Writing Technical Reports

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 Importance of Trending

What is Trending?

Trending, when used in a pharmaceutical microbiology laboratory, is the examination of long term data in order to examine if a controlled process is moving away from the state of control. Trending can also be used to determine the stability of a product’s efficacy by examining the results of testing over time. Stability trends are important to support expiry dates and storage conditions. Continue reading

Example of a Before and After Document

Last year I attended an interview for a technical writer role. Nothing came of it.  As part of the application process,  I was tasked with taking a provided “document” and rewriting it into something suitable for a scientific environment.   I retain the copyright to this rewritten instruction.

Here is the before version: Continue reading

The Need for Documentation

“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

Notes on International Standard ISO 13408-1: 1998(E)

One of the main International Standards used as a reference document in a sterile pharmaceutical microbiology laboratory is ISO13408 – Aseptic Processing of Health Care Products .  Long ago, I reviewed the 1998 edition.  The 2008 edition of the standard was last reviewed and confirmed in 2011 as current.  Part 1 details the general requirements.  The 2008 edition is edition 2 and is a techncial revision of the 1998 document.  The guts of the standard are not dissimilar to version 1.

My review of the 1998 edition follows.  When I get my hands on the 2008 edition, I’ll review that with reference to this review.

The use of italics is my way of emphasising points. Continue reading

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

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)

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