Ask your contamination control strategy expert
Based on the new Annex 1, numerous Pharma manufacturers are required to implement a contamination control strategy. MSAT expert Cornelia Haas is happy to answer your questions in an online one-to-one meeting to find solutions for your individual challenges.
Questions you might have regarding Annex 1 and the contamination control strategy
What is the best way to set up your contamination control strategy?
What are potential sources of contamination?
What do you need to take into account concerning pharmaceutical quality systems or facilities?
Does your equipment fulfill the requirements?
What about your value chain including raw materials and consumables as well as utilities?
The new Annex 1 of the EudraLex Volume 4 on Good Manufacturing Practice (GMP) guidelines from August 2022 requires the implementation of a control strategy concerning the microbial, pyrogen and particulate contamination of the drug product. This applies to a large number of pharmaceutical manufacturing facilities and includes sterile medicine products as well as certain products which are not intended to be sterile (e.g. liquids, creams, ointments, low-bioburden biological intermediates).