Tag Archives: documentation

Writing Technical Reports

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What is technical writing?

Technical writing is a style of writing used when preparing protocols, reports, investigations and other laboratory documentation.

What are some examples of technical documents?

In general, any regulated manufacturing site will use the following technical documents: validation documents, reports, Standard (Operating) Procedures, SOP’s and Work/Operator Instructions (OI’s), standard forms and overriding policies and a Site Quality Manual all within the framework of a Quality Management System (QMS), Continue reading →

The Need for Documentation

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“If It Was not Documented, It Was Not Done”

Reviewed and updated July 2020.

At one time there were three monkeys locked in a room. This room also contained a banana, suspended by a cord from the ceiling in the centre of the room. Whenever one of the monkeys grabbed the banana, all the monkeys were subjected to an icy cold shower. After several repetitions of this shower, no monkey in the room would touch the banana. Continue reading →

TOC: At the beginning of a document or at the beginning of each section/chapter?

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The Question posed on LinkedIn.

“Somebody asked me why we continued placing the TOC, List of Figures, and List of Tables at the beginning of a document and not having one these at the beginning of each section/chapter.

Several years ago I released technical manuals using section-based TOCs and other lists. However, that was because Word 97 in my PC (Win 98) could not work with large documents. Once I had a powerful enough PC/Word combination, I never did it again.

I mostly update the TOC and the other lists doing Ctrl-A + F9, which brings up the “Update XXX” dialog box for each table. Since I use appendixes, this methods also generates dialog boxes for them as well. I realize that using TOCs and lists at the beginning of each section would make the updating process longer, as more dialog boxes would pop-up.

However, I now ask myself whether it would be advantageous to do such thing, and why. ”

My advice:

At the beginning of the document as it is easy to find. A sub TOC at the start or each chapter could be a bit more informative.

Word is very bad for formatting and tables, but it seems “everyone” besides the graphic design industry uses it or something similarly bad.

Notes on USP31-NF26 <1116 - Microbiological Evaluation of Cleanrooms and Other Controlled Environments>

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Modified 20181212 – minor typos corrected. minor updates.

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.

I last reviewed USP 1116 in 2009 when it was version USP31–NF26.

Where one does not have direct access to the USP (it is behind a pay wall),  there are plenty of sites that review changes and publish their considered opinions.  The USP itself publishes Revision Bulletins, IRA’s (public comment documents showing proposed changes) and Errata.  From these one can build up a fairly accurate picture of the USP.

The latest iteration is USP 41–NF 36 — this became official on May 1, 2018.  The last version I managed to get my hands on was USP36 NF31.  What follows is my original review. Continue reading →

Notes on Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002)

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When it was current, I reviewed the Australian code of good manufacturing practice for medicinal products (16 August 2002) so I was aware of the pertinent details in relation to viable environmental monitoring and testing.

The Australian Code of Good Manufacturing Practice for Medicinal Products 2002 was revoked effective from 1 July 2010 and replaced by the PICS Guide for Good Manufacturing Practice for Medicinal Products 2009, as adopted in Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2009. The 2002 GMP Code for Medicinal Products remains available here for comparison purposes. Continue reading →