Supply Chain Governance
Quality & Technical Agreements
A Quality Agreement is not a formality — it is the document that defines who is accountable for what in your outsourced manufacturing network. Vitalane drafts, reviews, and negotiates Quality Agreements and Technical Agreements that protect your regulatory position from the sponsor's side.
Why Quality Agreements Matter
Regulators expect clear, written definitions of GMP responsibility for every outsourced activity. An ambiguous or absent Quality Agreement is a compliance finding waiting to happen.
Ambiguous agreements create regulatory risk
A Quality Agreement that does not clearly define who is responsible for change control, deviation management, or batch release creates gaps that regulators will find — and that can result in compliance failures at inspection.
Accountability must be defined before manufacturing begins
EU GMP Chapter 7 requires a Quality Agreement to be in place before outsourced activities commence. A retroactive agreement — or no agreement at all — is a significant GMP finding.
Sponsor-side drafting protects your regulatory position
A Quality Agreement drafted by the CMO will reflect the CMO's interests. Vitalane drafts and reviews agreements from the sponsor's perspective — ensuring your accountability obligations are clearly defined and your oversight rights are protected.
Delivered by Bright Gnanaselvam directly
Every Quality Agreement engagement is conducted by Bright — not delegated to a junior consultant. Clients work directly with the practitioner from drafting through to negotiation support.
What the Engagement Covers
Engagements are scoped to your specific contract relationship — whether you need a new agreement drafted, an existing one reviewed, or support negotiating with a CMO or supplier.
Conducted by Bright Gnanaselvam — MSc Pharmaceutical Sciences, MRSC — directly.
- Drafting of Quality Agreements (sponsor–CMO, sponsor–supplier, sponsor–distributor)
- Drafting of Technical Agreements and combined QA/TA documents
- Review of existing Quality Agreements against ICH Q10 and EU GMP Chapter 7
- Gap reports with recommended revisions for existing agreements
- Support during negotiation with CMOs and contract parties
- Quality Agreement templates for organisations managing multiple CMOs
- Alignment with TGA, FDA, EU GMP, and PIC/S requirements
- Review of Quality Agreements as part of CMO qualification or audit programmes
Common Questions
What is a Quality Agreement and when is it required?
A Quality Agreement is a written contract between a sponsor or brand owner and a contract party (CMO, supplier, or distributor) that defines the GMP responsibilities of each party. EU GMP Chapter 7 requires a written Quality Agreement for all outsourced GMP activities. The TGA and FDA have equivalent expectations. A Quality Agreement should be in place before manufacturing, testing, or distribution activities begin.
What is the difference between a Quality Agreement and a Technical Agreement?
A Quality Agreement defines GMP responsibilities and quality oversight obligations between parties. A Technical Agreement covers the technical and operational details of the manufacturing or supply relationship — specifications, processes, testing requirements, and change control. In practice, many organisations combine both into a single document. Vitalane can draft either format or a combined Quality and Technical Agreement.
Can Vitalane review an existing Quality Agreement rather than drafting a new one?
Yes. Vitalane can review an existing Quality Agreement against current regulatory expectations (ICH Q10, EU GMP Chapter 7, TGA, FDA) and identify gaps, ambiguities, or provisions that do not adequately protect the sponsor's regulatory position. A gap report with recommended revisions is provided.
Review or Draft Your Quality Agreement
Book a short call with Bright to discuss your contract relationships and what your Quality Agreements need to cover.