Type A Medicated Articles CGMP: 21 CFR Part 226

What this course covers

Every medicated feed starts with a Type A medicated article, the concentrated drug product that feed mills dilute into Type B and Type C feeds. If the article is wrong, every dose built on it is wrong. This course gives animal drug manufacturers, quality professionals, and feed industry suppliers a clear overview of 21 CFR Part 226, the current good manufacturing practice regulation for Type A medicated articles.

The course opens with scope. Learners see where Type A articles sit in the medicated feed chain, how sections 226.10 through 226.115 serve as the CGMP yardstick under FD&C Act 501(a)(2)(B), when automated and electronic equipment is acceptable, and how articles that need an approved NADA or an index listing also follow 514.80 and 516.165.

Next, learners review personnel, buildings, and equipment: key personnel with suitable education and experience, clean and orderly facilities sized to limit mix-ups, separation from pesticides, and equipment built and grounded to prevent contamination and uneven mixing.

The course then walks through production and control procedures under 226.40: critical steps performed by competent people, comparison of actual and theoretical yield, safeguards against drug buildup in sequential batches, and stopping distribution of anything that fails its controls.

Learners then study components and laboratory controls under 226.42 and 226.58, including component receipt and testing, the rule to assay every batch made from undiluted drug, and the schedule for diluted articles: assay each batch until five in a row meet limits, then at least 5 percent of batches, with a return to full assay after a failure.

Finally, the course covers labeling controls, lot numbers, master and batch records, distribution records that support recalls, complaint files, and the two-year retention periods.

Who this course is for

• Animal drug manufacturers and their quality and regulatory professionals
• Feed industry suppliers that make or handle Type A medicated articles
• Production, laboratory and records staff who work under Part 226

What you'll learn

• Where Type A medicated articles sit in the medicated feed chain and how sections 226.10 through 226.115 act as the CGMP standard
• When automated and electronic equipment is acceptable
• Personnel, building and equipment requirements that limit mix-ups, contamination and uneven mixing
• Production and control procedures under 226.40, including yield comparison and safeguards against drug buildup
• Component and laboratory controls under 226.42 and 226.58, including the five-batch assay schedule for diluted articles
• Labeling, lot numbers, master and batch records, distribution records, complaint files and two-year retention

Regulatory sources

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