21 CFR 111.205: What is the requirement to establish a master manufacturing record?

Manufacturers must prepare and follow a written master manufacturing record for each unique dietary supplement formulation and batch size, specifying control points and procedures so every batch meets specifications and is uniform.

Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements · Subpart H, Production and Process Control System: Requirements for the Master Manufacturing Record

Recent 483s citing 111.205

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The regulation text

§ 111.205 What is the requirement to establish a master manufacturing record?.

(a)You must prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch.

(b)The master manufacturing record must:

(1)Identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and

(2)Establish controls and procedures to ensure that each batch of dietary supplement that you manufacture meets the specifications identified in accordance with paragraph (b)(1) of this section.

(c)You must make and keep master manufacturing records in accordance with subpart P of this part.

Questions

What does 21 CFR 111.205 require?

Which sections are cited alongside 111.205?

In the same 483s, investigators most often also cite 111.255 (What is the requirement to establish a batch production record?), 111.70 (What specifications must you establish?), 111.260 (What must the batch record include?), 111.27 (What requirements apply to the equipment and utensils that you use?).