GMP Inspection Readiness Check

This check walks through the areas that the EU GMP Guide (EudraLex Volume 4, Part I) and 21 CFR Part 211 require of medicinal product manufacturers: quality system, self-inspection, deviations and CAPA, change control, product quality review, training, data integrity, validation, suppliers, complaints and recalls. All questions carry equal weight; the result is for orientation and does not predict an inspection outcome.

Question 1 of 11

Is your pharmaceutical quality system documented, and does senior management evaluate it periodically in a management review?

EU GMP Guide Ch. 1, 1.6 and 1.7; Directive (EU) 2017/1572 Art. 6.

Orientation only, not a substitute for a regulatory assessment.

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Contamination Control Strategy under Annex 1: what paragraphs 2.3 to 2.6 require of the CCS

The revised EU GMP Annex 1 requires, in paragraph 2.3, a Contamination Control Strategy across the whole facility that defines all critical control points and assesses the effectiveness of all controls. Existing systems may stay, but they must be referenced and their interactions understood. In our reading, a CCS that merely lists measures does not meet the second part.

Article

ArticleOct 4, 2026

Regulatory due diligence: the deadlines and registers against which a data room is measured (MDR Art. 120, IVDR Art. 110, EUDAMED, Art. 16 and 10a)

A data room shows what the target company produces. Whether that is enough is decided by the legal text: MDR Art. 120 ties continued sales under an MDD certificate to May 26, 2024 and September 26, 2024, IVDR Art. 110 sets staggered dates up to 2027, EUDAMED has been mandatory in four modules since May 28, 2026, and Art. 16 MDR turns a buyer who sells the device under its own name after closing into the manufacturer with all obligations. There are also three public registers: EudraGMDP, the EUDAMED module "Notified Bodies & Certificates" and the FDA Warning Letter database. What a regulatory due diligence has to establish per device, with references.

ArticleJul 28, 2026

FDA Inspections Under QMSR: What Program 7382.850 Changes

Since 2 February 2026 the FDA no longer inspects under QSIT but under Compliance Program 7382.850. More consequential than the new procedure, though, is a change in the regulatory text: the protection for management review, internal audits and supplier audit reports is gone.

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