Good Manufacturing Practice

Good Manufacturing Practice governs how medicinal products are made and controlled — facilities and equipment, materials, production and packaging, quality control, and the records that prove it — so that every batch is manufactured to consistent, defined quality regardless of who is on shift. It is the baseline body of requirements (21 CFR 210/211, EU GMP, WHO, PIC/S) that regulators inspect against.

GMP failures are behind a large share of recalls and inspectional observations. A single uncontrolled step — a cross-contamination event, an unvalidated process, an unreviewed batch record — can adulterate an entire batch and reach patients before anyone notices. GMP is where quality is either built into the product or lost, and it is the standard every downstream discipline assumes is in place.

Sterile and aseptic operations under a formal Contamination Control Strategy — environmental monitoring, gowning, media fills, and the barrier and cleanroom design that keeps product sterile (EU GMP Annex 1).

The lifecycle approach to validation — process design, qualification, and continued process verification — so the process is proven capable and stays in a state of control, not just qualified once.

Written procedures, executed batch records, and independent second-person review before release — the documented evidence that each batch met its specification.

Laboratory controls, method validation, out-of-specification investigation, and the disposition decision that releases or rejects product against its registered specification.

• ›Data integrity in LIMS and electronic batch records (ALCOA+, audit trails)
• ›Out-of-specification investigations — thorough root cause, not just closure
• ›Aseptic process simulations / media fills and environmental monitoring trends
• ›Deviation and CAPA trending — pattern recognition, not one-off fixes

Derived from the 60 standards SPEQ decodes for this discipline.