GMPs for OTC and Cosmetic Products - US and Global Requirements

Duration: 60 Minutes
This webinar will help the attendees learn the FDA requirements for OTC products related to drug establishment registration, drug product listing and adherence to GMP regulations. The speaker will also provide an overview of Current Good Manufacturing Practices for personal care, cosmetic and OTC products and how the Quality Systems approach can support regulatory compliance not only in the United States but also the European Union and elsewhere. The cosmetic good manufacturing practice is a set of manufacturing guidelines to ensure the safety and quality of cosmetic products. OTC drug manufacturers, labelers, packagers and holders must comply with good manufacturing practices.
Good Manufacturing Practices
Instructor: David R Dills
Product ID: 501385
Objectives of the Presentation
  • Describe the legal basis and standards regulating the manufacture of personal care products including OTC and cosmetic products
  • Compare and contrast regional specifics concerning GMPs requirements and industrial best practices
  • Describe specific regulatory requirements pertaining to good quality management/manufacturing practices of personal care products
  • Outline steps and tools to establish and implement an effective GMP/quality management system
  • Understand that once a regulation covering a specific class of OTC drugs is proposed, reviewed and finalized in what is known as a FDA OTC Drug Monograph, those drugs must either comply with the requirements of the monograph or be required to submit a New Drug Application (NDA) to FDA for review and approval
  • Good manufacturing practice (GMP) and good distribution practice (GDP) are related aspects of the quality assurance for medicines in the European Economic Area (EEA)
  • cGMPs are standards and regulations that spell out the manufacturing, processing and packaging regulatory requirements with the aim of ensuring products' effectiveness and safety for OTC and cosmetic products
  • FDA Cosmetic Good Manufacturing (GMP) Guidelines/Inspection Checklist
  • ISO 22716 (Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices. ISO 22716:200
  • Prohibited and Restricted Cosmetic Ingredients in the US
Why Should you Attend
Current Good Manufacturing Practices (cGMPs) represent the U.S. Food and Drug Administration's extensive requirements and expectations that OTC (over-the-counter) and cosmetic manufacturers must follow. This system of controls helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. Current Good Manufacturing Practices set standards for manufacturing and testing in the following areas: raw materials, quality assurance, record-keeping throughout the manufacturing process, standards for cleanliness and safety, qualifications of manufacturing personnel, product testing, production and process controls, and warehousing and distribution. Cosmetic products marketed in US are regulated under the authority of the Food & Drug Administration (FDA). The regulations pertinent to cosmetic products are published in Title 21, Code of Federal Regulations, in particular, parts 700 to 740. In addition, new legislation such as the Safe Cosmetics Act may lead to more stringent requirements in the foreseeable future. Over-the-counter (OTC) medicines are sold directly to consumers without a prescription and why 21 CFR 210/211 Good Manufacturing Practice for Finished Pharmaceuticals are important. There are approximately 800 OTC active ingredients available today that constitute more than 100,000 OTC products in the healthcare marketplace. Rigorous adherence to Good Manufacturing Practice (GMP) minimizes the risk of adulteration or misbranding of OTC and cosmetic products. A useful reference "Guidelines for Good Manufacturing Practice of Cosmetic Products (GMPC)" was published by the Council of Europe in 1995. Similar references are also available from United States Food and Drug Administration (FDA) and European Cosmetic Toiletry and Perfumery Association (Colipa). Personal care products in the US often fall into two regulatory product categories regulated by the FDA: The cosmetic and the OTC products. Both are regulated under the Federal Food, Drug and Cosmetic Act (FFD&C Act).

Areas Covered
  • Can OTC medicines be marketed without pre-approval from FDA?
  • FDA Guidance Documents for OTC's and Cosmetics
  • OTC Drug Products for existing Monographs
  • FDA's review of OTC drugs is primarily handled by CDER's Office of Drug Evaluation IV
  • FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations
  • CGMP regulations for OTC products contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product
  • What are the requirements for manufacturing OTC drug products and cosmetics?
  • Good manufacturing practice (GMP) is an important factor in helping to assure that your cosmetic and OTC products are neither adulterated nor misbranded
Who can Benefit
This session focuses on the regulatory requirements of good manufacturing practices for OTC and cosmetic products in the US while also referencing key international counterparts like in Europe. It is designed for professionals in the personal care, cosmetic, chemical application and pharmaceutical industries engaged in all aspects of personal care product development, including the raw material suppliers, in the following areas:
  • Research & Development
  • Technology, Formulation and Product Development
  • Marketing & Technical Sales
  • Regulatory Affairs
  • Manufacturing
  • QA Professionals
  • QC Professionals
Topic Background
Current Good Manufacturing Practices (cGMPs) represent the U.S. Food and Drug Administration's extensive requirements and expectations that OTC (over-the-counter) and cosmetic manufacturers must follow. As an OTC or Cosmetic manufacturer, you need to ensure that your products are consistently manufactured to a quality level appropriate to their intended use and why GMP's concern both manufacturing and quality control procedures and operations.
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Instructor Profile:
David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. Background encompasses broad capabilities in regulatory and compliance oversight and governance, regulatory and GxP training, and compliance with MEDDEV/MDD/IVDD Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EU and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.
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