Title: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal
1Advisory Committee for the Pharmaceutical
SciencesOctober 5-6, 2006
Pharmaceutical Quality by DesignA PAT Equipment
Vendor Certification Proposal Charles P.
Hoiberg, Ph.D. Regulatory CMC and QA Pfizer
Pharmaceutical Sciences and Neil Lewis,
Ph.D. Analytical Imaging Systems Malvern
Instruments
2Agenda Overview - IFPATMA
- Certification Rationale
- Benefits of the Certification Process
- Expectations from the stakeholders
- for the Vendor
- for the Pharma firms
- from Regulators
- Proposed Certification Process
- Use of Vendor Certification
- Support in place
- Next Steps and Timeline
- Questions
3What is IFPATma?
IFPATma is an organisation consisting of Pharma
companies and instrument vendors. The management
committee of IFPATma have taken on the task of
developing a system of audits to bring the
instrument audit process in to the GMPs for 21st
Century philosophy, and to avoid the expensive
replication of audits.
4IFPATma Objectives
- Reduce the burden of audits to both the
purchaser, the vendor. This will be achieved
through the development of an independent,
certified audit programme, that requires an
instrument manufacturer to undergo a single
audit, that establishes whether or not they can
be generally recognised as Pharma Industry
Compliant and which can be quoted by any
purchaser of equipment as showing due diligence
in their compliance records for the instrument
they have installed. -
5IFPATma Objectives
2) Change the focus of audits from tick the box
compliance to risk based, science driven audits.
The new focus will be on proving an instrument is
fit for purpose. That it can truly function in
a robust way, as a PAT instrument, installed in a
plant environment.
6Agenda Overview - IFPATMA
- Certification Rationale
- Benefits of the Certification Process
- Expectations from the stakeholders
- for the Vendor
- for the Pharma firms
- from Regulators
- Proposed Certification Process
- Use of Vendor Certification
- Support in place
- Next Steps and Timeline
- Questions
7Certification Rationale
- The rationale for putting in place this vendor
certification process is to produce significant
technical and business benefits for - Users
- Vendors
- Regulators
- Certification will enable PAT system users, and
regulatory bodies to be sure that - Vendors comply with a minimum set of agreed
criteria during the development, manufacture and
test of PAT systems prior to shipment to a
customer. - The certification will cover the instrumentation,
associated software and sample interface.
8Benefits of the Certification Process
- Pharma firms will then not have to carry out
their own quality audit of the vendor. - Vendors will be assured that customers of PAT
systems will not expect or carry out their own
quality audit of their systems or products. - All parties will reap benefits in
- Rapid and efficient qualification process prior
to sale and delivery/acceptance of a system. - Reduced cost of quality no vendor quality audit
necessary. - Implementation of a high-quality, systematic,
uniform and traceable certification process for
PAT hardware and software throughout the
pharmaceutical industry.
9Expectations for the Vendor
- To support the certification process the vendor
is expected to have in place the following - Product Development Process
- Preferably a certified Quality Management System
- Quality Improvement Process
- Product Specification
- Robustness Design Criteria
- To be derived from a consensus such as ASTM,
ANSI, ASQ, ASME, ISO, etc. - Final Test process and procedures
- Internal audit processes to test compliance with
internal processes
10Expectations for the Pharma Firm
- To support the certification process the Pharma
Company is expected to have in place the
following - An internal consensus that this certification
process satisfies the appropriate part of their
quality management system for vendor assessment
of PAT equipment and systems. - No further technical or quality audit of the
vendor is required.
11Expectations from the Regulators
- To accelerate the uptake of the certification
process by both Users and Vendors it is expected
that the regulators support this certification
initiative. - The regulators would expect to see a PAT system
certificate during an inspection. - Regulators would know the certification process
and know that the PAT product or system under
inspection had been certified by an expert in
that technology. - Regulators could then focus on how the PAT
product or system had been implemented by the
user.
12Proposed Certification Process
- Vendor Pre-Certification
- PAT Vendor Certification Guidelines use to carry
out internal vendor audit - Vendor carries our remediation if necessary
- Vendor Certification Audit
- Vendor audited by approved auditors
- Audit report issued
- Remediation plan put in place and executed if
necessary - Vendor Certified
- Vendor Certificate created for system
13Use of Vendor Certification
- A Pharma firm wanting to use a vendors system as
part of a PAT implementation would request a copy
of the Vendor PAT System certificate from the
vendor or the certifying body. - Review of the certificate will reveal that the
system of interest has been created in a quality
environment and has a specification suitable for
use. - No further inquiry of the vendor should be
necessary.
14Support in place
Pharma Firms
Vendors include
BRIMROSE
15Next Steps and Timeline
- Next Steps
- Increase the consensus across the Pharma firms
and Vendors - Identify the certification body
- Create the Vendor Certification guidelines
- Develop a timeline to deliver the certificate
scheme in the next two to three years - Secure Concurrence from the Agency on our
Proposed Vendor Program - PAT Equipment
Certification
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