The answer is clear: NO. Annex 1 (𝘔𝘢𝘯𝘶𝘧𝘢𝘤𝘵𝘶𝘳𝘦 𝘰𝘧 𝘚𝘵𝘦𝘳𝘪𝘭𝘦 𝘔𝘦𝘥𝘪𝘤𝘪𝘯𝘢𝘭 𝘗𝘳𝘰𝘥𝘶𝘤𝘵𝘴) does not apply to ATMPs manufacturing. However, it is surprising that we still find professionals in the field and specialized consultants who defend the opposite and, sometimes, even some poorly informed inspectors.

The position of the regulatory agencies is clear; the Guidelines of Good Manufacturing Practice specific to Advanced Therapy Medicinal Products in volume 4 of the GMPs were written precisely to cover this type of therapies in a specific way. Something different is that, for a specific point, the guidelines for ATMPs comment that it applies in the same way as described in Annex 1 or, also, that it is good practice to consult Annex 1 as a guide when we detect an ambiguous or missing point in the part corresponding to the ATMPS. However, in the latter case, it would be something that would not apply directly and that would have to be analyzed.

The guidelines for ATMPs of the GMPs already considers that these types of therapies are sterile, in fact, they address the requirements of production in closed systems and the requirements of the aseptic process simulation, to give a few examples. On the other hand, it must be taken into account that the regulatory agents, when drafting the part relating to ATMPs, not only took into account that they are sterile therapies, but also the specificity of this type of product when establishing certain requirements (the production restrictions, for example, of a small molecule, cannot be equated with those of a therapy based on cells or viral vectors).