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THE THAI PHARMACOPOEIA COMMITTEE AND SUBCOMMITTEES

          The Thai Pharmacopoeia Committee was first appointed by the Ministerial Cabinet in 1979. The functions of the Thai Pharmacopoeia Commission are to

          1. select therapeutically useful drugs for inclusion in the Pharmacopoeia;
          2. establish compendial limits, tolerances and specifications for selecteddrugs;
          3. specify appropriate tests and methods for quality control of the drugs;
          4. compile complete text of the Thai Pharmacopoeia for publication;
          5. issue supplements in compliance with the text;      
          6. revise the Thai Pharmacopoeia periodically;
          7. appoint appropriate subcommittees to undertake the functions as entrusted;
          8. perform any other tasks assigned;

          The Thai Pharmacopoeia Committee recruited assistance from the following subcommittees in carrying out its aforementioned functions:

1. The Subcommittee on Drug Selection

          This subcommittee is responsible for selecting drugs to be included in or excluded from the Pharmacopoeia, taking into account their categories of actions and therapeutic uses by:

          1.1 identifying the potential drugs for inclusion based on their therapeutic efficacy and safety;
          1.2 determining the most effective formulations and compositions of theselected drugs;
          1.3  specifying the official titles, synonym(s) for the monograph of eachdrug, and its preparations;
          1.4 revising the text of the monograph that appeared in earlier editions.

2. The Subcommittee on Drug Safety

          This subcommittee is responsible for detailing the safety, efficacy and potential side effects of the drugs by:

          2.1 specifying information on category, dose, strengths available, contraindication,warning, precaution, and additional information;
          2.2 identifying for safety verification the different tests including thepyrogen test, the sterility test, etc.;
          2.3 providing the appendices regarding testing methods stated in 2.2.

 

3. The Subcommittee on General Specifications and Reagents

          This subcommittee is responsible for establishing additional drug specifications corollary to those already described in 4. by:

          3.1 describing and identifying physical and chemical properties of thedrugs, such as their solubility, melting and boiling temperatures, acid value,ester value, and pH value, and prescribing the purity tests such as those forheavy metals, related substances, etc.;
          3.2 developing quality control methods for drug preparations, including leakage test, deliverable volume, minimum fill, completion of solutions after powder reconstitution, etc.;
          3.3 preparing appendices regarding testing methods stating in 3.1 and 3.2;
          3.4 surveying and preparing a list of reagents, volumetric solutions, standard solutions, pH indicators, buffer solutions, test solutions, reference substances,
and any other test substances that are mentioned in the monographs or in the appendices of the Thai Pharmacopoeia, but their specifications have not been established;
          3.5 assigning official names, synonyms, molecular formulae, and molecular weights to the above-mentioned reagents;
          3.6 drafting physico-chemical specifications, purity standards, methods of preparation as well as precautions and storage advices of the reagents mentioned in 3.4.

4. The Subcommittee on Standards and Analytical Methods

          This subcommittee is responsible for specifying standards and analytical methods used in drug testing by:

          4.1 selecting the most appropriate and economical method(s) from the different analytical methods described in established pharmacopoeia, published papers, or individual research works, with or without modifications, to be used in the analytical control of each drug and its preparations. The methods can be chemical, physico-chemical, microbiological, or biological in nature;
          4.2 specifying the content limits of the drugs;
          4.3 specifying the limits and identifying the methods for dissolution and content uniformity, where appropriate;
          4.4 identifying the methods for identification, microbial limit, water content, or loss on drying for each monograph;

5. The Subcommittee on Drug Stability

          This subcommittee is responsible for identifying the physical and chemical stability of the drugs by:

          5.1 specifying the appropriate pharmaceutical containers and closures, and providing information on packaging, storage and labelling;
          5.2 preparing appendices of the tests related to 5.1 and those beyond the responsibilities of the Subcommittee on General Specifications and Reagents and the Subcommittee on Standards and Analytical Methods;
          5.3 defining and preparing general information on various dosage forms, e.g. tablets, parenteral preparations, suspensions.

6. The Subcommittee on the Establishment of the Thai Herbal Pharmacopoeia

          This subcommittee is responsible for:

          6.1 selecting the herbal drugs proven effective and safe for further consideration by the Thai Pharmacopoeia Committee;
          6.2 establishing the specifications of herbal drugs which were preselected by the Thai Pharmacopoeia Committee and compiling to be monographs of the Thai Herbal Pharmacopoeia;
          6.3 preparing the final English draft;
          6.4 tending to pertinent matters related to the preparation of the Thai Herbal Pharmacopoeia.

7. The Subcommittee on Biological Products

          This subcommittee is responsible for:

          7.1 selecting the biological products that are therapeutically effective and safe for further consideration by the Subcommittee on Drug Selection;
          7.2 prescribing the various specifications of the selected biologicals and their preparations;
          7.3 providing any other information related to biological products that should be included in the Pharmacopoeia.

8. The Subcommittee on Editorial Style

          This subcommittee is responsible for:

          8.1 designing the format and style for printing;
          8.2 editing the text;
          8.3 keeping conformity of the molecular formula, chemical name, molecular weight, and expressions of the symbols of units throughout the text;
          8.4 organizing the information compiled by the subcommittees into a pharmacopoeial form and completing the final draft of the Thai Pharmacopoeia;
          8.5 tending to other matters related to editing the Pharmacopoeia.

9. The Subcommittee on the Pharmacognostic and Botanic Specifications of the Thai Herbal Monographs

          This subcommittee is responsible for:

          9.1 establishing drafts of the pharmacognostic and botanic specifications of the Thai herbal monographs, i.e. nomenclature, definition, description of the plant, macroscopical and microscopical description, and other related information;
          9.2 submitting the drafts to the Subcommittee on the Establishment of the Thai Herbal Pharmacopoeia for approval;
          9.3 tending to pertinent matters related to the preparation of the pharmacognostic and botanic specifications.

10. The Subcommittee on the Physico-chemical Specifications and Safety of the Thai Herbal Monographs

          This subcommittee is responsible for:

          10.1 establishing drafts of the physico-chemical specifications of the Thai herbal monographs, i.e. constituents, packaging and storage, identification, assay, ashes, extractives, and other related information;
          10.2 establishing information for safety of the Thai herbal monographs, i.e. category, contra-indication, warning, precaution, additional information, dose, and other related information;
          10.3 submitting the drafts to the Subcommittee on the Establishment of the Thai Herbal Pharmacopoeia for approval;
          10.4 tending to pertinent matters related to the preparation of the physicochemical specifications.

11. The Ad-hoc Subcommittee on Statistical Analysis of the Results of Biological Assays and Tests

          This ad-hoc subcommittee is responsible for:

          11.1 identifying appropriate statistical methods for biological assays and tests;
          11.2 preparing a preliminary description of statistical methods in 11.1 to be included in an appendix of the Pharmacopoeia;
          11.3 completing the final draft of the appendix concerning the statistical analysis of the results of biological assays and tests.

12. The Ad-hoc Subcommittee on Standards of the Thai Herbal Drug Preparations

          This ad-hoc subcommittee is responsible for:

          12.1 establishing the specifications of Thai herbal preparation which were preselected by the Thai Pharmacopoeia Committee and compiling to be monographs of the Thai Herbal Pharmacopoeia;
          12.2 preparing the final English draft;
          12.3 tending to pertinent matters related to establishing the specifications of Thai herbal preparation in 10.1.

CONTENT • THE THAI PHARMACOPOEIA COMMITTEE AND SUBCOMMITTEES
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หมายเหตุ / Note : TP II 2011 PAGE VI - VIII