The Quality Control Release System

In defining the overall system for Quality Control release of finished products, it is for the manufacturing organisation to decide on the following:

• The timing of the review of batch documents and analytical results
• The extent to which batch data is used to authorise further processing of intermediates and part finished products.

The two most common ways to approach this are:

• To review batch documents/analytical data on completion of each manufacturing stage and release the finished product on the basis of finished pack ‘inspection’ and confirmation that earlier stages have been previously approved.
• To sample finished packs for full analytical testing and carry out the batch document evaluation and finished pack inspection on completion of packaging.

Whatever system is chosen, quality control release of finished products will depend on the availability of satisfactory:

• Bulk manufacturing records (eg. Granulation)
• Intermediate processing records (eg. Tablet compression)
• Packaging records
• Records of in-process checks (the majority of these normally appear in the production records)
• Reconciliations of product and material usage at each stage of the process and evaluation of the yield for the manufacturing process overall
• Reports giving analytical and/or microbiological results
• Requests for release/transfer/shipping of the batch.

In Practice it may be convenient to use checklists for each product category or activity which ensures and records all the necessary documents and results have been gathered together, reviewed, checked, assessed as satisfactory and filed. The checklist should be filed with the batch records and the document authorising the disposition of the batch.

The batch documentation or suitable summary should be submitted to a person authorised to carry out Quality Control release who should then satisfy themselves that all the documents detailed above have been duly completed and checked, and any expectations investigated and reported. Where batches of product are sub-divided during processing, the checks should extend to all the relevant records including those of the parent batch and, where necessary, relevant data from associated sub-batches (eg. Numbers used/filled in order to carry out an overall reconciliation).

The way in which the Qualified Person or Quality Expert satisfies themselves that the batch/es concerned have been made in accordance with legal requirements is a professional and personal matter for them to decide. It is recommended, however, that this should be extended beyond the checking of batch documents and records and it should include the periodic review of the product and systems affecting and assuring product quality.

Where checks reveal deviations from the accepted practices, unforeseen events or analytical results outside ‘release’ limits, the person responsible for Quality Control and the Qualified Person or Quality Expert must agree the fate of the batch concerned. In these circumstances, the following factors should be taken into consideration:

• The requirements of the product licence and manufacturing licence
• The stability of the product and the end of life (check) specification for the product
• The results of investigations carried out on the batch concerned.

On completion of all the necessary checks, the person authorised to carry out Quality Control release should sign for the disposition of the batch in the formal records. If this person is also carrying out duties of the Qualified Person or Quality expert, then they should ensure that additional checks are carried out as appropriate and that the batch is entered on the register which is then signed. Where a second person is carrying out the duties of the Qualified Person or Quality Expert, Quality Control must ensure that they are provided with the sufficient information to carry out their duties and that each batch has been signed off in the batch register.

Once all these checks and batch certification is complete, the person responsible for Quality Control release can sign the documents that authorise transfer to stock or for shipping.