The EMA has published a Q&A on the principles of GMP for the manufacturing of starting
materials of biological origin used to transfer genetic material for the manufacturing of
Advance Therapy Medicinal Products (ATMPs).
Is a GMP certificate required for manufacturing and testing sites of starting materials for ATMPs?
No it isn’t. For certain starting materials of biological origin however (such as e.g. linear DNA used as template for ex vivo transcription into mRNA, plasmids to generate viral vectors and/or mRNA, and vectors) used to transfer genetic material for the manufacturing of ATMPs it is mandatory that the principles of GMP are complied with.
Does the document set new GMP requirements?
No, it doesn’t set new GMP requirements but gives guidance on what principles of GMP mean and how to implement them. A methodology is described to identify minimal requirements in the fields of quality management system, risk management product development, production and quality control to define the principles of GMP applicable to the relevant starting materials.
The document has six Q & As on the topic to facilitate clarification.
Source: EMA website