Category Archives: Commentary

PIC/S Guide for Good Manufacturing Practice for Medicinal Products (2013)

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From Jan 1, 2017, the PIC/S GMP guide for Medicinal Products V13 will be in effect.  In Australia, the TGA requires version 9 is used, though rumour has it, version 13’s going to be adopted soon.  If such proposals as this one, which is mainly concerned with herbal “medicine” from the Complimentary Healthcare Council are ratified, then all future PIC/s updates will automatically apply to Australian manufacture.  Something to keep an eye on.

Compliance wise adopting PICS/s 13 over 9 is  not too big as deal as the PIC/S guide is based on old ICH Q7A guidelines dating from August 2001 and the right and wrongs do not change much over time unless something major takes place.  What manufacturers will need to pay attention to are the changes between version 9 and 13, namely:

  • Chapter 1, 2, 4, 6 and 7 revised – Part 1
  • Annex 2, 6, 7, 11, 13, 14 and 15 revised
  • QRM principles in PIC/S GMP added – Part 2
Screen shot of PIC's news item

Screen shot of PIC’s news item

Link to guide. (possibly dead) – Google search will find it for you.

Based on the contents of V9, things to review:

  • Quality Management
  • Personnel
  • Documentation
  • Quality Control
  • Contract Manufacturing and analysis

You should already be in control of the above areas as otherwise, you’d be having and uncomfortable 3rd party audit experience.  The overall principles do not change, just the fine-print.

Annex 1 deals with the manufacture of sterile medicinal products, so not much impact to us there. If you are performing risk assessments and utilising ISO9001, QRM should already be familiar to you.

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Notes Would Benefit Interviews

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Like any other situation where you wish to convey accurate and important information, documentation/notes/written examples rule.

Attending a job interview is a very unnatural situation.  Once in a role, you have access to documentation, procedures, reference materials, pre-made presentations etc to get your point across.  In interviews you have your memory, your dress sense and your people skills.  To add confusion to the mix, recent studies are showing memory can be flawed so how am I to know an example I am providing actually happened, or was directly related to me?  Notes!  That is how! Continue reading →

Notes on the FDA’s Draft Data Integrity and Compliance With CGMP Guidance for Industry

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Having worked in the pharmaceutical industry where I’ve dealt with electronic systems, paper based systems, programmed my own access databases and Excel spreadsheet  and been on projects such as LIMS system validation, I figured I’d make notes on the FDA’s 2016 guidance for industry document regarding Data Integrity and Compliance With CGMP.  This draft is for currently open for comment and the guidance addresses data integrity in:

  • drug manufacture
  • finished pharmaceuticals
  • positron emission tomography drugs

Continue reading →

Communicating With Customer Focus In Mind

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I have taken part in lots of training over the years.  Training is great as if it is new, one learns new things.  If the training has been done before, it consolidates or updates existing knowledge.  In July 2016, I took part in communication training.  Heading into the training, I was interested to see if my communication style had altered since the last time a DiSC assessment was used on me in 2009. As a trained trainer, I know all about communication styles and how to pitch training programs for effective knowledge transfer.  Day to day communication is similar and I enjoy observing how trainers train.

In 2009 I took part in training using the DiSC model run by a company called Bridgeworks.  From the discprofile website “DiSC is a personal assessment tool used to improve work productivity, teamwork and communication. DiSC is non-judgmental and helps people discuss their behavioral differences.”  Then I scored 5223, making me a “panther”.  That indicated I had a dominant personality and summed me up as:

  • Sees the big picture
  • Can be blunt
  • Accepts challenges
  • Gets straight to the point

Continue reading →

Patties Foods Frozen Berries

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I reply to a post on LinkedIn.

“The Patties Foods frozen berries scandal is a warning for directors about managing risks – what lessons could you learn? ”

My comment:

There’s lots of testing for bacterial contamination in such products as it’s regulated at Government level. Testing for viruses is not a routine requirement (it is not regulated). There’s been discussions on changing this as reportedly, about 20% of food contamination is caused by viruses and it might be a good idea to start testing.

No Current Experience – Catch 22 In Job Seeking

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Updated 20/06/2020

June 2020: Yet another “failed” job interview where I was passed over as “we went with someone with recent experience who can hit the ground running”.

Introduction

  • My last microbiology/science role was made redundant by my employer towards the end of 2012.
  • I’ve been trying to get back into a microbiology lab, QA department or related area ever since with zero success.
  • I stay active in science by reviewing regulatory updates and championing science via social media and by providing advice on LinkedIn, posting articles to share my experiences and producing online training presentations.

Continue reading →

When Experts Get It Wrong

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I’ve had a post about bacteriology and mycology in the works for sometime, but as I’ve yet to finish it off here’s a link to a study titled The paradox of human expertise: why experts get it wrong. I generally defer to the experts as they are the experts. Sometimes, the status quo is incorrect and people new to the scene or uneducated in what the current thinking is come up with radical ideas that are later shown to be vidicated. So in honour of those times when those not in the know are actually ahead of the curve, here’s the link: The paradox of human expertise: why experts get it wrong.

One of the true measures of an expert is they will admit when they get things wrong or do not know the answer.

Here’s a local version.

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The Erroneous Reporting of Science

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I was flicking channels last night and came across an episode of Landline on the ABC.  Being broadcast at the time was an article entitled “Smell The Roses”.

Of most concern to me were the following words I heard shortly after tuning in “…we actually freeze dry the rose petals, they’re taken down to minus 20 to minus 40 degrees, which means it kills off all potential bacteria, diseases…”

As a microbiologist with over 15 years experience within the pharmaceutical industry, I happen to know a thing or two about preservation processes and the above statement is incorrect.

One of the aseptic manufacturing lines where I worked included a freeze drying chamber. Once the product was filled, it passed into this chamber where all the water would be removed at a negative air pressure and at reduced temperature. This turned liquid drugs into a powder which could be stored theoretically forever before use. To make the powder ready for injection, all the administering doctor or nurse needs to do is add water. The process is explained in the diagram below. I apologize for it being a quick and nasty sketch that is not to polished and to scale. Continue reading →

Another Job Interview, another unhappy with myself

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Today I attended an interview for a science role. I prepared. I researched. I got questions I’d not expected.

Despite my preparation using examples based around the STAR method, my answers were week, being generalisations, or examples that were not fresh in my mind.

The position I was being interviewed for today was basically a team leader role for a bunch of process validation staff. Something I think is suited to my skills, would be sufficiently challenging and keep me busy. My preparation focused on my strengths, how I motivate and lead teams, how I’d developed teams through training. I also focused on my GMP and QMS knowledge, but nothing about that was asked. I’m thinking I should spend a day a week reviewing this sort of stuff so the next time I get an interview, I handle it like a pro. I think I put in a better performance than my last interview, but it was still lacking.

So, here are the questions I was asked, but had to wing…

Q: Give us an example of how you have influenced people and brought them around to your way of thinking…

A: I used some example about how my manager was a chemist and I am a microbiologist. Chemists deal in absolutes, microbiologists deal in probabilities. A weak example of test results, repeat testing and the eventual result being in line with my original expectations and how, over time, my manager was more likely to take on board my advice.

Thinking back, I could have adapted my “how do you motivate people” answer, but that would have still been poor as it is a general answer and not specific.

Q: Give us an example of working on a project team. What was your role and what input did you provide. Who were the other members?

A: I used a site consolidation example I winged. I did not give a strong answer as to what my role was (it was as a microbiology consultant). My contributions were stated more or less and I emphasized how I’d proactively provided microbiology floor plans. I could have been clearer about the other member’s role. I then threw in how I’d lead a regional group of microbiologists through method harmonisation.

Q: Give us an example of when you have mentored and developed staff…

A: I used some example related to an assay falling over. I should have used an example of observing an analyst, suggesting improvements to their technique and how I’d share my scientific knowledge with them. I would have still needed proof that any of that helped them improve.

Q: Give us an example of how you have made process improvements.
A: More weak examples with some specific examples about micro identification methods of assay methods being improved being dragged out of me.

I used “I” a hell of a lot more than “we” to show I did things (as that is what the last interviewers wanted). Applicants will be contacted next week with a yay or nay.

I think the only thing that impressed the two interviewers was how I’d developed a 12 month training plan for my team with a training session each month.