Glossary
Master Production and Control Record (MPCR)
The approved document that sets components, quantities, theoretical yield, and manufacturing and control instructions for each product and batch size, and from which each batch record is copied.
Details
The master production and control record is the original document prepared in advance for each product and batch size to assure batch to batch uniformity, and the batch production and control record is its exact copy in which what was actually done is written — 21 CFR 211.188(a) requires the batch record to include an accurate reproduction of the appropriate master record, checked for accuracy, dated, and signed. 211.186 requires the MPCR to be prepared, dated, and signed in full handwriting by one person and independently checked, dated, and signed by a second, and to contain the product name, strength, and dosage form, the amount of active ingredient per unit, the list of components and their weights, the theoretical weight at each stage and the theoretical yield with the upper and lower percentage limits beyond which investigation is required, specimens of container, closure, and labelling materials, and complete manufacturing and control instructions with sampling and testing procedures and precautions (corresponding to the manufacturing formula and processing instructions of EU GMP Chapter 4 §§4.17–4.18). Inspections cite an MPCR issued without the independent second person check, missing upper and lower theoretical yield limits, manufacturing instructions so incomplete that operators relied on verbal instruction, and unauthorised personnel able to change a computerised MPCR (211.68(b)).
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your firm failed to establish and follow written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch.
FDA · FDA Warning Letter · 2022-03-22 -
Failure to prepare and use master production and control records.
FDA · FDA Warning Letter · 2026-08-18 -
Master production and control records lack sampling and testing procedures.
FDA · FDA 483 · 2019-02-19
