IMS Pharmaceutical GMP (WHO TRS 986, 21 CFR 211, ISO 9001, ISO 22301, ISO 31000, ALCOA+)
IMS Pharmaceutical GMP (WHO TRS 986, 21 CFR 211, ISO 9001, ISO 22301, ISO 31000, ALCOA+)
WHO TRS 986 and 21 CFR Part 211 expectations written out as procedures, records and checks a manufacturing site can actually run.
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Written by practising auditors with 20+ years in the field.
By document type
| Category | Files |
|---|---|
| Manuals | 2 |
| Policies | 1 |
| Procedures & SOPs | 15 |
| Forms & Records | 19 |
| Checklists & Audit Tools | 8 |
| Registers, Logs & Matrices | 1 |
| Training & Awareness | 3 |
| Guides & Work Instructions | 4 |
Key documents
| Reference | Document | Format |
|---|---|---|
| AGS-IMS-QM-01 | Integrated Management System Manual | Word |
| AGS-IMS-PR-14 | Data Integrity Governance ALCOA | Word |
| AGS-IMS-CL-07 | Batch Record Review Checklist | Word |
| AGS-IMS-CL-06 | Data Integrity ALCOA Self Assessment | Word |
| AGS-IMS-GD-03 | Guidance on GMP Essentials | Word |
| AGS-IMS-PR-13 | Business Continuity Management | Word |
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Overview
Pharmaceutical manufacturers working under the most demanding global regimes need one version of the truth, and that is what this Integrated Management System sets out to give. It aligns WHO TRS 986 Good Manufacturing Practice and US FDA 21 CFR Part 211 with ISO 9001, ISO 22301, ISO 31000 and ALCOA+ data integrity, so production, quality control, quality assurance and continuity planning all draw on the same Integrated Management System Manual and the same documentation scheme showing how processes interact.
Below the manual, procedures cover production and service provision, design and development, control of externally provided processes, control of nonconforming outputs, corrective action and CAPA, data-integrity governance under ALCOA+, risk and opportunity management, business continuity, internal audit and self-inspection, and management review. The evidence sits in registers and reports: calibration status, quality objectives monitoring, nonconforming output, approved external providers, incoming inspection, clausewise audit review and management review minutes. Checklists mirror what an inspection actually examines — batch record review, ALCOA+ self-assessment, supplier and CMO evaluation, business continuity exercises and a certification readiness gap review — and internal auditor training with a competence matrix develops the people who defend it.
What this system covers
- Production and batch record control — production and service provision through to documented batch record review
- ALCOA+ data-integrity governance — audit trails, good documentation practice and self-assessment against each attribute
- Nonconforming output, deviation and CAPA — containment, investigation and corrective action closure
- Supplier, CMO and outsourced process control — external provider approval, incoming inspection and calibration status
- Internal audit and self-inspection — clausewise audit review, nonconformity reporting and pre-inspection gap analysis
- Risk-based thinking to ISO 31000 — risk and opportunity analysis feeding quality objectives
- Business continuity to ISO 22301 — continuity arrangements proved through documented exercises
Who it's for
Quality assurance directors, site quality heads and regulatory affairs managers at manufacturers facing a pre-approval inspection, WHO prequalification or a routine GMP audit, and at firms remediating observations or opening a regulated export market. You adapt a harmonised, cross-referenced compliance architecture to your dosage forms, equipment and site layout, and end with documentation that supports batch release decisions and stands up to questioning on data integrity.
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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