We write about what we implement on site: qualification, CSV, data integrity, sterile manufacturing, utilities. Expert articles instead of marketing papers, technically precise and free of sales prose.
Fig. 01 · Instrumentation
Illustrative image
Expert articles on the questions that actually come up in customer audits and authority inspections. Written by engineers who stand at the plant every day.
Why the Contamination Control Strategy is not a binder document but contamination control lived across the entire facility.
Critical Thinking, clean software categorization, supplier leverage: how risk-based validation directs effort to where the risk actually sits.
Shared logins, disabled audit trails, Excel without access control: data integrity rarely fails on principle and almost always in practice.
Everyone knows the four stages of Annex 15: the quality of a qualification is decided at the URS, long before the first protocol is signed.
Leveraging instead of duplicate testing: how commissioning results flow into qualification traceably under Annex 15 and ASTM E2500.
Deviations in PW/WFI, cleanroom air and compressed gases creep in gradually: what matters in qualification and in ongoing monitoring with trending.
A process that works in the lab is far from working at production scale. What really matters in technology transfer and scale-up under GMP.
The User Requirements Specification is the foundation of every qualification. Why a good URS must be testable, unambiguous and traceable, and how it holds up in an audit.
With the draft of Annex 22, artificial intelligence gets a GMP framework for the first time. What the draft means for the validatable use of AI models, and where the limits are.
Any system can record audit trails. Reviewing them meaningfully is the real challenge. How a risk-based audit trail review under Annex 11 and Part 11 succeeds.
The cleanroom class stands and falls with the ventilation. How HVAC design, classification to ISO 14644 and the requirements of Annex 1 interact.
Water is the most used raw material in pharmaceutical production, and one of the most demanding. How WFI and PW systems can be qualified reliably with the three-phase model.
Process validation does not end with three successful batches. The modern lifecycle approach of Process Design, Process Qualification and Continued Process Verification, explained in practical terms.
A plant is qualified, and then? Annex 15 requires maintaining the validated state. How requalification can be planned on a risk basis instead of rigidly by calendar.
Our articles follow the four fields we work in every day: assessed against the applicable regulations, not against personal opinion.
Facilities and equipment to EU-GMP Annex 15: from the URS through DQ, IQ, OQ and PQ to requalification, integrated with commissioning to ASTM E2500.
Computerized systems, validated to GAMP 5 (Second Edition): data integrity to ALCOA+, requirements from Annex 11 and 21 CFR Part 11.
Annex 1, Contamination Control Strategy, cleanroom grades and monitoring: the requirements that set the pace of aseptic production.
Equipment, processes and utilities in live GMP operations: PW/WFI, HVAC and compressed gases, planned and supported across the lifecycle.
From practice
Articles show the standard. These insights show the work behind it: role-based, from daily life in GMP operations.
From URS to PQ: how a qualification lifecycle on a real installation is planned, checked and documented to be audit-ready, step by step to Annex 15.
DQ/IQ/OQ/PQ
How risk-based computerized system validation to GAMP 5 steers the effort to where data integrity is really built, instead of filling in forms.
GAMP 5 · ALCOA+
How equipment and utilities are changed in live operations without losing the qualified state, coordinated with operations and QA.
GMP · Change Control
Three distinctions that come up again and again in our articles, because they make the difference in audits.
Equipment is qualified, processes and systems are validated. Annex 15 is unambiguous here, and so are we.
Commissioning verifies function, qualification demonstrates suitability. Under ASTM E2500, commissioning results feed traceably into qualification.
The report summarises, the raw data carries the evidence. ALCOA+ demands both: complete, attributable, enduring.
GxP engineering and validation for life sciences: qualification to Annex 15, CSV to GAMP 5, data integrity to ALCOA+. From Visp in Valais, for Switzerland and Germany.
Vispact GmbH · Mondstrasse 6b · 3930 Visp · Switzerland · UID CHE-160.105.904
info@vispact.swiss