AAHP Compliance Thru Education Webinar ARCHIVE
Don’t put your business at risk by not thoroughly understanding and implementing the responsibilities & duties of a contract manufacturing and marketing relationship!
The Food and Drug Administration Safety and Innovation Act (FDASIA) profoundly affects all contract manufacturers and contract marketers. With the many changes elucidated by FDA, one thing is clear: the contract relationship puts both parties at considerable risk if either one fails to follow through on its obligations.
Managing contract manufacturing relationships requires that both parties, the contract manufacturer and the contract marketer, meet their regulatory compliance obligations; communicate frequently, effectively and honestly; comply with cGMPs; and work well together with mutual trust and respect. Contract manufacturing agreements can assist in managing responsibilities and liability for both parties. When one partner in the contract agreement fails to meet any of these requirements they place both companies, their other customers, and all end product consumers at risk.
FDA inspects both contract manufacturers and contract marketers. Here are examples of the FDA’s comments in recent months to contract manufacturers and marketers:
- Contract Marketer – your firm has not established any written specifications for your finished products for your contract manufacturer and has failed to test any received lots of products for conformance to specifications.
- Contract Manufacturer – your firm does not have adequate procedures for production controls designed to assure that the drug products you manufacture have the identity, strength, quality and purity they report or are represented to possess.
- Contract Marketer – your firm failed to conduct an investigation into numerous consumer complaints associated with broken or damaged tablets and bottles.
- Contract Manufacturer – your firm relies solely on the supplier’s COA for quality assurance of components and raw materials and has failed to establish written specifications for these materials and components and has not performed specific identity testing for approval for use and has not established the reliability of the supplier’s analysis through appropriate validation of the suppliers test results.
- Contract Marketer – your firm failed to establish product specifications for each of your contract manufactured products and failed to test each lot of finished product for conformance to specifications or manufacturer’s COA.
- Contract Manufacturer – your firm failed to establish adequate procedures for the quarantine, sampling, inspection, review, accuracy and approval of labeling supplied by contract marketers for all contract product labeling.
FDA is giving increasing attention to setting, validating and meeting product specifications. And the Agency increasingly expects both partners in a manufacturing relation to be equally responsible for many aspects of quality.
Contract manufacturers and contract marketers represent a major segment of the homeopathic industry, which is growing with new labels, marketers and manufacturers added each year. The FDA treats these relationships seriously, citing manufacturers for failure to meet GMPs, failure to list contract manufactured products and the lack of stability data. On the other side of the relationship, the FDA has cited contract marketers for failure to meet GMPs for their products due to contract manufacturer failures, failure to audit contract partners and for labeling errors.
Note: this webinar can also be utilized by your staff in fulfillment of your required mandatory training requirements. Homeopathic manufacturers and marketers have found the AAHP to be an excellent third party source for this training.
Meet the Presenters
Three industry leaders discuss the requirements and responsibilities of contract manufacturing relationships, agreements and complying with FDA cGMPs. At least 5 take-away handouts provide sample audit forms and suggested quality contract language to get you started, or to help clarify and improve your present agreements and implementation.
Cathy Raish, Quality & Regulatory Manager for Heel Inc. Cathy has over 25 years experience working in the homeopathic OTC and prescription drug industry with responsibilities for quality and regulatory compliance. She works closely with purchasing, suppliers, manufacturing, and distribution to help create a robust, GMP compliant supply chain for products manufactured at Heel for both branded and contract manufacturing products. Cathy is a member of APICS, The Association for Operations Management and ISPE, the International Society for Pharmaceutical Engineering and was recently accepted as an associate member of HPUS where she serves on the Council of Pharmacy and Standards and Controls Committees.
Robert Cohanim, owner Historical Remedies is a multicultural resident who immigrated to the US from Europe and the Middle East in the mid 1970s. He has a BA from Macalester College in St. Paul, MN, and an MA in interdisciplinary studies from the University of Minnesota. His interest in homeopathy developed soon after graduating, as a result of his exposure to the health care systems in France and other European countries. Robert founded Historical Remedies in the late 1980s in order to give a more accessible face to over-the-counter medicines, and to inspire a positive approach to self-care through homeopathy.
Travis Borchardt has spent 13 years at Enzymatic Therapy and Schwabe North America setting the standards of quality assurance, quality control, and regulatory compliance for products sold as dietary supplements, OTC homeopathic drugs, OTC monograph drugs, cosmetics, foods and a European Union (EU) prescription pharmaceutical. He has incorporated good laboratory practices, and transparency with governmental agencies; helping earn the following titles: National Sanitation Foundation’s (NSF’s) Good Manufacturing Practices (GMP’s) Certification, United States Department of Agriculture’s (USDA’s) National Organic Program Certification, and Therapeutic Goods Administration (TGA) GMP Certification. As a current board member of the American Association of Homeopathic Pharmacists (AAHP) and the American Herbal Products Association (AHPA), Travis helps to shape industry business and quality standards for the homeopathic and dietary supplement industries.
This 2.5 hour Webinar DVD also contains all the handouts available during the original on-line event.
Webinar DVD archives can be ordered directly from the AAHP office at 4332 SE Logus Road, Milwaukie, OR 97222. The cost of the DVD Archive is $395 (includes S&H); AAHP members get a $200 discount.
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