People. Progressive. Principled

Lean Supply Chain

Managing a Lean and Compliant Supply Chain

Are you interested in maintaining quality and regulatory compliance throughout the supply chain? Talk to us about our lean philosophy which reduces waste and minimises redundancy.

GMP requirements are now embodied in various regulatory documents e.g. EudraLex Annex 16, QP certification and batch Release, FDA Guidance for industry, Contract Manufacturing Arrangements for Drugs; Quality Agreements. Over the last few years the need to demonstrate control of the supply chain and assurance of quality has become one of the paramount requirements of a GMP environment. This has manifested in an increased scrutiny both from regulator and customer. The maxim expected is that both the owner and the supplier are both responsible for compliance with GMP. The QP release process in the EU requires the QP to establish a state of GMP compliance from the start to the end of the manufacturing supply chain verifying through the mechanisms of agreement and inspections.

Experience has shown that quality critical suppliers who perform activities covered in the GMP regulations must be covered by a Quality agreement.

Quality Agreements

What should be included and what should not?

Keeping it Lean – Why Lean?

To read more on using a lean approach in your laboratory, read our white paper

Lean principles transforming analytical laboratory servicespdf

Examples and Our Solution:

If you want to find out more about how you can maintain regulatory compliance and quality with a lean approach, then please call us on +44 (0) 1506 424270 or complete the contact form below and we can call you back.

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