The Tale of the Contract Manufacturer: A Story Based on an AAHP Member Question
By Eric Foxman, AAHP Secretary Once upon a time, a special creature, the CIAMP (Company Interested in Alternative Medical Products), wanted Phoxman Farmaceuticals (PhoxFarm) to contract manufacture a product for…
What About Your APIs and Q7 Requirements?
By Eric L. Foxman, R.Ph. Jan. 26, 2017 In September 2016, the U.S. Food and Drug Administration (FDA) issued a guidance document, entitled Q7 Good Manufacturing Practice Guidance for Active…
The European Pharmacopeia and How U.S. Manufacturers Can Use It
By Mark S. Phillips, Pharm. D. Jan. 26, 2017 On Jan. 1, 2017, the 9th edition of the European Pharmacopoeia (Ph. Eur.) became legally binding in its 37 European member…
AAHP Compliance Thru Education Webinar on FDA Inspections
The association just completed another successful Compliance Thru Education webinar: FDA Inspections of Homeopathic and Drug Manufacturing Facilities: An Agency View. This webinar, held on Dec. 1, was the last…
Label Comprehension Studies for Nonprescription Drug Products
The Food and Drug Administration (FDA) sometimes requires sponsors to conduct label comprehension studies that are designed to evaluate proposed nonprescription drug product labeling. A label comprehension study assesses the…
The Importance of Standard Operating Procedures
By Mark Land, AAHP President Manufacturers of health care products rely on precision, rigor and consistency to produce reliable products for patients, physicians and consumers time and again. To drive…
AAHP Encourages Clear and Open Communication on Teething Medicines Tragedies
In the interest of public safety, the American Association of Homeopathic Pharmacists (AAHP) encourages the U.S. Food and Drug Administration to provide clear and open communication on their ongoing investigation…
Document Management Systems
It is often said that the pharmaceutical industry produces two products: healthcare products and the paper that goes along with it. During the past 20 years, we have seen a…
What homeopathic manufacturers need to know, and what the FDA wants to see.
By Eric Foxman, AAHP Secretary Late last month, I joined Mark Vermette and Lyn Agostinelli of Halloran Consulting Group as they prepared for our upcoming Compliance Thru Education webinar: Document…
US FDA Establishment Inspections: Outcomes for Labelers for Homeopathic Drugs
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