Excipact pharmaceutical excipient certification
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EXCIPACT Pharmaceutical Excipient Certification. Milan September 8 th 2010 Iain Moore, Project Coordinator. Excipients are components of medicines Excipeints have no therapeutic activity Excipients formulate active pharmaceutical ingredients into finished drug dosage forms

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EXCIPACT Pharmaceutical Excipient Certification

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Excipact pharmaceutical excipient certification

EXCIPACTPharmaceutical Excipient Certification

Milan September 8th 2010

Iain Moore, Project Coordinator


Excipact pharmaceutical excipient certification

Excipients are components of medicines

Excipeints have no therapeutic activity

Excipients formulate active pharmaceutical ingredients into finished drug dosage forms

Value of the global excipients market: €3 bn

Thousands of different excipients used all dosage forms

Excipients can influence the potency and bioavailability of the active ingredient

Excipient Certification

Excipact - Minimise the Risks, Maximise the Benefits


Excipient certification

Motivation

Safety of medicines for patients – recent tragedies

Drug producers have to qualify their suppliers

Traditionally by a mixture of paper and physical audits

Now a regulatory expectation of physical audits on ALL suppliers – no current alternative to physical audits

= Armies of auditors and auditees

A familiar story?

Transparent certification schemes for all components of a drug benefit the entire industry

Excipient Certification

Excipact - Minimise the Risks, Maximise the Benefits


Excipact pharmaceutical excipient certification

Why Certification?

Absence of regulations for excipients

Certification Scheme for self regulation

Ability for supplier to initiate process

Applicability to manufacturers and distributors of excipients

Well developed and accepted assessment model

Excipient Certification

Excipact - Minimise the Risks, Maximise the Benefits


Excipact pharmaceutical excipient certification

Excipient Certification

Project commenced in May 2008 with EFCG and IPEC Europe, now comprises 5 trade associations

  • FECC – European Association of Chemical Distributors

  • IPEC-Americas

  • IPEC Europe

  • PQG - Pharmaceutical Quality Group (UK)

Excipact - Minimise the Risks, Maximise the Benefits


Excipact pharmaceutical excipient certification

Excipient Certification

Challenges to a user global audit program

  • User Issues

    • Suppliers will not agree to an audit

    • Not enough days in the year for an audit to every supplier

    • Travel costs continue to rise

    • Language barriers

    • Employees don’t want to travel

    • In house auditors are not familiar with chemical processing resulting in less effective audits

  • Supplier Issues

    • Not enough days in the year for an audit from every customer

    • Language barriers

    • Value of business with user does not justify audit time

Excipact - Minimise the Risks, Maximise the Benefits


Excipact pharmaceutical excipient certification

Excipient Certification

Certification & 3rd Party Audits

  • Provides information on Supplier’s GMP practices from experienced auditors with knowledge of excipient manufacturing & GMPs

  • Allow companies to focus resources on excipients with highest risk

  • Reduces audit load for suppliers and users

  • Can allow a level playing field for all

  • Help small companies (both users and suppliers) and those with limited budgets

  • Makes 100% audit verification of suppliers practical

Excipact - Minimise the Risks, Maximise the Benefits


Excipact pharmaceutical excipient certification

Excipient Certification

Nothing in FDA regulations prevents using 3rd party auditors to evaluate suppliers

  • Sec. 211.34 Consultants.

    • Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide

  • FDA have publicly stated 3rd party audits are acceptable

Excipact - Minimise the Risks, Maximise the Benefits


Excipact pharmaceutical excipient certification

Excipact Goals

Acceptance by all stakeholders

International: certificates accepted globally

Inclusive: applicable to as many excipients as possible

Certification assessable for as manyaccredited 3rd party organizations as possible

Evolutionary: builds on existing guides and standards

Simple: easy to understand and apply for all stakeholders

Excipient Certification

Excipact - Minimise the Risks, Maximise the Benefits


Excipact pharmaceutical excipient certification

Excipient Certification

GMP

Annex to ISO 9001 containing specific requirements for GMP – Certificate as Annex to ISO 9001 – same model as EFfCI

Suitable for excipient manufacturers

Harmonised requirements with IPEC GMP Guide for Pharmaceutical Excipients


Excipact pharmaceutical excipient certification

Excipient Certification

GDP

Annex to ISO 9001 containing specific requirements for GDP – Certificate as Annex to ISO 9001 – same model as EFfCI

Suitable for excipient suppliers (e.g. distributors)

Allowance for different distributor/trader operations (trading, warehousing, re-packaging, bulk transport etc.)

Harmonised requirements with IPEC GDP Guide for Pharmaceutical Excipients

In-line with SQAS ESAD Section F&G (www.sqas.org)

Where there is overlap, GMP- and GDP-Annexes contain same requirements


Excipact pharmaceutical excipient certification

Quality of auditors is critical

Competency framework defined using ISO 19011

Alternative starting routes to qualification possible i.e. experienced in ISO 9001, GMP or GDP

Considered best practices e.g. SQA and Qualified Person assessment processes

Training Guide included

Training programme for auditors to be developed

Excipient Certification

Excipact - Minimise the Risks, Maximise the Benefits


Auditor competency qualification

Auditor competency & qualification

Assessment of knowledge & audit skills will be

Tertiary scientific education

Work and Audit experience

ISO 9001 knowledge

GMP/GDP knowledge

Excipient Knowledge

Knowledge assessed orally or by exam

Supervised first audit

Excipient Certification

Excipact - Minimise the Risks, Maximise the Benefits


Certification scheme

Certification Scheme

Program elements

Excipact to be a Legal Entity representing partner organizations

Certification Body: Accredited to ISO 9001, ISO/IEC Guide 65, ISO 17021 or equivalent and verified by Excipact

Excipient suppliers to be Certified on a 3 year cycle

Annual site surveillance audit

Triennial recertification audit

Excipient Certification

Excipact - Minimise the Risks, Maximise the Benefits


Certification scheme1

Certification Scheme

Audit Documentation

Audit Report lists observations and rates findings as critical, major or minor

Technical Experts review audit report and findings, recommend certification if

No critical, no major without CAPA, no minors that indicate failure of quality system element

Audit Report available to pharmaceutical customer with excipient supplier approval

Excipient Certification

Excipact - Minimise the Risks, Maximise the Benefits


Certification scheme2

Certification Scheme

Website

List of Third Party Certification Providers

Directory of certified excipients suppliers

List of certifications suspended and withdrawn

Program Procedures

Appeals

Complaints

Requirements of Third Party Certification Provides

Study Guide for Excipient GMP Certification Auditors

Excipient Certification

Excipact - Minimise the Risks, Maximise the Benefits


Certification scheme3

Certification Scheme

Participation

Legal Agreement between Excipact and 3rd Party Assessment Body

Confirmation of certification held by 3rd party assessment body

Confirmation of auditor competency and qualifications to the requirements of the scheme

Excipient Certification

Excipact - Minimise the Risks, Maximise the Benefits


Excipact pharmaceutical excipient certification

EXCIPACT

Minimize Risks – Maximize Benefits

None of this would be possible without

the commitment and contribution from

the volunteers working in the task

forces and the on the steering committee.

Many thanks to them.

[email protected]

Dr. Iain Moore

Product and Quality Assurance Manager

Croda Europe Ltd

Cowick Hall, Snaith

East Yorkshire, DN14 9AA

Phone +44 (0) 1405 863282

Thank you for your attention

Excipact - Minimise the Risks, Maximise the Benefits


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