European pharmacopoeia, monographs

Currently, the primary use of NIR for pharmaceutical analysis is in the identification of raw materials. Some regulatory agencies have mandated that 100% of the materials to be released for use should be verified, rather than the use of traditional statistical sampling, before the materials are mixed and compounded in production. If NIR is utilized to comply with this mandate, a 1997 European Pharmacopoeia monograph, which specifies the minimum standards for an NIR identification method, should be consulted. ... 

Where the preparation is the subject of a European Pharmacopoeia monograph, the European Directorate for the Quality of Medicines Certification procedure (for Certificates of Suitability, CEPs) can be used to demonstrate compliance with the relevant European Pharmacopoeia monograph. 

The guideline on chiral active substances states that particular attention should be paid to identity and stereochemical purity. It states that specifications for a racemate should include a test to show that the substance is indeed a racemate and this is a position supported by the requirements of the European Pharmacopoeia for drug substance monographs [16]. 

European Pharmacopoeia technical guide for elaboration of monographs 2 ed. Pharmeuropa, Special Issue, November 1996. 

Pharmacopoeia publications provide a final important source of information for the pharmaceutical industry, regulatory authorities, and the healthcare professions. These are concerned with establishing quality standards. These publications include monographs that define specifications for the purity and identity of established pharmaceutical ingredients, both active and non-active, together with recognised analytical methods that may be used to evaluate them. The most relevant are the United States Pharmacopoeia (USP) and the European Pharmacopoeia (Ph.Eur). 

Certification Certification of suitability of Monographs of the European Pharmacopoeia... 

British Pharmacopoeia (1993) London Her Majesty s Stationery Office. (The British Pharmacopoeia contains edited versions of the monographs for immunological products that appear in the European Pharmacopoeia.)... 

Guidance concerning the extent of testing required is also given in the Technical Guide for the elaboration of monographs (1996) of the European Pharmacopoeia. These guidelines are specifically addressed to the establishment of reference substances for pharmacopoeial use. 

The monographs of the European Pharmacopoeia describe a so-called test for related substances which is intended to control the level of impurities. Reference substances may be used in this test in order to ensure the system suitability and/or to control the content of related substances. 

The laboratory of the European Pharmacopoeia applies the method specific approach (inter-laboratory study) as has been previously described (Technical Guide for the Elaboration of Monographs 1996). 

The procedure employed for the establishment of the chemical reference substances used in these assays has been previously published (Sandrin et al. 1997). The CRSs for the microbiological assays of antibiotics are first submitted to the chemical tests of the monograph. If the results are satisfactory, a collaborative microbiological assay is carried out, using the International Standard as calibrator. Thus, these reference substances are considered to be secondary reference substances since they are calibrated against existing standards. Potency is expressed in International Units. If an International Standard does not exist, European Pharmacopoeia Units are used. 

Since the CRSs and BRPs are officially certified by the European Pharmacopoeia Commission, which adopts the reports establishing their suitability for the intended use, it should be noted that neither certificates of analysis nor data which are not relevant to the use of the substances as defined by the Ph. Eur. monograph, are provided with the reference products or substances. Information required for the correct use of the chemical reference substance or biological reference preparation is provided. The label on the vials or ampoules gives ... 

Exchanges between pharmacopoeias are co-ordinated by the Pharmacopoeial Discussion Group (PDG) (International Harmonisation 1995) and it is frequent that one pharmacopoeia participates in a collaborative study organized by another pharmacopoeia, or that several pharmacopoeias share the same batch of reference substance to be used in their respective monographs nevertheless, in this case the reference substance can not be considered as harmonized. A new batch of erythromycin was shared between the United States Pharmacopoeia and the European Pharmacopoeia and was established in a common coEaborative study both for the microbiological assay (used in the USP for formulations) and the liquid chromatographic assay (used in the Ph. Eur. and USP for bulk material). 

Daas AGJ and Miller JHMcB (1997) Content limits in the European Pharmacopoeia (Part i). How to define limits in monographs and how to use them. Pharmeuropa 9 148-156. 

Monograph 0276 (1999) Insulin. European Pharmacopoeia 3rd Edn, Suppl. 2000. Council of Europe, Strasbourg. 

Monograph 0703 (1997) Atenolol. European Pharmacopoeia 3rd Edn. Council of Europe, Strasbourg. Monograph 0712 (1999) Desmopressin. European Pharmacopoeia 3rd Edn, Suppl. 2000. Council of Europe, Strasbourg... 

Rose U (1998) In situ degradation a new concept for system suitability tests in monographs of the European Pharmacopoeia. J Pharm Bio Anal 18 1-14. 

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