Q.R are planned and documented by an inspections of a review item The review item may be a product, a group of related products or a part of a product If the error identified earlier the cost of implication is less and the penalty for failing to conduct adequate reviews.

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PREPARED BY:AJAY KUMAR

2.  Q.R are planned and documented by an inspections of
a review item
 The review item may be a product, a group of related
products or a part of a product
 If the error identified earlier the cost of implication is
less and the penality for failing to conduct adequate
reviews
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3.  The US FDA proposed the requirement in Feb.13,
1976 rewriting of the GMP’s
 The purpose was to provide reliable procedure for a
drug manufacturer to review the quality standard
 Completeness
 Compliance with Instruction/directives
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4.  Q.R requirement was published in Sep. 1978 for drug
product (21 CFR 211.180(e)) and became effective on
march 28, 1979(1)
 Since Q.R publication, 21 CFR 211.180(e) has been
commonly referred to by FDA and the pharmaceutical
industry as the “Product Annual Review" (PAR) or the “
Annual Product Review"(APR)
 Check your own work
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5. The 3 required FDA objectives are:
1. Manufacturing process
2. Manufacturing controls and
3. Product specification
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6.  EU PQR required objectives are:
1. Product specification
2. Identification of improvement
3. High lightening trends
4. Appropriateness of starting material
requirement specifications
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7.  Conduct annually
 Extension of time may leads to “
potential problems”
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8.  Investigating Officer training- formal training by
the inspector-invesigation requirements- -Judge
advocate participation
 Planning- where do you want to go?. Brainstorm
with inspector- Identify the documents need-
prepare witness list-prepare questions
 Witness Interviews-Interview complaint list-outline
of questions-follow up procedure requirement
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9. The FDA PAR specifies - 6 items
 The EU PQR Specifies – 19 items
 The Q7A PQR specifies – 11 items
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10. Four of the six requirement common to both the
EU PQR and Q7A PQR are:
1. Complaints
2. Product recalls
3. Returned product
4. Investigation
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11. 1. Export only products
2. Marketing authorization variation
3. Post marketing
4. Equipment qualification status
5. Effectiveness of preventive actions
6. Adequacy of previous product process or
equipment corrective actions
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Other EU PQR requirements are:

12.  Review for all batches that failed specifications
 Critical deviation and non-conformities
 Product stability results
 Critical in process controls and test results
 Changes in analytical methods
 Effectiveness of corrective action
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EU PQR AND Q7A PQR REQUIREMENTS:

13.  FDA revised its GMP in Jan 1995 to review
representative number of batches.
 Representative batch –as a batch that are
- Released, rejected or recalled
- Subject of FDA field alert
- With manufacturing discrepancies
- In need for change
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14.  EU requirement – emphasis on license
- emphasis on drug safety
 During inspection – question the firm management
about their knowledge and assurance of commitment
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15.  Agreement between MAH (Marketing authorization
holder) and the manufacturer
 Analysis-process must be fully documented with
evidence- how it is resolved with credible witness-why
the documentary evidence was important?
 Findings-Unfounded-not substantiated-substantiated-
each one separately addressed
 Documentary evidence-Plan in advance- all
documentary evidence must be included
 Comments/ tones- No personnel attack, relevant
comments only
 Timely communication of results
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16.  Equipment qualification
 Equipment requalification
 Preventive maintenance and calibration programs
as per FDA’s 1987 validation guidelines
 Modular approach-divide in to smaller parts
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17.  Quality system approach to pharmaceutical CGMP
regulation have parallels in the EU PQR(7)
 Elements such as system review,
 Examination of inputs ( raw materials ),
 Process improvements,
 Data evaluation activities and addressing discrepancies
are common to both the modern quality system described
by the FDA guidance and the EU PQR
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18. :
 It is the responsibility of the chairman and presenter to
organize the Q.R and notify all reviewers invited
 Invitation and copies of the products being reviewed
should be issued, allowing sufficient time for each
reviewer to compile an error list
 In this phase reviewers should check the product for
defects or omissions' using the product descriptions and
review checklists
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19.  Error list and copies of annotated products should be
brought to the meeting by each reviewers
 During the review meeting the emphasis should be
on error detection, in line with the criteria, and only
limited discussion of corrective action should occur
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20.  It is important that 'personalities' and 'politics' are kept
out of the review
 For reviews that are ' complete' the action list tasks are
allocated along with designated reviewers, to verify that
the work is done
 A project exception report should be raised for any
errors detected in non review items
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21.  Follow up period during which the errors identified at
the review that were committed to follow up action list
are rectified and signed off
 At the end of the follow up period ' which is typically
restricted to one week, the follow up action list should
be signed off by the chairman
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22.  Quality review studies indicate that the product is within
the specified limits
 Q.R reviews all documents to be sure there are no
loose ends and also examines testing data to confirm
that the product meets specifications
 If there is significant problem with the product, GMP’s
require the Q.C group to reject the product and
investigate
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23.  http://www.fda.gov/cder/guidance/index.
htm.
 http://api.ning.com.
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