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Siegfried Schmitt, PhD, principal consultant at PAREXEL.
A drug sponsor?s responsibility does not end when a task is outsourced.
Q.We are part of a multinational company, and some regulated activities, such as supplier audits, are pooled at the corporate head office. In a recent internal audit, we received a finding that there were no quality agreements in place between the site and the head office covering these activities. Surely, as we are one company, no such agreements are needed?
A.‘If it is not documented, there is no proof of evidence.’ While the company may be following an old adage, internal auditors were correct in documenting this deviation from good practices. Close collaboration and a common understanding of work practices among staff does not absolve anyone from having documented processes, roles and responsibilities, and defined documentation requirements—all commonly referred to as a quality-technical agreement.
The basis for this can be found in relevant regulations by the European Medicines Agency (EMA), FDA, the World Health Organization (WHO), Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme (PIC/S), and the International Conference on Harmonization (ICH) (1-5).
When looking for applicable regulations relating to quality-technical agreements, it is important to note that explicit references to such agreements do not always exist. It is, therefore, necessary to look for other terms, such as contract manufacture or outsourced activities.
Apart from being a regulatory requirement, these mandates make good business sense. Their aim is to reduce errors, timelines, and cost. They should clearly describe all elements of respective roles and responsibilities, inputs and outputs, and expectations from both sides.
Items to address in a quality-technical agreement include all aspects that affect the identity, quality, safety, potency, and purity of a product, and/or aspects that may affect compliance status of either the contract giver or contract acceptor (6). In a specific case in which suppliers are audited by a corporate function, the quality-technical agreement should clarify, as a minimum
Finally, consider tracking agreement effectiveness through well-defined metrics. For every particular case, these metrics could include on-time delivery and in full (target 95%) and the number of audits overdue per quarter (target no more than 1; none for critical suppliers).
Just because activities are being outsourced, even if only to other entities within a company, this does not relieve a company of responsibility. On the contrary, a biopharmaceutical company must continue to assume responsibility, and quality-technical agreements are an important way to help ensure and retain this control.
1. EudraLex, Vol 4, Chapter 7 Outsourced Activities, accessed Apr. 11, 2014.
2. FDA, Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements, Draft Guidance (May 2013).
3. WHO,Pharmaceutical Production and Related Technology Transfer, 2011, accessed Apr. 11, 2014.
4. PIC/S, GMP Guide PE 009-11 (Part I).
5. ICH,Q10 Pharmaceutical Quality System.
6. PDA, Technology and Knowledge Transfer, Keys to successful implementation and management (PDA, May 2014).
About the Author
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses the importance of quality-technical agreements.