The role of contract manufacturing in the pharmaceutical and life sciences industries cannot be overlooked. It has gained favor with organizations in these industries, as it allows them the luxury of outsourcing their processes relating to manufacturing or other activities to a third party, saving them costs and hassles in the short and long terms. Entrusting their processes to Contract Manufacturing Organizations (CMO’s) enables them to concentrate on their core activities such as research and new drug discovery.
With the global economy more open than it perhaps has been at any other point of time in history, and with almost no economy of any country being isolated from the forces of globalization; CMO’s are a very viable option for pharmaceutical and related companies. As long ago as 2010; the global CMO size was put at over $26 billion, with a healthy CAGR of over 10 percent. With the global pharma market having crossed a trillion dollars in 2015; there is heavy optimism for the growth of CMO in the coming years.
While these figures look encouraging; a whole lot of issues need to be considered before embarking on contract manufacturing. The most important of these is quality. Ensuring that the supplier maintains the high quality standards set out by the contracting company is a major challenge for the client company.
The Quality Agreement
Quality Agreements are a very strong tool in addressing this issue. A Quality Agreement is a contract reached between a pharmaceutical firm and a GMP Contract Manufacturer, in which the responsibilities each of these parties has towards assuring the quality, safety and efficacy of the manufactured drug, are spelt out in detailed and clear terms. This is the only real means to ensure oversight of the processes and the quality of the products. Ensuring that they comply with the GMP regulations is at the core of these requirements and expectations.
How do contracting pharmaceutical and life sciences firms draft Quality Agreements that comply with the regulatory requirements and ensure the quality of products from the supplier? What are the elements of a Quality Agreement? What due diligence and scrutiny does the contracting organization need to keep in mind when drafting a Quality Agreement?
Complete learning on all aspects of the Quality Agreement
The nitty-gritty of these elements will be taught at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. This webinar’s speaker, Roger Cowan, is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. The experience he has gained in the industry after having worked in it for 37 years will be in full flow at this webinar.
Please register for this webinar by visiting Contract Manufacturing Arrangements for Drugs
In-depth look at the two recent FDA and EU guidelines
Roger will explain the dynamics of a CMO Quality Agreement at this webinar. He will discuss the two recent regulatory guidelines: the EU GMP Chapter 7 “Outsourced Activities” (Revised) issued by the EU, and the Draft Guidance for Industry – “Contract Manufacturing Arrangements for Drugs: Quality Agreements”, which was issued by the FDA in May 2013. These two guidelines are important from the CMO perspective, as they offer greater depth of understanding and clarity on quality contracts.
Roger will explain what aspects of Quality Agreements need to be taken care of from a regulatory perspective. Both the FDA and the EU have laid sufficient emphasis on the control of suppliers such as CMO’s. It is expected that these new these new regulatory documents will introduce written documentation of this control. Evidence of this kind of control can be presented to FDA/EU inspectors in the form of a Quality Agreement which is specific to a particular CMO.
Writing a Quality Agreement in line with the new guidelines
The speaker will help participants gain a thorough understanding of the Quality Agreement by fully analyzing each proposed section. He will suggest how to write it keeping the new guidelines in mind. He will also detail the comparisons between the two regulatory documents and will highlight their differences. Topics of critical importance in the Quality Agreement, such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc., will be examined. He will also present an analysis of the current status of the FDA draft guidance and will review the comments that this guidance has received from the industry.
Roger will cover the following areas at this session:
o The Who and What of a good Quality Agreement
o What a Quality Agreement is – and is not
o Responsibilities of the owner vs. contract facility
o GMP responsibilities
o A comparison of the new guidelines from the FDA and the EU.
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