Pharmaceutical Technology October 2020 Regulatory Sourcebook
For bio/pharmaceutical companies, quality must be more than a vague concept. Quality practices impact all aspects of drug development and manufacturing. In the Pharmaceutical Technology Regulatory Sourcebook, experts share insights and best practices on a range of quality issues including the following:
AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for solid oral dosage forms.
For planned acquisitions or licensing, a careful analysis of CMC factors is vital to ensure no problem areas are overlooked.
Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.
Ongoing and emerging cyber-risks to legacy operational technology systems in bio/pharmaceutical manufacturing must be addressed.
Consistent product quality requires a clear understanding of the essence of CGMPs. Experts fear that the message is not always getting through to compounders.
FDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.
The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.
Building employee participation and forming good habits contribute to a company-wide quality culture that pays off.
To read these articles, view the Pharmaceutical Technology October 2020 Regulatory Sourcebook online at www.PharmTech.com/journals/pharmaceutical-technology/pharmaceutical-technology-10-15-2020.