This course provides a comprehensive overview of 21 CFR 111 - Current Good Manufacturing Practices (cGMPs) for Dietary Supplements. Comprised of four modules, this course includes an introduction to current good manufacturing practices (cGMPs), required product quality elements, documentation, and investigations; as well as an overview of the relevant subparts. This course also reviews the proper way to execute GMP records, details personal hygiene requirements, examines the meaning of master and batch records for control of production, labeling and packaging, clarifies the requirements of quality, and describes the purpose of GMP rules, regulations and FDA enforcement.
As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis.
Module 1 of this course covers the following requirements of 21 CFR 111:
o Subpart A – General Provisions
o Subpart P – Records and Record Keeping
o Subpart H – Master Manufacturing Records
o Subpart I – Batch Production Record
Module 2 of this course covers the following requirements of 21 CFR 111:
o Subpart B – Personnel
o Subpart C – Plants and Grounds
o Subpart D – Equipment and Utensils
Module 3 of this course covers the following requirements of 21 CFR 111:
o Subpart E – Production and Process Control
o Subpart K – Manufacturing Process Control
o Subpart F – Quality Control
o Subpart J – Laboratory Operations
Module 4 of this course covers the following requirements of 21 CFR 111:
o Subpart G – Components, Packaging, and Label Control
o Subpart L – Packaging and Labeling Control System
o Subpart M – Holding and Distributing
o Subpart N – Returns
o Subpart O – Complaints
o The Role of the FDA and its Authority
By completing this learning path, you will attain the certificate DS Certificate
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