Knowledge Booklet
CQV & QMS Knowledge Booklet
An engineering, regulatory and quality reference series written for people who specify, deliver and defend pharmaceutical facilities — not an introduction to the subject, and not a restatement of the guidance.
Each page below is the overview of one module: what it covers, and the questions the full paper answers. The full paper — with its gap analysis checklist, self-assessment and references — is sent on request.
Clean Room Design & Classification
What a classified room must achieve, and how that is specified, delivered and proven — from the invention of unidirectional airflow in 1962 to the Contamination Control Strategy that EU GMP Annex 1 made mandatory in 2022.
- Origins
- Standards map
- Occupancy states
- Particle classification
- +10 more
HVAC System Design
For Pharmaceutical Facilities
The mechanical system that delivers the conditions a classified room is specified to hold — air handling unit architecture, how much air and why, filtration, humidity control and the qualification that proves it.
- Origins
- Standards map
- AHU architecture
- Determining air quantity
- +10 more
Pharmaceutical Water Systems
Potable Water → DM / Purified Water (PW)
Pharmaceutical water from source to point of use — the pharmacopoeial framework and its actual numbers, the generation engineering, and the storage, distribution and surface integrity that keep the water fit once it is made.
- Origins
- Standards map
- Potable water fundamentals
- Pharmacopoeial grades
- +10 more
Water for Injection (WFI)
Generation, Storage & Distribution
The water grade defined by a single attribute — bacterial endotoxin — and every design decision that follows from it, from a 1923 clinical mystery to the membrane routes all major pharmacopoeias now permit.
- Origins
- Standards map
- WFI versus PW
- Endotoxin
- +10 more
Introduction to GMP
What Good Manufacturing Practice is, what it exists to prevent, and how its principles translate into the documents, systems and engineering decisions a facility is actually judged on.
- Origins
- Standards map
- What GMP is
- Quality
- +6 more
The series is being written module by module. More are in preparation — ask if a subject you need isn’t here yet.
Let’s talk
Need the full module, or a review of your own documentation?
Request any module by name, or bring the system you’re working on and we’ll start from where it actually stands.