21 CFR 211.186 - Master Production and Control Records

What it says

To assure uniformity from batch to batch, master production and control records must be prepared for each drug product and batch size, dated and signed by one person, independently checked, dated and signed by a second person, and must include product identity, component lists, yield, manufacturing and control instructions, sampling and testing procedures and special notations.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The master record is the approved recipe from which every batch production record is generated, so errors in it propagate into every batch.
• The independent second-person check is a built-in control, and the record of that check is part of what the requirement expects to see.
• Changes to a master record should flow through change control so batch records in use always match the approved version.

What FDA inspectors look for

• Whether master records exist for each product and batch size and carry the required signatures and dates.
• Whether the batch records in use match the currently approved master record.
• Whether master record changes were made through documented change control with appropriate review.

Related regulations