Microbiological Trending of Environmental Monitoring Data

Microbiological trending of environmental monitoring data serves multiple purposes:

  • Trending helps to define and hone your limits
  • Trending helps to determine if control of your processes has been lost (or is heading that way)
  • Trending helps to identify the effectiveness CAPA and process ‘improvements’

In order to produce relevant trends, you need to have defined what your alert and action levels are and how many times in a row an alert constitutes an action. You also need to define how many below alert results may indicate an adverse trend. Basically you want to get what is heading out of control under control.

Data to trend includes all data collected from your viable environmental monitoring program.  Showing these trends in graphs allows for easy identification of trends.  As part of your trending, you should identify your top 10 microbe species detected within your production facility.

You need to have a defined trending and reporting period and reports need to be signed off both by the microbiologist and QA manager.

Your internal processes and documents will be dependent on which regulatory bodies have oversight at your facility.

A more detailed, though old post regarding trending can be read here.

Some resources:
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm124900.htm

http://www.microbiologyforum.org/content/file/PMFNews.17.03.1103.pdf

https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/midwest/making-sense-of-your-environmental-monitoring-data.pdf?sfvrsn=4

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

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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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

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

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

Notes on International Standard ISO 13408-1: 2008

One of the main International Standards used as a reference document in a sterile pharmaceutical microbiology laboratory is ISO13408 – Aseptic Processing of Health Care Products .  Long ago, I reviewed the 1998 edition.  More recently, I acquired ISO 13208-1 (2008), so I compared my notes from the 1988 version with what is stated in the 2008 version.  The use of italics is my way of emphasising points.  Notes on changes are in blue.

INTRODUCTION

When I reviewed the 1998 edition, I did not note down any of the introduction.

  • Anything labelled as sterile needs to made under tight control as part of a Quality Management System
  • This part of the ISO focusses on the risks to the maintenance of sterility
  • All possible sources of contamination need to be controlled and a risk based approach is recommended
  • Appropriate validation of the aseptic process is needed and process simulation trials are an essential part of this

Continue reading