QUALITY & REGULATORY
Qualification, documentation and regulatory context
Vencilla coordinates pharmaceutical sourcing through third-party manufacturing and supply partners. Documentation and source status are reviewed according to the requirements of the specific enquiry.
QualificationDocumentationEvidence status
APPROACH
Documentation at the centre of every enquiry
Each enquiry is assessed against its own product, source and destination requirements. The documentation reviewed depends on the product class, the source and the market.
Vencilla Medtex LLP is a merchant exporter and sourcing company, working with qualified third-party manufacturing and supply partners. Vencilla does not manufacture products.
FRAMEWORK
Six parts of the qualification framework
How Vencilla approaches qualification, documentation and regulatory context.
01
Supplier and source qualification
Third-party sources are assessed against the documentation they provide, as part of each enquiry.
02
Documentation
The documentation relevant to a product and source is requested and reviewed. Typical document types are listed below.
03
Product verification
Product information, such as specifications and certificates of analysis, is checked against the requirement.
04
Regulatory context
Regulatory requirements differ by destination market. Market guides will set out the general context with official sources.
05
Export documentation
Export documentation is coordinated by Vencilla as a merchant exporter and sourcing company.
06
Evidence status
Published records show the evidence state of Vencilla’s sourcing record. A status is not a certification.
DOCUMENT TYPES COMMONLY REQUESTED
ON REQUEST
| Category | Document types |
|---|---|
| API documentation | Specification, certificate of analysis, method of analysis, stability summary, DMF / ASMF access or CEP where applicable, manufacturer GMP evidence, safety data sheet. |
| Finished-product documentation | Finished-product specification, certificate of analysis, stability summary, certificate of pharmaceutical product (CPP / COPP), product dossier availability, manufacturer GMP evidence, labelling information. |
| Regulatory documentation | Market-specific requirements, confirmed for each destination. |
| Export documentation | Commercial invoice, packing list, certificate of origin, export authorisations as applicable. |
Documents are shared on request after qualification, depending on the product and source. This website does not host a document library.
DOCUMENTATION
Document types by category
The document types below are commonly part of pharmaceutical sourcing. Which ones apply depends on the product class, the source and the destination market.
EVIDENCE STATUS
Three evidence states
Statuses describe the state of a sourcing record. They are not certifications, approvals or regulatory statements.
SOURCE IDENTIFIED
A potential third-party source has been identified. Qualification has not started.
UNDER QUALIFICATION
Documentation for a third-party source is being collected or reviewed by Vencilla.
DOCUMENTED
Vencilla has received and reviewed the defined documentation set for a third-party source.
NEXT STEP
Need documentation for a sourcing requirement?
Tell us the product, destination market and the documentation you need. Documentation and sourcing suitability are assessed during qualification.
Or write to info@vencilla.com