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PRESENTATION ON PHARMACOPOEIA AND THEIR UPDATES (CHANGES)

PRESENTATION ON PHARMACOPOEIA AND THEIR UPDATES (CHANGES). Brief About the Presentation. This presentation discusses about Different Pharmacopoeias and their Updates (Changes). WHAT IS PHARMACOPOEIA.

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PRESENTATION ON PHARMACOPOEIA AND THEIR UPDATES (CHANGES)

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  1. PRESENTATION ON PHARMACOPOEIA AND THEIR UPDATES (CHANGES)

  2. Brief About the Presentation This presentation discusses about Different Pharmacopoeias and their Updates (Changes)

  3. WHAT IS PHARMACOPOEIA Pharmacopoeia is a book or encyclopedia of Drugs Standards, their formulas, Methods for making medicinal preparations and other related information's which is published under the jurisdiction of government body.

  4. Major Pharmacopoeias Following are the Major Pharmacopoeias Published across the world: • United States Pharmacopoeia - National Formulary (USP - NF) published by U.S. Pharmacopeial Convention (USP). • European Pharmacopoeia (Ph.Eur), published by European Directorate for the Quality of Medicines (EDQM).

  5. Different Pharmacopoeias (Continued…) • British Pharmacopoeia (BP) Published by British Pharmacopoeia Commission Secretariat of MHRA [Medicines and Healthcare products Regulatory Agency]. • Indian Pharmacopoeia (IP), published by Indian Pharmacopoeia Commission (IPC). • International Pharmacopoeia (Ph. Int), published by World Health Organization. • Other Pharmacopoeias like, JP, Chinese pharmacopoeia….

  6. Current Edition of Major Pharmacopoeias

  7. Changes or Updates to Pharmacopoeia Any change to the current Edition of the Pharmacopoeia is published as Supplement or Addendum to the Pharmacopoeia. Any monograph which is published in the supplement will become the current monograph irrespective of the availability of the monograph in the current edition of the Pharmacopoeia. Ex: If Atorvastatin Calcium monograph is published in EP 8.0 followed by EP 8.5, the current monograph will be the monograph which is published in EP 8.5.

  8. Publication schedule of Major Pharmacopoies United States Pharmacopoeia - National Formulary A new edition of USP – NF is published every year, any updates or changes to the initial publication is published as Supplements. Publication schedule is given below

  9. Publication schedule of Major Pharmacopoies (Continued ….) European Pharmacopoeia A new edition of EP is Published every three years, any updates or changes to the initial publication is published as Supplements.

  10. Publication schedule of Major Pharmacopoies (Continued ….) European Pharmacopoeia (Continued ….) Publication schedule of Ph.Eur is given below:

  11. Publication schedule of Major Pharmacopoies (Continued ….) British Pharmacopoeia British Pharmacopoeia is published every year and the publication schedule is given below:

  12. Publication schedule of Major Pharmacopoies (Continued ….) Indian Pharmacopoeia : There is no fixed Schedule for publishing Indian Pharmacopoeia. Any changes to the Existing pharmacopoeia is published as Addendums. Till date one addendum is published for IP 2014, i.e., Addendum 2015.

  13. Publication schedule of Major Pharmacopoies (Continued ….) International Pharmacopoeia: There is no fixed Schedule for publishing International Pharmacopoeia. Any changes in the product Monographs are published in WHO website from time to time. Further the changes to the International Pharmacopoeia is published as Supplements.

  14. PharmacopoeialForum (PF) Pharmacopoeial Forum is a journal in which Pharmacopoeia commission publishes proposed revisions to the Pharmacopoiea for public review and comment. (Ex: USP forums, EP forums…)

  15. Pharmacopoeial Forum (PF) (Continued.) USP-NF Pharmacopoeial Forum Pharmacopoeial Forum is posted online every two months at the beginning of the month. The comment period is 90-days and ends on the last day of the month.

  16. Pharmacopoeial Forum (PF) (Continued.) Pharmaeuropa (Ph.Eur Pharmacopoeial Forum) Pharmaeuropa is posted online every three months at the beginning of the month. The comment period is 60-days and ends on the last day of the month.

  17. Questions?

  18. Thank You

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