ANNA CLUET
GMP Consulting area Manager, Rephine, Spain

Abstract

Revised EU GMP Annex 1 requirements (1) for Manufacture of Sterile Medicinal Products come into force in August 2023. Anna Cluet of Rephine sets out the three key areas that life sciences companies must address, along with practical advice as to how to meet the requirements.

In August 2022, revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products were issued, starting the clock for compliance. All but one of the new provisions must be fulfilled by August 2023. The updated requirements, designed to protect and increase confidence in the sterility of these products, are significant and wide-ranging, spanning the Quality system and the manufacturing process itself.

The revised expectations span three key areas, which are set out below along with practical advice on how to fulfil the requirements.

1. CONTAMINATION CONTROL STRATEGY (CCS)
Developing and refining the CCS, which must ensure that consistent standards are upheld end to end across manufacturing operations, will require substantial resources – both now and on an ongoing basis. Here’s how to break that down:

a) Build a team
Defining the CCS will require the involvement of a number of different stakeholders, because the scope here transcends any one department. These include knowledgeable individuals from production, engineering, maintenance, quality control, the microbiological department, and quality assurance.
Between them the team must have technical knowledge of the facilities, the equipment (e.g. heating, ventilation and air conditioning (HVAC), and water generation and distribution systems), the manufacturing processes and the workings of the production department.

b) Document a formal contamination control policy
Once a multi-disciplinary team has been assembled, the next task is to prepare the policy, with input and approval from all stakeholders and the Quality director. This i ...