The need to retain Australian regulatory requirements for non-sterile pharmaceutical
products has been questioned following publication of guideline limits in the 1996 …

The US Pharmacopeia (USP), the Japanese Pharmacopoeia, and the European
Pharmacopoeia" Microbial Limits Tests" are in the final stages of harmonization. The …

Contamination of pharmaceuticals with microorganisms may lead to deleterious effects on
the therapeutic properties of the drug, and may potentially cause injuries to intended …

This chapter will discuss the microbiological analysis of nonsterile pharmaceutical products
with emphasis in the microbiological test requirements and test methods. When a nonsterile …

This chapter focuses on microbiological risk assessments, to evaluate if a recovered
microorganism is objectionable in a specific dosage form or not, and its contain case studies …

The quality of licensed herbal products was assessed by determining the nature and
quantity of contaminating microorganisms. A total of 425 licensed herbal products (for sale …

A scientifically pragmatic approach to management of the microbial bioburden in non‐sterile
products requires consideration of patient risk and the contamination‐control objectives …

The pharmacopeial standard applying to sterile products is that sterile products must be
capable of passing a test for sterility. The sterility test is an important, microbiological test in …

Any pharmaceutical product, whether manufactured in the hospital or industrial environment,
has the potential to be contaminated with microorganisms, which may include bacteria …