EMA: Q&A Paper on Measures to Prevent Microbial Contamination of Non-Sterile Medicinal Products
The EMA has published a new Q&A paper on technical and organisational measures to prevent microbial contamination of non-sterile medicinal products.
Chapter 5, section 5.10 of the GMP guidance requires products and materials to be protected from microbial and other contamination throughout processing, without specifying detailed measures.
The EMA emphasises that microbial contamination may also pose a risk to product quality and patient safety in non-sterile medicinal products. Appropriate control measures should be defined based on Quality Risk Management (QRM). Relevant principles of a Contamination Control Strategy (CCS) in accordance with Annex 1 of the EU GMP Guide may also be considered.
Recommended measures include microbiological testing as part of cleaning validation, consideration of the drying step, validated methods for microbiological testing of materials, equipment and products, and appropriate gowning, training and hygiene measures for personnel. An appropriate environmental monitoring programme should also be established.
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