In detail
Legal basis
The PQR is set out in sections 1.10 and 1.11 of Chapter 1 of the EU GMP Guide (Pharmaceutical Quality System). Regular periodic or rolling quality reviews must be conducted for all authorised medicinal products, including export-only products. They should normally be conducted and documented annually and take previous reviews into account.
Minimum content
The guide lists, among other things:
- starting materials and packaging materials, especially from new sources, and the supply chain traceability of active substances
- critical in-process controls and finished product results
- all batches that failed to meet specifications and their investigation
- all significant deviations, the related investigations and the effectiveness of the CAPA taken
- changes to processes or analytical methods
- marketing authorisation variations submitted, granted or refused
- results of the stability monitoring programme and any adverse trends
- quality-related returns, complaints and recalls
- qualification status of relevant equipment and utilities such as HVAC, water and compressed gases
- whether contractual arrangements under Chapter 7 are up to date
Evaluation and responsibility
The manufacturer and, where different, the marketing authorisation holder evaluate the results and decide whether corrective and preventive action or revalidation is needed. Implementation of these actions is tracked, and their effectiveness is verified during self-inspection. Where the marketing authorisation holder is not the manufacturer, a technical agreement defines who is responsible for which part of the PQR. Where scientifically justified, products may be grouped, for example as solid, liquid or sterile dosage forms.
What matters
A PQR is more than a collection of data. Its value lies in trend evaluation and traceable conclusions. Difficulties usually arise when data come from several sources, such as contract manufacturers, contract laboratories and the marketing authorisation holder, and responsibilities have not been agreed in a contract. It helps to define in advance who supplies which data, in what format and by when. It is equally important that the conclusions of the previous year are picked up in the new PQR and checked for implementation.
In practice at A&O Pharma
A&O Pharma prepares Product Quality Reviews for its clients, either as part of document preparation or within ongoing QM/QA support. This includes the topics that feed into the PQR, such as deviations, CAPA, change control and complaints.
Document PreparationFrequently asked questions
Does a PQR have to be prepared every year?
The EU GMP Guide requires regular periodic or rolling reviews, which should normally be conducted and documented annually.
Who is responsible for the PQR, the manufacturer or the marketing authorisation holder?
Both evaluate the results. Where they are different companies, a technical agreement defines who is responsible for which part of the PQR.
Can several products be combined in one PQR?
Yes, where scientifically justified. The guide gives grouping by solid, liquid or sterile dosage forms as an example.
