Tag Archives: documentation

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 →

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Continuous Improvement

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This is something I tend to be weak on when it comes to answering in an interview (it does not come up much).  Hence this post to begin to get things ticking over in my brain.

Continuous improvement (CI) is something I’ve routinely done as I’ve updated documents, mapped business processes or followed procedures.  I’ve not followed any official 6 sigma methodology (also known as Lean, Agile, Kaizen) as such, though I have the basics if this in my survival kit and ask why 5 times.

Ask Why 5 Times - pinned to the wall of my cubicle/office

Ask Why 5 Times – pinned to the wall of my cubicle/office

CI is a method for identifying opportunities for streamlining work and reducing waste. Continue reading →

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Developing a Quality Management System

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Why would anyone want a Quality Management System, or QMS?  To quote the ISO, “It helps businesses and organisations be more efficient and improve customer satisfaction.”  The document that details such a system is ISO 9001 (2015) Quality Management Systems.  A large part of this ISO reads as a business plan – improve performance; sustainable development; identify opportunities / enhance customer satisfaction etc.  Overall, the ISO employs the approach of Plan-Do-Check-Act and requires risk-based thinking. Continue reading →

Policy vs Standard Operating Proceedure vs Operator Instruction

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What follows will form part of a post tentatively titled “GMP Technical Writing”. The larger post will incorporate aspects of Writing Technical Reports and The Need for Documentation and detail the hierarchy of documents within a Quality Management System, what information goes where and how to conduct business process mapping. I’m tossing up on whether to present this as a series of posts or as some sort of presentation style document (pdf or Powerpoint). Continue reading →

Notes on ISO 13408-2 (2003) – Aseptic processing of health care products – Part 2 : Filtration

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I found the latest ISO online here.  As far as I can tell it is legit (in so far as allowing the ISO online for free) – it certainly is the current ISO.

A recent HR rep from a pharmaceutical company contacted me regarding an open role I Sydney.  After passing my details along to “senior management”, the response I got was “We have had some discussion with senior quality managers about your profile and unfortunately they feel your relevant experience in Sterile Micro going back 10 years is a little too long for us ideally”.

Such a response show a lack of foresight from the employer as they do not want the best candidate for the job.  Do they want someone who knows their stuff?  No.  Do they have a commitment to training and staff development?  No. Continue reading →

TGA Inspection Trends

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My reply to a post on LinkedIn.

Current TGA Inspection trends: This presentation will focus on the common types of deficiencies found by the TGA’s GMP Inspectors as well as some data on the number of inspections performed both locally and overseas and compliance rating outcomes for the inspections performed.

Comment 1 stated “…there are patterns that seem to repeat year after year. Poor QMS, inadequate investigations, lack of training.”

My reply to this was:

“The PIC’S guide to GMP stresses the need for a robust QMS and repeats over and over again the need for documentation, solid investigations and adequate training and retraining. It is a wonder why citations regarding a lack of these keep being given.” Continue reading →

Notes on PIC/S Guide for Good Manufacturing Practice for Medicinal Products (2009)

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When I was working in the sterile pharmaceutical industry, I reviewed the The Australian Code of Good Manufacturing Practice for Medicinal Products (2002) as part of my self-development.  This code 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.  Here’s the original review.

I have now reviewed the PICS Guide for Good Manufacturing Practice for Medicinal Products 2009, from the stand point of a microbiologist working collaboratively in a sterile pharma plant.  What my review does is make note of the salient points and I add comments to some.

Both the revoked 2002 Australian GMP code and the 2009 PICs guide are based on ICH Q&A Good Manufacturing practice Guide for Active Pharmaceutical Ingredients which was last modified in 2000.  In 2015 21 pages worth of clarifications were published to clear up some technical questions and to remove ambiguities.  Looking at them, I’m not sure why clarification was needed as they all seem straight forward and answerable by anyone experienced working within a pharmaceutical manufacturing environment.  This means that despite having “no recent experience” as deemed by some potential employers, my knowledge is still bang up to date. Combine that with my fantastic memory and impressive technical skills and I’d be an asset to your company. Continue reading →

Project Management

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Over the years I have been a member of various project teams.  These were great experiences as I gleaned how to manage projects as well as developed new skills.  Also, contributing to the success of a project is pleasing.

Not having access to MS Project until recently, I created and coded my own Gannt Chart using Microsoft Excel.  This allowed me to manage small projects within the laboratory such as:

  • media expiry date validation
  • Total Microbial Count validation
  • implementation of electronic worksheets

Continue reading →

Technical Illustration

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Shortly after beginning my very first microbiology role, I discovered a program called Microsoft Visio was installed on the work computers and it could be used to create diagrams.  I was performing  a lot of viable environmental monitoring duties at this time and the room maps were in need of improvement.    This was the perfect opportunity to improve some documentation. Continue reading →

FDA Guide To Inspections

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A great reference for ensuring you are audit ready are the FDA’s Guide to Inspections documents and Guidance for Industry documents.

The FDA Inspection guides are freely available from here.

For my own reference and review, I’ve saved some of the Guidance for Industry documents below.  However, you can get them all from this link.

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