Good Manufacturing Practice, GMP compliance, is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMP standards are concerned with both production and quality control.

Why is it Important?

GMP compliance enforces global quality guidelines for pharmaceutical and medical device manufacturers to follow. The development of automated processes has led to GAMP (Good Automated Manufacturing Practice) which provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. It offers guidance on:

• Adhering to processes that will satisfy the regulatory requirements
• A scalable approach to GxP compliance through the complete lifecycle
• Driving towards a risk based approach
• Effective supplier relationships
• Use of existing documentation and knowledge
• Continuous improvement within QMS
• Quality by design
• Effective governance to achieve and maintain GxP compliance
• Helping bring down the cost of compliance

GMP compliant systems are within any organisation manufacturing and testing with pharmaceuticals and medical devices.  To find out more about the GMP standards and what is GMP ? Visit www.ispe.org for more information.

PRISYM ID has developed PRISYM Medica, PRISYM Pharmacy and PRISYM ClinTrial labelling software as purpose design labelling solutions for Life Science organisations and are supplied as a validated labelling solution including auditable security protocols and lifecycle documentation based on the GAMP V Model.

PRISYM software allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind that it has purpose built user security, group security and secure audit logging. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print.

To find out how Prisym ID Software can help you achieve your GMP compliance requirements please contact the PRISYM ID Life Sciences team or leave a comment below.

Tags: GMP, Labeling Regulations

This entry was posted on Sunday, March 14th, 2010 at 9:43 AM and is filed under GMP, Knowledge Base, Labeling Regulations. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.