QMS/GMP Consulting

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QMS
A quality management system (QMS) covers a set of business processes focused on achieving quality policy and quality objectives to meet customer requirements.

GMP
Good Manufacturing Practice (GMP) is a system that ensures organizations produce and control products consistently aligned with quality standards. GMP is part of a QMS that covers the manufacturing and testing of pharmaceuticals, active pharmaceutical ingredients, diagnostics, foods, and medical devices.

Regulators develop GMP requirements to minimize the risks involved in pharmaceutical production. Although many countries develop country or region-specific pharmaceutical and medical device quality standards, GMP guidelines follow a few basic principles.

With a GMP, the entity must:

• Clearly define and control its manufacturing process
• Validate critical processes to ensure consistency and compliance with established specifications
• Evaluate and validate any changes, which have an impact on quality
• Write instructions and procedures in clear and unambiguous language
• Train staff to perform operations in line with documented procedures
• Keep manufacturing records and document and investigate deviations from the set standard
• Keep records of distribution to enable tracing and history of a specific batch
• Establish a system to enable any necessary product recalls for specific batch

QMS and GMP Services

• Our team of consultants can help you establish and maintain a standards-compliant GMP system. We can help you:
• Design and implement a QMS appropriate for your organization and target markets
• Prepare for regulatory submissions
• Design and implement an effective validation system for processes and suppliers
• Audit suppliers and/or vendors
• Conduct a pre-certification audit for all processes
• Establish the appropriate record keeping and tracking systems
• And more

Regulators use Quality Management Systems and Good Manufacturing Practices as the foundation for their certification standards. JJK consulting has constructed a team of veterans across every industry and business sector. Our approach will demystify the process and lead to measurable, repeatable results that have bottom line impact.

To discover how we can help you improve your bottom line with a well-structured QMS system, please contact us.