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11/22/2010
1
CAPA Programs
Managing Supplier Audits Follow-U A ti iti
C C F 2010
0 Cangene Corporation Fiscal 2011 www.cangene.com 1
Up Activities
Cangene Corporation Fiscal 2011 www.cangene.com 2
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2
Managing Supplier Audits Follow-Up Activities
1. Understanding The Current Regulatory
Climate
2. CAPA Defined
3. Case Studies for Managing CAPA
Cangene Corporation Fiscal 2011 www.cangene.com 3
4. Interactive Exercise
Understanding The Current Regulatory Climate
Challenges in assuring supply chain integrity Complexity and hazardsCo p e ty a d a a ds Lack of traceability
Increased brokerage and trade Repackaging and relabeling
EMA Economically Motivated Adulteration Animal feed - melamine Heparin oversulfated chondroitin sulfate
Cangene Corporation Fiscal 2011 www.cangene.com 4
Heparin oversulfated chondroitin sulfate Over-reliance on CoAs Non-specific ID tests frequently performed on
composite samples.
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3
Understanding The Current Regulatory Climate
Cangene Corporation Fiscal 2011 www.cangene.com 5
Understanding The Current Regulatory Climate
FDA Commissioner
Margaret Hamburg
Cangene Corporation Fiscal 2011 www.cangene.com 6
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4
Understanding The Current Regulatory Climate
companies that sell contaminated products
because of loose supply chain oversight need
to face serious penalties and cannot excuse
themselves by blaming their suppliers, blaming
the FDA or blaming anyone else
Cangene Corporation Fiscal 2011 www.cangene.com 7
the FDA, or blaming anyone else.
Understanding The Current Regulatory Climate
we are moving from a system that places
most of the regulatory burden on the FDAs
modest inspection force, to one that creates
greater oversight at points further back along
the production chain
Cangene Corporation Fiscal 2011 www.cangene.com 8
the production chain.
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5
Understanding The Current Regulatory Climate
We need to know who is making our foods and
drugs, where they are located, and we need to
be sure that these facilities are being inspected
and are accountable for what goes into their
d t ll th d t th d
Cangene Corporation Fiscal 2011 www.cangene.com 9
products as well as the products they produce.
Understanding The Current Regulatory Climate
I can assure you that addressing the problem of
global supply chain safety, and shifting the
existing paradigm from reaction to
prevention, is one of my highest priorities for
FDA
Cangene Corporation Fiscal 2011 www.cangene.com 10
FDA.
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6
Understanding The Current Regulatory Climate
Supplier questionnaire (audit by mail) not considered adequate any more. q y
FDA is looking for on-site audits; site of actual production see the process.
One day audits are suspect. Need to invest time, planning, resources, gain
understanding. The purpose is to gain understanding of your
Cangene Corporation Fiscal 2011 www.cangene.com 11
p p g g ysuppliers manufacturing and quality processes.
Understanding The Current Regulatory Climate
The Agency is backing its regulations with
enforcement action in 2009, 12% of 483
observations and 16% of Warning Letters issued
were all related to inadequate supplier
qualification
Cangene Corporation Fiscal 2011 www.cangene.com 12
qualification.
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7
Understanding The Current Regulatory Climate
The quality assurance of starting materials, and
supplier approval, was deficient in thatthere was no
documented evidence of QA follow-up of progress with
remedial actions arising from the adverse [supplier]
assessment, either in terms of alternative material
Cangene Corporation Fiscal 2011 www.cangene.com 13
sources, or [the suppliers] progress with remediation
plans.
Understanding The Current Regulatory Climate
Corrective actions were not effective to prevent f iti l d f t i i l Th freoccurrence of critical defects in vials ... The for-cause
audit of the glass vial manufacturer found significant evidence indicating that the vial lots were not manufactured with adequate controls to ensure consistent quality in the finished product. Vial
Cangene Corporation Fiscal 2011 www.cangene.com 14
manufacturing was moved to another line which has improved inspection capabilities, but additional defective vials were received from the new line.
11/22/2010
8
Understanding The Current Regulatory Climate
You have not executed the new plan to audit
suppliers of active ingredients and raw materials as
committed in your response. Problem with excessive rejection of vials due to visible particles.
Contacted the contract sterilizer.
No steps were taken to audit and perform a complete evaluation of
Cangene Corporation Fiscal 2011 www.cangene.com 15
No steps were taken to audit and perform a complete evaluation of
the contractors sterilizer process or to increase sampling and
monitoring of this API after finished lots were reported as above
limits for particles rejects.
Understanding The Current Regulatory Climate
The Rules
Cangene Corporation Fiscal 2011 www.cangene.com 16
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9
Understanding The Current Regulatory Climate
820.100
Each manufacturer shall establish and maintain
procedures for implementing corrective and preventive
action. The procedures shall include requirements for:
Cangene Corporation Fiscal 2011 www.cangene.com 17
action. The procedures shall include requirements for:
Understanding The Current Regulatory Climate
(2) Investigating the cause of non-conformities relating to
product, processes, and the quality system;
(3) Identifying the action(s) needed to correct and
prevent recurrence of non-conforming product and other
quality problems.
(4) V if i d lid ti [th ] t th t h
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(4) Verifying and validating [them] to ensure that such
action is effective
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Understanding The Current Regulatory Climate
211.192
the failure of a batch or any of its components to
meet any of its specifications shall be thoroughly
investigated
Cangene Corporation Fiscal 2011 www.cangene.com 19
investigated
Understanding The Current Regulatory Climate
A written record of the investigation shall be made and
shall include conclusions and follow-up.
Cangene Corporation Fiscal 2011 www.cangene.com 20
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11
CAPA Defined
Title: Quality Management System Medical Devices
Guidance on the Control of Products and Services
Obtained from Suppliers
Authoring Group: GHTF Study Group 3
Endorsed by: The Global Harmonization Task Force
Cangene Corporation Fiscal 2011 www.cangene.com 21
Date: December 11, 2008
CAPA Defined
If a Corrective Action or Preventive Action
(CAPA) is initiated additional feedback and
communication may be necessary. As part of
this action the manufacturer may need to re-
evaluate the continued suitability of the
Cangene Corporation Fiscal 2011 www.cangene.com 22
evaluate the continued suitability of the
supplier.
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12
CAPA Defined
Depending on the nature of the procured
product/service, portions of the activities that are to be
performed under CAPA may be delegated by the
manufacturer to the supplier. The combined CAPA
related activities of both the manufacturer and the
supplier must satisfy the requirements of applicable
Cangene Corporation Fiscal 2011 www.cangene.com 23
supplier must satisfy the requirements of applicable
regulations and standards.
CAPA Defined
While some of the CAPA activities may be
delegated to a supplier, the overall
responsibility for these activities resides with
the manufacturer. CAPA related decisions
and effectiveness checks cannot be
Cangene Corporation Fiscal 2011 www.cangene.com 24
and effectiveness checks cannot be
delegated and reside with the manufacturer.
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13
CAPA Defined
Cangene Corporation Fiscal 2011 www.cangene.com 25
CAPA DefinedCAPA P A P
D
D
I
E
A
E
I Identify actions
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V R V
I I
D F
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CAPA DefinedCAPA P A P
D
D
I
E
A
E
I Identify actions
Cangene Corporation Fiscal 2011 www.cangene.com 27
V R V
I I
D F
CAPA Defined
Cangene Corporation Fiscal 2011 www.cangene.com 28
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15
CAPA Defined
Each link of the chain must add value:
It only takes one weak link in the chain to put product at risk.
Verification and positive checks are required.
Cangene Corporation Fiscal 2011 www.cangene.com 29
p q
CAPA Defined
The purpose of assessing the capabilities of
your suppliers is to provide a greater degree of
assurance, beyond that provided by in-coming
inspection and testing, that the raw materials
and components received meet the needs of
Cangene Corporation Fiscal 2011 www.cangene.com 30
and components received meet the needs of
your product and process.
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16
CAPA Defined
The purpose of audit follow-up is to provide a
greater degree of assurance, beyond that
provided by review of an audit response, that the
actions planned and proposed have been
implemented and are effective
Cangene Corporation Fiscal 2011 www.cangene.com 31
implemented and are effective.
CAPA Defined
One of the fundamental steps in any CAPA process is
completing an evaluation of the actions that were taken.
Verification and validation:
Were they completed?
Cangene Corporation Fiscal 2011 www.cangene.com 32
Were they timely?
Were they appropriate and effective?
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CAPA Defined
Two important questions:
Can you follow up on every corrective action
commitment?
Is it necessary or required?
Cangene Corporation Fiscal 2011 www.cangene.com 33
It depends
CAPA Defined
Effective decision making in a quality systems
environment is based on an informed understanding of
quality issues. Elements of risk should be considered
relative to intended use of a product, and in the case of
pharmaceuticals, patient safety
Cangene Corporation Fiscal 2011 www.cangene.com 34
- Quality Systems Approach to Pharmaceutical cGMP
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CAPA Defined
It depends on
Criticality of supplier deficiency and its potential
to impact on the quality attributes of your
product, and ultimately, on patient safety.
Cangene Corporation Fiscal 2011 www.cangene.com 35
CAPA Defined
It depends on
Criticality of supplier deficiency and its potential
to impact on the quality attributes of your
product, and ultimately, on patient safety.
Cangene Corporation Fiscal 2011 www.cangene.com 36
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CAPA Defined
How much is enough?
Cangene Corporation Fiscal 2011 www.cangene.com 37
CAPA Defined
Risk
Management
Cangene Corporation Fiscal 2011 www.cangene.com 38
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20
CAPA Defined
First, we are seeking better controls at the point of productionpoint of production.
A second key element of our strategy is to hold importing companies responsible for their supply chain.
Third, we are going to deploy our agencysresources strategically. This is essential as our
d t k di i th
Cangene Corporation Fiscal 2011 www.cangene.com 39
mandate keeps expanding, even in these economically challenging times.
CAPA Defined
Model for industry
better controls at the point of production
hold suppliers responsible
deploy resources strategically
Cangene Corporation Fiscal 2011 www.cangene.com 40
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21
CAPA Defined
Developing a risk-based approach
Understand the needs of your product and process
Rate audit deficiencies according to severity/criticality
to your product and process needs.
Use risk management to prioritize work.
Cangene Corporation Fiscal 2011 www.cangene.com 41
g p
Level how soon, how often, to what extent
Formality
CAPA Defined
Required work, including follow-up, can be
prioritized but cannot be eliminated using risk
management principles.
Manufacturers cannot risk-manage away
l t i t
Cangene Corporation Fiscal 2011 www.cangene.com 42
regulatory requirements.
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CAPA Defined
Identify risk factors important to your operationD fi it i / i k f h f t Define criteria/risk scores for each factor
Create risk assessment tools Define action levels for each risk level Mechanism to feed forward information for the
next rating in supplier quality management
Cangene Corporation Fiscal 2011 www.cangene.com 43
g pp q y gsystem periodic supplier risk review, done at least yearly by
many companies
CAPA Defined
Risk factors
CQAs of finished product directly dependent on the
relevant quality attributes of components.
Purity
Content, strength, concentration
Cangene Corporation Fiscal 2011 www.cangene.com 44
Sterility
Impurities
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CAPA Defined
Define action levels
Level A: evaluation of effectiveness before receipt of next lot.
Level B: evaluation of effectiveness within 6 months
Level C: evaluation of effectiveness at next scheduled dit
Cangene Corporation Fiscal 2011 www.cangene.com 45
audit
CAPA Defined
Benefits
Rationalized approach to manage follow-up
Prioritization
Manages risk effectively
Uses resources efficiently
Cangene Corporation Fiscal 2011 www.cangene.com 46
11/22/2010
24
CAPA Defined
If CAPA activities are delegated to suppliers, the manufacturer needs to ensure that:
1. CAPA related activities performed by suppliers are defined in the manufacturers QMS.
2. Based on the products provided by a supplier, all CAPA specific activities to be performed and data/information to be provided by that supplier are identified (e.g. related to the extent of control necessary at the supplier).
3. The suppliers obligations related to CAPA activities are communicated to the supplier and clearly defined and documented.
Cangene Corporation Fiscal 2011 www.cangene.com 47
4. The supplier fulfils his obligations in relation to the CAPA activities (e.g. timely processing of corrections).
5. Documentation and records related to a suppliers CAPA activities are controlled and readily available.
Case Study for Managing CAPA
Excipient Supplier
Cangene Corporation Fiscal 2011 www.cangene.com 48
11/22/2010
25
Case Studies for Managing CAPA
Two consecutive out-of-specification (OOS) results that
occurred with bulk product endotoxin testing:
The first OOS occurred with the batch manufactured in the week
of Jan 7, 2008.
The second OOS occurred with the batch manufactured in the
k f J 14 2008
Cangene Corporation Fiscal 2011 www.cangene.com 49
week of Jan 14, 2008.
Case Studies for Managing CAPA
Batch 1
Sample Endotoxin (EU/mL) Bacteria (CFU/mL)Sample Endotoxin (EU/mL) Bacteria (CFU/mL)
Pooled plasma
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Case Studies for Managing CAPA
Batch 2Sample Endotoxin (EU/mL) Bacteria
Pooled plasma
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Case Studies for Managing CAPA
Container Batch Endotoxin (EU/mL)A 0.1
B 0.0421
B 0.042C 0.1D 0.185E 0.169
2
F 0.2G 0.3H 0 6
Cangene Corporation Fiscal 2011 www.cangene.com 53
2 H 0.6I 2.3 [OOS]J 2.4 [OOS]
Case Studies for Managing CAPA
Interim conclusions
Maltose was the source of the endotoxin
Either we contaminated the maltose during storage
and handling, or
The maltose was contaminated by the supplier
Cangene Corporation Fiscal 2011 www.cangene.com 54
Contamination was variable, non-uniform
Next step??
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Case Studies for Managing CAPA
Contacted the supplier
Discussed the incident being investigated
Reviewed their process
Deviations?
Cangene Corporation Fiscal 2011 www.cangene.com 55
Case Studies for Managing CAPA
Deviations
Discovered that this batch had been reprocessed.
Cangene Corporation Fiscal 2011 www.cangene.com 56
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Case Studies for Managing CAPA
Cangene Corporation Fiscal 2011 www.cangene.com 57
Case Studies for Managing CAPA
11 audit observations
Observation rating Risk Response Level
2 critical Level A
4 j L l B
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4 major Level B
5 minor Level C
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Case Studies for Managing CAPA
Define action levels
Level A: evaluation of effectiveness before receipt of next lot.
Level B: evaluation of effectiveness within 6 months
Level C: evaluation of effectiveness at next scheduled dit
Cangene Corporation Fiscal 2011 www.cangene.com 59
audit
Case Studies for Managing CAPA
Audit observations:
No evaluation of starting material quality before
reprocessing
Lack of adequate validation (process and cleaning)
Limited in-process testing/ heavy reliance on testing
Cangene Corporation Fiscal 2011 www.cangene.com 60
p g y g
of final product
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Case Studies for Managing CAPA
Audit response
Finished product testing met specifications
No previous failures
Limited corrective action commitments
Cangene Corporation Fiscal 2011 www.cangene.com 61
Case Studies for Managing CAPA
Notes
We had used this supplier for 12 years with no
previous issues.
Ironically, we had switched to the suppliers low
endotoxin grade of maltose just over a year previous
Cangene Corporation Fiscal 2011 www.cangene.com 62
to the incident. Basically, it was the same process,
same material, just certified to meet endotoxin
specifications [through additional testing].
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Case Studies for Managing CAPA
Assessment
Looking for better controls at the point of production
Could not verify or validate effectiveness
Cangene Corporation Fiscal 2011 www.cangene.com 63
Case Studies for Managing CAPA
Depending on the nature of the procured
product/service, portions of the activities that are to be
performed under CAPA may be delegated by the
manufacturer to the supplier. The combined CAPA
related activities of both the manufacturer and the
supplier must satisfy the requirements of applicable
Cangene Corporation Fiscal 2011 www.cangene.com 64
supplier must satisfy the requirements of applicable
regulations and standards.
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Case Studies for Managing CAPA
Combined CAPA related activities
Critical observations
related to high risk of endotoxin contamination during
manufacturing of subsequent lots
Critical observation = Level A evaluation
l ti f ff ti b f i t f t l t
Cangene Corporation Fiscal 2011 www.cangene.com 65
evaluation of effectiveness before receipt of next lot
Response adequate?
Implemented additional quality control testing.
Case Studies for Managing CAPA
Responses to other significant (major)
observations
Evaluated during subsequent discussions with
supplier
Provision of evidence of completion
Cangene Corporation Fiscal 2011 www.cangene.com 66
Provision of evidence of completion
Additional follow-up during subsequent on-site audit
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Interactive Exercise
Cangene Corporation Fiscal 2011 www.cangene.com 67
Interactive Exercise
1. Observation
2. Your expected response
3. Suppliers actual response
4. Your evaluation of the suppliers response
5. Audit Team evaluation of the response
Cangene Corporation Fiscal 2011 www.cangene.com 68
p
6. Action plan/ follow-up
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35
Observation #1
The firm lacks a documented quality management
system.
Auditors were informed that the set of standard operating
procedures (SOPs) that exist are outdated are not used by the
organization. These SOPs were created in the 1990s as part of
an unsuccessful attempt to achieve ISO registration. There are
Cangene Corporation Fiscal 2011 www.cangene.com 69
g
multiple uncontrolled forms in use (i.e. for QC testing and
Assembly). The organization does not have a Quality Manual.
Observation #1
What would be an adequate or appropriate response
from the supplier?
Cangene Corporation Fiscal 2011 www.cangene.com 70
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36
Supplier Response
The lack of a documented quality management system
will be addressed by registering to the most current
ISO9001 standard. (target completion date: 7 months)
Cangene Corporation Fiscal 2011 www.cangene.com 71
Your Evaluation
Is the suppliers response adequate?
Does it address the observation?
What, if any, other factors would you consider in your
evaluation?
Cangene Corporation Fiscal 2011 www.cangene.com 72
11/22/2010
37
Audit Team Evaluation
Provide Supplier with Cangene expectations and
industry guidelines surrounding quality management
systems and manufacturing process controls.
Cangene to source alternate supplier(s) for these raw
materials.
C t f i k t t d t i if
Cangene Corporation Fiscal 2011 www.cangene.com 73
Cangene to perform a risk assessment to determine if
any other immediate actions are required.
Audit Team Evaluation
Lead Auditor deemed [other] corrective actions within
their response to be unacceptable and concerns were
elevated to Supplier Quality Team. CAPA was initiated
to discontinue use of this supplier.
Cangene Corporation Fiscal 2011 www.cangene.com 74
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38
Additional information
Supplier repackaged raw materials
No line clearance procedures
No documented/validated cleaning procedures for
common utensils/equipment
Repackaging in unclassified/uncontrolled conditions
Cangene Corporation Fiscal 2011 www.cangene.com 75
p g g
Action plan/ follow-up
Interim steps/controls?
Cangene Corporation Fiscal 2011 www.cangene.com 76
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39
Observation #2
Quality Control procedures are deficient in that investigation of Out
f S ifi ti lt did t f ll di ti tli d i th FDAof Specification results did not follow directives outlined in the FDA
Guidance for Industry Investigating Out of Specification Test
Results for Pharmaceutical Production. Suppliers procedure for
Non Conforming Material is focused on detailed instructions
regarding disposition of nonconforming product without providing
ffi i t i f ti i ti ti f OOS lt d ti
Cangene Corporation Fiscal 2011 www.cangene.com 77
sufficient information on investigation of OOS results and reporting
of re-test results.
Expected Response
What would you expect the supplier to address in their
response?
Cangene Corporation Fiscal 2011 www.cangene.com 78
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40
Actual Response
[Supplier] is committed to provide product which meets specifications. We do not investigate out of specifications results according to the "Control of Nonconforming Product" Procedure. As
i d b thi d h t f ifi ti lt i i t d t th Ch i trequired by this procedure , each out of specification result is communicated to the Chemistry Technical Support designate & authorized personnel. These personnel provide technical scrunity for each questionable result. The Technical Support along with QC Management makes decisions regarding retesting or resampling & retesting. The decisions are documented in the QC records. All results are reported as required by QC procedure. This approach renders a very good protection of product quality and good efficiency of the operations. We take into account out of specification results very seriously. We monitor performance using a variety of metrics such as 1st pass quality. Metrics are presented & evaluated by Senior Management during Management review As a result of the audit observation the current system for OOS results was reviewed by
Cangene Corporation Fiscal 2011 www.cangene.com 79
review. As a result of the audit observation, the current system for OOS results was reviewed by Management, and it was concluded that the current system is adequate for our operations and no changes are required.
Your Evaluation
Cangene Corporation Fiscal 2011 www.cangene.com 80
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41
Audit Team Evaluation
Your commitments to resolution of OOS results through your NCR procedure are appreciated. I would need only to confirm that your procedure p pp y y pmeets industry standards. Could you please summarize your approach to handling OOS results:
rules for re-testing and re-sampling
rules for reporting the re-test results
approach to investigation of OOS root cause
timelines for closing the investigation
Cangene Corporation Fiscal 2011 www.cangene.com 81
Alternatively please comment if your NCR procedure meets expectations regarding handling OOS results as outlined in the FDA guidance document Investigation of Out of Specification Test Results for Pharmaceutical Production .
Suppliers response
Our Quality Management System has been established according to ISO 9001 requirements We ensure & monitor theaccording to ISO 9001 requirements. We ensure & monitor the compliance of our systems & processes through Surveillance & Recertification ISO Audits, Internal Audits, and Management Reviews. [Supplier] does not manufacture finished Pharmaceutical products and is therefore not subject to the FDA guidance. [Supplier] is solely a manufacturer of raw
t i l Th t i l d t h ifi i t d d
Cangene Corporation Fiscal 2011 www.cangene.com 82
materials. These materials do not have a specific intended use and are used in a variety of industries. Our Quality Management Systems has established controls that govern our operations and assures the quality or our products.
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Action plan/ follow-up
Next steps?
How would you close-out this observation?
Cangene Corporation Fiscal 2011 www.cangene.com 83
Observation #3
Routine surveillance audit scope included investigation of a significant quality issue.q y
White tacky substance on vial exterior
1 major, 3 minor observations
Organization and maintenance of the warehouse for Raw Materials and Finished Goods appeared deficient in that:
housekeeping practices appeared insufficient. Procedure and logs for warehouse cleaning and sanitization were not implemented
Cangene Corporation Fiscal 2011 www.cangene.com 84
g p
packing trays in warehouse area were not stored as per written procedure. The trays were not stored in an orderly fashion, a number of trays were not wrapped in plastic foil, dust/dirt was collected on a number of trays, wiping of trays pre-and post-use in clean area was not documented in the Batch Record.
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Expected response
Cangene Corporation Fiscal 2011 www.cangene.com 85
Actual response
Cangene Corporation Fiscal 2011 www.cangene.com 86
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44
Your evaluation/action plan
Cangene Corporation Fiscal 2011 www.cangene.com 87
Action Plan
Lead auditor escalated to Supply Quality Team.
Supply Quality Team
Reviewed current relevant information
History of quality defects
Supplier responsiveness to quality issues/audit observations
Recent quality issues (cracked vials/overlaps) resulting in batch
Cangene Corporation Fiscal 2011 www.cangene.com 88
Recent quality issues (cracked vials/overlaps) resulting in batch
rejection.
Scheduled a for cause audit
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Action Plan
Audit observations
1 critical - directly related to audit cause
6 major contributing factors leading to vial quality issues
1 minor
Cangene Corporation Fiscal 2011 www.cangene.com 89
Critical Observation
Vial lot was not manufactured in a state of control to ensure product quality and conformity. Review of the manufacturing batch record revealed the following deficiencies:
repeated observations of overlaps and minimum lip thickness defects. No apparent investigation and/or corrective action for these issues.
QA Auditors gave at least six verbal warnings to Production of the defects (and borderline passing vials) that they were seeing during consecutive QA Audits. No documented investigation/corrective action.
The [electronic] inspection system which identifies such defects was not verified
Cangene Corporation Fiscal 2011 www.cangene.com 90
[ ] p yprior to use as per [supplier] procedure.
The repeated overlaps defects noted in the Packing Production Report did not trigger any re-work (re-inspection). Only the failure of the first QA Audit Lot, for minimum lip thickness, resulted in re-inspection of the first six trays of the manufactured lot.
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46
Your Evaluation/ action plan
Cangene Corporation Fiscal 2011 www.cangene.com 91
Supply Quality Team action plan
Escalated to Senior Management
Senior Management discussions with supplier
Recommended sourcing of new vial supplier
Action on remaining inventory from supplier
Cangene Corporation Fiscal 2011 www.cangene.com 92
11/22/2010
47
Thank you!
Jeff Broadfoot
Director Quality Assurance
Cangene Corporation Fiscal 2011 www.cangene.com 93
Director, Quality Assurance
Cangene Corporation