Good Manufacturing Practice (GMP) refers to a set of regulations that ensure products are consistently produced and controlled according to quality standards. GMP is mandatory in industries such as pharmaceuticals, medical devices, food, and cosmetics — where safety, consistency, and traceability are critical.
GMP guidelines cover all aspects of production: from raw materials, facilities, and equipment, to staff training, recordkeeping, and hygiene. Regulatory authorities like the FDA (US), EMA (Europe), and WHO enforce GMP to ensure products are safe and meet intended use.
A central component of GMP is the requirement for documented procedures and instructions. This includes Standard Operating Procedures (SOPs), batch records, and evidence of compliance for every step in the process.
Manual, paper-based instructions are prone to errors, version control issues, and poor traceability. To meet GMP expectations, companies must ensure:
The Work Instruction App empowers regulated companies to meet GMP requirements by replacing paper procedures with standardized, digital work instructions. Key features include:
Whether you’re preparing for an audit or scaling production, our platform helps you demonstrate control, consistency, and compliance — all essential to GMP.