Thursday 30 September 2021

Techniques for conducting quality audits


The purpose of a quality audit is to assess or examine a product, the process used to produce a particular product or line of products or the system supporting the product to be produced. A quality audit is also used to determine whether or not the subject of the audit is operating in compliance with governing source documentation such as company directives and applicable standards and regulations. In contrast to this there are inspections, which are conducted by accrediting organizations and inspectorate (regulatory) bodies.


Audits are systematic and independent examinations of manufacturing related activities and documents to determine whether the process is being conducted and records made according to protocols and SOPs. Audits are part of the quality system and are designed to be part of continuous improvement. They are undertaken in a way which is generally co-operative. In contrast, an inspection is the act by a regulatory authority of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the manufacture of the product.


There are different ways for conducting audits and inspections, and indeed there is a difference between and audit and inspection. This article surveys the more common approaches and how they differ and provides summaries of different styles of audits.


The reference is:


Sandle, T. (2021) Techniques for conducting quality audits, GMP Review,19 (4): 4-8


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Wednesday 29 September 2021

Robots in pharmaceutical manufacturing


Robots have become increasingly popular across all industries. While the manufacturing sector remains the most prominent, other areas are recognizing the benefits of these machines too. Robots in the pharmaceutical industry are playing an increasingly crucial role in the sector.  The pharmaceutical robot market was worth $64.37 million in 2016 and could surpass $119 million next year. Considering how these machines have supported the industry through the COVID-19 pandemic, that number could be higher.


While the word “robot” conjures up images of physical machines, not all robotics look like that. Some of the most promising pharmaceutical robots are software bots, which automate digital processes. Perhaps the most significant application for these bots is in drug discovery.


This article presents ten reasons why robots are so revolutionary for pharmaceuticals.


The details are:


Sandle, T. (2021) Ten reasons why pharmaceutical manufacturing robots are revolutionary, Pharma Machines and Technology, 15 (5): 32-36


Direct link: 

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Tuesday 28 September 2021

Quality risk management for cleanrooms


To be effective, microbiological environmental monitoring of cleanrooms needs to be risk-based. This not only delivers an effective programme, Dr. Tim Sandle finds, it also meets the regulatory expectation presented in the revised EU GMP Annex 1 and hence risk assessments are needed to build a compliant monitoring regime.


Developing well-designed environmental monitoring programmes requires an understanding the risks, contamination sources, strategies to reduce risks. This necessary in order for determining frequencies of monitoring, assessing suitable monitoring locations, and for understanding the significance of contamination events, should they occur.  With any established environmental monitoring programme it is important to review this programme regularly and to update or adapt the regime according to process changes, room design, shift changes, cleaning and disinfection levels, and to set and evaluate corrective and preventative actions put in place to address contamination events.



Sandle, T. (2021) Quality risk management leads to more effective environmental monitoring, European Pharmaceutical Review, Environmental Monitoring Supplement (Important considerations for every bio-pharmaceutical microbiology QC lab), June 2021: 9-12


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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