A library of 323 ready-to-use SOPs, forms and policies grounded in FDA, EMA, ICH and JP guidance — preview any document free, then own the complete catalog in your language and customize every document for your clients.
A real document — header, body and footer. Rebrand the header, edit the body, issue it under your client's name.
Every SOP, form and policy — browse the full catalog, preview the first 3 pages of any document free, and buy the whole catalog in your language.
Written for both drug substance and drug product operations — formulation, filling, inspection, labelling and packaging.
Every document opens with the same controlled anatomy — so you know exactly what you're buying before you rebrand a single line.
Forms are single-page controlled records — pre-built fields, acceptance criteria and sign-off blocks, ready to issue and complete.
Read the first 3 pages of any document free. Buy to unlock the whole thing and get the editable master plus a print-ready PDF, delivered to your email.
Open any document and read the first 3 pages — real content, header and footer, free.
Buy the complete catalog in the language you work in. Enter the email where your files should land.
The editable master and PDF arrive in your inbox — customize and reissue under your client's name.
Every document ships with a neutral [Your Company] placeholder in the header, footer and body. Once you own it, it's an editable master — shape it to each client and reissue it as theirs.
Every document is written against the standards your inspectors actually cite — so the work you hand a client stands up to an FDA, EMA, PMDA or WHO audit.
US current Good Manufacturing Practice for finished pharmaceuticals, plus electronic records and signatures (Part 11).
European GMP, including sterile manufacturing (Annex 1) and computerised systems (Annex 11).
Internationally harmonised quality — from active ingredients to full product-lifecycle management.
Japan’s GMP ministerial ordinance and Japanese Pharmacopoeia expectations.
The global GMP baseline recognised by medicines inspectorates in more than 50 countries.
Instant digital download. EU and UK consumers normally have a 14-day right of withdrawal. By requesting immediate access at checkout you agree the download starts right away and you lose that right once it begins. Otherwise, because each document is an editable file delivered on download, orders can’t be refunded once the download has started. Preview any document free first, and if you have any question before buying, email us at Contact@Zentrum24.com — we’re happy to help.
Guidance from the FDA, EMA, ICH and PMDA keeps evolving — and we maintain the catalog alongside it. We monitor the standards and work to revise the masters they affect, so you’re generally downloading a recent version. It remains your responsibility to confirm the current requirements for your market before use.
We track changes across the frameworks your inspectors cite and aim to flag the documents a new rule affects.
When a standard shifts, we work to update the affected masters — content, references and controls, not just the revision line.
Bought already? Sign in to My Library and re-download the latest published revision any time — no repurchase, no extra cost.
The documents are yours to use anywhere. If you also want to run them like a quality department, two companion products from Zentrum24 plug straight in.
Load your purchased documents into ProveWise to version them, route change requests, e-sign and keep a Part 11 / Annex 11 audit trail.
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Assign any document you own as a ComplyWise course — with 20-question assessments and certificates a client's team and an inspector can follow.
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You never need ProveWise or ComplyWise to buy or use a document — they're there only if you want to manage or train on what you own.
Buy the catalog in the language your clients work in — every document is maintained across all thirteen.
Read any document free. When you're ready, buy the entire catalog in your language — and add the companion tools any time.
Preview a document free, own it in minutes, and walk into every client engagement with a defensible, regulation-grounded system.