Record, batch processing

A batch processing record should be kept for each batch processed. It should be based on the relevant parts of the currently approved master formula. The method of... 

The sterility test applied to the finished product should be regarded only as the last in a series of control measures by which sterility is assured and can be interpreted only in conjunction with the environmental and batch processing records. 

Batches failing an initial sterility test should not be released on the basis of a second test unless an investigation into the type of organism found, and into the environmental and batch processing records involved, show that the original test was invalid. 

Prior to packaging and labelling of a given batch of a drug the Batch Processing Records specified should show that the batch has been duly tested and approved for packaging by the Quality Control unit. 

Batch processing records for sterile products should include details of the sterilisation of the batch and, where the batch is aseptically processed, details of the sterilisation of the components and equipment used. 

The charts of automatic recorders of cycle parameters should constitute part of the batch processing records of sterile products and should be marked to identify the batch or batches to which each applies. 

Rejected or discarded tablets should be placed in containers clearly identifying them as such and the quantity recorded in the Batch Processing record. 

Batch processing records for sterile products should include details of the sterilisation of the components and equipment used. 

Tests to demonstrate the integrity of seals of closures on product containers should be carried out during the production of each batch. These results should form part of the batch processing records. 

Master Packaging instruction (Ref. 3.21), supplemented as necessary by Standard Operating Procedures. Details of the operation should be recorded on the Batch Processing Record (Ref. 3.34 - 3.38). 

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