Review of Draft Standard: AS 2828.2 Health records, Part 2: Digitized health records

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.  For this draft standard, I have some knowledge of IT and IT security so am able to critically review the draft standard and offer comment.

Notes: refer to the conditions for comment stated towards the beginning of the draft standard.

DR AS 2828.2 Health records, Part 2: Digitized health records Continue reading

Review of Draft Standard: AS 2243.2 Safety In Laboratories – Part 2: Chemical Aspects

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.

Notes: refer to the conditions for comment stated towards the beginning of the draft standard.

DR AS 2243.1 Safety In Laboratories – Part 2: Chemical Aspects Continue reading

Review of Draft Standard: AS 2243.1 Safety In Laboratories – Planning and Operational Aspects

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.

Section 1 Continue reading

IMM3022 Immunocytochemical and Lectin Labelling of Acid Secreting Cells in the Stomach and Kidney

IMM3022 Immunocytochemical and Lectin Labelling of Acid Secreting Cells in the Stomach and Kidney

Paul Yeatman

Partner/s: Rachael Davies, Tanya De Jong, AnnalieseSampey, Adreana Lambrinakos, Anna Rentoulis, Steve Argirio, Spiros Foscolos.

Date: 24th August -> 5th October 1994.

Introduction

Certain organs in the body contain cells, which are involved in acid secretion. In the stomach such cells are called parietal cells and exist in gastric pits contained in the stomach body. (Diagram.1 and Diagram.2). In the kidney such cells are known as intercalated cells, and line the collecting ducts of the kidney. (Diagram.3 and Diagram.4) In both cases, a two-subunit ATP dependent (ATPase) proton pump controls the acid secretion. Continue reading

Science In Australia

There was an advert for a science communicator / project manager this week.  The twitter post said must love science (*tick*) and have skills (*tick*).  I checked it out.  The role was skewed towards science communication and requires someone with a history of producing media reports, blogging, liaison with the science industry etc.  Enthusiasm alone would not cut it, though it would make the role a challenge, and that’s what I’m here for – challenges.

One requirement was to be able to name at least 10 science organisations in Australia.  Hmm, thought I cannot do that.  That’s embarrassing.  So, here’s what I could name off the top of my head and then here’s what I could find using the great advertising machine known as Google.

Off the top of my head with lots of brain racking

  1. Australian Synchrotron – http://www.synchrotron.org.au/
  2. CSIRO – https://www.csiro.au/
  3. Australian Signals Directorate – https://www.asd.gov.au/ (actually intelligence, thought this was science, or science based)
  4. Walter and Eliza Hall Institute of Medical Research (WEHI) – https://www.wehi.edu.au/ (I should know more of these)
  5. Florey, aka the Howard Florey Institute – https://www.florey.edu.au/
  6. The Australian International Gravity Observatory – http://www.aigo.org.au/ Everyone who visits should do the solar system walk.  Pluto is so far away!  Take water.
  7. The Australian Telescope National Facility – http://www.atnf.csiro.au/ – technically CSIRO.
  8. The Australian Antarctic Division – http://www.antarctica.gov.au/
  9. The Australian Association for Microbiology – http://www.theasm.org.au/
  • CSL before it went private (so not counting it).
  • Many pharma companies (which I’m not going to count).
  • Museums (Canberra, Melbourne, Sydney) – do these count.  They should count.
  • I could name ScienceInPublic, as they posted the advert.  That would be cheating!
  • All our universities.  Again, cheating if I named them.

Nine’s not bad, though I should know at least 20.

Ones I needed to look up (shame on me)

After four, I felt I was scraping the bottom of the Google barrel.  I soon discovered that while many about pages may list the organisation name in the header meta, the names were missing from the body of the page.  I also found that in lots of articles about science produced by Australia, the organisation producing the science was not named. Not how you build brand recognition.

  1. Australian Science Communicators – http://www.asc.asn.au/
  2. Australian Academy of Science – https://www.science.org.au/ Tad worried I’d forgotten about them.  I remember them as the premier science outfit and I had an old photo ruler from here.
  3. Innovation and Science Australia (ISA) – https://www.innovation.gov.au/page/innovation-and-science-australia
  4. Great Barrier Reef Marine Park Authority – http://www.gbrmpa.gov.au/ – I knew something existed, but could not name it.
  5. Woodside Australian Science Project – www.wasp.edu.au/
  6. The Australian Academy of Technology and Engineering (ATSE) – https://www.atse.org.au/
  7. The Royal Institution of Australia – http://riaus.org.au/
  8. Australian National Centre for the Public Awareness of Science – http://cpas.anu.edu.au/ Perhaps needs to work harder?  Three Google pages down using “australian science” as my search term.
  9. The Terrestrial Ecosystem Research Network (TERN) – http://www.tern.org.au/
  10. Peter Doherty Institute for Infection and Immunity – https://www.doherty.edu.au/  Most disappointing I did not know this given I’ve an immunology degree!
  11. Australian Centre for Advanced Photovoltaics (ACAP) – http://www.acap.net.au/

Related to this, I could name lots of science Australia has produced or is working on.  The various inventions reportedly to come out of Australia, (Hills hoist, the ute, the stump jumper), stomach ulcers being caused by Helicobacter pylori, matter transport/Quantum entanglement, eradicating rats by using dogs from an Island off the coast of Warrnambool (awww, Oddball died in February.  I’ve also merged this with Macquarie Island where dogs were used to eat all the rabbits, rats and mice – Oddball was a fox eaterupperer), wi-fi (CSIRO), the joint US-Australian military research project called Hypersonic International Flight Research Experimentation (HIFiRE) testing hypersonic engines, the people developing organs in a petri dish, various cancer research and I’m sure I could come up with more.

On the topic of Australian science, have a read of Australia’s National Science Statement – 2017.  It states science means “Natural, physical and life sciences, including medical and health sciences, mathematics, engineering and technology‑related disciplines.”

That’s not a proper description.  Science is the methodical and rigorous study of phenomena to understand them and the application of such methods and results to produce things.  The results can be knowledge, TV’s, vaccines, better car tyre rubber, ducks that go woof, less harrowing cancer treatments, key hole surgery, the “discovery” that fat is turned to water and CO2 and expelled in order to lose weight – even if it is obvious, it needs proving.

Making sure I had some idea my above description in bold was more or less correct, I checked our a dictionary and it said “the intellectual and practical activity encompassing the systematic study of the structure and behaviour of the physical and natural world through observation and experiment.”  Yup – within acceptable error limits.

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

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.

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

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

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