Managing a Lean and
Compliant Supply Chain

Are you interested in maintaining quality and regulatory compliance throughout the supply chain? Our lean philosophy 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?

Lean principles are all about efficiency and focus. In a regulated but still commercial environment there are pressures to comply but with minimal waste. Maximising output against effort reduces waste time delivering quality results quickly benefiting all stakeholders.
The whole process of Supplier management was well suited to lean principle review. The existing process was mapped out and from the map it could be seen there were duplications and redundancies.

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

Examples and Our Solution:

  • Two forms where essentially one was sufficient
  • Multiple signatures – Cut down to essential.
  • Risk assessment, introduced consistency.
  • Classification of Suppliers, focus efforts on quality critical.
  • No standardised review process, reduce chaos
  • Using a database