Amendment status not verified — confirm the current text below against the official source.
Batch Processing Records 21.1 There shall be Batch Processing Record for each product. It shall be based on the relevant parts of the currently approved Master Formula. The method of preparation of such records included in the Master Formula shall be designed to avoid transcription errors. 21.2 Before any processing begins, check shall be performed and recorded to ensure that the equipment and work station are clear of previous products, documents or materials not required for the planned process are removed and the equipment is clean and suitable for use. 21.3 During processing, the following information shall be recorded at the time each action is taken and the record shall be dt. and signed by the person responsible for the processing operations: - (a) the name of the product, (b) the number of the batch being manufactured, (c) dates and time of commencement, of significant intermediate stages and of completion of production, (d) initials of the operator of different significant steps of production and where appropriate, of the person who checked each of these operations, (e) the batch number and/or analytical control number as well as the quantities of each starting material actually weighed, (f) any relevant processing operation or event and major equipment used, (g) a record of the in-process controls and the initials of the person(s) carrying them out, and the results obtained, Drugs and Cosmetics Rules, 1945 400 (h) the amount of product obtained after different and critical stages of manufacture (yield), (i) comments or explanations for significant deviations from the expected yield limits shall be given, (j) notes on special problems including details, with signed authorization, for any deviation from the Master Formula, (k) addition of any recovered or reprocessed material with reference to recovery or reprocessing stages.