What are the guidelines for autoclave re-Validation?

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

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

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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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.

Update 20190103: After proceeding to submit comments, I observed page numbers were required.  That is important to note for future reviews.  Page numbers added.

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.

Update 20190103: page nubmers added.

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Continuous Improvement

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

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

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 buisiness 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).

A Policy A SOP An OI
What’s What  Course of action adopted due to one or more considerations such as legal or regulatory requirements

Contains regulatory, corporate or scientific policies, rules or principles.  Explains why these are considerations.

generally affect multiple SOPs.  If affects one SOP, should include detail in SOP after Additional Information section.

  • If information >1 page and affects >1 SOP
  • or >3 pages and affects 1 SOP, write a separate policy document
  • Who, what, when where and why.
  • A series of stages describing the sequence of tasks performed
  • Describes processes lasting an extended time (hours, days, weeks).
  • Tends to encompass multiple users.
  • Written with the overall goal of achieving the outcome via a number of specified outcomes.

Each stage in a SOP comprises a number of action or steps. Length dictates their placement in a SOP or an OI:

  • ≤4 steps -SOP content.
  • >4 steps – place in an OI.
  • How to do something.
  • Step wise instructions.
  • Takes place in the now.
  • Tends to involve single user.
  • Written to achieve a specified outcome.
Tables  Informational
  • Overview only – Section/Description.
  • Stage/Description.
Step/Action
Flow Charts  Informational

Must not exceed 1 page.

Used a process overview.

  • If ≥5 sections, a flow chart can be used.
  • If <5 sections, a Section/Description table use used.
  • Must not exceed 1 page.
  • Suitable only where instructions are straightforward.
  • Must not exceed 1 page.
Naming Convention  N/A Use present continuous. eg. Sampling of Water for Injection
!!”ing” in the title.
Use the present simple. Daily Check of Equipment Calibration
!!If the proposed title includes “How to…” the it’s likely an OI.
In General
  • Section headings do not include full stops
  • For all nouns and verbs in document titles, use capitals. Does not apply to section headings.

-Title: Using The Autoclave
-Section Heading: Load the autoclave

  • Be consistent in the use of bullets and font.
  • Be consistent with capitalisation and use of punctuation.
  • Read your work out loud. If you stumble, the reader will too.
  • Plan. Talk to SME’s. Before you begin writing, identify the information type(s).
  • Chunk the information 7±2

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

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