Quality & Regulatory Due-Diligence Checklist
A structured checklist for the quality and regulatory diligence stream in a transaction: regulatory standing and inspection history, quality-system health, data integrity, validation and facilities, supply chain and recalls, a findings/remediation summary, and post-close integration readiness. The quality practitioner’s contribution to a deal — not legal, financial, or transaction advice. Structured on ICH Q10, ICH Q9(R1), 21 CFR 211, and EU GMP Chapter 1.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
A structured checklist for the quality and regulatory diligence stream in a transaction — the quality practitioner’s contribution to a deal team’s work. It enumerates the evidence to request, the regulatory standing to verify, and the findings to cost, so nothing load-bearing is missed. It explains how quality connects to a transaction; it is not legal, financial, valuation, or transaction advice.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
Structured on ICH Q10 (the pharmaceutical quality system), ICH Q9(R1) (quality risk management), 21 CFR 211, and EU GMP Chapter 1. Accountability for product quality stays with the authorisation holder and transfers with the asset, which is why the checklist scopes open commitments and post-close integration deliberately. The checklist structure is SPEQ synthesis; the regulatory concepts it organises are established.