EMA clarifies application of GMP principles to ATMP starting materials

The European Medicines Agency (EMA) issued a question-and-answer guidance on 23 April addressing how good manufacturing practices (GMP) principles should be applied to starting materials for advanced therapy medicinal products (ATMPs) of biological origin.

EMA said that the Q&A is not meant to set new GMP requirements but rather to give guidance on “what principles of GMP mean and how to implement them.” The guideline describes “minimal” requirements in the fields of quality management, risk management and production and quality control applicable to relevant starting materials.

The issues set forth in the guidelines had been previewed by Ana Hidalgo-Simon, MD, PhD, EMA’s head of advanced therapies, during a September 2020 presentation at RAPS’ Convergence. (RELATED: Convergence: EMA close to finalizing guidance for advanced therapies, Regulatory Focus 17 September 2020)

The guidance states that “a GMP certificate is not required for manufacturing and testing sites of starting materials for ATMPS. For certain starting materials of biological origin (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, however, mandatory that the principles of GMP are complied with.”

For example, when vectors, plasmids and linear DNA templates are used as starting materials, the ATMP manufacturer should apply a risk-based approach to identify which sections of Part IV of the EU’s GMP Guideline are most relevant to ensure their quality.

The guideline stated that a risk -based approach is critical to screen the starting material for transmissible spongiform encephalopathy, viral contamination and cross contamination with other vectors or other genetic material, or for microbiological contamination.

If these starting materials are procured from different manufacturers, the guideline recommends including “appropriate principles of GMP” in the agreement between the ATMP manufacturer and the manufacturer of the relevant starting material.

EMA also issued on 23 April an updated compilation of question-and-answer documents on GMPs and Good Distribution Practices (GDPs), which includes this Q&A.

EMA question and answer guidance on the GMPs for starting materials of biological origin used in ATMPs

EMA updated compilation of guides on GMPs and GDPs

EMA clarifies application of GMP principles to ATMP starting materials

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