Supply Chain Maps - Who Needs Them?

Supply chain maps are invaluable to all organisations, especially when you outsource. Pictures speak a thousand words when communicating to others, saving time and cost, and avoiding misunderstandings.

Communicating with who?

• CMC

• Project Management

• Quality

• Certifying Qualified Person

• Other organisations in the supply chain

• Regulatory

• Auditors

• Inspectors

• Investors

• Yourself (a reference document)

Essentially, anybody that needs to understand an aspect of the supply chain will tune in quickly if they are provided with a map that is carefully designed to ensure all parties are clearly illustrated.

Ultimately it is a requirement for certifying QPs to understand the whole supply chain that influences the quality of your product. You will have a document to provide, saving time and cost. 

A supply chain map easily identifies the vendors that need sponsor GMP oversight, and which vendors are responsible for oversight when certain activities are subcontracted. It is therefore a useful reference source when writing other essential documents, such as:

• Quality agreements

• QP to QP agreements

• Technical Reference File documents

• IMPD

• Certificates of Conformity

We recommend you start drafting a supply chain map as soon as you identify your initial vendors, and finalise it just before a GMP campaign. A signed document illustrates the internal decisions you have made, preventing conflicting messaging which, in JWQC’s experience, has the potential to delay release due to a lack of understanding of responsibilities within the supply chain.

This document can be up-versioned if a change is needed, or if a new vendor is needed for the next stage of manufacture. 

Need help?

Please contact us if you need help in drawing your supply chain map.  We have experts who can help you identify all parties for the map, ensure there are no gaps, and to put it in a format where responsibilities are easily understood. If you like our format, we can provide you with a basic starting point procedure for your own quality system.