excipient auditing and ipea certification of excipient auditors
TRANSCRIPT
ANSI Activities American National Standard: Excipient GMP
Accreditation of Product Conformity Bodies
Certification to Excipient GMP
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IPEA and IPEC-Americas IPEC-Americas: industry association
that develops, implements, and promotes global use of appropriate quality, safety, and functionality ...
IPEA: provides cGMP audit services to the pharm, chemical, and nutriceutical industries to facilitate the assessment of excipient manufacturers to appropriate GMP requirements.
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Excipient GMPs
IPEC-PQG GMP Guide for Pharmaceutical Excipients
U.S. Pharmacopeia <1078>
WHO good manufacturing practices-starting materials
ANSI American National Standard (2010-2011)
NSF 363 Under development
Draft Q1 2011
Approval mid-2011
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ANSI Excipient GMP National StandardAuditable Standard
Development
Open Process to Ensure Level Playing Field
Available for Public Comment
Balanced Review and Approval by Impacted Parties
Consideration of Views and Objections
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ANSI Excipient GMP National StandardConsensus Approval
Developed for Public Good
Voluntary Compliance
FDA can adopt an ANSI standard as regulation. FDA has expressed the importance of this
standard.
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National Technology Transfer and Advancement Act (1996) NIST to coordinate Federal, State and local
standardization and conformity assessment activities
Agencies adopt private sector standards, particularly those developed by standards developing organizations, wherever possible, in lieu of creating proprietary, non-consensus standards
Goal is to reduce unnecessary government standards that create confusion and add expense for compliance
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OMB Circular A119 (1993) “Federal Participation in the Development and Use of
Voluntary Consensus Standards and in Conformity Assessment Activities”
Establishes policies for Federal use and participation in consensus standards and on conformity assessment activities
Revised in 1998 to achieve consistency with NTTAA terminology
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ANSI Excipient GMP National Standard ANSI Standards Developer Proposes to Write Standard
Committee Assembled
Balance of interests:
Excipient Producer
Excipient Users
General Interest
Public Notice of Standard Development
Public Comment Period
Published in Standards Action
Minimum 30-Days
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ANSI Excipient GMP National Standard Consideration of Views and Objections
Resolve or
Notify Objector of Appeals Process
Report objection to ANSI Board of Standards Review (BSR)
Final Approval
Consensus Vote
Demonstrate to ANSI consensus was achieved
Review by ANSI BSR
Affirm ANSI requirements were met
Standard Published
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ANSI Excipient GMP National Standard Essentially a rewrite of IPEC-PQG Guide into
Standards format
Should to Shall
Require documented risk analyses
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Excipient Certification Accredit to American National Standards Institute
Develop Auditable Standard
IPEC-PQG Excipient GMP
Document the Certification Program
Create Program Administration
Establish Objective Expectations
Create Certification Body
Prepare Quality Manual
Host ANSI Assessment
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ANSI Accreditation Application filed July 13, 2009
Application 15 pages
plus 97 pages of supporting details
IPEA To Do List1. Complete internal audit Scheduled for July
2. Contract with applicant
3. Schedule audit
4. Assign audit team
5. Train Certification Board members
6. Assign Certification Board
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ANSI Product Conformity Accreditation Accreditation Issues
1. Financial Stability and Resources
Demonstrate independence
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ANSI Accreditation Accreditation Issues
2. Conflict of Interest
SOP 11
Voluntarily Disclose:
Employed or Consulted prior 5 years
Employees Immediate Family Member
Significant Financial Interest
Recuse from:
Certification Audit
Certification Audit Report Review
Certification Board
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ANSI Accreditation Accreditation Issues
3. Auditor QualificationSOP 2 Education and Experience
Training by IPEA
3-Day Workshop or Expedited 1-Day
Report Writing
Excipient GMP Expectations
Performance Review
Observation of an Audit
Ongoing Review
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ANSI Accreditation Accreditation Issues
4. Certification Board
SOP 7
Education and Experience (Preferably Management Level)
Excipient Maker, User or Independent (FDA, USP, Academia)
Training by IPEA
Excipient GMP Certification Program
Excipient GMP Expectations
Performance Review
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ANSI Accreditation Accreditation Issues
5. Surveillance
SOPs 9, 17, and 20
Certification for 2 years
Surveillance audit annually
Notification of Change that Impacts GMP Quality System
Incidents that Impact Conformance
Customer Audit or Complaint
Regulatory Inspection
Unauthorized use of the Mark or Certificate
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ANSI Accreditation ANSI Assessment
1. Review and accept application
2. Establish assessment team
3. Team reviews documentation.
No records to review.
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ANSI Accreditation ANSI Assessment
4. Team witnesses audit
5. Team witnesses Certification Board review
6. Team reviews certification records
7. The Team makes a recommendation to ANSI
8. ANSI Board decides on Accreditation of IPEA
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ANSI Accreditation Process
Procedures
Assessment
Application
Evaluation Task Force
Accreditation
APPROVED
Preliminary Application
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IPEA ANSI Accreditation
ANSI Assessment
1. Review and accept application
2. Establish assessment team
3. Assessor reviews documentation
Quality Manual
SOPs
Policies
Records
4. Assessor witnesses audit
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No Findings
No Findings
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IPEA ANSI Accreditation
ANSI Assessment
5. Assessor reviews audit report and Board minutes Approved Certification of Grace Davison Curtis Bay: Silicon Dioxide
NF
6. Assessor presents accreditation report to Evaluation Task Group (ETG)
7. ETG recommended accreditation to ANSI Accreditation Board
8.Accreditation Board approved Accreditation of IPEA program
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IPEA Certification Auditor Competency and Qualification
Education
Audit Experience (Excipient or Pharmaceutical)√ GMP Auditor √ CQA, ISO Lead Auditor, etc
Personalized Training — Excipient Auditing Workshop
Supervised Qualification Audit
Review of Audit Report by
Audit Supervisor
IPEA Executive Management
Consensus Acceptance by CEO and COO
Ongoing Performance Review
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Excipient Certification Board 2-Members each from Maker and User
Community or IndependentReview Audit Report and Findings
Interview Auditor
Assess Adequacy of Quality System
Recommendation Certification or
Correction of Deficiencies
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Excipient Certification Audit Verification Excipient is Produced Using Appropriate
Quality System Emphasizing:
Manufacturing
Quality Unit
Packaging, Labeling, and Tamper-Evident Seal
Documentation and Records
Change Control
Audit Duration
Per Excipient: 2 Auditors for 2 Days
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Certification Criteria1. No Items Rated “Critical Failure”
2. No Items Rated “Does Not Meet” Unless Interim Action or Implemented CAPA
3. No Section with “Partially Meets” Cumulatively Indicating Noncompliance
4. No impression there is a significant risk that the quality system is inadequate to assure excipient safety and quality.
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Excipient GMP Certification Comprehensive Site Audit to Excipient GMPs
Minimum 2-days, 2 auditors
Certify Conformance Issue Certificate
Post to Website
Make audit report available at nominal cost Off-set cost for certification
Certification Status Certified
Certification suspended
Certification withdrawn
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IPEA Certification Program Oversight
Certification Board
4 Independent Qualified Experts
Review Application and Audit Report to Certify
IPEA Management Board
Internal Audit
IPEA Board of Directors
Annual Program Review
ANSI
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President and Chief
Executive Officer
Vice President and Chief
Operating Officer
Secretary-
Treasurer
Past Chair
IPEC
Management Committee
IPEA Excipient GMP Conformance
Certification Program
Qualified Auditors
Certification Board
IPEA Staff
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IPEA Certification Process
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Certified
Application Planning Audit
Report ReviewCertificationReview Board
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