The Validation Master Plan

Posted on by

I was recently asked where I would start if I was tasked with developing the Validation Master Plan or VMP for a microbiology laboratory.

That got me thinking. I’ve done my share of validations over the years, encompassing such things as viable particle air samplers, large format incubators, temperature mapping, autoclave validation, sterile media trials, computer system validation and various microbiological test methods. I’ve also written validation documentation in the form of user requirement specifications (URS), installation qualifications (IQ), operational qualifications (OQ), performance qualifications (PQ) as well as the validation protocols and reports. To take on the task of developing the master plan would be challenging and to my mind, an exciting and fun/rewarding project. I love documentation!

Microbiology-wise, my experience encompasses:

  • viable environmental monitoring and testing of sterile processes
  • envionmental monitoring of prodution personell
  • training production and microbiology personnel to conduct aseptic sampling in clean rooms
  • training microbiology personnel to conduct sterile and aseptic tests on samples
  • water for injection (WFI) sampling and testing
  • purified water (PW) sampling and testing
  • viable particle testing of air and nitrogen
  • bacteriology
  • container integrity testing
  • antibiotic potency testing
  • endotoxin / LAL testing of WFI
  • raw material, bulk, processed and finished goods testing
  • a swathe of microbiology tests including total microbial count (TMC, TMAC, TYMC, TAMC)
  • media making
  • autoclave validation
  • equipment validation
  • housekeeping and process auditing
  • leading investigations into process deviations and out of specification results
  • conducting risk assessments
  • developing and delivering training

About the only thing I do not have direct experience with, though am still fairly cluey about, is sterility testing. Running a sterile media trial program assisted here as a certain number of sterility failures require a sterile media fill or two as part of the investigation.

Over the years I’ve gathered quite a bit of information which I keep in a well structured file system on my computer. More and more, the Internet is becoming a useful resource as well, though like everything else, the n+1 rule must be applied as well as common sense.

So, getting back on track, where would I start if tasked with developing a VMP for a microbiology lab?

  • Check the site’s VMP
  • Consult my own references such as:
    • document writing guides and information mapping guides
    • AS 1807.8 – 2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators – methods of test
    • AS 1386.1 – 1989 Cleanrooms and Clean Workstations
    • DR 09017 Safety in laboratories – Plant and equipment aspects
    • DR 09033 Laboratory design and construction
    • ASNZS 2982.1-1997
    • AS-NZS ISO 146441.1 – 2002
    • ISO 13408-1
    • ISO 14698-1-2003-09-01
    • ISO 14698-2-2003-09-15
    • Passionate About Change Control
    • Planning aspects of the VMP
    • ISPE Validation Plan Template
    • Planning aspects of the VMP
    • PI-006-3 – Recommendation On (the) Validation Master Plan
    • FDA guideline on general principles of process validation
    • Culture Storage Technique Evaluation j.1472-765X.2004.01490
    • Taking A Pragmatic Approach To Achieving Systems Compliance For The Biotech Industry – A Business Perspective
    • Australian Code of GMP for Medicinal Product
    • The 10 Commandments of GMP
    • WHO Biosafety Manual – 3rd ed
    • The Pharmaceutical Microbiology Interest Group archive
    • Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories
    • Any local documents I have, I’d also see if there is a more recent version on-line.

That’s a lot of information to start with. That way I can read it all, let it percolate for a day or two and then get stuck into the project.  Here I should note that where I have access to those more knowledgeable about VMP’s than me, or certain processes that fall under it’s umbrella, I’d also use them as my resources.

Did you find this informative or useful? Please consider a small donation so I can expand and improve on what I deliver.