Pharmaceutical Quality and Compliance Glossary

Pharmaceutical quality and compliance runs on a dense set of abbreviations. This glossary gives plain-English definitions of the terms a Head of Quality, a virtual pharma company or a newcomer to UK and EU GxP meets most often. Where a term has a fuller treatment, the definition links to it.

Licences and named persons

MIA (Manufacturer's or Importer's Authorisation)

The MHRA licence that allows a company to manufacture, assemble, import and certify the release of licensed medicines, held against EU GMP and requiring a named Qualified Person. See MIA vs WDA for how it differs from a wholesale licence.

MIA(IMP)

A variant of the MIA covering investigational medicinal products used in clinical trials, rather than commercial licensed medicines.

WDA(H) (Wholesale Dealer's Authorisation for human medicines)

The MHRA licence that allows a company to store, distribute, supply and export already-released medicines under EU GDP, requiring a named Responsible Person. It does not permit manufacture or batch certification.

QP (Qualified Person)

The legally named person on an MIA who certifies that each batch has been made and tested in line with GMP and the marketing authorisation before it is released. See what a Qualified Person does.

RP (Responsible Person)

The named person on a WDA who ensures medicines are handled in line with GDP across distribution. See the Responsible Person duties.

RPi (Responsible Person for import)

The named person on a WDA who oversees the importation of medicines into Great Britain from approved countries, confirming the required checks have taken place. See the RPi role.

Quality system terms

PQS (Pharmaceutical Quality System)

The overarching quality management system for a pharmaceutical operation, described by ICH Q10. It links development, manufacturing and distribution under one framework. See ICH Q10 explained.

CAPA (Corrective and Preventive Action)

The process of correcting a problem, finding its root cause, and preventing recurrence. Inspectors look for evidence of effectiveness, not only closure. See a CAPA system.

Deviation

A departure from an approved procedure, specification or standard. Deviations are risk-assessed, investigated and closed with appropriate action. See deviation management.

Change control

The formal process for assessing, approving and implementing changes that could affect product quality, the licence or the validated state, with evidence at each step.

OOS (Out of Specification)

A test result that fails a registered or compendial acceptance limit, questioning the conformance of a batch. It needs a two-phase investigation. See OOS and OOT investigations.

OOT (Out of Trend)

A result that stays within limit but departs from the expected historical pattern. It is an early warning of drift that needs a documented assessment.

Self-inspection

The internal audit required by EU GMP Chapter 9, where a company examines its own compliance and quality system to find and fix gaps before a regulator does.

Validation and data integrity

Qualification (IQ, OQ, PQ)

Documented proof that equipment, utilities or systems are installed correctly (IQ), operate across their range (OQ), and perform in real use (PQ). Qualification precedes process validation.

Process validation

Documented evidence that a manufacturing process consistently produces product meeting its quality attributes, run as a lifecycle under EU GMP Annex 15. See process validation.

CSV (Computerised System Validation)

Evidence that a GxP computerised system performs its intended function reliably and keeps data secure, delivered under Annex 11 and GAMP 5. See computerised system validation.

ALCOA+

The data-integrity principle that records should be Attributable, Legible, Contemporaneous, Original and Accurate, with the plus adding complete, consistent, enduring and available. See a data integrity programme.

Audit trail

The secure, time-stamped record of who created or changed GxP data and when. Inspectors expect audit trails to be both enabled and reviewed. See audit-trail review.

Key regulations and guidelines

EU GMP (EudraLex Volume 4)

The European Good Manufacturing Practice rules, published as EudraLex Volume 4, which the UK continues to apply. They set the standard the MHRA inspects manufacturing against.

GDP (Good Distribution Practice)

The standard for the procurement, storage, supply and transport of medicines, held by WDA holders and inspected by the MHRA. See GDP essentials.

Annex 1

The EU GMP annex governing the manufacture of sterile medicinal products, built around a contamination control strategy and tight environmental control.

Annex 11

The EU GMP annex setting expectations for computerised systems used in GMP, covering validation, data integrity, audit trails and access control.

Annex 15

The EU GMP annex on qualification and validation, which underpins the Validation Master Plan and the risk-based, lifecycle approach to validation.

GAMP 5

The ISPE Good Automated Manufacturing Practice guide, a risk-based framework for delivering and maintaining validated computerised systems.

21 CFR Part 11

The US FDA regulation governing electronic records and electronic signatures, relevant to companies that supply the United States market.

ICH Q9 and ICH Q10

The international guidelines on quality risk management (Q9) and the pharmaceutical quality system (Q10), which sit within EU GMP and shape how quality is managed across the lifecycle.

Key takeaways

• An MIA covers making and releasing medicines under a QP. A WDA covers distributing them under an RP.
• The PQS, CAPA, deviations and change control are the working parts of a quality system.
• Qualification proves equipment works. Validation proves the process and systems do.
• ALCOA+ and audit-trail review are the heart of data integrity.

If you need help applying any of these in practice, book a discovery call with a senior Qualified Person, or read more across our insights.