European Pharmacopoeia
Introduction
The European Pharmacopoeia is a single reference work for the quality control of medicines in the signatory states of the Convention on its elaboration 1. It provides common quality standards throughout the pharmaceutical industry in Europe. It also control quality of medicines and the substances used to manufacture them 4. The Ph. Eur. is legally binding in the signatory states to the Council of Europe Convention and in the EU 1.
History
The European Pharmacopoeia was first published in 1964 by the Council of Europe. Since then, it has been revised and updated regularly to keep up with the changing needs of the pharmaceutical industry 3.
Scope
The European Pharmacopoeia covers a wide range of substances and products, such as chemical substances, antibiotics, biological substances, vaccines, immunosera, radiopharmaceuticals, herbal drugs, and homoeopathic preparations 1. It is complemented by national pharmacopoeias for texts of interest to only one Member State 3. The Ph. Eur. is mandatory at the same date in 37 Member States (CoE) and the EU 6.
Standards
The official standards published within the European Pharmacopoeia provide a legal and scientific basis for quality control during the development, production, and marketing processes 3. They concern the qualitative and quantitative composition and the tests to be carried out on medicines, on the raw materials used in the production of medicines, and on the intermediates of synthesis 3.
All producers of medicines and/or substances for pharmaceutical use must therefore apply these quality standards in order to market their products in the signatory states of the Convention 3.
European Pharmacopoeia Commission
The European Pharmacopoeia Commission is composed of the delegations representing the contracting parties to the Convention on the Elaboration of a European Pharmacopoeia, currently 39 member states and the European Union (EU) 7.
The Commission is responsible for the elaboration of the European Pharmacopoeia and for ensuring that the texts are kept up to date 7.
Conclusion
The European Pharmacopoeia is a major regional pharmacopoeia that provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines and the substances used to manufacture them 4. It is legally binding in the signatory states to the Council of Europe Convention and in the EU 1.
The official standards published within the European Pharmacopoeia provide a legal and scientific basis for quality control during the development, production, and marketing processes 3.
The European Pharmacopoeia Commission is responsible for the elaboration of the European Pharmacopoeia and for ensuring that the texts are kept up to date 7.
Source(s)
1. The European Pharmacopoeia | PharmaCentral | Materials and Knowledge … 2. European Pharmacopoeia – Wikipedia 3. European Pharmacopoeia – Background and Mission 4. https://www.ema.europa.eu/en/documents/presentation/presentation-european-directorate-quality-medicines-healthcare-edqm-european-pharmacopoeia_en.pdf 5. https://www.edqm.eu/en/the-european-pharmacopoeia-commission 6. https://bing.com/search?q=Overview+of+European+Pharmacopoeia 7. European Pharmacopoeia | European Medicines Agency
Suggested readings:
First Year Pharm D Subjects Syllabus, Notes, PDF Books, MCQ
1.1 | Human Anatomy and Physiology |
1.2 | Pharmaceutics |
1.3 | Medicinal Biochemistry |
1.4 | Pharmaceutical Organic Chemistry |
1.5 | Pharmaceutical Inorganic Chemistry |
1.6 | Remedial Mathematics/ Biology |