Setting the standards for medicines - the British Pharmacopoeia by rma97348


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Setting the standards for medicines
— the British Pharmacopoeia
The British Pharmacopoeia, published annually, is the only comprehensive collection of standards for UK medicinal substances. Ged Lee, Matilda
Vallender and Stephen Young discuss the history behind and the current work that produces the British and European pharmacopoeias

     he British Pharmacopoeia (BP),                                                                                  the EU. A further 17 European and
     which is now published annu-                                                                                    non-European countries plus the
     ally, is the only comprehensive                                                                                 World Health Organization have
collection of standards for UK me-                                                                                   observer status at the European
dicinal substances. It contributes to                                                                                Pharmacopoeia           Commission
the overall control of the quality of                                                                                (EPC). Monographs of the Ph Eur
medicinal products by providing an                                                                                   are legally enforced in the countries
authoritative statement of the stan-                                                                                 which are signatories to the
dard that a product is expected to                                                                                   Convention, and they are enforced
meet at any time during its period                                                                                   in the EU through Directive EC
of use. The publicly available and                                                                                   2001/83.1
legally enforceable pharmacopoeial                                                                                       Preparation of the Ph Eur is the
standards are designed to comple-                                                                                    responsibility of the EPC.The tech-
ment and assist the licensing and in-                                                                                nical secretariat of the EPC is part
spection processes, and are part of                                                                                  of the Council of Europe’s
the system for safeguarding public                                                                                   European Directorate for the
health. The BP is an essential refer-                                                                                Quality of Medicines and
ence for all individuals and organi-                                                                                 Healthcare which is located in
sations involved in pharmaceutical                                                                                   Strasbourg. The UK participates at
research, development, manufacture                                                                                   all stages of Ph Eur monograph de-
and testing of medicines.                                                                                            velopment and revision via UK
                                                                                                                     membership of the Groups of
History of the BP                                                                                                    Experts, and through the UK dele-
The regulation of medicinal prod-                                                                                    gation to the EPC.
ucts by officials in the UK dates                                                                                        The Ph Eur contains mono-
back to the reign of Henry VIII                                                                                      graphs for pharmaceutical sub-
(1491–1547).The Royal College of                                                                                     stances, general monographs for
Physicians of London had the                                                                                         formulated dosage forms and indi-
power to inspect apothecaries’                                                                                       vidual monographs for vaccines,
products in the London area and                                                                                      immunosera and radiopharmaceuti-
destroy defective stock.The first list                                                                               cal preparations. The monographs
of approved drugs with information                                                                                   of the Ph Eur apply to substances
on how they should be prepared                                                                                       used in either human or veterinary
was the London Pharmacopoeia                                                                                         medicines, or in both. The Ph Eur
published in 1618. The first edition                                                                                 also contains individual mono-
of the BP was published in 1864                                                                                      graphs of vaccines for veterinary
and it was one of the first attempts                                                                                 use. Other than vaccines and im-
to harmonise pharmaceutical stan-                                                                                    munosera and radiopharmaceuti-
dards across different countries, by merging              the work of the earlier commissions ap-         cals, there are no monographs for individual
the London, Edinburgh and Dublin pharma-                  pointed by the General Medical Council. A       dosage forms in the Ph Eur.
copoeias.                                                 commission was first appointed by the GMC
   The 1968 Medicines Act established the                 when it was made statutorily responsible,       The British Pharmacopoeia The
legal status of the British Pharmacopoeia                 under the Medical Act 1858, for producing a     monographs of the BP are legally enforced by
Commission and of the BP as the UK stan-                  BP on a national basis.                         the Medicines Act 1968. Where a pharma-
dard for medicinal products under section 4                                                               copoeial monograph exists, medicinal prod-
of the Act. The BP Commission continues                   Legal status of pharmacopoeias                  ucts sold or supplied in the UK must comply
                                                          There are two pharmacopoeias that have legal    with that monograph.
        M. G. Lee, PhD, FRPharmS is secretary and         status within the UK — the BP and the              All the monographs and texts of the Ph
        scientific director of the British                European Pharmacopoeia (Ph Eur).                Eur are reproduced in the BP. These include
        Pharmacopoeia Commission                                                                          the monographs for pharmaceutical sub-
        M. Vallender, MSc, MIBiol, is editor-in-chief     The European Pharmacopoeia The                  stances, general monographs, and individual
        of the British Pharmacopoeia                      legal basis for the Ph Eur is the Council of    monographs.
        S. Young, BSc, MRSC, is head of science,          Europe Convention on the elaboration of a          The BP Commission is responsible for
        British Pharmacopoeia                             European Pharmacopoeia, an international        preparing new editions of the BP and the BP
        Medicines and Healthcare products                 treaty signed by member states. There were      (Veterinary) and for keeping them up to date.
        Regulatory Agency, Market Towers, 1 Nine          eight founder countries in 1964 and cur-        Under Section 100 of the Medicines Act, the
        Elms Lane, London SW8 5NQ                         rently 34 countries are parties to the          BP Commission is also responsible for select-
        (e-mail )                 Convention as individual states together with   ing and devising British Approved Names.

566    The Pharmaceutical Journal (Vol 279) 17 November 2007                                                            
   The BP Commission is comprised of ex-
perts from the pharmaceutical industry, aca-      Panel 1: Contents of volumes I–VI of the BP 2008
demia, regulators and hospital pharmacy and,
in addition, there are two lay members.There
are also seven expert advisory groups that ad-    Volumes I and II               Medicinal substances
vise on and finalise the BP texts (three of       Volume III                     Formulated preparations, blood-related products, immunological
these advise on medicinal chemicals and the                                      products, radiopharmaceutical preparations, surgical materials and
remainder on antibiotics, pharmacy, herbal                                       homeopathic preparations
and complementary medicine, nomenclature          Volume IV                      Appendices, infrared reference spectra, supplementary chapters and
and unlicensed medicines) and four panels of                                     index
experts on inorganic chemistry, biological        Volume V                       British Pharmacopoeia (Veterinary) 2008
products (including blood products and im-        Volume VI                      CD-ROM version of BP 2008 and BP(Vet) 2008
munological products), microbiology and ra-
diopharmaceuticals that provide advice in
these fields when necessary.                     gether with its companion edition, the BP            identified by the statement “There are cur-
   In contrast to the Ph Eur, the BP contains    (Veterinary) 2008, incorporates all the mono-        rently no licensed formulations in the United
monographs for individual dosage forms.          graphs of the fifth edition of the Ph Eur as         Kingdom” in the text of the monographs.
This allows the BP to define standards for in-   amended by supplements 5.1 to 5.8 and con-
dividual medicinal products on the UK            tains approximately 3,100 monographs in-             Traditional herbal medicines In sup-
market.                                          cluding 49 new monographs of national                port of the new regulatory requirements for
   The BP also develops and publishes stan-      origin and 60 new monographs from the Ph             registration of traditional herbal medicinal
dards for products such as unlicensed medi-      Eur. In addition to the new monographs, sev-         products,2 seven new monographs for herbal
cines, and herbal and complementary              eral of the supplementary texts and chapters         materials and processed herbs used in tradi-
medicines, that would not be otherwise sub-      have been reviewed and revised, editorial            tional Chinese medicines (TCM) are pub-
ject to any quality standard that could be       changes, including colour printing, have been        lished. The monographs define only the
legally enforced.                                introduced and new areas of work have been           quality of the materials; safety and efficacy
                                                 added.                                               have not been assessed.
Production of the BP
The BP comprises six volumes.The contents        Supplementary texts The supplementary                Homoeopathic preparations As part of
of these volumes are given in Panel 1. In con-   chapter on dissolution testing of solid oral         another new initiative to support the simpli-
trast to the Ph Eur, the BP contains individ-    dosage forms has been revised to give consis-        fied registration scheme for the regulation of
ual monographs for dosage forms (Vol III)        tency with internationally harmonised guid-          homoeopathic products,3 five new mono-
and monographs for veterinary substances         ance notes. All new monographs included in           graphs for homoeopathic stocks and mother
and individual dosage forms are published in     the BP 2008 and subsequent editions will             tinctures are included in the BP 2008.As with
a separate volume (Vol V).                       apply the harmonised dissolution criteria.           TCM, the monographs define only the qual-
    The BP is now integrated into the work of        Information on the BP policy for mono-           ity of the materials; safety and efficacy have
the Medicines and Healthcare products            graph initiation is included in a supplemen-         not been assessed.
Regulatory Agency. The BP is prepared by         tary chapter for the first time.
the Pharmacopoeial Secretariat of the                A new chapter on pharmacopoeial quan-            A truly global resource
MHRA working in collaboration with the           titative analysis has been introduced. Sections      Since its first publication in 1864, the distri-
BP Laboratory, the BP Commission and its         on pharmacopoeial calculations and titrimet-         bution of the BP has grown throughout the
expert advisory groups. The development of       ric analysis are provided for the benefit of an-     world. Now used in over 100 countries with
pharmacopoeial standards receives input from     alysts and information on indicator colour           exposure in most continents of the world, the
relevant industries, hospitals, academia, pro-   changes is given with examples of colour             BP is setting the standard for pharmaceutical
fessional bodies and governmental sources,       change intervals for common indicators,              compliance across the globe. In Australia and
both within and outside the UK.                  printed in colour for the first time.                Canada it is still a legally enforced national
    The BP Laboratory provides analytical and                                                         standard and it is used by competent author-
technical support to the BP. Its major func-     Unlicensed medicines The primary                     ities throughout Europe and the
tions are:                                       focus of the BP has been the provision of            Commonwealth to advise and complement
                                                 standards for licensed medicinal products.           the licensing and regulation of medicines.
■ Development of new pharmacopoeial              However, the use of unlicensed medicines in              While addressing the requirements for
  monographs — the laboratory undertakes         the UK is increasing and becoming more               standards of medicines in the UK, the needs
  the development and validation of qualita-     widespread and so standards for those prod-          of this wider market are also recognised. By
  tive and quantitative test methods for new     ucts are also necessary.                             continuing to include monographs for phar-
  monograph specifications for publication          The general chapter on unlicensed medi-           maceutical substances and active pharmaceu-
  in the BP, and refines and revalidates test    cines has been revised and expanded. It now          tical ingredients alongside monographs for
  methods for existing BP monographs             gives the background to the use of unlicensed        individual finished dosage forms, the BP is
■ The BP chemical reference substance            medicines in the UK; it provides guidance to         meeting these needs by providing users with
  (BPCRS) — the laboratory is responsible        prescribers, manufacturers and suppliers on          one comprehensively indexed compendium
  for the procurement, establishment, main-      the legal and ethical considerations for unli-       of pharmacopoeial standards for medicines
  tenance and sale of BPCRSs and the cata-       censed medicines and also provides guidance          for human and veterinary use.
  logue currently contains approximately         on standards for the preparation and manu-
  500 BPCRSs, which are needed as stan-          facture of unlicensed medicines.
  dards for monograph tests in both the BP          A new general monograph for unlicensed            References
  and the BP (Veterinary).                       medicines provides mandatory quality re-             1. Directive 2001/83/EC The Community Code relating to
                                                 quirements that are generally applicable to all         Medicinal Products for Human Use.
2008 British Pharmacopoeia                       unlicensed medicines. It also includes la-           2. Directive 2004/24/EC amending as regards to Traditional
                                                                                                         Herbal Medicinal Products, Directive 2001/83/EC.
The BP 2008 was published on 28 August           belling requirements.
                                                                                                      3. Directive 2004/27/EC amending Directive 2001/83/EC on
2007. It comes into force on 1 January 2008         The BP 2008 contains 10 new mono-                    the Community Code relating to medicinal products for
and supersedes the BP 2007. This edition, to-    graphs for unlicensed medicines. These are              human use.                                                                                    17 November 2007 The Pharmaceutical Journal (Vol 279) 567

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