Plain language

The GMP terms, in plain language.

Quality management is full of abbreviations that gatekeep more than they explain. Here is what the words on this site actually mean — in the same plain register we build the product in.

GMP — Good Manufacturing Practice: The rules for making medicinal products so that every batch is consistently safe and of the intended quality. In the EU they live in EudraLex Volume 4.
GACP — Good Agricultural and Collection Practices: The equivalent rules for the cultivation side — growing, harvesting, and primary processing of plant material that will become a medicinal product.
EudraLex Volume 4: The EU's collected GMP rulebook: Part I for medicinal products, Part II for active ingredients, plus annexes for special cases — Annex 7 covers herbal medicinal products.
Annex 11: The EU GMP annex on computerised systems: what a regulated company must be able to show about any software that touches its quality records — access control, audit trails, data integrity, and validation for intended use.
GAMP 5: An industry framework for validating computerised systems, built on categories of software and risk-based testing. A "category 4 configured product" is standard software configured to your process — which is what an eQMS should be.
ALCOA+: The data-integrity checklist regulators use: records must be Attributable, Legible, Contemporaneous, Original, Accurate — plus complete, consistent, enduring, and available.
eQMS: An electronic quality management system: the software that holds a company's controlled documents, training, deviations, CAPAs, and the rest of its quality records.
SOP — Standard Operating Procedure: A controlled document that says how a task is done. "Controlled" means it has an owner, an approval history, one current effective version, and a review schedule.
Effective version: The one version of a document that is currently in force. Everything before it is superseded; everything after it is still a draft.
Periodic review: The scheduled re-check of an effective document to confirm it still reflects reality — so procedures don't quietly go stale.
Deviation: Anything that didn't go according to procedure — a missed step, an unexpected result, a spill. Reporting one is not an accusation; it is how a quality system learns.
OOS / OOT — Out of Specification / Out of Trend: A test result outside its acceptance limits (OOS) or drifting oddly while still inside them (OOT). Both trigger a structured investigation before anyone acts on the result.
CAPA — Corrective and Preventive Action: The fix for a problem's cause, run as its own tracked record: what will change, who approved it, when it was done — and a later check that it actually worked.
Effectiveness check: The follow-up that keeps a CAPA honest: after the fix has had time to work, evidence is reviewed to confirm the problem actually stopped recurring before the CAPA may close.
Change control: The discipline of changing a regulated process on purpose: a structured request, an assessment of impact and risk, an approval, and verification that the change landed as approved.
MBR / EBR — Master / Executed Batch Record: The MBR is the approved recipe and instructions for making a product. An EBR is one batch's filled-in copy: each step recorded and signed as it was executed.
Batch release: The reviewed, signed decision that a finished batch may be used or sold — made against the executed batch record and everything attached to it.
QP — Qualified Person: In the EU, the named person legally responsible for certifying each batch before release.
Environmental monitoring: Scheduled measurements of the rooms production happens in — temperature, humidity, particulates, microbial counts — with defined limits and a formal response (an "excursion") when a reading breaks them.
Calibration: Regularly proving an instrument reads true against a reference standard. An out-of-tolerance finding asks the uncomfortable, necessary question: what did this instrument touch since it drifted?
Approved-supplier list: The register of suppliers a company has assessed and approved to supply specific materials or services — with requalification on a schedule, not on trust.
Audit trail: The record of who did what to a record, and when. In Truth QMS it is append-only: corrections are new signed entries, never rewrites of old ones.
E-signature: An electronic signature that binds signer, time, and meaning — reviewed, approved, witnessed — to a specific record, so it carries the same weight as ink.
Validation: Documented proof that a system does what it is intended to do. Under Annex 11 the regulated company owns this proof for its eQMS — which is why Truth QMS ships a validation-support package rather than a shrug.
URS / FS / DS: User Requirements, Functional Specification, Design Specification — the layered statements of what a system must do, what it does, and how. Traceability links each requirement to the tests that prove it.
Management review: Leadership's scheduled, minuted look at the quality system as a whole — trends, overdue work, recurring problems — with decisions recorded and signed.
ICH Q9: The international guideline on quality risk management: identify what could go wrong, judge how bad and how likely, act proportionately, and keep the register current.