BRCGS Issue 7 & ISO 15378:2017 (GMP)
BRCGS Issue 7 & ISO 15378:2017 (GMP)
One drafted document set, two audited frameworks, for packaging that ends up touching medicine.
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Written by practising auditors with 20+ years in the field.
By document type
| Category | Files |
|---|---|
| Manuals | 9 |
| Procedures & SOPs | 43 |
| Plans & Programmes | 1 |
| Forms & Records | 36 |
| Checklists & Audit Tools | 15 |
| Registers, Logs & Matrices | 4 |
| Training & Awareness | 4 |
| Guides & Work Instructions | 5 |
Key documents
| Reference | Document | Format |
|---|---|---|
| AGS BRCGS Product Safety and Quality Manual | Word | |
| AGS Quality Manual ISO 15378 2017 | Word | |
| SCH-05 | BRCGS Issue7 Document Compliance Matrix | Word |
| PRO-HACCP-04 | HACCP Plan and CCP Control | Word |
| E-HACCP-05 | HACCP Control Plan | Word |
| F-SYS-08 | BRCGS Issue7 Internal Audit Checklist | Word |
- Need the complete document list? Request it — same day
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Overview
This system joins the BRCGS Global Standard for Packaging Materials, Issue 7, to ISO 15378:2017, so one site can govern good manufacturing practice across primary pharmaceutical packaging and the printed materials that go with it. It is written for converters and printers making cartons, labels, blister foils, bottles and closures — packaging in direct or potential contact with a medicinal product, made under controlled, hygienic and traceable conditions that protect product integrity and patient safety.
The BRCGS side carries senior management commitment, a documented product safety and quality management system, and HACCP-style hazard analysis across physical, chemical, microbiological and product-safety hazards, with site standards, plant hygiene and contamination control, product and process control including print and artwork management, and reconciliation from incoming materials through work in progress to finished goods. ISO 15378:2017 lays the pharmaceutical GMP layer over the ISO 9001 process approach: validation, change control, deviation management, cleanliness classification where required and personnel training. Between them they answer what retailers, pharmaceutical customers and regulators working to EU GMP, FDA cGMP and comparable regimes expect of a packaging supplier, each scheme mapped to its own clause structure so one body of evidence serves twice.
What this system covers
- Hazard and risk analysis — prerequisite programmes, hazard identification and control at critical control points
- Site standards and zoning — layout, plant hygiene, housekeeping and contamination control
- Print and artwork management — approval, line clearance and reconciliation against mix-ups
- Traceability from incoming materials to finished goods, through to withdrawal and recall
- ISO 15378 GMP controls — validation, change control, deviation handling and cleanliness classification
- Foreign body control — glass and brittle plastic registers, pre-operational inspection and site security
- Approval, audit and ongoing control of material suppliers
- Internal audit and management review against both schemes, with corrective action to closure
Who it's for
Technical and quality managers at packaging converters and print sites supplying pharmaceutical customers, usually working towards a booked BRCGS audit while a pharmaceutical client presses for ISO 15378 evidence in supplier qualification. One drafted system, branded and populated, then serves both audits instead of two parallel piles of paperwork.
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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