GMP, explained properly and sourced
An encyclopedia of the subjects a quality team actually deals with. Each entry explains the requirement in plain English, says where it goes wrong in practice, and links to the primary regulation rather than paraphrasing it second-hand.
27 articles across three sections. Each one is written for people who already know what a CAPA is, and each ends with the primary EU, ICH or PIC/S source so you can verify it yourself.
Looking for a definition instead?GMP
What Good Manufacturing Practice is, where the rules come from, and what an inspectorate is actually looking for.
What is GMP?
Good Manufacturing Practice (GMP) is the body of rules that requires medicinal products to be consistently produced and controlled to the standards appropriate to…
ReadGMP principles
Nearly every detailed GMP requirement is a consequence of a small number of principles: define the process, validate that it works, resource it with qualified peo…
ReadEU GMP
EU GMP is set out in EudraLex Volume 4, given legal force by EU Directives, and enforced by the national inspectorate of each member state — IGJ in the Netherlands.
ReadGMP compliance
GMP compliance is the demonstrated, current state of operating to GMP — evidenced continuously by your own records, and confirmed periodically by an inspectorate.
ReadGMP quality systems
A pharmaceutical quality system (PQS) is the management system that makes GMP work as a whole rather than as a set of separate procedures — defined by EU GMP Chap…
ReadGMP inspection
A GMP inspection is a competent authority verifying, on site and against evidence, that a manufacturer operates to GMP — with findings graded by patient risk and …
ReadQuality
The processes a quality system runs on: deviations, CAPA, change control, risk, complaints, release and suppliers.
Quality management system (QMS)
A quality management system is the documented, connected set of processes through which a manufacturer controls quality — in the pharmaceutical sector usually cal…
ReadCAPA
CAPA is the system for correcting the cause of a problem that has occurred (corrective action) and for preventing one that has not yet occurred (preventive action…
ReadDeviations
A deviation is any departure from an approved instruction, specification or established standard — recorded, assessed for product impact, and investigated to a de…
ReadChange control
Change control is the formal process by which proposed changes are assessed for quality, validation and regulatory impact, approved, implemented and verified — be…
ReadQuality risk management (QRM)
Quality risk management is the systematic process for assessing, controlling, communicating and reviewing risks to product quality across the lifecycle — set out …
ReadComplaints and recalls
Complaints and suspected quality defects must be recorded, investigated for product and patient impact, trended, and escalated to a recall and to the competent au…
ReadOOS — out of specification
An out-of-specification (OOS) result is a test result that falls outside the specification or acceptance criteria — and it stands as valid unless a laboratory inv…
ReadOOT — out of trend
An out-of-trend (OOT) result is within specification but inconsistent with the expected pattern — a signal that a process or product is drifting while it is still…
ReadBatch release
Batch release is the decision that a batch may be placed on the market; in the EU each batch must be certified by a Qualified Person who confirms it was made and …
ReadSupplier qualification
Supplier qualification is the risk-based process of establishing and maintaining confidence that a material supplier or contract organisation can consistently mee…
ReadTechnical
Validation, qualification, computerised systems and data integrity, plus the Annexes that govern them.
Validation
Validation is documented evidence that a process, method, cleaning procedure or computerised system consistently produces a result meeting its predetermined accep…
ReadQualification (URS, DQ, IQ, OQ, PQ)
Qualification is documented evidence that equipment, utilities and facilities are correctly specified, installed, operating and performing for their intended use …
ReadCleaning validation
Cleaning validation is documented evidence that a cleaning procedure consistently reduces residues of product, cleaning agent and microorganisms to levels justifi…
ReadProcess validation
Process validation is documented evidence that a manufacturing process, operating within its defined parameters, consistently produces product meeting its predete…
ReadComputerised systems
A computerised system in GMP is the hardware, software and associated business process together — validated for its intended use, with the depth of validation dri…
ReadData integrity
Data integrity is the extent to which data is complete, consistent and accurate throughout its lifecycle — attributable to who generated it, contemporaneous with …
ReadALCOA and ALCOA+
ALCOA is the set of attributes every GMP record should have — Attributable, Legible, Contemporaneous, Original and Accurate — and ALCOA+ adds Complete, Consistent…
ReadAnnex 1 — sterile medicinal products
Annex 1 sets the requirements for manufacturing sterile medicinal products, and its revised version made a documented, holistic contamination control strategy (CC…
ReadAnnex 11 — computerised systems
Annex 11 sets the GMP requirements for computerised systems used in regulated activities, covering the full lifecycle from supplier assessment and validation thro…
ReadAnnex 15 — qualification and validation
Annex 15 sets out the qualification and validation requirements for EU GMP, from the validation master plan and the qualification stages through process, cleaning…
ReadAnnex 16 — QP certification and batch release
Annex 16 sets out the responsibilities of the Qualified Person in certifying that each batch was manufactured and tested in accordance with GMP and the marketing …
ReadTwo companions to this section
GMP glossary
Every abbreviation a quality team meets, defined in one line — with a second line on where it actually bites.
Open the glossaryPractical guidesWhat inspectors look for
Before, during and after an inspection: what to prepare, what gets asked, how to answer, and how to respond to observations afterwards.
Read the guidesKnowing the requirement is the easy part
Sequencing what to fix first, by exposure and by what your team can absorb this quarter, is the work. The readiness score is the fastest way to find out where you stand.