New regulations for dietary supplement manufacturers require a Quality Control function to oversee manufacturing and packaging operations. Quality Control personnel are expected to ensure the quality of the dietary supplement a manufacturer makes as well as the correct packaging and labeling as specified in the master manufacturing record. In this role, Quality Control must approve or reject factors affecting the identity, purity, strength, or composition of a dietary supplement. This includes processes, specifications, written procedures, controls, tests, and examinations as well as any deviations from or modifications to an operation. In this course, you will be able to identify regulatory requirements for quality control operations, including material review and dispositions, laboratory operations, product complaints, returned products, and other process control operations.

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The U.S. Federal Drug Administration issued the Dietary Supplement Current Good Manufacturing Practice (cGMP) Final Rule (21 CFR Part 111) in 2007. The regulations cover good practice in all stages of the product’s life cycle from manufacturing through packaging and labeling to storage, including ongoing operations, testing, consumer complaint handling, and design. Procedures and practices designed to keep equipment operating properly and to prevent product contamination are a key focus of several specific GMP regulations. This course will familiarize the learner with the FDA requirements for manufacturing plants and grounds including design and construction, and requirements for sanitation, equipment and utensils, automated equipment, contamination prevention, and record keeping.

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In the wake of mounting concerns over contaminated ingredients increasingly found in foods, animal feeds, and health products sold to U.S. consumers, the U.S. Federal Drug Administration (FDA) issued the Dietary Supplement Current Good Manufacturing Practice (cGMP) Final Rule (21 CFR Part 111) in June, 2007. The final rule requires that manufacturing companies maintain proper controls during the manufacturing, packaging, labeling, and holding operations of dietary supplements. After completing this course you will be familiar with the origin and scope of cGMPs
for dietary supplements. You will also be able to identify the purpose of general provisions and personnel subparts as well as the 16 basic subparts of the 21 CFR Part 111 Final Rules.

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FDA reports that approximately 25% of all product recalls are due to packaging and labeling mix-ups. The authors of CGMP regulations understand the dramatic impact that poor packaging and labeling procedures can have on the welfare of consumers. CGMP packaging and labeling requirements were developed primarily to protect consumers. Companies must establish and follow written procedures for fulfilling the requirements of managing and handling of all product related materials. These include components used in the manufacture of dietary supplements as well as packing and labeling materials. This also includes instances when a dietary supplement manufacturer may outsource the packaging, labeling, and distribution operations to another company. This course is designed to help the learner become familiar with the requirements for dietary supplement product packaging, labeling, holding, and distribution operations.

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Process controls are the principles and practices that help ensure that a dietary supplement product will meet its specifications for quality, purity, strength, and safety. FDA encourages manufacturers to develop process controls that support innovation and efficiency in product development, manufacturing, and quality assurance.

This course is designed to help you understand and recognize the principles and practices of process control and the role they play in assuring quality dietary supplement products. After completing this course, you will be able to identify the cGMP process control requirements for manufacturing operations, including sanitation, contamination, rejected products, specifications, in-process adjustments, reserve sampling, and records.

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Effective documentation is an essential part of the production and process control system for assuring product quality. Good documentation is an important GMP requirement; it ensures a complete and accurate record of the manufacturing, packaging, testing, and distribution of a product. However, just creating documents is not enough; you must follow specific established practices that allow everyone who reads your documentation to understand exactly what you mean.

Upon completion of this course, you will recognize the importance of the Master Manufacturing Record, Batch Production Records, effective documentation practices, the requirements for records retention, and Part 11 for electronic records.

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