American Association of Homeopathic Pharmacists
5112 Wilshire Drive
Santa Rosa, CA 95404
The American Association of Homeopathic Pharmacists
Presented a Compliance Through Education:
cGMP Seminar for Homeopathic Pharmacies and Laboratories
This seminar, part of the AAHP's continuing commitment to Compliance Through Education, focused on the cGMP requirements for testing of components and raw materials for products. The course included information on Good Laboratory Practices (GLP's), documentation, record keeping standards and sampling.
This interactive workshop provided attendees with a practical insight into the application of the Food and Drug Administrations' cGMP laboratory regulations (21 CRF 211.80, 160, and 194) that apply to the manufacture of Homeopathic drug products. The program enabled each participant to establish manufacturing plans that comply with the FDA requirements for analysis and record keeping. Understanding the serious implications of non-compliance, developing internal strategies to test for compliance and solving cGMP analytical problems in an FDA Compliant manner were all covered.
The course began with an overview of the legal requirements for compliance,
definde the terms that are used in the law and regulations, examined the requirements
for the receipt, testing and analysis of components, packaging and labeling,
examined the analytical aspects of processing , reviewed the requirements
for an analytical laboratory and concluded with an examination of the record
keeping requirements for all of these aspects of homeopathic drug product
Upon completing the course, attendees left with an up-to-date awareness of the cGMP in current industry practices and as interpreted by the FDA. Another very worthwhile aspect of the program was the opportunity to share experiences and solutions with counterparts in the industry.
Owen Lamb, the presenter of the seminar is a consultant to the drug industry and drew upon his many years of working within the FDA and providing enforcement of the very regulations he was speaking about. Mr. lamb also provided some insights on dealing with FDA inspections.
The seminar was held in April 2001. Pharmacists earned 1.2 hours of Continuing Education Credit (=12 CEUs) and all attendees received a certificate of completion from the Center for Professional Advancement.