GMP Good Manufacturing Practice

What is GMP?

GMP (Good Manufacturing Practice) is a set of practices that ensures the quality, safety, and consistency of production processes in sectors such as pharmaceuticals, food supplements, cosmetics, and medical devices. It ensures products are manufactured under correct conditions, contamination risk is minimized, and every production batch meets reproducible quality standards.

BESA Consulting Scope

• Assessment of existing production processes against GMP principles
• Facility design and validation process guidance
• Personnel hygiene and training programs
• Establishment of Standard Operating Procedures (SOPs) and record systems
• Internal audit and pre-inspection support

Benefits

• Regulatory compliance in licensing and export applications
• Reduced risk of product recall and deviations
• Increased customer trust and brand value

Certification Process

1. 1 Application and scope definition
2. 2 Gap analysis and documentation
3. 3 System implementation and internal audit
4. 4 Stage 1 and Stage 2 audit
5. 5 Certificate issue
6. 6 Annual surveillance and recertification

The certificate is issued by an accredited certification body; BESA manages the process from application to certificate.