Microbial quality control of non-sterile drug products has been a concern to regulatory
agencies and the pharmaceutical industry since the 1960s. Despite being an old challenge …

Relying on practical examples from the authors' experience, this book provides a thorough
and modern approach to controlling and monitoring microbial contaminations during the …

This article will address a model for implementation of quality risk management for the
manufacturing of a non-sterile product through a real case. The risk addressed in the article …

Pharmaceutical manufacturing generally comprises a complex, multi-step processing
system in which significant risks from microbial contamination are presented by diverse …

The microbiological attributes of pharmaceutical ingredients are often critical to final product
quality. FDA expects from the manufacturers to measure and characterize the bioburden of …

Background Ensuring good quality of antibiotics is essential for desired health outcomes.
Risk assessment of products for quality issues arising along the manufacturing and supply …

Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents
that latest information on protecting pharmaceutical and healthcare products from spoilage …

Risk management and formal risk assessment represents an efficient vehicle for achieving
enhanced quality assurance and regulatory compliance. One area of pharmaceutical …

Background Counterfeit and unapproved medicines are inherently dangerous and can
cause patient injury due to ineffectiveness, chemical or biological contamination, or wrong …

Injectable drugs, like those manufactured by the BioPharmOps group of Novartis
Pharmaceuticals AG, must conform to strict guidelines for purity and potency. Recent non …