Annex 1

Annex 1: EU-GMP Guidelines for the Production of Sterile Pharmaceuticals

“Annex 1” refers to the EU-GMP (Good Manufacturing Practice) guidelines, which outline specific requirements for the production of sterile pharmaceuticals. It provides detailed regulations on cleanroom technology, qualification and validation of equipment, microbiological contamination control, sampling and testing procedures, and personnel requirements.

Compliance with Annex 1 is essential for manufacturers of sterile pharmaceuticals to ensure that their products meet the required quality standards and remain free from microbial contamination. The guideline establishes strict requirements for the manufacturing environment, process control, and quality assurance to guarantee the safety, efficacy, and quality of the final products.

Annex 1 is regularly updated and revised to reflect best practices, technological advancements, and evolving regulatory requirements. Pharmaceutical manufacturers must ensure they adhere to the latest version of Annex 1 and continuously update their production practices to maintain compliance.