1. ANSI NSF/IPEC 363 and EXCiPACT GMP Standards – Need for Global Harmonization
Ann Van Meter
Business Quality Leader – Dow Pharma & Food Solutions
Chair – GMP Committee – IPEC-Americas

2. Excipient Maker Example
Personal Care Increasing
Food regulations
Excipients and
Atypical Actives Expectations
Industrial Products
ISO Quality
Excipient Maker
Typical “Excipient Manufacturer” produces products for a variety of markets
Majority of production supplies industrial markets – customers buy on price
Profit margins are typically low
Personal Care, Food Additives, Excipients and Atypical Actives represent increasingly smaller percentages of production
Increasing and differing regulations and expectations in regulated markets make it difficult to develop and maintain a sustainable quality system
Geographic differences in regulations and customer expectations add another layer of complexity

3. One Manufacturer: Many Quality Management Systems
Industrial Customers
ISO highest quality system expected
Biggest volume, buy on price, speed and availability of supply
Personal Care
Differing quality standards globally
Customer expectations in many cases greater than for food or pharmaceuticals
Expect multi-day audits
Food
Country specific registrations and requirements
FSC not satisfying many customers
Customer specific questionnaires, quality manuals, agreements
Expect on-site audits
Excipients
IPEC PQG GMPs generally accepted
Country specific requests cause additional, non-sustainable work
Monographs different for same material, additional testing, country specific COAs
Customer specific quality agreements
Atypical Actives
ICH Q7 concepts expected but not economically supportable.
Expectations vary greatly by country and by customers
Makers often do not know their products are used as atypical actives
Number of customers can be hundreds!

4. Concept of Harmonization
Number and complexity of regulatory requirements and customer expectations is no longer manageable
Number of customer audit requests is no longer manageable
Mutually accepted standards are the only viable option
Mutually accepted third party audits are critical to success across all regulated markets
SOLUTION: Harmonized Excipient GMP Standards – ANSI/IPEC 363 and EXCiPACT

5. Common Basis and Goals We can all agree on the following:
Patient safety is paramount
Verifiable compliance schemes
Sustainable Quality systems
IPEC PQG GMP Guide has been broadly accepted for many years as the “Gold Standard” of excipient GMPs
Consensus-based and mutually accepted guides and standards

6. Guide vs. Standard
The current GMP documents for excipients are “guides”
A guide is perceived as voluntary
Guides use words such as “should” and “may”
A standard is perceived as requirements
Standards use words such as “shall” and “must”
A GMP certification to a standard is desired since it is verified compliance to requirements
Two standards for Excipient GMPs
ANSI /IPEC 363 (Non-ISO based GMP certification standard)
EXCiPACT (Annex to ISO Quality Management System Standard)
Both standards used the IPEC PQG GMP Guide as the basis document

7. ANSI/IPEC 363 Features
A voluntary initiative of the IPEC Americas and ANSI/NSF Standard setting organization
Committee representation across all stakeholders including pharmaceutical excipient manufacturers, distributors, regulators, academia, etc.
Ensures relevant GMP requirements are applied to pharmaceutical excipients through a recognized auditing and certification process
Certification provides a cost-effective method of ensuring GMP are applied throughout the pharmaceutical supply chain by reducing the audit burden
Standard issuance is imminent

8. EXCiPACT Features
EXCiPACT is a voluntary self regulated initiative of the global pharmaceutical excipient manufacturing, distributing and processing industry supported by excipient users
Ensures contemporary GMP and GDP requirements are applied to pharmaceutical excipients through a recognized auditing and certification process thereby increasing safety and reliability as well as transparency, of the pharmaceutical supply chain
Accepted by all major stakeholders including relevant authorities globally
Certification provides a cost-effective method of ensuring GMP and GDP are applied throughout the pharmaceutical supply chain by reducing the audit burden

9. IPEC PQG Guide: Update and Harmonization
Steering team formed to lead update and harmonization of IPEC PQG GMP guide
Membership from IPEC Americas, IPEC Europe, PQG
Update needed for the guide to remain current and to ensure alignment with ANSI/IPEC 363 and EXCiPACT standards
Provide supporting guidance for implementation of the standards, particularly those areas requiring risk assessments
Will include an annex on risk assessment concepts and techniques

10. Harmonization
IPEC Americas and EXCiPACT collaborated closely during the development of each standard
The IPEC PQG GMP guide was the basis document for both initiatives
Some common membership to ensure that the standards were as similar as possible
Both utilize the concept of documented risk assessment to ensure that the implementation of the standards provide appropriate controls in manufacturing to produce excipients that are:
Safe
Of appropriate quality
Consistent composition
The mutual recognition of these standards goes a long way toward the goal of harmonization

11. Harmonization: Monitoring Emerging Regulations
China: new regulations for excipients by SFDA
China: Pharmacopeia revision
US: FDASIA Legislation
EU: Falsified Medicines Directive makes GMP applicable to excipients, using a risk based approach
Brazil: Excipient GMPs

12. Other Harmonization Needs
Monographs
Lack of consistency leads to increased testing and costs for non-value added activities
Documentation issues across countries and geographies
Risk Management/assessment of excipients
Increasing regulatory focus on risk based approaches
Excipient Risk management guides currently being discussed/developed
ICH Q3D Elemental analysis
More on this topic later today
Appropriate GMPs for atypical actives

13. Conclusions
Globalization of sourcing will require increased movement to harmonization
Harmonization doesn’t just happen, it must be deliberate
Countries, Geographies, Regulators need to look at how they can be more alike than how they can be different
Patient safety is patient safety – no matter where in the world that patient is
Sustainable quality management systems at excipient makers are based on ONE standard
Mutually accepted standards, monographs, etc. are better than hundreds of different requirements when it comes to compliance AND patient safety
REMEMBER - We all have the same goals

14. Thank You!