AAHP Compliance Thru Education Webinar ARCHIVE
Current FDA activities emphasize compliance with 21 CFR 211 Subpart E for components and raw materials. The FDA has repeatedly stated: all raw materials must receive at least an ID test to confirm it is the correct material according to the HPUS, USP or other appropriate authority. Marketing companies have received warning letters about labeling controls and inventory practices. Manufacturers have been issued warning letters and FDA-483 inspection reports for failure to adequately control incoming materials including quarantine, release, evaluation and identity testing.
This webinar provides an overview for marketers and manufacturers of the regulations establishing the requirements for components, raw materials and labeling, starting with the establishment of specifications and covering receiving, sampling, evaluation and testing for release or rejection. The FDA has made written specifications, identity testing and labeling controls a mandate in its inspection of manufacturers. Manufacturers are responsible for following these regulations and private label marketing companies are responsible for making certain their manufacturing partners are in compliance. Failure to follow these regulations can result in the issuance of FDA warning letters and product recalls.
Compliance in these critical quality areas is essential to the identity, quality and safety of homeopathic products and is the responsibility of private label marketers and manufacturers alike. Sometimes, an innocent action is actually a critical lapse of compliance. For instance:
Is it acceptable for a firm to use drug components, drug product containers, or drug product closures simultaneously with testing and/or prior to determination of conformity to all specifications? {References: Federal Register Vol.43 No. 190, 9/29/78, 45013 [at 45045]}
No. It is not acceptable to use drug components containers, or closures prior to completion of all testing to determine conformance to established written specifications. The above preamble to 21 CFR 211.84, clearly states that the use of drug components, containers, or closures prior to completion of testing for conformity to specifications violates the precept of good quality control because untested and possibly non-compliant materials would be used in drug product processing. This type of procedure substantially increases the risk to the consumer that an unsatisfactory lot might erroneously be released. {From FDA Human Drug CGMP Notes, Vol. 4, No. 4, December 1996 The Division of Manufacturing and Product Quality, HFD-320, Office of Compliance, CDER, Project Manager: Paul J. Motise, HFD-325.}
This webinar presents an overview of FDA cGMP and Homeopathic Pharmacopoeia requirements for testing of packaging components and active ingredients. The webinar is designed as a compliance overview for private label marketers and manufacturers and will address the regulations for conformance of homeopathic drug products. Compliance with 21 CFR 211 Subpart E, for raw materials, is critical to product quality and safety. Manufacturers are responsible for following these regulations and private label marketing companies are responsible for making certain their manufacturing partners are in compliance.
Example of observations in recent FDA 483’s for failure to identity test raw materials:
- You did not follow your written procedure, “Approval/Rejection of Raw Materials and Packaging Components” for collecting representative samples of each unique shipment of components. Under 21 CFR Subpart E, you must establish and follow written procedures for fulfilling the requirements of subpart E. This subpart includes the requirement that you collect representative samples of each unique lot of components (21 CFR 211.80).
- The inspection revealed the following deficiencies: 1. You failed to determine whether specifications are met before use of components as required by 21 CFR 211.84. Specifically, you failed to conduct at least one appropriate test or examination to verify identity of a drug ingredient prior to its use. From the time period between June 25 and October 6, 2009, you did not perform identity testing on any drug ingredients that you received, and during the time period between October 6, 2009 and May 10, 2010 you only performed identity testing on randomly selected drug ingredients.
- Your firm failed to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality and purity [21 C.F.R. § 211.84(e)]. For example, a [redacted] raw material (lot (b)(4)) failed to meet specifications and was not rejected. The raw material was subsequently used to manufacture [redacted] (b)(4)). These lots were released and distributed.
- Failure to verify the identity of each component of a drug product, as required by 21 C.F.R. § 211.84(d)(1). Components used in all drug products are not tested for identity. For example, the active ingredient [redacted] USP, used in [redacted], batch (b)(4) was not tested.
- For example, your firm does not have a sampling and test procedures designed to assure that the water from the purification system conforms to appropriate standards.
- Your firm failed to conduct at least one appropriate test or examination to verify the identity of a drug ingredient prior to its use, to comply with 21 CFR 111.75(a)(1)(i).
- The CGMP deviations documented during the inspection include, but are not limited to, the following: Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of components used in the manufacture, processing, packing, or holding of drug products, as required by 21 CFR 211.160(b)(1).
These recent FDA activities emphasize compliance with 21 CFR 211 Subpart E for components and raw materials. The FDA has repeatedly stated that all raw materials must receive at least identity testing to confirm it is the correct material according to the HPUS, USP or other appropriate authority. Marketing companies bear responsibility to ensure that their products are manufactured under cGMPs and have received warning letters about labeling controls and inventory practices, and for failure to adequately control incoming materials including quarantine, release, evaluation and identity testing. All homeopathic drug manufacturers are responsible for following these regulations and private label marketing companies are responsible for making certain their manufacturing partners are in compliance.
In this Seminar you will learn the importance of…
- Protecting your consumers and your business by meeting the FDA regulatory requirements for specifications, receiving, testing and evaluating components, labeling and raw materials
- Ensuring product quality with the establishment of material and component specifications
- Confirming raw materials with required identity testing
- Compliance with FDA ‘hot button’ inspection issues
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.
Who should view this webinar?
- Manufacturers, contract manufacturers and private label producers responsible for ensuring the compliance of homeopathic products.
- QA/QC staff responsible for establishing specifications, sampling, evaluating and testing of components and materials.
- Marketers of private label brands who are responsible for the compliance of their contract manufactured product’s quality, safety and labeling.
- Personnel required to maintain appropriate and documented training in current Good Manufacturing Practices.
Meet the Presenters:
Rachael Carlisle Roehrig, Ph.D.–Director of Technical and Scientific Affairs for the Regulatory and Scientific Affairs department of the Consumer Healthcare Products Association (CHPA), coordinator for CHPA’s Product Quality & Operations Workshop and the CHPA liaison to the Manufacturing Controls Committee. Rachael presents FDA regulations 21CFR 211 Subpart E – Control of Components and Drug Product Containers and Closures and requirements. She will discuss specific quality processes, requirements for specifications, documentation and required identity testing.
Eric Foxman, RPh—Executive Secretary for the AAHP, Board Member of the HPCUS, and consultant on regulatory and GMP issues with over 30 years of involvement in homeopathic pharmacy and manufacturing. Eric discusses the HPUS requirements for testing of starting materials, botanicals and chemical substances, and for finished tinctures, providing examples of material specifications and identity testing requirements.
Kevin Carrasco—VP, Speed Laboratory Inc Kevin will review the reasons for the use of USP and NF testing methods for most excipient and for some homeopathic ingredients. He presents examples of the identity testing requirements for some of the most common homeopathic product excipients and active ingredients and cover basics in good laboratory practices for manufacturers.
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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