The Role of the American National Standards Institute (ANSI) Irwin Silverstein, Ph.D. IPEA

Transcription

1 The Role of the American National Standards Institute (ANSI) 1

2 ANSI Activities American National Standard: Excipient GMP Accreditation of Product Conformity Bodies Certification to Excipient GMP 2

3 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. 3

4 Excipient GMPs IPEC-PQG GMP Guide for Pharmaceutical Excipients U.S. Pharmacopeia <1078> WHO good manufacturing practices-starting materials ANSI American National Standard ( ) NSF 363 Under development Draft Q Approval mid

5 ANSI Excipient GMP National Standard Auditable 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 5

6 ANSI Excipient GMP National Standard Consensus Approval Developed for Public Good Voluntary Compliance FDA can adopt an ANSI standard as regulation. FDA has expressed the importance of this standard. 6

7 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 7

8 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 8

9 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 9

10 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 10

11 ANSI Excipient GMP National Standard Essentially a rewrite of IPEC-PQG Guide into Standards format Should to Shall Require documented risk analyses 11

12 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 Irwin Silverstein, Ph.D. IPEC 12

13 ANSI Accreditation Application filed July 13, 2009 Application 15 pages plus 97 pages of supporting details IPEA To Do List 1. 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 13

14 ANSI Product Conformity Accreditation Accreditation Issues 1. Financial Stability and Resources Demonstrate independence 14

15 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 15

16 ANSI Accreditation Accreditation Issues 3. Auditor Qualification SOP 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 16

17 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 17

18 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 18

19 ANSI Accreditation ANSI Assessment 1. Review and accept application 2. Establish assessment team 3. Team reviews documentation. No records to review. 19

20 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 20

21 ANSI Accreditation Process Preliminary Application Application Evaluation Task Force APPROVED Accreditation Procedures Assessment 21

22 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 No Findings No Findings 22

23 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 23

24 IPEA Certification Auditor Competency and Qualification Education Audit Experience (Excipient or Pharmaceutical) GMP Auditor Personalized Training Supervised Qualification Audit Review of Audit Report by Audit Supervisor IPEA Executive Management CQA, ISO Lead Auditor, etc Excipient Auditing Workshop Consensus Acceptance by CEO and COO Ongoing Performance Review 24

25 Excipient Certification Board 2-Members each from Maker and User Community or Independent Review Audit Report and Findings Interview Auditor Assess Adequacy of Quality System Recommendation Certification or Correction of Deficiencies 25

26 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 26

27 Certification Criteria 1. 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. 27

28 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 16 28

29 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 29

30 IPEA Excipient GMP Conformance Certification Program President and Chief Executive Officer Management Committee Secretary- Treasurer Vice President and Chief Operating Officer Past Chair IPEC Qualified Auditors IPEA Staff Certification Board 30

31 IPEA Certification Process Application Planning Audit Certified Certification Review Board Report Review 31

32 Accredited April 2010 First surveillance audit: No nonconformances