Align CMO agreements with release responsibilities

Compare commercial supply terms and technical quality agreements on testing, deviations, changes, batch records, release, complaints and recalls. QA and legal resolve gaps before production is placed.

A draft, counterparty revision or request to update a playbook is received.

People in the process

SSourcing & Contract ManufacturingProcess Owner
QQuality AssuranceParticipating Team
LLegalParticipating Team
RRegulatory AffairsParticipating Team

Records it works with

Current draft and previous versions
Approved playbook and fallbacks
Negotiation history and business instructions

The process is a starting point.The standards are yours.

Configure by product, authorisation and destination market. Regulatory Affairs and authorised quality personnel retain product-change, submission and batch-release decisions. Safety reporting and UCPMP requirements use the applicable reviewed scope.

Keep the work connected.

Sourcing & Contract Manufacturing

Qualify a new API or excipient source

Tie supplier audits, specifications, trial batches and quality agreements to the approved formulation and market dossier. Sourcing obtains QA and regulatory disposition before changing purchase allocation.

QRR

Sourcing & Contract Manufacturing

Close CMO deviations against product disposition

Bring the contract manufacturer’s investigation, affected lots, sponsor records and notification duties together. Sponsor QA makes the disposition and regulatory teams assess any market commitment before shipment.

QRC

Sourcing & Contract Manufacturing

Protect supply when a CMO changes its site

Connect capacity plans, site qualification, validation, quality agreement and each product-market registration. Sourcing can plan transfer only after QA and regulatory assess the implementation sequence.

QRM

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Order for the work. Room for the people.