Good Manufacturing Practice (GMP) is the part of quality assurance that ensures medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by their marketing authorisation. It covers the whole operation: personnel and training, premises and equipment, documentation, production, quality control, complaints and recalls, outsourced activities and self-inspection.
The main GMP texts include US current GMP (cGMP) in 21 CFR Parts 210 and 211, EU GMP in EudraLex Volume 4 with its annexes, the PIC/S GMP Guide used by inspectorates worldwide, WHO GMP, and Revised Schedule M in India. The “c” in cGMP signals that manufacturers are expected to use technologies and systems that are up to date, not merely those that were acceptable years ago.
Why it matters
GMP compliance is a condition of holding a manufacturing licence and of supplying regulated markets. Inspections by the FDA, MHRA, EU authorities, CDSCO, WHO and others check whether a site follows GMP, and serious failures can lead to warning letters, import alerts, suspended licences and recalls.
- Written procedures, followed and documented.
- Qualified people, premises, equipment and processes.
- Records that show every batch was made and tested correctly.
- A quality unit independent of production with the authority to release or reject.
How Swat iQua Suite handles it
Swat iQua Suite connects the GMP records of the QC laboratory, quality system, batch manufacturing, materials and release on one platform with one audit trail. It is designed to comply with 21 CFR Part 11, EU GMP Annex 11 and Annex 1, WHO GMP and Revised Schedule M, following ALCOA+ data integrity principles and a GAMP 5 risk-based validation approach.