Project Management | Pharma & Chemistry GxP

Our services for project management in pharma and chemistry

A GxP project has a fourth dimension alongside schedule, budget and quality: the evidence. Without an approved specification, executed tests and a documented deviation assessment, a unit does not enter routine operation even if it runs technically. We plan that dependency in from the start.

We work for site management, project management, QA and IT in pharmaceuticals, biotechnology, medical devices and chemistry. Typical projects: new build or modification of a unit, LIMS and MES implementation, migration of an Access application, a site transfer, or requalification after a finding.

Reference: LabWare LIMS rollout for around 400 users including PMO and change management. Read the case story

The most common schedule killer in qualification projects is not the technology but the document status: tests are executed against a specification that has not yet been approved. We gate the start of testing on approval and make the bottleneck visible in the status report.

Project guide

Which project are you planning?

Choose your starting point. You receive a focused entry point with relevant deep links and a direct route to contact.

Qualification of equipment or facilities

We plan DQ through PQ in the schedule, tie the start of testing to approved specifications and keep deviations traceable in the risk register.

Discuss qualification View equipment qualification

What You Get

The five steps build on one another. Each step ends with a deliverable you can hold in your hands and present in an audit.

Initiation

We clarify objectives, scope, roles and decision authority and record them in a robust project charter.

Deliverable

Project charter with objectives, scope, roles and decision authority.

Planning

The schedule shows dependencies between engineering, testing and document approval so milestones are not illusory.

Deliverable

Schedule showing dependencies between engineering, testing and document approval.

Governance

Status reports state percentage complete, open points, risks and decisions required with a due date, planned and tracked in your tools such as Jira, Confluence or MS Project.

Deliverable

Risk register with assessment, mitigation and named owner plus status report on a fixed cycle.

GxP integration

CSV, change control and document approvals are not a side track but schedule preconditions in the project plan.

Deliverable

Traceable change control records, approved specifications before testing starts and embedded validation evidence.

Close-out

At the end you have not only a technically running system but an ordered project file ready for QA and audit.

Deliverable

Final report and an ordered project file ready for archiving.

Clarify project charter and scope?

Book an initial call

Our Project Management Expertise

Take over or reinforce project leadership

Full project leadership or reinforcement for a phase, for example qualification, with clear decision authority and reporting route in the project charter.

Governance on solid data

Status reports with percentage complete, risks, open points and decisions required, planned and tracked in Jira, Confluence or MS Project.

Classical, agile or hybrid

The V-model suits equipment qualification, an iterative approach suits software. Traceability from requirement to test remains binding and the definition of done includes test evidence.

Classical PM

Schedule without approval milestones
Status = percent complete
Documentation at project end

GxP-integrated

Testing starts only after specification approval
Status = open findings + decisions required
Evidence in parallel with project progress

GxP-Specific Requirements

Validation

CSV in the project context

For GxP-relevant IT projects we integrate Computer System Validation (CSV) according to GAMP 5 seamlessly into schedule, change control and release decisions.

Change Control

Steer changes formally

Scope changes during qualification are handled through change control records with an impact assessment on specification, test scope and schedule. Details under Change Control Management.

Industries and Application Areas

Experience from pharmaceutical production, biotech, medical devices and laboratory IT – different regulatory mixes, but the same evidence logic in the project.

Pharma & Biotech

Equipment and CSV programmes

Qualification and validation projects for production and laboratory – aligned with equipment qualification and CSV.

Medical Devices

MDR and process evidence

Project governance under MDR with focus on process validation, supplier qualification and design controls – see Production Plant Qualification.

API & Chemistry

ICH Q7 and process validation

Process design, PPQ and ongoing process verification per FDA Process Validation Guidance and ICH Q7 – complemented by Change Control in operations.

Where several projects run in parallel, portfolio governance is handled by our PMO; organisational rollout is supported by our Change Management.

Regulatory framework: Annex 15, Annex 11 and GAMP 5

Project planning in GxP work follows the evidence obligations in the rules:

EU GMP Annex 15: defines the validation master plan, the qualification stages and the handling of deviations.
EU GMP Annex 11: governs computerised systems across the full lifecycle, including supplier assessment.
ISPE GAMP 5, 2nd Edition: provides the risk-based framework for software categories and test scope.

FAQ: Project Management in GxP Environments

What distinguishes GxP projects from general IT projects?

The evidence. A GxP system may only go into productive use once specification, test execution, deviation assessment and release are documented. That shifts effort forward into the specification phase and turns document approvals into genuine schedule preconditions.

What qualifications must a project manager bring to GxP projects?

In addition to classic PM skills, the project manager requires a deep understanding of relevant GxP regulations (EU GMP Annex 11, FDA 21 CFR Part 11) and experience with qualification and validation processes. Experience dealing with regulatory audits is also highly valuable.

Can agile project management be applied in GxP projects?

Yes. GAMP 5 in its second edition explicitly describes iterative and agile approaches. The condition is that traceability and test evidence form part of the sprint acceptance rather than being caught up at the end of the project.

What happens at the end of a GxP project with the results?

At project close, the final report is prepared (e.g. the validation report), which confirms the successful completion of all phases and the release of the system for GxP-regulated operation. All project documentation is archived and must be retained in accordance with regulatory requirements.