EU GMP Annex 1 (2022) · CCS · APS
Annex 1 software for Contamination Control Strategy evidence — EM trending, aseptic simulation and PUPSIT records.
Sterile and aseptic manufacturing under the revised EU GMP Annex 1 (August 2023 effective) — a live Contamination Control Strategy (CCS), Grade A/B/C/D environmental monitoring with trending and alert/action limits, aseptic process simulations (APS / media fills), PUPSIT for sterilising filters, and QRM tied to every intervention. Written for sterile CMOs, biologics fillers, and pharma sites that just failed an Annex 1 gap assessment.
Contamination Control Strategy
Environmental monitoring (Grade A/B/C/D)
Aseptic process simulation (APS)
PUPSIT + Filter Integrity
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
You're shopping because the Annex 1 gap assessment says your CCS is a PowerPoint, not a running system.
Contamination Control Strategy exists as a slide deck, not a live document
Environmental monitoring trending is a monthly Excel pivot, not an alert
Aseptic process simulations (media fills) live in a QA folder
PUPSIT (pre-use post-sterilisation integrity test) evidence is scattered
Interventions during aseptic fill are logged on paper, then re-typed
QRM (ICH Q9) risk assessments don't update when the process changes
Annex 1, run as one live contamination-control system.
Contamination Control Strategy
The CCS is a living document tying facility, utilities, personnel, materials, process and monitoring to identified contamination risks. Not a slide deck — a system with change control and evidenced updates.
Environmental monitoring (Grade A/B/C/D)
Grade A continuous monitoring integrates with the fill batch record.
Aseptic process simulation (APS)
Media-fill schedule per shift, per line, per operator. Intervention library, run acceptance criteria (zero positive), and re-qualification triggers automated.
PUPSIT + Filter Integrity
Pre-use post-sterilisation integrity testing for sterilising-grade filters with bubble-point / diffusion test capture, filter change control, and lot-to-fill traceability.
Intervention + Deviation
Aseptic interventions classified (routine vs corrective), logged in real time from the cleanroom, and reviewed against the APS intervention library at batch release.
QRM (ICH Q9) tied to the process
Quality Risk Management assessments (FMEA / HAZOP) linked to the process step and the CCS element they cover. When the process changes, the risk assessment surfaces for re-review.
What changes when Annex 1 is one live system.
- The CCS is one document inspectors can walk with real evidence links
- EM excursions trigger workflow, not at month-end pivot time
- Media-fill schedule and results roll up per line, per operator, per shift
- PUPSIT evidence is attached to the batch, not to a filter-house binder
- Interventions during fill are captured live and reviewed against the APS envelope
- Annex 1 inspection findings on documentation trend toward zero
Every framework a sterile QA director owns.
EU GMP Annex 1 (2022)
Revised Annex 1 in operation since 25 August 2023 (point 8.123 on lyophiliser loading from 25 August 2024) — CCS as central concept, Grade A/B/C/D classification, EM alert/action limits, APS, PUPSIT, and QRM integration all modeled.
ICH Q9 (R1)
Quality Risk Management revision (R1) — subjectivity, hazard identification, risk-based decision-making — tied to CCS elements and process steps.
USP <1116> / PIC/S PE 009
For non-EU markets, USP <1116> microbial control and PIC/S PE 009 alignment supported by the same EM and APS data model — no parallel record-keeping.
21 CFR Part 11
§11.10(e) audit trail, §11.10(f) operational checks, §11.10(g) authority checks, §11.50 / §11.70 signature manifestation and binding — all native, all reviewable.
EU GMP Annex 11
Risk management, validation, data integrity, e-signatures, printed-copy criteria, incident management, business continuity — software controls that support your Annex 11 approach; validation and procedures remain yours.
Annex 1 software, answered.
What is Annex 1 software?
Annex 1 software is the sterile-manufacturing GMP platform that operationalises EU GMP Annex 1 (2022) — the Contamination Control Strategy, environmental monitoring in Grades A/B/C/D, aseptic process simulations, PUPSIT, and QRM — as one running system. It replaces the slide-deck CCS plus monthly Excel EM pivot plus paper intervention log that most sterile sites inherited from the previous Annex 1.
How does V5 handle the Contamination Control Strategy?
The CCS is a living controlled document that indexes into every underlying element — facility design, utilities, personnel qualification, material flow, process, EM, APS. When a change control lands on any indexed element, the CCS flags for review. Inspectors walk the CCS from top-level narrative down to signed evidence.
Does V5 handle EM trending and excursion?
Yes. Viable and non-viable EM samples are captured per Annex 1 Table 5/6, with alert and action limits per location. Trending is real-time, not a monthly QA task.
How are aseptic process simulations scheduled?
APS (media fills) are scheduled per line, per shift, per operator on the frequency Annex 1 requires (initial three consecutive successful runs; periodic re-qualification twice yearly per line per shift). Intervention library, run acceptance criteria and re-qualification triggers are automated.
Does V5 cover PUPSIT for sterilising filters?
Yes. Pre-use post-sterilisation integrity testing (PUPSIT) — bubble-point or diffusion — is captured against the specific filter lot, sterilisation cycle and fill batch. Filter change control and lot-to-fill traceability are native.
How long does implementation take?
Existing paper EM and APS records migrate through a structured import.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
Turn the Annex 1 CCS from a slide deck into a running system.
Free trial. Real EM + APS + PUPSIT evidence.