Traceable Manufacture

As an intermediary quality level between research and GMP grade, HFR offer a traceable manufacture service similar to ISO 9001 standards.

Traceable Manufacture manages gram to kilogram synthesis via a defined route in clean segregated laboratory. Manufacture is quality assured for cleanliness, traceability of materials used and documentation review.  The equipment used during manufacture and testing is qualified according to defined procedures. Specifications and controls of working practices are controlled by a bespoke technical agreement which is signed by both the client and HFR prior to the undertaking of any work.

Traceable Manufacture services are typically used for:

• Pre-clinical studies. Documentation generated in this phase of work provides justification for manufacturing and test specifications. Templates for GMP synthetic and analytical methodology are also based on work completed in this phase
• API Starting Materials
• Performance materials