Manufacturing / CMO
External manufacturing partner identification
Finding and evaluating a qualified manufacturer for an oral solid product for a regulated market.
Illustrative use caseCapability
External Manufacturing
Identifying, evaluating and coordinating qualified external manufacturers so your product is made where the technical, quality and regulatory fit is right.
What we do
DGXPComplianceLab can support project coordination and the identification and engagement of suitable external pharmaceutical manufacturing capabilities based on project requirements.
Manufacturing is performed by the selected qualified organisation, not in DGXPComplianceLab-owned facilities. Our role is to make the selection defensible, the transfer complete, and the quality interface clear through a quality agreement and agreed responsibilities.
Where it fits in the pharmaceutical lifecycle
Typical activities
Each activity shows who performs it. We do not claim facilities we do not own.
DGXP-led Led by the DGXPComplianceLab team Partner-coordinated Performed by a qualified partner, coordinated by us
Product and process assessment
DGXP-ledDosage form, batch size, equipment train, special handling and market requirements.
Manufacturer identification
DGXP-ledLong-list and short-list of organisations matching technical and regulatory needs.
Technical evaluation
DGXP-ledEquipment, capacity, experience with similar products and change history.
Quality and compliance assessment
DGXP-ledAudit planning, inspection history review and quality agreement drafting.
Technology transfer
DGXP-ledTransfer protocol, documentation package and exhibit/validation batch planning.
Manufacturing
Partner-coordinatedCommercial or clinical supply manufacturing at the qualified partner site.
Testing and batch review
Partner-coordinatedRelease testing coordination and batch record review support.
Delivery coordination
DGXP-ledScheduling, release status tracking and stakeholder communication.
External manufacturing workflow
- 1Client requirement
- 2Product/process assessment
- 3Manufacturer identification
- 4Technical evaluation
- 5Quality/compliance assessment
- 6Documentation
- 7Technology transfer
- 8Manufacturing
- 9Testing
- 10Batch review
- 11Delivery
Technologies and processes
- Supplier qualification
- Quality agreements
- Technology transfer protocols
- Process validation (Stage 1–3)
- Batch record review
- Annual product quality review
Example projects
Illustrative use cases showing how this capability is typically applied.
CMO / Manufacturing
CMO technology transfer support
Transferring a granulated tablet process from a development site to a contract manufacturer.
Illustrative use case
Regulatory / Manufacturing / Quality
Technology transfer documentation
Building a complete documentation set for transferring a product between sites.
Illustrative use caseOur project execution model
Every engagement follows the same eight steps, scaled to the size and risk of the project.
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01
Understand
Understand business and technical requirements.
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02
Assess
Assess scientific, technical, regulatory and operational requirements.
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03
Design
Design the appropriate solution.
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04
Identify
Identify appropriate internal and external capabilities and partners.
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05
Execute
Coordinate and execute the project.
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06
Verify
Test, verify, qualify or validate where applicable.
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07
Document
Create technical, quality and regulatory documentation.
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08
Improve
Monitor, optimise and continuously improve.
Related services
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Frequently asked questions
Does DGXPComplianceLab manufacture products itself?
No. Manufacturing is carried out by qualified external organisations. We coordinate identification, evaluation, transfer and the project interface.
How is a manufacturer selected?
Against documented criteria: technical fit, capacity, regulatory inspection history, quality systems and commercial terms. The rationale is recorded for your quality file.
Who is responsible for batch release?
Responsibilities are defined in the quality agreement between the marketing authorisation holder and the manufacturer; we help draft and review it.
Discuss a external manufacturing requirement
Share the product, stage and timeline. Capability is confirmed after technical assessment and partner availability.