Quality by Design (QbD) describes a systematic approach in the development of medicines which is based on a scientific process understanding, the precise knowledge of critical quality attributes and the principles of Quality Risk Management. Guidance related to QbD can be found in the ICH Q8, Q9 and Q10 Guidelines.
APIs play a great role already in the early stage of development with regard to the characteristic of the product and the production process. Therefore, there should be a cooperative dialogue between the drug manufacturer (as users of the APIs) and the excipient manufacturer as early as possible - ideally at the beginning of the clinical phase IIB.
The International Pharmaceutical Excipients Council (IPEC) Europe has published three useful documents which facilitate the use of QbD principles with regard to APIs and should harmonise communication between the suppliers and the users of APIs: a collection of Questions and Answers on QbD, a checklist for the users and a checklist for the manufacturers/suppliers of APIs.
The three documents are structured in the same way and divided in 5 chapters:
1. Effective communication
2. Development of the Dosage Form
3. Critical quality attributes of APIs
4. Equipment and Production
5. Supply of samples
These documents have been elaborated by a working group of the IPEC made up of representatives of the pharmaceutical industry and excipients suppliers. The authors highlight that the Q&A document should be considered as a living document which needs to be fed by the feedback from both branches of industry.
For further information please see the Q&A document, the checklist for "Excipient Users" and the checklist for "Excipient Manufacturers/Suppliers".
Note: Learn more about all the novelties related to GMP and Certification of APIs in the ECA Education Course"GMPs for Pharmaceutical Excipients" in Barcelona, Spain from 27-28 September 2011. Author