Annex 1 of the European Union’s Good Manufacturing Practice (GMP) guidelines sets out the requirements for the manufacture of sterile medicinal products. To become Annex 1 compliant, a pharma company needs to ensure that its manufacturing processes and facilities meet the standards outlined in the guideline.

The following are some of the key requirements that a pharma company must fulfill to become Annex 1 compliant:

  1. Facility design and layout: The manufacturing facility should be designed to ensure proper segregation of different manufacturing areas, to minimize the risk of contamination.
  2. Environmental monitoring: The manufacturing area must be monitored for viable and non-viable particles, temperature, humidity, and pressure differentials.
  3. Personnel qualification and training: Personnel involved in the manufacture of sterile medicinal products must be appropriately qualified and trained to perform their tasks.
  4. Aseptic processing: The manufacturing process must be designed to ensure that the product is not contaminated during processing.
  5. Cleaning and disinfection: The manufacturing area must be regularly cleaned and disinfected to prevent contamination.

Should your organisation or any CMO in your network need any assistance in the generation of their CCS, GAP analysis or implantation plans, MIAS Pharma would be happy to offer any help we can in order to accelerate compliance and ensure continued delivery of medicines to our patients.

For any questions get in touch with us at