EMA publishes Guideline Draft on Validation of biotechnology-derived Products

In a GMP News dated 16 June 2011, we reported a concept paper of the EMA on process validation of biotechnology derived proteins of active substances. For the EMA, it was necessary to develop an independent guideline on the topic as - despite the existence of harmonised ICH documents - specific aspects of the validation of biotechnology-derived products have been missing. A draft is now available. 

With 11 pages, the document entitled "Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission" is rather long.

Beside the table of contents, an executive summary, definitions and references, the document is divided into 6 chapters:

1. Introduction
2. Scope
3. Legal basis
4. Process development
5. Process validation
5.1. Process evaluation
5.2. Process verification
5.3. Ongoing process verification
6. Points to consider in process validation
6.1. Upstream process
6.2. Downstream process
6.3. Multifacility production

The draft is the second validation document published by the EMA within a short period of time. At the end of February, the EMA first published the final revision of an "old" Note for Guidance". The new title of this "general" process validation guideline for marketing authorisations is: "Guideline on Process Validation for finished products - information and data to be provided in regulatory submissions." The draft on the process validation of biotechnology-derived APIs describes the data required for submission of a marketing authorisation application or variation to be submitted for the validation of biotechnology-derived proteins used as APIs in the manufacture of medicinal products. A traditional approach, an enhanced approach to process validation, or a combination of both can be used.

Judgemental comment
The draft explicitly mentions that process development is not a part of process validation. Nothing is said about a process validation lifecycle. On the contrary, the introduction of the general EMA guideline on process validation points out a lifecycle approach should be incorporated "linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production". For the FDA, process development is - as stage 1 (process design) of its validation lifecycle - an essential component of process validation. Surprisingly, (traditional) process validation is divided into two validation parts: process evaluation and process verification. This is something new which is neither included in the general EMA's process validation guideline, nor in that of the FDA. There isn't much information about the "enhanced approach" and even less about Design Space, and, almost nothing about the combination of both approaches, the traditional and "modern" one. Nothing is said about a number of validation runs to be done. Only some criteria are mentioned to be considered for the justification of the number of validation runs. The points to consider in process validation listed under Point 6 are partly interestingly detailed which should be surely helpful for the industry. The definition of the "high impact model" notion - which has no reference in the document - could be omitted in the final version without any problems. All in all, closer coordination with the "general" EMA process validation guideline would be desirable.

The draft can be commented until the end of October. The document can be found here. A detailed analysis will be available in the next Newsletter.

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