Which Information on Stability of Pharmaceutical Bulk Products is required in the Application Dossier?

Many guidelines inform about information to be included in the applications regarding the stability of finished products, but regarding bulk products, guidance is unclear and rather vague. The GMP Guide indicates that bulk products should be stored under "appropriate conditions". However detailed indications cannot be found in the Guide nor in other documents. The suitability of these conditions in relation to the proposed storage and/or transportation arrangements of a bulk product and the effect of these on the quality of the given finished product over its declared shelf-life has to be demonstrated in the application dossier. The EMA has now published details about those "appropriate conditions" in a Questions and Answers document.

The document is composed of 7 questions about the topic "Storage and Transport of Bulk Products":

  • What is the definition of bulk storage?
  • What information should be provided on the bulk container?
  • What information should be provided on the storage conditions?
  • What information is necessary regarding the transportation of bulk products between manufacturing sites?
  • What data should be provided to support bulk storage and transportation arrangements?
  • How should the calculation of a product's shelf-life be performed?
  • Which stability conditions should be chosen to support bulk storage?

The objective of the EMA is to increase the transparency of the supporting data required regarding the submission of data about transport and storage stability for bulk products. The EMA often publishes Q&A documents which provide a real-time and unbureaucratic alternative to official guidelines and close existing loopholes in the regulations.

You can access EMA's Q&A webpage at "Stability - Stability issues of pharmaceutical bulk products use in manufacture of the finished product".

Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.