Quality Metrics at PQRI

Complements, Context, and

Implementation

Russell Wesdyk
Acting Director
Office of Surveillance

Metrics Discussion in a
Draft Guidance Free Zone

Draft Guidance
Note: Collection of inputs is by product, segmented by site
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10.

Total number of lots attempted

Total number of lots rejected due to specification failure
Total number of lots pending disposition for more than 30 days
Total number of OOS, including stability
Total number of lot release tests conducted
Total number of invalidated OOS
Total number of product quality complaints
Total number of lots released
Was the APR or PQR completed within 30 days of annual due date
Total number of APRs or PQRs for the product
Optional Metrics
11. Senior management engagement (multiple choice on APR sign-off)
12. CAPA effectiveness (calculate % due to retraining)
13. Process Capability yes/no
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Complements
Amgen
CGA
The power of 706 In Lieu of

Context Office of Surveillance

DIB

Sites/Products

Who/what is out
there?

QIB

RAMB

Quality
Metrics

SSM &
SSI List

QDAB

IAB

ORA
FARs/BPRDs
Sampling

EIR
Evaluation

Quality
Intelligence
Where to go?
What might we find?
(dossiers)

NIPP
What are we seeing?
What should we do when we get there?
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Context - FDASIA 705

Risk-based Inspection Frequency Factors
(A) The compliance history of the establishment.
(B) The record, history, and nature of recalls linked to the establishment.
(C) The inherent risk of the drug manufactured, prepared, propagated, compounded,
or processed at the establishment.
(D) The inspection frequency and history of the establishment, including whether
the establishment has been inspected pursuant to section 704 within the last 4 years.
(E) Whether the establishment has been inspected by a foreign government or an
agency of a foreign government recognized under section 809.
(F) Any other criteria deemed necessary and appropriate by the Secretary for
purposes of allocating inspection resources.
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Context - Surveillance Model Structure

Quality
Metrics

Proposed Implementation of QM Program

This is a surveillance program not an enforcement program
Submission of metrics would not result in
483 observations or other enforcement actions

Submission of metrics would result in

Diminished risk rank score in SSM (routine surveillance inspection
scheduling)
More metrics = greater reduction
Metric data itself would not influence reduction
Until learning period complete and relationships established this will take
time

First principle more information is better than less information

Signal detection leads to OPQ QIT (quality collaboration program)
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Goals for Quality Metrics

For industry
Promotes responsible practices and quality driven
corporate culture

For public:
Focus on quality leads to fewer recalls and quality
related shortages

For FDA:
Industry achieves and is rewarded for quality, without
extensive regulatory oversight

Two days after the meeting, FDA gave industry more

time to decide on its position by changing the deadline
for written comments from Sept. 28 to Nov. 27. Thats
the Friday after Thanksgiving, the holiday traditionally
reserved for families to put aside their differences and
feast together.
Bowman Cox Gold Sheet

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