Articles from our team on validation, qualification, monitoring and compliance.
Continuous particle monitoring in Grade A after the 2022 Annex 1
Where the probes go, how alarms should be set and what to do with the 5 µm channel now that Annex 1 is in force.
Manish Patel14 Oct 20264 min read
Read the article
Thermal Validation
9 Oct 20264 min read
Steam sterilizer validation: Bowie-Dick, heat distribution and heat penetration
What each test on a porous-load autoclave tells you, and the mistakes that send a qualification back for a repeat.
Read more
Clean Room Validation
5 Oct 20263 min read
ISO 14644-1 classification: how many sampling locations does your room need?
The 2015 revision replaced the square-root rule with a look-up table. Here is how to use it without over- or under-sampling.
Read more
CSV & Data Integrity
30 Sep 20263 min read
GAMP 5 Second Edition: what actually changes on a validation project
Less paperwork for low-risk functions, more thinking up front. A practical reading of the 2022 update.
Read more
High-Tech Industries
24 Sep 20263 min read
Battery dry rooms: holding the dew point at −40 °C and below
Why lithium-ion cell lines care so much about moisture, and what to measure when you qualify a dry room.
Read more
CQV
18 Sep 20263 min read
Using FAT and SAT results in qualification without repeating every test
Annex 15 allows it, inspectors accept it, yet many projects still repeat factory tests on site. What it takes to leverage them.
Read more
Bio-Decontamination
11 Sep 20263 min read
VHP or dry fogging? Choosing a bio-decontamination method for a cleanroom
Both use hydrogen peroxide, both claim a 6-log kill. The differences show up in coverage, materials and cycle time.
Read more
Thermal Validation
4 Sep 20263 min read
Mapping a warehouse: where the sensors go, and for how long
A mapping study is only as good as its plan. Grid spacing, heights, duration and the summer-versus-winter question.
Read more
High-Tech Industries
28 Aug 20263 min read
Semiconductor cleanroom monitoring is not pharma monitoring
Smaller particles, tighter classes and molecular contamination. Why a pharma-style monitoring plan falls short in a fab.
Read more
Clean Room Validation
21 Aug 20263 min read
HEPA filter integrity testing: what actually counts as a leak
Aerosol challenge, photometer scanning and the 0.01 % rule, with the field problems that cause false passes.
Read more
GAMP Services Limited 2026. All Rights Reserved.