A Contract Manufacturing Company Has Been Analysing A Tablet

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A contract manufacturing company has been analysing a tablet product by the method described in the British Pharmacopoeia (BP) monograph. This is the method detailed on the product License and BP methods are generally considered to be validated. After trend analysis for the annual Product Quality Review (PQR) report, it has been discovered that 5 batches were rejected in 2013 due to high out of specification assay results. Furthermore, several batches had assay values close to the upper specification limit. The release specification limits for the product are 95-105%.

As a result of this finding, the Head of Quality Assurance has requested full validation to be performed on the method to assure the quality of the assay results generated
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The need for adequate facilities and trained personnel to follow approved procedures for sampling and testing materials.
2. Records of all the required sampling, inspection and testing procedures to demonstrate that all the products, formally assessed against the outlined specifications.
3. Any deviations are fully recorded and investigated
4. The finished product need to contain active ingredients complying with the qualitative and quantitative composition of the marketing authorisation and are of the purity required.
5. No batch of product can be released for sale or supply without the approval of QP (Qualified person).
6. Sufficient references samples of the starting materials and products need to be retained for future examination of the batch if necessary.

Quality assurance and Quality control

Quality assurance collectively influence the quality of a product. The product need to be designed and developed, considering GMP and GLP (Good laboratory practice). The system ensured that there is a procedure regularly for self-inspection and auditing.
The head of productions and QC and head of quality assurance generally have shared responsibilities, in ensuring the effective quality management system. According to MHRA guidelines the head of production department has the following responsibilities:

1. To ensure that the product is produced and stored according to the appropriate

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