Pharmaceutical waters come directly or indirectly into contact with the product that will be administered to the patient. Their production and distribution are therefore governed by strict country-specific standards, designed to guarantee their physico-chemical and microbiological properties.
Here is an overview of the regulatory frameworks currently in force in Europe and the United States.
Good Manufacturing Practices (GMP) in France and Europe
In France, GMPs have legal status. Their application is verified by supervisory authorities such as the ANSM (French National Agency for the Safety of Medicines and Health Products) during inspections or when manufacturing authorisations are requested. A medicinal product must comply with these GMP standards to be placed on the market.
In Europe, GMPs were originally defined by Directive 91/356/EEC.
In 2003, Directive 2003/94/EC established the updated principles and guidelines for Good Manufacturing Practices applicable to medicinal products for human use.
The version of GMPs published in Official Bulletin No. 2011/8bis includes the integration of quality risk management.
Current Good Manufacturing Practices (cGMP) in the United States
This document, issued by the FDA (Food and Drug Administration) — the US regulatory authority — serves as the official reference in the United States. It takes a pragmatic approach, addressing work methods, control procedures and equipment requirements to achieve a targeted quality level.
Two sections of the Code of Federal Regulations apply to the pharmaceutical industry:
- 21 CFR 210 – “Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs: General”
- 21 CFR 211 – “Current Good Manufacturing Practice for Finished Pharmaceuticals”
Although there may be differences between the European and US systems, expectations are similar regarding:
- Design, maintenance and cleaning of premises and equipment
- Use of written procedures and traceability of activities
- Implementation of quality management independent from production systems
- Employment of qualified personnel
European and US Pharmacopoeias
A pharmacopoeia is a regulatory reference made up of a collection of monographs. It establishes standards to standardise the qualitative and quantitative composition of medicines. A product’s compliance with a monograph determines its quality level.
European Pharmacopoeia
Developed by the European Pharmacopoeia Commission, composed of national delegations and overseen by the European Directorate for the Quality of Medicines (EDQM).
Created in 1964, it standardises pharmaceutical product quality across 37 European Union member states.
The current edition in force is the 9th edition.
French Pharmacopoeia
It includes specific texts and monographs that complement those of the European Pharmacopoeia.
Note: the general provisions of the European Pharmacopoeia apply to all monographs and texts within the French Pharmacopoeia.
The current edition in force is the 11th edition.
US Pharmacopoeia
The U.S. Pharmacopeial Convention (USP) defines quality and purity standards for raw materials and pharmaceutical products.
Together with the Japanese Pharmacopoeia, the European, French and US Pharmacopoeias constitute the three core references integrated into the international harmonisation system of pharmaceutical standards.
Pharmacopoeias and pharmaceutical waters
Pharmacopoeias define binding quality standards for pharmaceutical-grade waters. They also describe the production methods and quality control procedures required. In addition, they specify the required physico-chemical and microbiological properties, the analytical methods used to ensure compliance, and the production processes.
Four types of pharmaceutical waters are defined:
- Water for injectable preparation (WFI): includes bulk Water for Injection (WFI) and sterilised Water for Injection, intended to be filled into appropriate containers.
- Highly purified water (HPW)
- Purified water (PW): either in bulk or packaged. Used for non-injectable medicines such as APIs, syrups and solid dosage forms.
- Pure steam, used for sterilisation.
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