EFfCI GMP Certification Review and Update Brussels September 19 th 2012

1. EFfCI GMP CertificationReview and Update BrusselsSeptember 19th 2012

2. EFfCI GMP Certification Agenda • Experiences with EFfCI Certification Scheme • EFfCI GMP Guide 2012 Version • Implementation Plan

3. EFfCI GMP Certification • 9 Certification Bodies registered to date: AQA International • BSI • Bureau Veritas • Certiquality • CsQa • DNV • SGS • SQS • TUV SUD Italia

4. EFfCI GMP Certification • A total of 15 Certificates registered with EFfCI and included on the website: • Certiquality 4 • Bureau Veritas 1 • BSi 4 • SGS 5 • TuV Sud Italia 1 • DNV 1 (recommended for certification) • Total 15 • High profile within EFfCI

5. EFfCI GMP Certification • Review of the Existing Scheme • Implementation • uptake • Experiences of Certifying bodies • Issues and concerns

6. EFfCI GMP Guide 2012 Version Developments since the last meeting (Sept 2010) • Collaboration with FEBEA – French Cosmetic Association (e.g. L’Oreal, Chanel, Yves Rocher, Pierre Fabre etc.) to review Guide and standard to align with their audit checklist • FEBEA intend to conduct shared audits using 3rd parties • FEBEA plan to train your auditors • Achieved equivalence • New Guide and Standard – 2012 edition has customer input as well

7. EFfCI GMP Guide 2012 Version Introduced several concepts from the New Pharmaceutical Excipients standards: • EXCiPACT • ANSI NSF 363 US National Standard Both based on IPEC-PQG GMP Guide 2006 – which is the original basis of the EFfCI GMP Guide and Standard But now includes modern GMP concepts especially use of Quality Risk Management Removes many of the “as applicable” statements

8. EFfCI GMP Guide 2012 Version Key Changes: • Retention periods of records linked to expiry or retest interval plus one year • Documented change control procedure, with significant changes evaluated by quality unit and communicated to customers

9. EFfCI GMP Guide 2012 Version Key Changes: • Requirement for quality risk assessments • Determine the threats to product purity and quality • Determine the risks posed by those threats • Implement control measures to reduce those risks • Document analysis

10. EFfCI GMP Guide 2012 Version Risk Assessments • Infrastructure (6.3) • Effectively can be used to justify current arrangements • Removes the need for “as applicable” in the guide and standard • Simplifies the auditors role as can use experience and knowledge to judge completeness and suitability of risk assessment • Builds on the principle that the manufacturer should know their processes (risks) best • Detailed requirements in 6.3 then follows and applies IF those controls are identified as needed

11. EFfCI GMP Guide 2012 Version Risk Assessments • Work Environment (6.4) • Same approach, possibly the same risk assessment • Cleaning of manufacturing equipment (7.5.1.2) • When and if required • Infrastructure and Work Environment introduce no new requirements other than the need for risk assessment(s)

12. EFfCI GMP Guide 2012 Version Key Changes: • Cleaning of manufacturing equipment (7.5.1.2) • Need to have evidence that the cleaning process works • NOT VALIDATION • So could be photographs, rinse analysis or cross-contamination analysis etc. • Evidence needs to be reported and available at Audit • Product release requires assessment of lab test results on batch AND review of production batch records (8.2.4.2)

13. EFfCI GMP Guide 2012 Version Other Changes: • The quality unit needs to retain an obsolete copy of controlled documents (4.2.3) • If Special storage conditions needed then communicated to the customer on each delivery - not only on the label (7.5.3.3) • Special storage conditions to be controlled with records retained (7.5.5.1)

14. EFfCI GMP Guide 2012 Version Other Changes: • Written evidence that the packaging does not contaminate the product (7.5.5.2) • Clarification on “experience of the material” in determining stability – use “historic and/or retrospective data” (8.2.4.7) • Justification of expiry or retest interval needed and communicated to customer (8.2.4.8)

15. EFfCI GMP Guide 2012 Version Other Changes: • Inclusion of “Critical Deficiency” in glossary • A deficiency which has produced, or leads to a significant risk of producing a product which is harmful to the customer or which does not comply with regulatory requirements or commercial claims. • But no use in Guide or Standard • Helps define “critical” which is used a lot!

16. EFfCI GMP Committee Consider these changes to be Significant • Therefore require a cut-over period for existing certified companies • And new companies • How long is reasonable to give then to make the changes to their systems? • Do we need an auditor training course?

17. EFfCI GMP Certification Other Developments • EFfCI GMP now accepted as suitable GMP for cosmetic ingredients by major blue chip companies • FEBEA members (but may still want to do their own audits) • Unilever • Unilever will accept EFfCI Certification in place of their own standard, and in some cases will demand yearly audits as well • J&J • Others…..

18. EFfCI GMP Certification • EFfCI in discussion with PCPC (Personal Care Products Council) in USA, to work out how EFfCI GMP can be applied in the USA • Certificated being requested outside Europe • FDA are aware of EFfCI and its heritage • How can we increase promotion of the scheme? • Press release on new edition? • Promotional materials?

19. EFfCI GMP Certification Thank you for your attention Any Questions