Regulatory prospective of Quality Agreements in Pharmaceuticals
Friday, 30 October 2015
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.
· 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.
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