This whitepaper considers sterility testing to support pharmacopoeial monographs with an emphasis on products that are difficult to test or validate.
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Reading Scientific Services Limited
This webinar considers the fundamental importance of water system control within pharma processing and the best control and monitoring practices.
This whitepaper outlines the important components of an environmental monitoring programme, providing practical advice and best practice guidance.
This webinar presents the fundamentals of a contamination control strategy including forms of contamination, as well as cleaning and disinfection.
This whitepaper discusses the analytical testing considerations for complex biological materials in ATMPs.
This on-demand webinar focuses on the importance of cleaning and disinfection, covering legal requirements and the global guidelines for disinfection in cleanrooms.
This white paper discusses the over-arching strategy for performing a successful cleaning validation, with detail on some of the key factors to consider at both the manufacturing, microbiological and analytical stages, highlighting many common pitfalls to avoid..
Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient...
This selective detection method greatly improves the prospect of detecting nitrosamines in pharmaceutical products and medical devices that incorporate rubber or latex...
In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation...