Product Quality Reviews (PQRs) are conducted annually to review manufacturing processes, specifications, trends, and identify improvements for pharmaceutical products. PQRs can be done on individual products, grouped products, or through exception reviews. The objective is to verify consistency, specifications, identify trends, and improvements. PQRs provide information on processes, quality requirements, and release decisions. Outcomes are used to identify continuous quality improvements through action plans. Manufacturers are responsible for preparing review data and lists, while reviews consider starting materials, specifications, failures, deviations, changes, variations, stability, complaints, and contractual arrangements.

1. Product Quality Reviews (PQRs)

2. PQR
 Product Quality Review (PQR) is a mechanism to ensure that data captured by the
Pharmaceutical Quality System (PQS) is reviewed for trends.
 Regular periodic or rolling quality reviews of all authorised medicinal products,
including export only products, should be conducted with the objective of verifying the
consistency of the existing process, the appropriateness of current specifications for
both starting materials and finished product, to highlight any trends and to identify
product and process improvements.

3. Objective of a PQR are:
 Verify the consistency of the existing manufacturing process
 Verify the appropriateness of current specifications for both starting materials and
finished products
 Highlight any adverse quality trends
 Identify product and process improvements

4. PQRs provide:
 Useful information and additional controls over manufacturing processes and quality
requirements
 Important information for release for supply (RFS) authorised persons

5. Implementation of PQR outcomes
 The data generated and evaluated in the PQR should be used to identify any items for
continuous quality improvements and an action plan should be documented to manage
this process.

6. Manufacturer Responsibilities
 Prepare the data for the PQR related to their manufacturing steps
 List significant non-conformances, deviations and CAPAs for equipment, process and
products
 Submit data and lists to the PQR compiler
 Retain a copy of the data and lists, for provision to TGA inspectors
 Hold objective evidence that demonstrates that responsibilities have been undertaken

7. Frequency of PQRs
 PQRs are normally conducted and documented annually.
 Where a small (statistically invalid) number of batches of a product have been
manufactured in the year:
• a review can be conducted every 2 years
• products may be grouped with other similar products
• products may be included in the review using the ‘by exception’ option

8. Content of a PQR
The review should:
• Capture product quality events
• Investigate and thoroughly document any potential impacts on the process or systems
as a whole
• Be intended to result in continuous product improvement

9. PQR should include at least:
(i) A review of starting materials including packaging materials used in the product, especially those from new
sources and in particular the review of supply chain traceability of active substances;
(ii) A review of critical in-process controls and finished product results;
(iii) A review of all batches that failed to meet established specification(s) and their investigation;
(iv) A review of all significant deviations or non-conformances, their related investigations, and the effectiveness of
resultant corrective and preventive actions taken;
(v) A review of all changes carried out to the processes or analytical methods;
(vi) A review of Marketing Authorisation variations submitted, granted or refused, including those for third country
(export only) dossiers;
(vii) A review of the results of the stability monitoring programme and any adverse trends;
(viii) A review of all quality-related returns, complaints and recalls and the investigations performed at the time;
(ix) A review of adequacy of any other previous product process or equipment corrective actions;
(x) For new Marketing Authorisations and variations to Marketing Authorisations, a review of post-marketing
commitments;
(xi) The qualification status of relevant equipment and utilities, e.g. HVAC, water, compressed gases, etc;
(xii) A review of any contractual arrangements as defined in Chapter 7 to ensure that they are up to date.

10. Producing PQRs
There are three pathways available to produce PQRs.
1. Product-specific pathway
2. Product grouping pathway
3. Review by exception pathway

11. 1. Product-specific pathway
• A product-specific PQR for all batches manufactured during the review period
• A report for each product
The product-specific pathway is available for any medicinal product.
2. Product grouping pathway
• Grouping of products is when one PQR is prepared for a group of products. The grouping
process should be appropriate for conducting a PQR and reporting cannot be based on a
representative product.
• Prepare a scientific justification for how you group products for PQRs. This justification will
be assessed for the acceptability of grouping products for PQRs during TGA inspections.

12. Grouping for any medicines
Grouping (sometimes referred to as bracketing or matrixing) can be acceptable for any medicinal product when
the number of batches manufactured annually for each product within the group is low and the grouped
medicines are both:
• of the same pharmaceutical form containing the same or very similar active ingredients
• manufactured using the same equipment
For listed and complementary medicines, grouping can be based on products that have similarly constructed
formulations and a similar method of manufacture.
The PQR for a group should:
• document the grouping approach, with a scientific justification for the approach
• include a documented review of all applicable items specified in the Product Quality Review section of PIC/S
Guide to GMP
• be performed on all batches of a specific group of products manufactured during the review period

13. 3. Review by exception pathway
 The PQR by exception is a holistic interrogation of the PQS and quality related events as they
relate to the twelve specified items in the Product Quality Review
 The aim of the PQR is to identify adverse, out-of-trend or unusual events that indicate potential
quality vulnerabilities.
 Review by exception is a review of PQS adverse trends in each of the twelve specified items that
captures all batches of all products manufactured in the review period.
• Adverse trends can be mapped back to identify products or product groups potentially impacted.
• The design of the PQR report should highlight any adverse trends detected during the review.
A report by exception may be generated to cover: – all products
– a group of products
– a client’s products
– each specific product

14. Aspects of PQS to consider when conducting a
PQR by exception
1. A review of starting materials including packaging materials used in the product, especially
those from new sources
2. A review of critical in-process controls and finished product results
3. A review of all batches that failed to meet established specification(s) and their investigation
4. A review of all significant deviations or non-conformances, their related investigations, and
the effectiveness of resultant corrective and preventative actions taken
5. A review of all changes carried out to the processes or analytical methods
6. A review of marketing authorisation variations submitted, granted or refused

15. 7. A review of the results of the stability monitoring program and any adverse trends
8. A review of all quality-related returns, complaints and recalls and the investigations performed
at the time
9. A review of adequacy of any other previous product process or equipment corrective actions
10. For new marketing authorisations and variations to marketing authorisations, a review of
post-marketing commitments
11. The qualification status of relevant equipment and utilities, e.g. HVAC, water, compressed
gases, etc.
12. A review of any contractual arrangements as defined in Chapter 7 of the PIC/S Guide to
ensure that they are up-to-date

16. References
 Product Quality Reviews (PQRs) for listed and complementary medicines, Version 2.0,
January 2019
 TGA-Health safety regulation, Product Quality Review section of Chapter 1, Part 1 of
the PIC/S Guide to GMP).
-KARISHMA K. MAJIK