Tag Archives: training

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What Makes An Objectionable Organism in 2020?

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Introduction

I wrote the first version of this article in 2014 based on training I developed in 2006.   I have updated and reviewed the content to ensure it remains relevant in 2020.

When testing non sterile products, as well as allowed numbers of microbes, there are certain types of microbes that are specified in the regulations as not allowed and still others that can de deemed to be objectionable.

If you work as a microbiologist where you test total microbial aerobic counts (TMAC), total yeast and mould counts (TMYC) and for specific microbes or conduct investigations into the nature of microbes and what impact they may have on the product and the end user, this presentation will benefit you. I will teach you the the following:

  • What makes a specified organism
  • What makes an objectionable organism
  • How to determine if a microbe is objectionable
  • Risk assessment considerations
  • The benefits of knowing the differences between specified & objectionable organisms

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What are the guidelines for autoclave re-Validation?

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The Question posed on LinkedIn:

“Dear Experts, What are the guidelines that clarify the frequency and number of cycles required for re-Validation of equipment? For example, during re-qualification of the autoclave should each cycle be repeated 3 times (empty, minimum and maximum loads)? Or is it based on risk assessment by choosing the maximum loads only? (On initial qualification each cycle was performed 3 times consecutively). Also for depyrogenation tunnels, should the runs be repeated 3 times? Thank you“

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Question regarding classification of passthroughs and laminar flow hoods

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The Question posed on LinkedIn:

“Can we provide the grades of pass box and lafs in on critical area with respect to material movement ? For example if a pass box installed between grade c and grade d environment can be designated as grade b? Similarly laf installed in grade c area can be designated as grade c? If yes what woukd be the viable and non viable limits to be applied?“

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Ability to manage the release of the software/device exactly with the support mechanisms

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The Question posed on LinkedIn:

“I have been working with an academic team of global R & D partners on TECH DOC, Product Support, Training, and Learning/Development solutions. One item on the hot list is the ability to manage the release of the software/device exactly with the support mechanisms such as the KB, the release notes, and the manual/quick start guide. Across several sectors, this issue seems to exist. How do I save the most time, yet not overwork the team, and remain as precise as possible without creating confusion for the internal teams/external teams? Any product manager, project managers, or other TECH DOC specialists care to share how to provide precision across the different LOBs in a global environment where time zones matter?“

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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 →

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 →