The USFDA requires that the quality standards of each drug product must be evaluated at least once a year. Other regulatory bodies have similar requirements and these can be met through the performance of an annual Quality Review.
An annual product quality review is the evaluation of a given
product’s quality to verify that the existing processes used in its manufacture
are consistently producing the desired quality product. This helps to ensure
that current specifications for that drug product are adequate; the trends
revealed by the data also provide insights for any changes to be introduced in
either the manufacturing or control procedures or in the product
specifications.
A representative number of batches must be selected, and a
review must be done of the documents associated with them to check for
adherence to specifications. Both approved and rejected batches must be a part
of this study. Along with this, it is also important to evaluate any complaints
received regarding the same product batches, or any returns or recalls that
have been associated with those batches.
By doing these activities, it is possible to find areas
where improvement is necessary. When such improvements are introduced into the
next batch being manufactured, it leads to a process that is better capable of
manufacturing products of the desired quality.
The quality review includes:
• Starting materials
• Packaging materials
• Critical in-process controls
• Critical equipment qualifications
• Finished product test results
• Stability studies
• Change control procedures
• CAPA effectiveness
• Returns/recalls
• Market complaints
• Deviations/non-conformances
• Failed batches
• Previous batches review
Typically, in a quality review, historical data from batches
of a particular product manufactured over the past 12 months is reviewed and
analyzed using statistical techniques. This helps to assess if the process is
in control or not and if any changes are necessary. Based on the results of the
review, re-validation or CAPA may be undertaken.
Following a review of all relevant headings, the higher
management must highlight the major observations made, and arrive at
conclusions regarding quality improvement. The inferences drawn must result in
appropriate recommendations on any corrective actions that may be necessary
such as a formulation or packaging change, revision of specifications, or
making processes more robust.
Performing a quality review is vital because it enables a
better understanding of processes and this can guide further quality
improvements. Such a review also serves as a method of continued process
verification. The trends observed in the quality review can be an indication of
areas of potential risk; thus, this exercise is also a part of the risk
management plan of the company that is recommended by ICH guidelines.