21 CFR 111.255: What is the requirement to establish a batch production record?

Manufacturers must prepare a batch production record for every dietary supplement batch, containing complete production and control information, accurately following the master manufacturing record with each step performed, and retained under recordkeeping requirements.

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

Recent 483s citing 111.255

See all 483s citing 111.255

The regulation text

§ 111.255 What is the requirement to establish a batch production record?.

(a)You must prepare a batch production record every time you manufacture a batch of a dietary supplement;

(b)Your batch production record must include complete information relating to the production and control of each batch;

(c)Your batch production record must accurately follow the appropriate master manufacturing record and you must perform each step in the production of the batch; and

(d)You must make and keep batch production records in accordance with subpart P of this part.

Questions

What does 21 CFR 111.255 require?

Which sections are cited alongside 111.255?

In the same 483s, investigators most often also cite 111.205 (What is the requirement to establish a master manufacturing record?), 111.70 (What specifications must you establish?), 111.27 (What requirements apply to the equipment and utensils that you use?), 111.83 (What are the requirements for reserve samples?).