Laboratory / Quality
Contract laboratory testing programme
Setting up release and stability testing at a contract laboratory for a new product.
Illustrative use caseCapability
Contract Laboratory Services
Analytical testing, method work and stability programmes arranged with contract laboratories, with clear lines between what we do and what partners perform.
What we do
Testing programmes run through qualified contract laboratories. DGXPComplianceLab defines the testing scope, checks method and specification readiness, and reviews results and documentation before they reach your quality unit.
Each activity below is labelled so you can see whether it is led by our team or performed by a partner laboratory.
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
Analytical testing
Partner-coordinatedRelease and in-process testing against approved specifications.
Method development
Partner-coordinatedNew or improved methods for assay, impurities and dissolution.
Method validation
Partner-coordinatedValidation to ICH Q2(R2) with protocol and report.
Stability studies
Partner-coordinatedStorage, pulls and testing under ICH conditions.
Microbiology
Partner-coordinatedMicrobial limits, sterility and environmental monitoring support.
Quality control support
DGXP-ledOOS/OOT investigation support and specification review.
Documentation
DGXP-ledProtocol, report and certificate-of-analysis review.
Laboratory data management
DGXP-ledData flow, audit-trail review expectations and LIMS considerations.
Direct capability vs. partner-coordinated capability
Testing is always performed in a qualified laboratory. This is how responsibilities are split.
DGXP-led
What the DGXPComplianceLab team does
- Define the testing scope, specifications and method status
- Identify and evaluate suitable laboratories
- Prepare or review the testing quality agreement
- Coordinate sample logistics and timelines
- Review data, audit trails and reports
- Laboratory data management and LIMS workflows
Partner-coordinated
What the qualified laboratory does
- Analytical testing to approved methods
- Method development and validation
- Stability storage and pull testing
- Microbiology testing
- Issuing results and certificates of analysis
- Maintaining its own accreditation and GMP status
Testing programme flow
- 1Testing need
- 2Method & spec check
- 3Laboratory selection
- 4Sample management
- 5Testing
- 6Data review
- 7Report / CoA
- 8Archive
Technologies and processes
- HPLC / GC
- Dissolution
- Karl Fischer
- UV / IR spectroscopy
- Microbiological methods
- LIMS
- Chromatography data systems
Example projects
Illustrative use cases showing how this capability is typically applied.
Laboratory / Digital
Digital laboratory workflow
Replacing paper sample logs and result sheets with a barcode-driven laboratory workflow.
Illustrative use case
Digital / AI / Laboratory
Pharmaceutical data intelligence
Bringing batch, laboratory and quality data together for trending and product review.
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
Do you own a testing laboratory?
No laboratory is claimed. Testing is performed by qualified contract laboratories; our team handles scoping, coordination and review.
Can you handle an OOS investigation?
We support the investigation process — phase I/II structure, hypothesis testing and documentation — with the testing laboratory and your quality unit.
What about data integrity in outsourced testing?
Audit-trail review, raw-data access and archiving are defined in the laboratory agreement before testing starts.
Discuss a contract laboratory requirement
Share the product, stage and timeline. Capability is confirmed after technical assessment and partner availability.