Process Validation - EMA & US Guidance Comparison

Process Validation  - EMA & US Guidance Comparison

 

Similarities
Incorporates product life cycle, QRM and efficient quality system practices (ICH Q8, Q9 & Q10).
Emphasis on continued process verification through analysis of pre and post release data to provide confidence of an ongoing valid process.
Acknowledgement and provision of scope to emerging processing technologies, such as PAT, to assist the validation effort.
Enhanced detail to provide understanding of regulator expectation on what constitutes an appropriate validation effort.
EMA	US
Definition “documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.”	Definition “the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”
The EMA draft guideline states “a minimum of three consecutive batches”, with justification to be provided (there are some exceptions to this statement).	The US FDA guidance states that the number of batches must be sufficient to provide statistical confidence of the process. It is a subtle, but important distinction in the approaches.
The US FDA guidance emphases documenting the development phase as part of PV.	The EMA draft encourages the use of the product development activities, but is less prescriptive on requirements.
The EMA guideline specifically allows the use of CPV to replace traditional validation efforts.	US FDA approach does not place high emphasis on CPV, and requires all three stages of process validation to be fully addressed, regardless of whether contemporary or traditional methods are utilised.
The US FDA guidance considers equipment and process design, as well as equipment qualification as part of the overall process validation effort.	The EMA guideline sees process as independent from equipment and facility. Currently, the EMA still relies on Annex 15 of the GMP guide for instruction on equipment qualification.