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Title: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal


1
Advisory 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
2
Agenda 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

3
What 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.
4
IFPATma 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.
  •  

5
IFPATma 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.
6
Agenda 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

7
Certification 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.

8
Benefits 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.

9
Expectations 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

10
Expectations 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.

11
Expectations 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.

12
Proposed 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

13
Use 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.

14
Support in place
Pharma Firms
Vendors include
BRIMROSE
15
Next 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

16
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