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Regulatory Resources

The official guidance we work to

The primary UK and EU GMP/GDP sources behind our audits, QP services and quality systems — MHRA, EMA and EudraLex Volume 4. Bookmark them; always check the latest published version.

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UK regulator — MHRA

The UK authority for medicines and the GMP/GDP inspections we help you prepare for.

MHRAMedicines & Healthcare products Regulatory Agency — UK licensing, inspections and guidance.MHRA Inspectorate BlogFirst-hand inspector insight on GMP, GDP, data integrity and common inspection findings.
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EU GMP guidelines — EudraLex Volume 4

The EU Guidelines to Good Manufacturing Practice — the basis of EU/UK GMP expectations. Key chapters and annexes:

EudraLex Volume 4 — EU GMP GuidelinesThe full set of EU GMP guidelines (basic requirements, Part II and annexes).Chapter 1 — Pharmaceutical Quality SystemThe PQS / ICH Q10 foundation for a compliant quality system.Chapter 7 — Outsourced ActivitiesContract giver/acceptor duties and technical/quality agreements.Chapter 9 — Self InspectionThe basis for internal audit and self-inspection programmes.Part II — Active Substances (APIs)GMP for active substances used as starting materials.Annex 1 — Manufacture of Sterile Medicinal ProductsContamination control strategy and sterile manufacturing expectations.Annex 11 — Computerised SystemsValidation, data integrity and controls for computerised systems.Annex 15 — Qualification and ValidationURS/DQ/IQ/OQ/PQ and process validation requirements.Annex 16 — Certification by a QP and Batch ReleaseQualified Person certification and batch release responsibilities.
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EU guidance & legislation

Interpretive guidance and the wider EU pharmaceutical legislation library.

EMA — GMP/GDP Questions & AnswersInterpretive Q&A agreed by the GMP/GDP Inspectors Working Group.EudraLex — EU Pharmaceutical LegislationThe complete EudraLex collection (Volumes 1–10).

Disclaimer: these links point to external official sources, provided for convenience. Guidance is updated periodically — always confirm against the latest published version. Double Helix Pharma UK Ltd is not affiliated with the MHRA, EMA or European Commission.

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