Sterile-filling and inspection enquiries
An enquiry to GALVANTA COMPANY LIMITED about a sterile presentation should identify the formulation, container system, process and regulatory scope.
Components
Identify the proposed container and closure system, component-preparation question and evidence of suitability for a sterile product beyond a container image.
Formulation and filtration
Specify the formulation subject and process information requested, distinguishing filtration, sterilisation and aseptic processing and providing evidence for each relevant activity beyond a general filling description.
Ampoules
Identify the proposed ampoule presentation and requirements relevant to filling and sealing.
Vials
State the vial and closure presentation, documentary question and separate evidence of closure integrity and an authorised filling process.
Cartridges and syringes
Distinguish the pharmaceutical formulation, container and any delivery device, identifying specific evidence of compatibility and performance.
Inspection
Identify the inspection scope or record requested and separate evidence of sterility, composition and suitability for release beyond visual examination.
Contact and prerequisites
Email [email protected], identifying the organisation, presentation, jurisdiction and purpose.
Do not send confidential formulations, physical materials or patient information through an initial enquiry.
Prerequisites
The company holds no pharmaceutical manufacturing licence or GMP certificate. Any proposed activity requires evidenced capability, applicable authorisations and a separate agreement. An aseptic facility, validated sterilisation process and operational filling line require separate evidence. No ampoule-filling capability is claimed.