Overview
Designed for pharmaceutical distributors, wholesalers, and warehouse operators, this Integrated Management System embeds Good Distribution Practice — per WHO TRS 957 and the EU GDP Guidelines — alongside ISO 9001 quality management and ISO 22301 business continuity. It gives distribution businesses a complete, audit-ready control system for the safe storage, handling, and movement of medicinal products across the supply chain. The suite provides a Quality Manual, a GDP compliance scheme, and detailed procedures for goods receipt, storage and temperature control, order picking, dispatch, transportation qualification, returns, recalls, and management of falsified medicines. Forms and records capture temperature-mapping data, cleaning, calibration, deviation, and customer-qualification evidence with full traceability. Checklists convert GDP chapters into everyday warehouse routines, while training modules develop staff in cold-chain integrity, hygiene, and documentation discipline. The ISO 22301 layer ensures continuity of supply during power failures, equipment breakdowns, or wider disruption — protecting both patients and contracts. Ideal for companies applying for or renewing a wholesale distribution authorization, onboarding new pharmaceutical clients, or closing audit findings, the kit removes the heavy lifting of drafting a GDP quality system from scratch. Each document is fully editable to your sites, temperature zones, and product portfolio. The result is demonstrable control over product integrity end-to-end, faster licensing and client approvals, reduced risk of temperature excursions and rejections, and a distribution operation that inspectors, principals, and customers can trust.
Included: 58 ready-to-use, fully editable documents (manual, procedures, forms, records, checklists, guidance and training material).
License: single-organization license; delivered electronically as a ZIP archive.
From purchase to audit-ready
Buy & download instantly
Pay securely by card. Your ZIP download link appears immediately on the confirmation page and in your email.
Edit & brand as your own
Open the native Word & Excel files, add your logo and details, and adapt everything to your organisation.
Implement & get audit-ready
Roll out the manuals, procedures, forms and checklists to build a working, certification-ready system.
Frequently asked questions
What exactly do I receive?
A downloadable ZIP containing the full set of ready-to-use documents for this toolkit — manuals, procedures, forms, records, checklists, guidance and training material, all in editable Word and Excel format. The exact document count is shown at the top of this page.
Are the documents really editable?
Yes. Every file is native Microsoft Word or Excel — no locked PDFs. Add your logo, change wording, and tailor the content to your organisation. The toolkit is yours to keep and reuse.
Does this certify my organisation?
No. These are documentation toolkits aligned to the relevant standard to help you prepare. Certification itself is issued by an accredited certification body after their audit. Our toolkits give you a strong, audit-ready starting point.
How is it delivered?
Instantly and digitally. There's no physical shipment — you download the files right after payment and receive a backup link by email.
Do I get updates?
Yes. If we revise this toolkit, you're entitled to the updated version at no extra cost — just contact us with your order details.
What is your refund policy?
Because these are digital products delivered instantly, all sales are final once downloaded. If you have any issue with your files, contact us and we'll make it right. See our Refund Policy for full details.