FDA Trends and Remediation Efforts | Author: Kim Lim Introduction There are several different cases of microbial contamination in manufacturing settings cited by FDA warning letters in 2022. These cases cross several different manufacturers, from medical devices to over-the-counter (OTC) to compounding pharmacies to positron emission tomography (PET) for parenteral administration. The cause of the …
There are several current challenges in cleaning validation that manufacturers in the pharmaceutical and biopharmaceutical industries must navigate and the Experts at MEDVACON can assist you with navigating these cleaning validation challenges
Topic: Cleaning Validation When conducting cleaning validation, calculations are used to determine the effectiveness of cleaning procedures and to ensure that equipment is properly cleaned and free from contamination. The Experts at MEDVACON can assist you and your company in establishing the correct calculations. Some of the key calculations used in cleaning validation include: Acceptance …
Topic: Cleaning Validation Cleaning Validation should be conducted at appropriate intervals to ensure that the equipment used in the manufacture of pharmaceutical and biopharmaceutical products is properly cleaned and free from contamination. The Experts at MEDVACON can assist you and your company in establishing the correct intervals. The frequency of cleaning validation will depend on the …
Topic: Cleaning Validation (CV) Cleaning validation in the biopharmaceutical industry is similar to the process used in the traditional pharmaceutical industry, but with some key differences. Biopharmaceutical products, such as monoclonal antibodies, are derived from living organisms and are therefore more sensitive to contamination. This means that cleaning validation for biopharmaceuticals requires more stringent procedures …
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