Risks, Regulations and Determining the Best Method for Your Product

Time: 2:50 pm - 3:10 pm

Date: 30 April 2019

30-april-2019 14:50 30-april-2019 15:10 Europe/London Risks, Regulations and Determining the Best Method for Your Product

Determination of microbial quality is something which every pharmaceutical manufacturer must consider in the development life cycle. Depending on the product in question, the methods utilised for microbial limits testing can vary broadly and it is important to understand in advance what the best suited method is for each individual product. Crucial to the decision… Read more »

Making Pharmaceuticals

Synopsis

Determination of microbial quality is something which every pharmaceutical manufacturer must consider in the development life cycle. Depending on the product in question, the methods utilised for microbial limits testing can vary broadly and it is important to understand in advance what the best suited method is for each individual product. Crucial to the decision on which method is suitable is to have familiarity with both the regulatory guidelines and awareness of how the available methods work with specific product types.

This presentation will provide an overview of the general pharmacopoeial guidelines involved in the Microbial Examination of Non-Sterile Products, including the harmonisation of these methods across global regulatory bodies. There will be an additional focus on indicator organisms and determining which organisms are objectionable as well as risk assessments and their place in the testing process.

We will also discuss the various microbial limits testing methods with a pros and cons approach to best practices in determining the appropriate method for specific products including an experience-based assessment of the specific roadblocks certain product types might pose in the testing process.

Speakers

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