EU GMP Annex 1 (2022/2023) Compliance Solution
An instrumentation roadmap aligned to the revised EU GMP Annex 1, covering contamination control strategy documentation needs across filtration, CCIT, environmental monitoring, and isolator barrier integrity.
The 2022 revision of EU GMP Annex 1, effective August 2023, restructured expectations around sterile manufacturing into a single, overarching Contamination Control Strategy (CCS) - requiring sites to justify, document, and interlink decisions across filtration, packaging integrity, environmental monitoring, and personnel/barrier controls rather than treating each as a standalone requirement. Many manufacturers now find gaps between their existing instrumentation and the evidence a modern CCS needs to withstand inspection.
Regulatory Basis
EU GMP Annex 1 (2022 revision, effective 25 August 2023) is the anchor regulation, with cross-references into PDA Technical Reports (No. 26 on sterilizing filtration, among others), USP <1207> for CCIT, ISO 14644 for cleanroom and isolator classification, and FDA 21 CFR Part 11 for the electronic records supporting each of these test streams.
Our Solutions
We map Annex 1's CCS expectations to a practical instrumentation set: filter integrity testers, CCIT container closure integrity testers, airborne particle counters, glove integrity testers, TOC total organic carbon analyzers, microbial air samplers and compressed air purity testing units, each generating Part 11-ready, traceable records that a CCS document can directly cite as objective evidence. Rather than selling isolated instruments, we help structure how these data streams fit together under one contamination control narrative. As the manufacturer, we provide one-stop instrument procurement, full set of GMP-compliant validation documentation packages including IQ/OQ/PQ protocols, global localized after-sales & field service network, seamless data system integration compatible with LIMS, long-term calibration and preventive maintenance contracts, as well as professional Annex 1 and 21 CFR Part 11 compliance consulting support.
Products
FAQ
Q1: What is a Contamination Control Strategy (CCS) under Annex 1?
A1: A CCS is a documented, holistic set of controls across facility design, equipment, personnel, and testing that collectively manages contamination risk in sterile manufacturing, replacing a patchwork of standalone SOPs and qualifications.
Q2: Does Annex 1 apply outside the EU?
A2: While it is an EU regulation, many manufacturers exporting into EU markets, or benchmarking against global best practice, apply its expectations regardless of their home market.
Q3: What is the biggest instrumentation gap sites find under the revised Annex 1?
A3: Gaps most often appear in traceable, Part 11-ready data capture for filter integrity, CCIT, and glove/barrier integrity testing that can be cited directly as CCS evidence.
Q4: How long is the transition period for Annex 1 compliance?
A4: The main annex took effect 25 August 2023, with a longer transition period granted for Annex 1's provisions specifically on lyophilization; sites should confirm current enforcement timelines with their local regulatory authority.