Tag Archive: USP

Preservative Testing – Choice of Challenge Isolates

“What you see is that the most outstanding feature of life’s history is a constant domination by bacteria.” – Stephen J. Gould. Preservation capacity is a central element of consumer product quality.  Though necessary to any microbiological risk assessment, adequate…
Read more

Growth Promotion Best Practices Auditors are Looking for in Pharmaceutical Labs

Performing growth promotion testing (GPT) on new batches of media is an essential task for all sterile and non-sterile pharmaceutical manufacturing laboratories. Your laboratory performs GPT regularly, but are you certain of what best practices auditors will look for when…
Read more

Dear Stanley: Why We Recommend Testing in Parallel for Growth Promotion

Dear Stanley, When performing growth promotion with Microbiologics products, do you recommend testing in parallel with a previously approved media? The USP, EP, and JP don’t require testing in parallel. They only state “Test each batch of ready-prepared medium and…
Read more

8 Best Practices for Growth Promotion Testing

The growth promotion test (GPT) can be a hassle, but it’s necessary for determining if a new batch of media is acceptable. Follow our best practices below to make your testing process as smooth as possible when using Microbiologics products…
Read more

7 Reasons Why Your Lab Should Perform Growth Promotion Testing

Growth Promotion Test (GPT) – this combination of words might make you wince, but the test is essential for labs following pharmacopeia guidelines. GPT is more challenging than a qualitative or ecometric test. It is deemed successful if a small…
Read more

The Great Debate Over B. cepacia Testing: Your Opinions and FDA Recommendations

Last month we outlined the debate for and against requiring B. cepacia testing for all nonsterile pharmaceutical, personal care products and water systems (The Great Debate Over B. cepacia Testing). At the end of the post, we asked our readers…
Read more

The Great Debate Over B. cepacia Testing

To test, or not to test – that is the question. A frequent reason for recalls of nonsterile products is contamination with Burkholderia cepacia, a microorganism capable of causing serious illness in patients with impaired immune systems or chronic lung…
Read more

Objectionable Microorganisms: Keeping Bad Bugs Out of Good Products

No pharmaceutical company wants to sell a non-sterile drug contaminated with objectionable microorganisms, but how does a company know which organisms are objectionable and how do they ensure their drugs do not contain them? An objectionable organism is one which…
Read more