Robust Quality Audits Are The Solution To Avoiding Expensive Recalls

Compliance is an affirmative indication or judgement that the supplier of a product or service has met the requirements of the relevant specifications, contract or regulation; also the state of meeting the requirements. Compliance is something that meets both the text and the spirit of a requirement. This is the central message of the book Audit and Control for Healthcare Manufacturers” by Tim and Jennifer Sandle (published by DHI, http://www. dhibooks.com/books/17351.html)

Robust Quality Audits Are T... 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Biocontamination Control for Pharmaceuticals and Healthcare

A new book has been published – “Biocontamination Control for Pharmaceuticals and Healthcare” by written Tim Sandle. The book outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy.

Biocontamination Control fo... by Tim Sandle on Scribd

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

ISO 14644-16:2019 – Part 16: Energy efficiency in cleanrooms and separative devices

A new standard has been issued:

“This document gives guidance and recommendations for optimizing energy usage and maintaining energy efficiency in new and existing cleanrooms, clean zones and separative devices. It provides guidance for the design, construction, commissioning

and operation of cleanrooms.

This document covers all cleanroom-specific features and can be used in different areas to optimize energy use in electronic, aerospace, nuclear, pharmaceutical, hospital,

medical device, food industries and other clean air applications.

It also introduces the concept of benchmarking for the performance assessment and comparison of cleanroom energy efficiencies, while maintaining performance levels to ISO 14644 requirements.

See: https://www.iso.org/standard/66331.html

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Robust Quality Audits Are The Solution To Avoiding Expensive Recalls

Audit and Control for Healthcare Manufacturers” by Tim and Jennifer Sandle (published by DHI, http://www.dhibooks.com/books/17351.html)

Robust Quality Audits Are T... by Tim Sandle on Scribd

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

The Use of Microbiological Culture Media Article

Free-to-read article on microbial culture media best practices.

The Use of Microbiological ... by Tim Sandle on Scribd

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology