Structure and Application of the State Pharmacopoeia
The State Pharmacopoeia comprises general and specific monographs and serves as the normative basis for standardization, quality control and registration.
The State Pharmacopoeia of the Republic of Uzbekistan is built on two kinds of text — general and specific (individual) pharmacopoeial monographs — and serves as the single normative basis for the standardization, quality control and registration of medicines.
Structure
General pharmacopoeial articles (monographs) set out uniform rules for test methods, general requirements and reagents. Specific monographs contain the particular requirements for individual medicinal substances. The numbering and titles of sections and monographs are harmonized with the European Pharmacopoeia (Ph. Eur.), enabling consistent comparison with international texts.
Application
The State Pharmacopoeia serves as the normative basis for standardizing, controlling the quality of and registering medicines. In international practice, registration dossiers are compiled in the Common Technical Document (CTD) format.
CTD — the five modules of the Common Technical Document
- Module 1 — regional (administrative) information;
- Module 2 — quality, nonclinical and clinical summaries;
- Module 3 — the Quality section;
- Module 4 — nonclinical study reports;
- Module 5 — clinical study reports.
Users
The State Pharmacopoeia is used by medicine manufacturers, quality control laboratories and regulatory (oversight) authorities.