Batch Packaging Records

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 preparing such records should be designed to avoid transcription errors. 

Additional information may be displayed in accordance with the order (e.g., dosing instructions, treatment period, standard warnings). When necessary for blinding purposes, the batch number may be provided separately (see also Blinding operations ). A copy of each type of label should be kept in the batch packaging record. 

The results of any in-process testing should form part of the batch packaging records. 

A batch packaging record shall be kept for each batch of product. It shall at least contain ... 

All packaging operations should proceed in accordance with the instructions given and using the specified materials in the Master Packaging Procedure. Details of the operation should be recorded on the Batch Packaging Record. 

Results of in-process tests/inspection must be recorded, and those documents must become a part of the Batch Packaging Records. 

The supervisor should oversee the counting and destruction of non-returnable packaging components and bulk product. All unused coded materials shall be reconciled and destroyed. Quantities destroyed should be recorded on the Batch Packaging Record. 

Batch Packaging Records should be kept for each batch or part-batch processed and should be based upon the currently approved version of the Master Packaging Instruction and prepared from it by a method designed to avoid transcription errors (photocopying or some similar method is to be preferred). The Record should carry the quantity of bulk product to be packed, the planned quantity of finished product and should bear a batch reference number, which is specific to a particular packaging run. The batch number which appears on the finished product should be this number, or one which may be easily related to it... 

If the Batch Packaging Records do not include details of the method of packaging, these should be readily available to the operators). 

During packaging, the following should be entered onto the Batch Packaging Records, at the time that each action is taken ... 

Production staff should follow defined and authorized procedures for each stage of each manufacturing process, i.e. the manufacture of a product should proceed in accordance with the Master Formula and Method, and/or with the Master Packaging instruction (Ref 3.17 to 3.21), supplemented as necessary by Standard Operating Procedures. The details of the operation should be recorded on the Batch Manufacturing Record, or Batch Packaging Record (Ref 3.30 to 3.38). 

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