Bulk Drug Manufacturers Association (BDMA), will organize an International Conference on Pharmacopeial Standards for Bulk Pharmaceuticals at Hyderabad, from September 22 to 24, 2002. The conference is to focus on the translation of regulatory approaches recently harmonized at the International Conference on Harmonization (ICH) and the Pharmacopeial Discussion Group (PDG).

The event organized in association with Drugs Controller General of India (DCGI), Indian Drug Manufacturers Association (IDMA), Indian Pharmaceutical Alliance (IPA), Organization of Pharmaceutical Producers of India (OPPI), Indian Pharmacopeia (IP) and United States Pharmacopeia (USP) is to be useful to pharmaceutical industry scientists engaged in manufacture, QA and QC, exporters of bulk pharmaceuticals, regulatory agencies, academia and other interested parties.

According to Venkat Jasti, president BDMA, the multidisciplinary conference is to generate an understanding and awareness of the following scientific and technical issues related to specifications (tests, test procedures and acceptance criteria) of bulk pharmaceuticals, including non-complex and complex active and inactive ingredients. The conference will have a Plenary Session and a Round table discussion.

Jasti informed that the specific topics for the Plenary Session include Universal tests: description, identification, assay, specific quality tests and criteria for inclusion, microbiological considerations, specific rotation, heavy metals, Loss on drying and others, Impurities: isolation, characterization, and qualification, analytical procedures, limits, multiple procedures, and labeling, New Monograph development: procedures and Time frame, Reference standards and Validation of Analytical procedures, system suitability tests etc.

The round table discussions which are to follow will be designed to encourage participants in small groups to discuss the issues under each of the identified topic in greater detail thus enabling the participants gain a better understanding of divergent views on standards, issues associated with the manufacture and registration of bulk pharmaceuticals in various countries and how they can be built into Pharmacopeial standards.

General test requirements and their significance or relevance to pharmacopeial standards for bulk pharmaceuticals; Challenges in the development of analytical procedures and acceptance criteria for impurities; Validation of Analytical procedures and system suitability tests and challenges faced by pharmacopeias in providing public standards for different routes of synthesis would all be the major topics to be discussed in the meeting.