of-specification (OOS) and pertinent stages of manufacture; data reports. on special problems including details, with signed authorisation for any deviation from the Manufacturing Formula and Processing Instructions. 4.21 A Packaging Record should be kept for each 4.18 A Batch Packaging Record should be kept for each batch Moved the Nil batch or part batch processed. It should be based on the or part batch processed. It should be based on the relevant second relevant parts of the Packaging Instructions. parts of the Packaging Instructions and the method of paragraph of PE preparation of such records should be designed to avoid 009-8 clause The batch packaging record should contain the following transcription errors. The record should carry the batch 4.18 to PE information: number and the quantity of bulk product to be packed, as well clause 4.19 as as the batch number and the planned quantity of finished a new entry f), as The name and batch number of the product that will be obtained. product;
A record of the in-process controls and the initials of the person(s) carrying them out, and the results obtained; The product yield obtained at different and pertinent stages of manufacture; Notes on special problems including details, with signed authorisation for any deviation from the Manufacturing Formula and Processing Instructions; Approval by the person responsible for the processing operations. Note: Where a validated process is continuously monitored and controlled, then automatically generated reports may be limited to compliance summaries and exception / out-of-specification (OOS) data reports. initials of the operator of different significant steps of production and, where appropriate, of the person who checked each of these operations (e.g. weighing); the 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 and major equipment used; a record of the in-process controls and the initials of the person(s) carrying them out, and the results obtained; the amount of product yield obtained at different and pertinent stages of manufacture; on special problems including details, with signed authorisation for any deviation from the Manufacturing Formula and Processing Instructions. responsible for the operations Inclusion of a provision for automated reporting systems 4.21 A Packaging Record should be kept for each batch or part batch processed. It should be based on the relevant parts of the Packaging Instructions. The batch packaging record should contain the following information: The name and batch number of the product; 4.18 A Batch Packaging Record should be kept for each batch or part batch processed. It should be based on the relevant parts of the Packaging Instructions and the method of preparation of such records should be designed to avoid transcription errors. The record should carry the batch number and the quantity of bulk product to be packed, as well as the batch number and the planned quantity of finished product that will be obtained. Moved the second paragraph of PE 009-8 clause 4.18 to PE clause 4.19 as a new entry f), as Nil trial
consult-manuf-automatic-adoption-pics-130529-comparison.docx