Annual
Product Quality Review – APQR/APR/PQR
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Product quality review is an annual evaluation of
a pharmaceutical preparation, which looks back at production and quality
control data to assess changes, trends and weaknesses.
In other words it is a structured procedure in
which all information, changes and dependencies that have arisen during a
calendar year with regard to the manufacture and control of a preparation are
detected, evaluated and documented and in which suggestions for improvements
are recommended.
Importance of PQR in Pharmaceuticals
1.
PQR is a regulatory requirement
CFR 211.180 (e) basically
specifies that the quality standard of every product must be evaluated at least
once a year based on the current specifications and records to determine
whether modifications to product specifications, manufacturing instructions or
control procedures are required.
Chapter 1
(Pharmaceutical Quality System) of EU guidelines also recommends to evaluate
the consistency of existing process annually through PQR.
2. PQR is an effective quality improvement tool to enhance the consistency of the existing
process & overall quality of the product (PQR helps to highlight any trends
and to identify product & process improvements).
3. PQR will provide a broader view of product data &
it can serve as a historical document.
4. PQR will
capture trends & will help to determine the need for revalidation and
changes any.
5. PQR offers
the opportunity to critically examine the functions of internal systems, such
as change controls, documentation, storage, investigation of deviations, OOS procedures
and the processing of complaints.
6. In short
product review serves as "ongoing validation" and, on the other hand,
the data and results obtained are important prerequisites for continuous
improvement (CIP).
PQR Preparation Procedure
•
PQR preparation
should typically be carried out for each product manufactured in the previous
year.
•
All documents which directly or indirectly refer to the
manufacture and control of a preparation in the period concerned must be
investigated.
•
Data should
be presented in tabular form or in graphical form (i.e., charts or graphs),
when applicable.
What data
must be given in product quality review?
•
A review of
starting and primary packing materials used in the FPP, especially those from
new sources.
•
All analytical results obtained from the certificates of
analysis must be recorded and evaluated. The results must be included as
averages or individual values, depending on the test item.
•
A tabulated
review and statistical analysis of quality control and in-process control &
finished product results.
•
Yield control - The yields at the individual manufacturing
stages must be recorded. Losses at critical production stages must be evaluated
for possible risk. Yields that fall below the tolerance range must be
explained.
•
Qualification status of critical equipments, facilities &
utilities.
•
Change to starting material & product specifications.
•
A review of
all critical deviations or non-conformances and related investigations.
•
A review of
all changes carried out to the processes or analytical methods.
•
Details of
stability testing & process validations etc.
•
A review of
the results of the stability-monitoring program
•
A review of all quality-related returns,
complaints and recalls - All internal and external
complaints, as well as the affected measures must be presented in order to
prevent complaints of a similar kind in the future.
Consequences of PQR
•
Process optimisation
•
Revalidation
•
Adaptation of manufacturing or control procedures
•
Amendments in current specifications
•
Strict change control programs
•
Improvement of complaint processing
References
•
Guidance
note on PQR – HSA guideline.
•
EU
guidelines for good manufacturing practice for medicinal products for human
& veterinary use.
•
PIC/S PE 009
-10 (effective 01 january2013)
