Manufacturing information
Pharmaceutical manufacturing is part of the adopted purpose of GALVANTA COMPANY LIMITED. A manufacturing enquiry must distinguish the proposed site, process, product presentation and destination market.
Site and permission
The registered office is the company’s legal address. It does not establish an authorised manufacturing site.
Permission for one activity or location cannot be assumed to cover another.
Materials and personnel
The company’s adopted quality objectives include control and documentation of manufacturing materials and required personnel training.
A proposed manufacturing scope needs defined responsibilities for material identity, receipt, storage, movement and status, together with the personnel requirements for the work. These matters require supporting operational records before they can establish readiness.
Equipment, utilities and processes
A technical enquiry should identify the process requirements and any relevant equipment, utility or environmental specification.
The adopted objectives include documented procedures for qualification and maintenance of manufacturing equipment. Installation, qualification and validation of particular equipment or utilities require evidence of implementation separate from those objectives.
Presentation-specific enquiries
The directory separates enquiries concerning:
- Oral solid dosage
- Liquids and semisolids
- Sterile filling and inspection
- Lyophilisation
- Device assembly
- Packaging and artwork
Current performance of a listed activity requires separate operational evidence.
Records and responsibilities
Proposed work requires a defined scope, technical responsibilities, appropriate quality documentation and the applicable authorisations. Product registration and permission to supply a market remain separate from manufacturing permission.
The Quality page states the adopted objectives.
Manufacturing enquiries
Email [email protected] with the subject, presentation, jurisdiction and purpose of the enquiry. Keep confidential formulations and technical files out of the initial message.
No capacity, completion date or commitment to perform work arises from a website enquiry.
Prerequisites
The company holds no pharmaceutical manufacturing licence or GMP certificate. Manufacturing may begin only after the authorisations required for the relevant activity have been obtained. This page states no licensed production scope, installed capacity or production timetable. Any proposed work requires evidenced capability, applicable authorisations and a separate agreement.