Documentation

GMP's most important principle is often quoted as: "If it wasn't written down, it didn't happen." This is not a philosophical stance — it is a regulatory one. In a GMP environment, any action that cannot be demonstrated through documentation is treated as though it did not occur. Documentation serves two essential purposes: it proves that processes were followed correctly at the time, and it provides the traceability needed to investigate failures and protect patients if something goes wrong.

The main document types in a GMP operation include: Batch Manufacturing Records (BMRs), which capture every step, measurement, and check performed during production of a specific batch; Standard Operating Procedures (SOPs), which define precisely how tasks must be carried out; equipment logbooks; deviation and out-of-specification (OOS) reports; change control records; and qualification and validation documentation. Each type serves a specific function within the quality system. Regulators expect to see all of these during inspections, and gaps are treated as critical findings.

The gold standard for data quality in GMP records is the ALCOA+ framework. Data must be: Attributable (you can tell who did what and when), Legible (readable now and in the future), Contemporaneous (recorded at the moment the action was taken, not reconstructed later), Original (the first recorded observation), and Accurate. The "+" extends this to: Complete, Consistent, Enduring, and Available. When an error is made in a paper GMP record, the correct procedure is a single line through the error, leaving the original text readable, with the author's initials and the date of correction beside it. Using correction fluid, overwriting, or obscuring entries are serious data integrity violations.