Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards, minimising manufacturing risks.
GMP covers all aspects of production — from start materials, premises, and equipment to staff training and personal hygiene, preventing contamination and errors.
Discuss scope, objectives and current state.
Assess current practices against the standard’s requirements.
Build the policies, procedures and records the standard calls for.
Roll out the system and test it with an internal audit.
Leadership reviews performance and readiness for certification.
An accredited certification body audits conformance.
The certification body issues the accredited certificate.
Annual audits maintain certification status.
We don’t publish a fixed price, because cost depends on organisation size, number of locations, scope, process complexity, audit duration, consulting requirements and certification body fees. Request a scoped estimate and we’ll walk you through each factor.
Timelines depend on organisational readiness, scope and the complexity of your processes. A well-prepared, single-site organisation typically moves faster than a multi-site or highly regulated one — we’ll give you a realistic timeline after the initial gap analysis.
ISO 9001 is a generic quality management standard. GMP is a specialized quality assurance system with rigid requirements for hygiene, sanitation, contamination prevention, and validation, widely mandated in health-regulated sectors.
A system of quality assurance ensuring products are consistently manufactured to required specifications.
Good Manufacturing Practices guidelines established by the World Health Organization, commonly required for exporting pharmaceuticals to developing nations.
A detailed document that records the manufacturing history of a specific batch of product, proving it was made in compliance with SOPs.
Book a free initial consultation with an OMCS ISO consultant.