TRACEABLE MANUFACTURE IS HFR’S OWN TERMINOLOGY FOR MANUFACTURE UNDER A QUALITY SYSTEM THAT ALLOWS OUR CLIENTS TO TAILOR A QUALITY SYSTEM TO SUIT A SPECIFIC PROCESS THAT DOES NOT REQUIRE GMP MANUFACTURE.
By selecting GMP quality standards to control high risk processes, but excluding the lower risk processes, traceable manufacture allows HFR to provide cost effective control. Its principles are firmly based on the same GMP system so you can be sure quality is not compromised.
Typically we work with clients to construct a bespoke technical agreement that is fit for purpose for the product’s end use within the appropriate industry sector.
Traceable manufacture at HFR is controlled by QA. Traceability from raw materials through manufacture analysis and delivery is at the core of this quality standard. Other systems may be altered, for example:
Synthesis will be carried out in an isolated laboratory or a segregated area of HFR’s main
Batch record information is recorded on a defined production record designed to provide batch traceability.
Contact equipment used is logged for use to control TSE risk. Project dedicated equipment can be assigned, should the client prefer this. Equipment will remain dedicated to the project for the duration of the campaign.
Key raw materials will be identified/analysed by QC prior to use. Intermediates and product/s will be analysed by QC. Retention samples will be kept.
Documentation will be completed and shared in real-time with the customer to allow traceability of each batch of material. Prior to manufacture a technical agreement will be written and agreed by both parties to define key quality attributes and responsibilities.
Supply of material will be accompanied by;
- A certificate of conformity against an agreed manufacturing technical agreement.
- A TSE statement (if required).
- A certificate of analysis
Examples of successful projects are:
- API starting materials
- API used for pre-clinical proof of concept studies or toxicology
- Medical Devices
- Materials used for clinical diagnostics
- Monomers used for high performance polymers
- Organic electronics (OLEDS)
If you have a new or established product that requires small scale quality manufacture without compromise please contact us