11th Edition of The International Pharmacopoeia

The International Pharmacopoeia (Ph. Int.) contains recommended procedures for analysis and specifications for pharmaceutical substances and dosage forms. According to the WHO (World Health Organization) it is intended to serve as source for reference or adaptation by any WHO Member State. The Ph. Int. is available online. It has legal status, whenever a national or regional authority refers to it in appropriate legislation.

11th Edition of the Ph. Int.

New and revised texts are introduced for

• 16 monographs on pharmaceutical substances,
• 10 monographs on dosage forms (pharmaceutical preparations),
• 3 methods of analysis, 
• 3 general monographs on dosage forms.

A list of new, revised and omitted texts is provided as an annex to the preface of the 11th Edition.

Contribution to Quality Assurance

It is emphasized that pharmacopoeial specifications represent only one element of quality assurance. Pharmaceutical substances and dosage forms should be manufactured according to the current GMP requirements (GMP = Good Manufacturing Practices). In many cases, this compliance cannot be verified by only analyzing a sample of the final product against a pharmacopoeial monograph. The national, regional or other competent authority will need to ensure that all relevant provisions have been met (e.g. by GMP inspection of the manufacturing sites or testing of samples beyond specifications).

In addition, there is a distinction between pharmacopoeial standards and the manufacturers' release specifications:

• Pharmacopoeial standards are publicly-available compliance specifications and provide the means for an independent check of the quality of a product at any time during its shelf life.
• Release specifications should generally be aligned to pharmacopoeial specifications; they may, however, include additional tests or limits to meet regulatory requirements (e.g. for other possible impurities).

For more information please see The International Pharmacopoeia, Eleventh Edition.