Questions and Answers on the Principles of GMP for the Manufacturing of Starting Materials of Biological Origin Used to Transfer Genetic Material for the Manufacturing of ATMPs

On 23 April 2021 the EMA announced the availability of the updated Q&A guidance on GMP.

A GMP certificate is not required for manufacturing and testing sites of starting materials for ATMPs. For certain starting materials of biological origin1, (e.g. linear DNA used as template for ex vivo transcription into mRNA, plasmids to generate viral vectors and/or mRNA, and vectors2) used to transfer genetic material for the manufacturing of ATMPs it is, however, mandatory that the principles of GMP are complied with.

This Q&A document doesn’t set new GMP requirements but gives guidance on what principles of GMP mean and how to implement them. To this end, 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.

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