PQR

Question 1

PQR is a critical part of the Quality System aimed at demonstrating that products and the manufacturing processes used to produce them continue to exhibit:

Answer 1

• Appropriate quality
  
  • Conformance with registered specifications
    …in a reliable, consistent way throughout the registered shelf life.

Question 2

In order to produce product of appropriate quality the manufacturing processes by which they are produced must be:

Answer 2

• In control
  
  • Capable
  • Validated

Question 3

What is it essential that there is an adequate plan for producing PQRs

Answer 3

• You must be continuously collecting the data needed
  ○ Retrospective data collection is a nightmare
  
  • Must be able to easily access and analyse the data
  • Cannot perform all PQRs at once so they should be spread throughout the year

Question 4

What products should be included in the PQR?

Answer 4

• All licensed medicinal products, including export only products
  
  • Discontinued products, until last batch has expired

Question 5

What is the scope of the PQR?

Answer 5

• Actions identified in last PQR
  
  • Starting/packaging materials
    ○ Release testing results
    ○ Supplier changes
    ○ Specification changes
  • All changes
    ○ Planned changes
    ○ Deviations
    ○ Variations
  • Changes to
    ○ Process
    ○ Test methods
    ○ Facilities or equipment
  • Finished product
    ○ In-process test results
    ○ Release test results
    ○ Stability test results
    ○ Actual vs. expected yield
    ○ Rejected or reworked lots
    ○ Complaints, Returns, Adverse Events and Recalls
    ○ Retained sample inspections (US)

Question 6

Data analysis is the most important part of the PQR. This data analysis should:

Answer 6

• Look for trends
  
  • Look for links between events and data
    ○ E.g. shift in assay results at time production process changed

Question 7

The conclusion of your PQR should provide answers to the following questions:

Answer 7

• Is the process ‘in control’?
  
  • Is the process capable of consistently meeting specification?
  • Is the production process operating in a validated state?
  • What follow-up actions are needed?

Question 8

The PQR report should identify all necessary follow up actions:

Answer 8

• Corrective and Preventative Actions (CAPA)
  ○ Revalidation, re-training, etc.
  
  • Responsibilities and time-lines
  • Justification for decisions