Technical Agreements That Work: Writing, Negotiating & Managing GMP Contracts
In pharmaceutical manufacturing and distribution, control doesn't end at your site boundary. Whenever GMP activities are outsourced — from contract manufacture and testing to storage and digital data systems — a clear, compliant Technical Agreement is essential.
This practical 3.5-hour masterclass teaches quality professionals how to draft, negotiate, and manage Technical Agreements (TAs) that protect product quality, QP decisions, and regulatory compliance.
Course Details
Instructor
Paul Palmer
Level
Beginner
Duration
3.5 Hours
Type
Instructor led
Course Content
Why is this course essential?
Technical Agreements are one of the first documents requested by MHRA during inspection — and often one of the first to cause findings. Observations range from unsigned contracts and unclear responsibilities to conflicts between the TA and internal SOPs.
Participants will learn how to:
- Avoid vague clauses, conflicting contracts, or undocumented responsibilities
- Ensure TAs reflect actual practice, not legal boilerplate
- Build QP trust through visibility and access
- Demonstrate control over outsourced GMP activity through documentation and metrics
What does the course cover?
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- When Technical Agreements are required (GMP manufacture, testing, storage, digital tools)
- How to assign responsibility clearly and traceably
- What clauses MHRA expects: deviation handling, audits, change control, data access, batch record timelines
- How to align agreements with QMS procedures, SOPs, and QP expectations
- Integration of TA content into Annex 16, ICH Q10, and QP declarations
- Common inspection failures related to missing, outdated, or unimplemented agreements
- Templates, role matrices, and audit-ready documentation formats
Ideal for?
- Qualified Persons (QPs)
- QA professionals managing third-party operations
- Regulatory Affairs staff involved in licence or supply chain oversight
- Contract manufacturing and technical operations leaders
- Supply chain quality staff and vendor managers
- Anyone who drafts or reviews GMP agreements
Benefits:
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- Based on EU GMP Chapter 7, Annex 16 and ICH Q10
- Suitable for all GxP third-party activities (manufacture, testing, distribution, IT, cleaning)
- Equips QA and QPs to defend TAs during inspections
- Includes editable tools and templates for immediate application
What's Included
3.5Hrs of instructor led learning
Usable documents and templates
Real work examples and exercises
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