Biosisto Whitepapers

Microbiological Reference Material in Pharmaceutical Laboratories

Pharmaceutical Quality Control

A Biosisto Whitepaper about the ins and outs of Microbiological Reference Material in Pharmaceutical Laboratories.

In the pharmaceutical industry, accuracy and reliability are crucial. Pharmaceutical laboratories are bound to strict prescribed quality standards and regulations such as the US Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), EudraLex, International Organization for Standardization (ISO), GMP guideline and the GLP guideline.

Every product entering the market must meet strict standards and regulations to ensure safety and effectiveness. In pharmaceutical laboratories, reference materials are essential to meet these standards. This whitepaper focuses on the importance of reference materials in pharmaceutical laboratories and their role in ensuring quality and improving analytical results.

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Microbiological laboratories should be able to receive reliable analysis without much overhead. A microbiological analyst must be able to focus on the primary activities, for example analysis of the sample material. Quality control should support the analyst in a logical and simple manner. By using modern information technology, process control and quality assurance are designed smarter and more effective.

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