Regulatory
prospective of Quality Agreements in Pharmaceuticals
|
Quality
agreement is a crucial element in pharmaceutical industry, because it delineates
GMP related roles and responsibilities of each party involved and avoids misunderstandings
and conflicts between the parties. Purpose of quality agreement is to establish
and document the individual roles and responsibilities of contract giver and
contract acceptor involved in the contract manufacturing of pharmaceutical
product. Quality agreement is also known as technical agreement.
In
pharmaceuticals quality agreements shall be in place for all the out sourced
activities like manufacturing, supply, production, analysis etc. Generally a
quality agreement talks only about GMP aspects. A quality agreement is
different from so called commercial agreements, because instead of GMP aspects
a commercial agreement portray pricing, legal aspects, delivery terms and liabilities.
More over quality agreements are prepared by QA function of each party where as
commercial agreements are prepared by legal experts. Usually quality agreements
are signed after the signing of commercial agreements. Quality agreements are
useful documents in business as well as GMP prospective, because it will
improve business relations and helps to avoid misunderstandings and conflicts.
In
pharmaceutical industry quality agreement is a regulatory requirement. EU GMP chapter 7 (Out sourced activities) explains in detail about quality agreement
requirements for products placed in the EU markets. USFDA also published a
draft guideline on May 2013 for “Contract
manufacturing arrangements for drugs: Quality agreements”. ICH guideline Q7
also insists for a formal agreement which outline the roles and
responsibilities of both contract acceptor and contract giver.
In
FDA guidance ‘contract giver’ of the drug product is titled as ‘owner’ whereas ‘contract
acceptor’ as ‘contracted facility’. In pharmaceuticals contract giver is
responsible for assessing contract acceptor’s competency to perform outsourced
activities and periodic monitoring and review of contract acceptors
performance. Whereas contract acceptor should have enough knowledge, adequate
premises, equipments, experience and competent person to perform assigned
activities. Contract acceptor should not make unnecessary changes from the
agreed terms of contract without intimating the contract giver. Contract
acceptor should allow the contract giver to audit outsourced activities and he
should not out source any of the activities specified in the agreement to a
third person without prior intimation from the contract giver. Both contract
giver and acceptor are responsible for ensuring that their product are not
adulterated and misbranded and they should work together to ensure the product
quality, safety and efficacy.
To
minimum a quality agreement shall contain following elements.
·
Purpose/scope
·
Terms and conditions (including effective date and termination
clause.
·
Dispute resolution
·
Responsibility matrix, communication mechanisms and contacts
·
Details of products covered by the quality agreement
·
Documentation retention
·
Change controls and revisions
·
Laboratory controls
·
Material management
·
Supply chain details & requirements
·
Maintenance, qualification and validation
·
Batch release
·
GMP audits
·
Reporting and investigating deviations, OOS and market
complaints
·
Product recall
All quality agreements and
amendments/addendums require legally binding signatures. It is the
responsibility of each party to assure the signatures in the quality agreement
reflect the legally binding signatures representing each party.
Quality
agreements are very good mechanism in the pharmaceutical industry in business
and GMP prospective, as it reduces misunderstandings and conflicts between the
contract giver and acceptor. Quality
agreements are not designed to replace commercial supply agreements but rather complement
them.
References
1.
FDA, Guidance for Industry – Contract
Manufacturing Arrangements for Drugs: Quality Agreements, draft guidance, May 2013
2. EU GMP
chapter 7 – Out sourced activities
3. ICH, Q7, Good Manufacturing
Practice Guide for Active Pharmaceutical Ingredients
"In pharmaceutical industry quality agreement is a regulatory requirement. " I quite agree with those words. Quality control is quite important in the biotech field especially in the drug development.
ReplyDeleteThe pharma manufacturers in India are now keen to produce all types of medical drugs such as amoxicillin and clav India on a contract term. As the focus shifts towards globalization for pharmaceuticals to save human lives, there has been a major transformation in the papers of pharmaceutical contract manufacturing in India.
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