Tag Archives: regulations

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Contamination Control

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Having worked in sterile production environments where contamination control was vital, there were zero exceptions to following the established procedures. Exceptions would invariably lead to unacceptable outcomes. With regards to lock-down and quarantine in relation to SARS-COV-2, there are many exceptions and deviations from the requirements. That will only lead to….you guessed it, an unacceptable outcome.  With this in mind, I present to you a brief article on contamination control in sterile production environments. Continue reading →

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What is Data Trending and How To Identify, Action and Report Trends

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The following is an article I placed on LinkedIn and was written as part of my Developing My Writing While Helping Others series.

Paul Yeatman is a microbiologist with over 15 years’ experience in documentation, validation and running investigations in TGA and FDA regulated environments. He has a strong interest in process improvement, documentation, training and developing others. From 9-5 Paul investigates and solves software problems.  By night he works on his science chops.  He has an arty streak, runs several blogs and enjoys communicating his experiences and knowledge in arenas such as this. Continue reading →

Review of Draft Standard: AS 2828.2 Health records, Part 2: Digitized health records

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One way I keep myself up to date with developments within laboratories and related areas is by reviewing draft standards.  This keeps me appraised of the current state of affairs, keeps my documentation audit skills fresh and potentially allows me to contribute to the content of standards.  For this draft standard, I have some knowledge of IT and IT security so am able to critically review the draft standard and offer comment.

Notes: refer to the conditions for comment stated towards the beginning of the draft standard.

DR AS 2828.2 Health records, Part 2: Digitized health records Continue reading →

Review of Draft Standard: AS 2243.2 Safety In Laboratories – Part 2: Chemical Aspects

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One way I keep myself up to date with developments within laboratories and related areas is by reviewing draft standards.  This keeps me appraised of the current state of affairs, keeps my documentation audit skills fresh and potentially allows me to contribute to the content of standards.

Notes: refer to the conditions for comment stated towards the beginning of the draft standard.

Update 20190103: After proceeding to submit comments, I observed page numbers were required.  That is important to note for future reviews.  Page numbers added.

DR AS 2243.1 Safety In Laboratories – Part 2: Chemical Aspects Continue reading →

Review of Draft Standard: AS 2243.1 Safety In Laboratories – Planning and Operational Aspects

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One way I keep myself up to date with developments within laboratories and related areas is by reviewing draft standards.  This keeps me appraised of the current state of affairs, keeps my documentation audit skills fresh and potentially allows me to contribute to the content of standards.

Here I step through the draft standard making comments.  Where a comment is answered later in the standard, I go back to my original comment and make notes.  An uncommented comment is potentially worthy of becoming an official comment on the standard.

Update 20190103: page nubmers added.

Section 1 Continue reading →

Notes on USP36-NF31 <1116 - Microbiological Evaluation of Cleanrooms and Other Controlled Environments>

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The USP is the United State’s Pharmacopeia.

If you are selling pharmaceuticals in the USA, you need to follow the USP and are subject to FDA regulation.  For the layperson, a pharmacopeia is an official publication containing a list of medicinal drugs with their effects and directions for their manufacturing, testing and use.

The latest iteration of this section of the USP is 39-NF34,  The last version I managed to get my hands on was USP36 NF31.  I’ve compared the two and noted the changes from the NF I reviewed initially.  The identified changes are in blue. Continue reading →