IMS Cold Chain Management - CCM (GDP, ISO 9001, ISO 22301)
IMS Cold Chain Management - CCM (GDP, ISO 9001, ISO 22301)
A single excursion can destroy a consignment, so every stage of the chain here is qualified, monitored and evidenced.
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Written by practising auditors with 20+ years in the field.
By document type
| Category | Files |
|---|---|
| Manuals | 3 |
| Policies | 1 |
| Procedures & SOPs | 18 |
| Forms & Records | 24 |
| Checklists & Audit Tools | 7 |
| Training & Awareness | 4 |
| Guides & Work Instructions | 4 |
Key documents
| Reference | Document | Format |
|---|---|---|
| AGS-CCM-MAN-01 | Integrated Management System Manual | Word |
| AGS-CCM-POL-01 | Integrated Quality GDP and Business Continuity Policy | Word |
| AGS-CCM-PR-06 | Qualification Validation and Temperature Mapping | Word |
| AGS-CCM-PR-12 | Temperature Controlled Transport and Delivery | Word |
| AGS-CCM-PR-16 | Temperature Excursion Deviation and CAPA Management | Word |
| AGS-CCM-CL-02 | GDP Cold Chain Compliance Checklist | Word |
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Overview
Holding vaccines, biologics and temperature-sensitive medicines within range is a validation problem before it is a logistics one. This Integrated Management System combines Good Distribution Practice with ISO 9001 and ISO 22301 to govern the complete temperature-controlled journey, from qualification of refrigerated storage and vehicles through to last-mile delivery, under an Integrated Management System Manual, documentation and process interaction schemes, and a single integrated quality, GDP and business continuity policy.
Procedures address qualification, validation and temperature mapping; temperature monitoring and calibration management; preventive maintenance and equipment reliability; goods receipt and temperature verification; controlled storage and FEFO stock management; cold-chain picking, packing and dispatch; temperature-controlled transport and delivery; change control; and temperature excursion, deviation and CAPA management. The evidence layer is deliberately heavy — qualification protocols and reports, temperature mapping reports, calibration and maintenance records, receipt verification records, packing and dispatch records and transport and delivery records, giving continuous traceability from arrival to handover. Checklists cover cold room and equipment inspection, pre-dispatch shipment readiness, GDP cold-chain compliance and continuity exercises; training builds competence in monitoring technology, excursion decision-making and emergency response; and the ISO 22301 layer keeps product protected through power failure and equipment breakdown.
What this system covers
- Qualification, validation and temperature mapping — protocols and reports for storage areas, equipment and vehicles
- Monitoring and calibration — continuous temperature monitoring backed by calibrated, recorded instruments
- Preventive maintenance and equipment reliability — maintenance regimes and response for refrigeration assets
- Receipt, controlled storage and FEFO — arrival temperature verification and stock rotation under documented control
- Cold-chain packing, dispatch and transport — shipper preparation, pre-dispatch readiness and delivery records
- Excursion, deviation and CAPA — investigation, product disposition and corrective action after a temperature event
- Continuity through outage and breakdown — business impact analysis, RTO, RPO and MTPD and exercised contingency plans
Who it's for
Cold-chain and quality managers at distributors, third-party logistics providers, hospital pharmacies and vaccine programmes who must demonstrate temperature control to regulators, principals and customers, typically before a client qualification audit or a GDP inspection. Set to your temperature ranges, equipment and network, it makes monitoring, response and validation systematic, so each consignment carries the evidence that it stayed in range.
Everything you get
Every toolkit gives you a full set of working documents for your standard, ready to edit and use.
Native Microsoft files. Add your logo and adapt every document to how you work.
Your full toolkit arrives as a ZIP the moment payment clears.
One purchase covers everyone in your organisation. No per-seat fees.
Built by people who run real audits, so the content matches what assessors check.
One payment, perpetual licence for your organisation. No subscriptions, no renewals.
Full refund if your files are faulty, incomplete or not as described and we can't put it right
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?
These are digital products, so once a toolkit has been downloaded we cannot take it back. If you have not downloaded yet, contact us and we will cancel the order and refund you in full. We also refund in full if the files are damaged, incomplete, or not what the product page described.
Cannot find your standard?
Tell us which scheme you work to. We will point you to the right toolkit.
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