GMP Services

Good Manufacturing Practice (GMP)

Compliance to GMP or cGMP is a pre-requisite for the application of a manufacturing licence for cosmetics, health supplements, traditional medicine and pharmaceuticals as well as for product registrations in Malaysia. GMP consists of a set of processes, procedures and documentation to ensure that products are consistently produced and controlled according to set quality standards, in order that the products are not cross-contaminated, adulterated or mislabelled. The National Pharmaceutical Regulatory Agency (NPRA) is responsible for GMP inspections.

Key Areas of GMP

Having GMP status provides consumers with confidence that the product is safe, efficacious and of good quality. A GMP QMS ensures that:

All manufacturing processes are clearly defined
Qualification and validation are performed
Personnel are appropriately qualified and trained
Resources such as premises and equipment are adequate, clean and suitable
Materials are checked
Products are properly stored and handled
Records are made and kept
Post market and Compliance handling systems are in place.

The Process for Implementing GMP

Understand the requirements for GMP
Develop and implement a GMP QMS
Validate the effectiveness of the SOPs
Conduct an internal GMP audit
Have the GMP QMS inspected by NPRA

How We can Help

Appointing the right consultant is key to your success with a GMP QMS. At Cubic Life Sciences, we have a team of experienced professionals who possess the necessary expert knowledge to help you create an efficient GMP QMS that minimises costs and complexity and complies with the regulatory guidelines.

Malaysia Consulting Service for GMP

Searching for a Professional GMP Consultant?

We understand the challenges of designing and implementing quality management systems. Find out how we can help you get a head start.