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Pharmaceutical Quality by Pharmaceutical Quality by Design: Design: A PAT Equipment Vendor A PAT Equipment Vendor Certification Proposal Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences and Neil Lewis, Ph.D. Analytical Imaging Systems Malvern Instruments Advisory Committee for the Pharmaceutical Sciences October 5-6, 2006

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Page 1: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences

Pharmaceutical Quality by Design:Pharmaceutical Quality by Design:A PAT Equipment Vendor A PAT Equipment Vendor

Certification ProposalCertification Proposal

Charles P. Hoiberg, Ph.D.Regulatory CMC and QA

Pfizer Pharmaceutical Sciencesand

Neil Lewis, Ph.D.Analytical Imaging Systems

Malvern Instruments

Advisory Committee for the Pharmaceutical SciencesOctober 5-6, 2006

Page 2: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences

• Certification RationaleCertification Rationale• Benefits of the Certification ProcessBenefits of the Certification Process• Expectations from the stakeholdersExpectations from the stakeholders

– for the Vendorfor the Vendor– for the Pharma firmsfor the Pharma firms– from Regulatorsfrom Regulators

• Proposed Certification ProcessProposed Certification Process• Use of Vendor CertificationUse of Vendor Certification• Support in placeSupport in place• Next Steps and TimelineNext Steps and Timeline• QuestionsQuestions

AgendaAgenda::Overview - IFPATOverview - IFPATMAMA

Page 3: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences

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 GMP’s for 21st Century philosophy, and to avoid the expensive replication of audits.

What is IFPATma?What is IFPATma?

Page 4: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences

1) 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.

 

IFPATma ObjectivesIFPATma Objectives

Page 5: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences

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.

IFPATma ObjectivesIFPATma Objectives

Page 6: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences

• Certification RationaleCertification Rationale• Benefits of the Certification ProcessBenefits of the Certification Process• Expectations from the stakeholdersExpectations from the stakeholders

– for the Vendorfor the Vendor– for the Pharma firmsfor the Pharma firms– from Regulatorsfrom Regulators

• Proposed Certification ProcessProposed Certification Process• Use of Vendor CertificationUse of Vendor Certification• Support in placeSupport in place• Next Steps and TimelineNext Steps and Timeline• QuestionsQuestions

Agenda:Agenda:Overview - IFPATMAOverview - IFPATMA

Page 7: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences

• The rationale for putting in place this vendor certification process is to The rationale for putting in place this vendor certification process is to produce significant technical and business benefits for:produce significant technical and business benefits for:– UsersUsers– VendorsVendors– RegulatorsRegulators

• Certification will enable PAT system users, and regulatory bodies to Certification will enable PAT system users, and regulatory bodies to be sure that:be sure that:– Vendors comply with a minimum set of agreed criteria during the Vendors comply with a minimum set of agreed criteria during the

development, manufacture and test of PAT systems prior to shipment to a development, manufacture and test of PAT systems prior to shipment to a customer. customer.

– The certification will cover the instrumentation, associated software and The certification will cover the instrumentation, associated software and sample interface. sample interface.

Certification RationaleCertification Rationale

Page 8: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences

Benefits of the Certification ProcessBenefits of the Certification Process

• Pharma firms will then not have to carry out their own quality Pharma firms will then not have to carry out their own quality audit of the vendor. audit of the vendor.

• Vendors will be assured that customers of PAT systems will not Vendors will be assured that customers of PAT systems will not expect or carry out their own quality audit of their systems or expect or carry out their own quality audit of their systems or products.products.

• All parties will reap benefits in:All parties will reap benefits in:– Rapid and efficient qualification process prior to sale and Rapid and efficient qualification process prior to sale and

delivery/acceptance of a system.delivery/acceptance of a system.– Reduced cost of quality – no vendor quality audit necessary.Reduced cost of quality – no vendor quality audit necessary.– Implementation of a high-quality, systematic, uniform and traceable Implementation of a high-quality, systematic, uniform and traceable

certification process for PAT hardware and software throughout the certification process for PAT hardware and software throughout the pharmaceutical industry.pharmaceutical industry.

Page 9: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences

Expectations for the VendorExpectations for the Vendor

• To support the certification process the vendor is expected to have To support the certification process the vendor is expected to have in place the following:in place the following:– Product Development ProcessProduct Development Process– Preferably a certified Quality Management System Preferably a certified Quality Management System – Quality Improvement ProcessQuality Improvement Process– Product SpecificationProduct Specification– Robustness Design CriteriaRobustness Design Criteria

• To be derived from a consensus such as ASTM, ANSI, ASQ, ASME, ISO, To be derived from a consensus such as ASTM, ANSI, ASQ, ASME, ISO, etc. etc.

– Final Test process and proceduresFinal Test process and procedures– Internal audit processes to test compliance with internal processesInternal audit processes to test compliance with internal processes

Page 10: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences

Expectations for the Pharma FirmExpectations for the Pharma Firm

• To support the certification process the Pharma Company is To support the certification process the Pharma Company is expected to have in place the following:expected to have in place the following:

– An internal consensus that this certification process satisfies the An internal consensus that this certification process satisfies the appropriate part of their quality management system for vendor appropriate part of their quality management system for vendor assessment of PAT equipment and systems.assessment of PAT equipment and systems.

– No further technical or quality audit of the vendor is required.No further technical or quality audit of the vendor is required.

Page 11: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences

Expectations from the RegulatorsExpectations from the Regulators

• To accelerate the uptake of the certification process by both To accelerate the uptake of the certification process by both Users and Vendors it is expected that the regulators support Users and Vendors it is expected that the regulators support this certification initiative.this certification initiative.

– The regulators would expect to see a PAT system certificate The regulators would expect to see a PAT system certificate during an inspection.during an inspection.

– Regulators would know the certification process and know that Regulators would know the certification process and know that the PAT product or system under inspection had been certified by the PAT product or system under inspection had been certified by an expert in that technology.an expert in that technology.

– Regulators could then focus on how the PAT product or system Regulators could then focus on how the PAT product or system had been implemented by the user.had been implemented by the user.

Page 12: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences

Proposed Certification ProcessProposed Certification Process

• Vendor Pre-CertificationVendor Pre-Certification– PAT Vendor Certification Guidelines PAT Vendor Certification Guidelines

use to carry out internal vendor audituse to carry out internal vendor audit– Vendor carries our remediation if Vendor carries our remediation if

necessarynecessary

• Vendor Certification AuditVendor Certification Audit– Vendor audited by approved auditorsVendor audited by approved auditors– Audit report issuedAudit report issued– Remediation plan put in place and Remediation plan put in place and

executed if necessaryexecuted if necessary– Vendor CertifiedVendor Certified

• Vendor Certificate created for systemVendor Certificate created for system

Page 13: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences

Use of Vendor CertificationUse of Vendor Certification

• A Pharma firm wanting to use a vendor’s system as part of a PAT A Pharma firm wanting to use a vendor’s system as part of a PAT implementation would request a copy of the Vendor PAT System implementation would request a copy of the Vendor PAT System certificate from the vendor or the certifying body.certificate from the vendor or the certifying body.

• Review of the certificate will reveal that the system of interest has been 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. created in a quality environment and has a specification suitable for use.

• No further inquiry of the vendor should be necessary.No further inquiry of the vendor should be necessary.

Page 14: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences

Support in placeSupport in place

Pharma FirmsPharma Firms Vendors include:Vendors include:

BRIMROSE

Page 15: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences

Next Steps and TimelineNext Steps and Timeline

• Next Steps:Next Steps:– Increase the consensus across the Pharma firms and Increase the consensus across the Pharma firms and

VendorsVendors

– Identify the certification bodyIdentify the certification body

– Create the Vendor Certification guidelinesCreate the Vendor Certification guidelines

• Develop a timeline to deliver the certificate scheme in Develop a timeline to deliver the certificate scheme in

the next two to three yearsthe next two to three years

• Secure Concurrence from the Agency on our Secure Concurrence from the Agency on our Proposed Vendor Program - “PAT Equipment Proposed Vendor Program - “PAT Equipment Certification”Certification”

Page 16: Pharmaceutical Quality by Design: A PAT Equipment Vendor Certification Proposal Charles P. Hoiberg, Ph.D. Regulatory CMC and QA Pfizer Pharmaceutical Sciences

Questions and CommentsQuestions and Comments