case-studies
Case Studies in Excipient Quality & Compliance
A summary of real regulatory guidance and peer-reviewed evidence from EU, UK and global public-health bodies that shapes how Nurogen Healthcare Ltd sources, tests and documents every excipient we distribute.
About this page: The case studies below summarise publicly available guidance documents and peer-reviewed literature from named regulatory and scientific sources. Each summary links directly to the primary source. This page is provided for general industry education and does not constitute regulatory or legal advice — always consult the primary source or your own regulatory affairs team for compliance decisions. Nurogen Healthcare Ltd was not involved in and makes no claims about the underlying events described in these third-party publications; they are cited here solely to illustrate why rigorous excipient sourcing, testing and documentation matter industry-wide.
Good Distribution Practice & Falsified-Medicines Vigilance
The UK Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate maintains an ongoing Good Distribution Practice (GDP) inspection and guidance programme for every UK Wholesale Dealer’s Licence holder. Its published guidance repeatedly emphasises two themes directly relevant to excipient distribution: rigorous qualification of suppliers and customers before goods change hands, and active vigilance against falsified or diverted medicinal products entering the legitimate UK supply chain.
As a UK-based Wholesale Dealer’s Licence holder, Nurogen Healthcare Ltd aligns its supplier qualification, batch traceability and deviation-management procedures with this MHRA guidance for every excipient we distribute.
Source:
MHRA Inspectorate. “Good Distribution Practice.” MHRA Inspectorate Blog, GOV.UK (ongoing guidance series). mhrainspectorate.blog.gov.uk
Guidelines on the Formalised Risk Assessment for Excipients (2015/C 95/01)
Published by the European Commission on 19 March 2015, these guidelines require every holder of a manufacturing authorisation for a medicinal product to conduct a documented, formalised risk assessment for each excipient it uses, in order to determine the appropriate level of GMP. The assessment must weigh factors such as the risk of cross-contamination from shared equipment, supply-chain length and complexity, excipient stability, packaging integrity, and known patterns of fraudulent adulteration specific to that excipient — then be kept current through ongoing supplier monitoring and periodic review.
Nurogen Healthcare Ltd builds this same risk-based logic into its own supplier qualification and change-control procedures, so that formulators sourcing from us inherit documentation that is already aligned with their own Article 46(f) obligations.
Source:
European Commission. “Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use” (2015/C 95/01). Official Journal of the European Union, C 95/1, 21 March 2015. eur-lex.europa.eu
The EDQM Certificate of Suitability (CEP) Scheme
The European Directorate for the Quality of Medicines & HealthCare (EDQM), a body of the Council of Europe, operates the Certification of Suitability (CEP) procedure: manufacturers of a pharmaceutical substance covered by a European Pharmacopoeia monograph can obtain independent, centralised confirmation that their production and control methods are suitable to guarantee the quality defined in that monograph. A valid CEP lets a medicine manufacturer demonstrate excipient or API quality to national regulators across Europe without repeating a full quality dossier assessment in every member state.
Where a CEP exists for an excipient we distribute, Nurogen Healthcare Ltd references it directly in the documentation package supplied with every quotation, alongside the relevant Ph. Eur., USP/NF or BP monograph compliance data.
Source:
European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe. “Certification of Suitability to the Monographs of the European Pharmacopoeia (CEP) — Fact Sheet.” edqm.eu
Why Excipient Traceability Matters: The 2022–2023 Diethylene Glycol Contamination Events
Between 2022 and 2023, paediatric liquid medicines manufactured with liquid excipients (of the propylene glycol / glycerin type) adulterated with diethylene glycol (DEG) and ethylene glycol (EG) were linked to acute kidney injury and child deaths in several countries, including a widely documented outbreak in The Gambia traced to product imported from a single overseas manufacturer. The U.S. CDC and a WHO-supported field investigation subsequently characterised the outbreak in detail, and the case was analysed in the New England Journal of Medicine as part of a wider pattern of at least 14 such mass-poisoning events recorded worldwide over the past 80 years.
These events are the reason regulators worldwide now expect DEG/EG limit testing on every batch of glycerin, propylene glycol, sorbitol solution and similar liquid excipients. Nurogen Healthcare Ltd only sources these excipients from WHO-GMP or EXCiPACT-audited manufacturers and supplies a batch-specific Certificate of Analysis, including DEG/EG limit results, with every liquid-excipient shipment.
Sources:
Bastani P, Jammeh A, Lamar F, Malenfant JH, et al. “Acute Kidney Injury Among Children Likely Associated with Diethylene Glycol–Contaminated Medications — The Gambia, June–September 2022.” MMWR Morb Mortal Wkly Rep. 2023;72(9). Centers for Disease Control and Prevention. cdc.gov/mmwr
Schier JG, Chang A, Kapil V. “Medication-Associated Diethylene Glycol Mass Poisoning — A Preventable Cause of Illness and Death.” N Engl J Med. 2023;388(13):1156–1157. doi.org/10.1056/NEJMp2215840
Full References
- MHRA Inspectorate. “Good Distribution Practice.” MHRA Inspectorate Blog, GOV.UK. mhrainspectorate.blog.gov.uk
- European Commission. “Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use” (2015/C 95/01). Official Journal of the European Union, C 95/1, 21 March 2015. eur-lex.europa.eu
- European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe. “Certification of Suitability to the Monographs of the European Pharmacopoeia (CEP) — Fact Sheet.” edqm.eu
- International Pharmaceutical Excipients Council (IPEC) & Pharmaceutical Quality Group (PQG). Joint IPEC–PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients. ipec-europe.org
- Bastani P, Jammeh A, Lamar F, Malenfant JH, et al. “Acute Kidney Injury Among Children Likely Associated with Diethylene Glycol–Contaminated Medications — The Gambia, June–September 2022.” MMWR Morb Mortal Wkly Rep. 2023;72(9). cdc.gov/mmwr
- Schier JG, Chang A, Kapil V. “Medication-Associated Diethylene Glycol Mass Poisoning — A Preventable Cause of Illness and Death.” N Engl J Med. 2023;388(13):1156–1157. doi.org/10.1056/NEJMp2215840
- “Contaminated cough syrups death toll passes 300 in four months.” Chemistry World, Royal Society of Chemistry (further reading on the international scope of these events). chemistryworld.com
Have Questions About Our Quality Documentation?
Every excipient we supply comes with full regulatory documentation — CoA, CoO, SDS, and CEP references where applicable.
Contact Our Quality Team