A product-specific master record that sets out manufacturing and control instructions for use as a production reference. In U.S. 21 CFR 211 terminology, the heading is “Master production and control records”; §211.188 separately describes batch production and control records for an individual batch.
Updated
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Master batch record translations occur in pharmaceutical production, technology transfer, contract manufacturing agreements, and regulatory submission packages. These documents are often translated when production moves between sites or when an application is prepared for a new market. Translators must maintain exact process parameters, equipment identifiers, in-process controls, and sampling points across languages without paraphrasing operational sequences.
Do not label a blank master template as the completed record for an individual batch, or vice versa. Keep the source file ID, revision and stated status with the translated title. If the status is unclear, mark it for confirmation instead of inferring it from the filename.
From reading to a project
Review status: questions to confirm
Identify whether each source is a master/template or a record for an individual batch; keep the two document roles separate in the Chinese file list.
Keep the source file ID, revision and any stated status beside the translated title so reviewers can match the Chinese file to the supplied source.
If the source does not identify whether it is blank or completed, record the question for the document owner instead of guessing from the filename.
List the source files and revisions, identify blank master templates versus individual batch records, and confirm the Chinese readers and return format.
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Request a Chinese batch-record file quote →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.