IPEC QA Guide & Template – Content, application and ... June 25, B1 IPEC QA Guide...• IPEC...

IPEC QA Guide & Template –Content, application and benefit for industry

Dr. Johanna EiseleEvonik Industries AG

Amsterdam, June 2014

June 2014, Johanna Eisele, Evonik Industries AG2

• Why quality agreements?• Regulatory requirements• Objectives of quality agreements• Negotiate quality agreements • IPEC quality agreement guide and template• Content of quality agreements• Quality agreements with manufacturers • Quality agreements with distributors

Agenda


Why quality agreements?

• Beneficial in supply relationship

• Create a quality partnership

• Mutual understanding of expectations

• Know and understand products / processes involved

• Clearly defines and assign quality responsibilities and activities

• Based on quality procedures in place

• In some jurisdictions required for manufacturing under contract



Agenda


Regulatory requirements

EU:• EMEA refers to a quality agreement as a „technical

agreement“• Required in legislation such as Directive 2003/94/EC (Article

12) and EU GMP Guide• Refers to contract manufacturing,

contract analyses, etc.• Does not refer to supply of goods USA:• Assumed for contract manufacturing, draft guideline May

2013

There are no legal requirements for QA between buyers and suppliers of excipients!


EU GMP guideline -2013 draft of chapter 5

• Newly introduced Point 5.33 is about the minimal requirements concerning the subcontracting of the testing of starting materials by the manufacturers of the medicinal product to the approved starting material manufacturer

• Formal agreement should be signed between the two parties.

• Special attention should be paid to the distribution in order to ensure that the initial test results remain valid even after the transport

• (…..)No Action on this draft for some time…..



Agenda


Objectives of quality agreements

Buyer and Supplierdefine obligations

Supplier adoptsadditional

responsibilities

Buyer and Supplieragree on joint

definition of quality with regard on

excipients supplied

Buyer adopts additional

responsibilitiesQuality agreements complement

supply/commercial agreements



Buyer and Supplierdefine obligations

Supplier adoptsadditional

responsibilities

Buyer and Supplier agree on joint

definition of quality with regard on

excipients supplied

Buyer adopts additional

responsibilitiesQuality agreements complement

supply/commercial agreements

A quality agreement does not replace the qualification or an

audit of the supplier!



Define!Why and with whom to execute quality agreements?Buyer: • Key suppliers / critical suppliers• Key materials / critical materials

Supplier:• Key accounts• Key development partners• Key external service providers


• Why quality agreements?• Regulatory requirements• Objectives of quality agreements• Negotiate quality agreements• IPEC quality agreement guide and template• Content of quality agreements• Quality agreements with manufacturers • Quality agreements with distributors

Agenda


Negotiation of quality agreements –who should be involved?

• Quality Assurance staff of supplier and buyer• Legal department of supplier and buyer

Case to case: • Sales and Account Managers (recommended)• Regulatory Affairs• Production • Quality Control

Define: who gets in the lead for negotiations?


What influences negotiation?

Time period of negotiation

Complexity andrichness of details

Staff involved in review

and negotiation



Supplier’s Q-SystemISO 9001 IPEC GMP

USP <1078>

Supplier(Manufacturer /

Distributor)Suppliers Sites, Legal counsel

QA, other Personnel

Buyer’s Q-SystemUS, EU or WHO

-GMP

BuyerBuyer Sites Legal Counsel

QA, other Personnel

Content of QA

- Complexity - Term- Sites


• Observe consistency to existing or planned supply agreements

• Liability and liability caps should be addressed and have to be agreed on.

• A quality agreements is a fully-fledged legal contract applicable to contract partners as legal entities.

• A quality agreement is more than a contract between quality departments.

Copenhagen - September 2012, Johanna Eisele, Evonik Industries AG15



Agenda


The IPEC QA guide and template

• To improve communication between excipient users and suppliers

• Template designed as a common starting point to create quality agreements

• Templates addresses fundamental quality issues specific to the manufacture and use of excipients

• Intended to reduce time and effort needed to complete a Quality Agreement

Download IPEC Guidance documents for free at http://www.ipec-europe.org/


IPEC‘s quality agreement template

• Flexible model for crafting quality agreements

• Tool box “Build you own quality agreement”

• Defines appropriate topics that should be addressed in a quality agreement related to excipients.

• Manufacturer Template: Designed for use between the original manufacturer and either the end user or a distributor.

• Distributor Template: Designed for use between the distributor and the end user.


Pitfall: parties to conclude a QA

Liability insurance terms often prevent direct quality agreements between original manufacturer and end user when the material is purchased via distributor.

Manufacturer Distributor End user

End user



Agenda


Content of quality agreements (1)

Introduction and Purpose• Scope• Define product(s)• Define quality criteria (IPEC GMP, EXCiPACT™,

ISO 9001, USP<1078>, etc.)• Responsibilities for quality activities • Sites involved• Use of third parties• Assignment of responsibilities• Choice of Law and other legal clarification• Compliance


Content of quality agreements (2)

• Manufacture, testing, packaging, labelling, release• Documentation and records• Storage and distribution• Change control• Non-Conformance• Auditing• Quality contacts• Clarification of liability• Signatories – authorized to sign?• References• List of attachments


• Why quality agreements?• Regulatory requirements• Objectives of quality agreements• Negotiate quality agreements• IPEC quality agreement guide and template• Content of quality agreements• Quality agreements with manufacturers• Quality agreements with distributors

Agenda


Quality agreements with manufacturer

• Contract with the original manufacturer of an excipient

• Executed with buyer, end user or distributor

• Original manufacturer: the company that manufactures a material to the stage at which it is designated as a pharmaceutical starting material.


Quality agreement with a manufacturer – case study

• Evonik Industries AG Product Line Pharma Polymers & Services

• Manufacture of acrylic copolymers EUDRAGIT® (excipient in oral and dermal dosage forms)

• Backward integrated for raw materials (i.e. monomers)

• ISO 9001 / 14001 / BS OSHAS, EXCiPACT™ certified

– Last ISO Certificate February 2012 (first audited 1993)

• In place and certified according to ISO 9001:

– Quality Manual, Central Audit System, Central Purchase and Supplier Evaluation, Central Analytical Department, …


How to approach?

• As of 2004 increasing demand to sign quality agreements

• Multi-national and small companies

• In 2004 / 2005 Evonik started to elaborate: what would be the contents of quality agreements?

• Involved parties: QA, Regulatory, Representative of Account managers, Legal Department, Sales and Distribution.

• Educate the organization!

• Be resource efficient

• Flexible template is used


• Why quality agreements?• Regulatory requirements• Objectives of quality agreements• Negotiate quality agreements• IPEC quality agreement guide and template• Content of quality agreements• Quality agreements with manufacturers• Quality agreements with distributors

Agenda


• Distributor: handles the excipient after the point at which the excipient is transferred outside the control of the original manufacturer

• Any supplier other than the original manufacturer.

Examples: • Re-processors, Re-packagers, • Transport and warehousing companies• Forwarding agents• Brokers, traders• But also distributing legal entities of the original

manufacturer.

Quality agreements with distributors (1)


Quality agreements with distributors (2)

• Contents similar to quality agreements with original manufactures

• To be adopted for Good Distribution Practices• To be adopted depending on the activities of the distributor

(Re-packaging? Re-Labelling? Re-analysis?)• Distributor shall have quality agreement in place with original

manufacturer.


How to prepare a quality agreement?

• Supplier may consider to prepare a quality agreement in advance based on the IPEC template

• Parties should verify if quality responsibilities may require action

• Ensure that the obligations of the agreement are consistent with the quality systems of both supplier and buyer

• Modify template with care

• Seek legal counsel

• Ensure effective implementation at both parties

• Observe life cycle of quality agreement


Quality Agreement – Life Cycle

Expiration QA

Amendments

Staff involved

Negotiation

Signatures QA

Content QA

Contracts in place

Negotiate subsequent QA


Summary

• Quality agreements foster a successful and trustful cooperation between supplier and buyer

• IPEC template allows to build and prepare an appropriate agreement

• Quality agreements should correctly describe actual procedures.

• Quality agreement are legally binding documents / contracts.

• Negotiation and maintenance of quality agreements involve various departments including legal.


Thank you for your

attention !

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