Change control in the GMP arena can become an especially complex activity when contract manufacture and testing or other outsourced activities are involved. Which parties need to know about which changes, along with the need to report some changes to the regulators can sometimes seem to complicate this activity entirely out of proportion. Here we provide a two part article intended to provide some clarity and structure to this activity. Also, please find a recent blog entry that addresses FDA’s most recent draft guidance on changes to “established conditions” in approved applications.
Part I addresses communication of change and events between partners of a Quality Agreement. Several templates prepared by trade organizations are provided as links. Examples of the type of changes that maybe be considered for reporting between the parties are provided. Some of these changes may also result in reporting to regulatory authorities.
Part II addresses communication of change between the license / MA holder and regulatory authorities in the US and EU. We provide high level concepts to be considered when evaluating changes, and a list of references regarding post approval change reporting from the EMA and FDA. Guidance can never cover all possible options but rather provide a structure and the current opinions of regulatory authorities in this area. Firms are advised to monitor regulatory agency publications to ensure they are considering the most current requirements and guidance in this area. As this article was being written FDA published a draft guidance that is important to consider both for general change control and for changes made by the contract recipient under a Quality Agreement. It is also useful to monitor enforcement activities taken regarding these requirements for their current interpretation.
PART I Coordination and Communication between Partners in Outsourced GMP Activities
PART II Post Approval Change Reporting Requirements to Regulatory Authorities, EMA and FDA