Quality Risk Management and Product Quality Review


Quality Risk Management and 

Product Quality Review

Quality Risk Management:

1.8 QRM is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively.

1.9 QRM should ensure that:

– The evaluation of the risk to quality is based on scientific knowledge, 

experience with the process and ultimately links to the protection ofthe patient;

– Tlevel of effort, formality and documentation of the QRM process 

is commensurate with the level of risk. 

Product Quality Review:

1.10 Regular, periodic or rolling quality reviews of all pharmaceutical products, including export-only products, should be conducted with the objective of verifying the consistency of the existing process and the appropriateness of current specifications for both starting materials and finished product, to highlight any trends and to identify product and process improvements. Such reviews should normally be conducted and documented annually, taking into account previous reviews, and should include at least:

a) Review of starting materials and packaging materials used for the product, especially those from new sources and in particular the review of supply chain traceability of active substances;

b) A review of critical in-process controls, and finished product results;

c) A review of all batches that failed to meet established specification(s) and their investigation;

d) A review of all significant deviations or non-conformances, the related investigations and the effectiveness of resultant CAPAs taken;

e) A review of all changes made to the processes or analytical methods;

f) A review of dossier variations submitted, granted or refused;

g) A review of the results of the stability monitoring programme and any adverse trends;

h) A review of all quality-related returns, complaints and recalls and the investigations performed at the time;

i) A review of adequacy of any other previous corrective actions on product processes or equipment;

j) Post-marketing commitments for new dossiers and variations to the dossiers;

k) The qualification status of relevant equipment and utilities, e.g. heating, ventilation and air-conditioning (HVAC), water or compressed gases and a review of the results of monitoring the output of such equipment and utilities;

l) A review of technical agreements to ensure that they are up to date.

The manufacturer and, where different, marketing authorization holder, should evaluate the results of the review and an assessment should be made as to whether CAPA or any revalidation should be undertaken, under the PQS. CAPAs should be completed in a timely and effective manner, according to documented procedures. There should be procedures for the ongoing management and review of these actions, and the effectiveness of these procedures should be verified during self-inspection. Quality reviews may be grouped by product type, e.g. solid dosage forms, liquid dosage forms, or sterile products, where scientifically justified. Where the marketing authorization holder is not the manufacturer, there should be a technical agreement in place between the various parties that defines their respective responsibilities in producing the quality review. The authorized person responsible for final batch certification, together with the marketing authorization holder, should ensure that the quality review is performed in a timely manner and is accurate.

WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles

(Annex 2, WHO Technical Report Series 986, 2014)

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