Quality by Design (QbD) - Contribution by Excipients Manufacturers

The International Pharmaceutical Excipients Council Europe (IPEC Europe) has published a document with questions and answers on the topic of Quality by Design (QbD).

Since excipients are used in the manufacture of medicinal products and have an influence on the properties of the product and on the production process, QbD in the development of medicinal products can also be relevant to excipients manufacturers. Therefore, suppliers have increasingly to fulfil the task of assisting manufacturers of medicinal products in reaching their QbD aims.

For this reason, a small working group has created a questions-and-answers document on QbD. This Q&A document is meant to give advice and guidance on general questions that are addressed at an early stage and also intends to try to harmonise the answers and comments from both sides and to promote and facilitate the co-operation in this field.

A total of 28 questions are listed, some of which are asked by the suppliers and the remaining ones by the users in the pharmaceutical industry.

The 28 questions are grouped in five topics bearing the following titles:

I. Effective communication between suppliers and users
II. Development of the dosage form
III. Questions related to excipient CQAs (critical quality attributes)
IV. Equipment- and production-related questions
V. Supply of samples 

The topics addressed include among others "Design Space", "Critical Quality Attributes (CQAs)", "Functionality Related Characteristics (FRCs)", "Change Control Notification Process", or the protection of confidential information.

The complete document can be found here

QbD is also the focus topic of the University of Heidelberg QbD/PAT Conference 2009, to be held in Heidelberg, Germany, from 29 September to 1 October 2009. The programme can be found at www.pat-conference.org.

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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