AIGLON Group Certification GMP

AIGLON, the only petroleum jelly manufacturer certified European GMP Part II

AIGLON has chosen to specialise in pharmaceutical and cosmetic applications. Considering the purity of Aiglon petroleum jellies, customers commonly describe them as active ingredients in their marketing authorisation files. The GMP certification was the logical step for Aiglon.

GMP, a guarantee of safety

Manufacturing of all drugs is subject to a marketing authorisation. The use of petroleum jelly as an active ingredient (API) requires the pharmaceutical laboratories to declare the grade and quality of the product used, the manufacturer’s name and the production site in the marketing authorisation application.

The European GMP Part II certification is the only enforceable regulatory referential for inspections of pharmaceutical establishments by the competent authorities.

Other “good manufacturing practice” alternative references, created by membership organisations, are much less restrictive and do not give the right to sell petroleum jellies as API’s.

In France, the competent authority is ANSM (National Agency for the Security of Medicines and Health Products), previously AFSSAPS (French Agency for the Sanitary Security of Health Products). This agency delivers the GMP certificate and conducts regular inspections to validate the certification.

Highly demanding provisions

This quality referential is based on risk management (security and quality). It takes into account the traceability of the product, the qualification of the installations, the control procedures, complete documentation for all procedures and analytic methods, etc.

The Aiglon group respects the quality criteria in all services, whether this is purchasing, sales administration, manufacturing, control analysing or shipments.

All raw materials and finish products are identified and analysed according to written procedures, and followed through by quality trained staff.

Important investments

GMP implies hygiene practices and organisation at all levels. Their implementation requires significant financial and human resources from the company.

Aiglon/Synteal

  • GMP (Good Manufacturing Practices) for active substances used as starting materials in medicinal products
  • ISO 9001 : 2015

Civetea

  • ETA (European Technical Approval) for CIVETEA according to the requirements of the ETAG 013 standard
  • CE Marking