A training workshop is being held on the ICH Q7A guidelines at Hyderabad on the 5th and 6th of October, 2004.
This two-day workshop will provide training on the implementation of GMP for APIs as described in the ICH Q7A guidance document. It will also throw light on the Ingredient Verification Programme started by the USP. The workshop is being co-sponsored by Bulk Drug Manufacturers Association (India), officials said in a release.
The programme covers all aspects of the manufacturing, controlling and regulating of APIs. The workshop is designed to benefit API manufacturers, production managers, Quality Assurance / Quality Control and Regulatory Affairs Personnel, auditors of API Manufacturing Operations, contract manufacturers, process engineers, regulatory inspectors, consultants to the API Industry, agents, traders, distributors, re-packers and re-labelers of APIs.
The faculty is comprised of experienced people from the pharmaceutical industry. The principal speaker in the workshop is Allan Whiston, Head of Quality Systems and Business Support, Quality Systems and Services, Global Quality Operations, Aventis, Germany.
The ICH Q7A document, the first GMP guidance jointly developed between regulators and industry, is intended for use worldwide. It impacts any manufacturer who manufactures in, or intends to supply to, the ICH regions (USA, Europe, Japan). The ICH Q7A API Guide was adopted by the Committee of the PIC/S in May 2001 and entered into force on 1 September 2001 under the name of PIC/S GMP Guide for Active Pharmaceutical Ingredients (PE-007-1). This Guide has also been incorporated into the EU guide to Good Manufacturing Practice as Annex 18 and in US FDA regulations for APIs, the release added.
The workshop is organised by Asharma Pharma Associates, Hyderabad.