Newly Released Annex 1 Looks to Modernize the Manufacture of Sterile Medicinal Products

The European Medicines Agency (EMA), Pharmaceutical Inspection Co-operation Scheme (PIC/S), and World Health Organization (WHO) has released a new globally harmonized revision of Annex 1: Manufacture of Sterile Medicinal Products. With this extensive update, the worldwide regulatory bodies have sent a strong signal that they want the pharmaceutical industry to embrace modern manufacturing practices when making sterile drugs. Employing these practices can help alleviate drug shortage issues and patient safety concerns through increased product quality and manufacturing efficiency. This relies heavily on the principles of Quality Risk Management (QRM) and encouraging the use of new technologies.

This change in focus can be seen in the requirements for environmental monitoring. The previous version of Annex 1 was often sited as inhibiting the adoption of new monitoring methods. The new revision goes beyond simply removing it as a barrier to outright encouraging it. This can be seen with the statement: “The adoption of suitable alternative monitoring systems such as rapid methods should be considered by manufacturers in order to expedite the detection of microbiological contamination issues and to reduce the risk to product.” It is clear that what is acceptable now may no longer be acceptable in the future. Manufacturers will be expected to look to employ new methods if they can improve process understanding and reduce the risk of product contamination.

Check out TSI solutions that meet the new Annex1 environmental monitoring requirements for continuous sampling with no interventions to assure product quality and eliminate risk.

Content Contributor
Mike Dingle, Product Specialist, TSI Contamination Control