Self-Inspection Support
Independent support for internal audit and self-inspection programmes.
Inspected at the source,trusted to the end.
Independent, on-site supplier and CMO audits for importers qualifying partners across the medical cannabis supply chain.
Long-term success in the medical cannabis industrydepends on a robust Pharmaceutical Quality System.
Here’s how we can support you:
Supplier & Third-Party Qualification
Risk-based audits supporting qualification, requalification and ongoing oversight.
Fractional Quality Assurance
Flexible senior QA support integrated into your operations when needed.
Project-Based QA Advisory
Focused expertise for defined quality, compliance and improvement projects.
How the audit works
How good is it to know exactly where you stand? From self-inspection to supplier qualification, our audit methodology is the first step towards a state of control.
01Scoping Call
We start with you to define why the supplier is being audited, the scope, criteria, sites and timeline, plus the required deliverables.
- 02
Supplier PQS Review
You share what you already hold. We request and review the supplier’s PQS documentation and audit history, plus available data, to focus the audit.
- 03
Audit Planning
We turn the agreed scope into a clear audit plan, then coordinate the agenda, interviews, sampling and access with the supplier.
- 04
Audit Execution
At the supplier’s site, we assess systems and processes, interview staff, sample records and collect objective evidence.
- 05
Conclusions & Reporting
We present conclusions to the supplier, classify each finding and issue the formal report you need to support your supplier qualification decision.
- 06
CAPA Follow-Up
If included in scope, we review the supplier’s CAPA response and supporting evidence, then report back to you on whether the findings were adequately addressed.
Four questions, and the quotation follows.
Why trust us
In medical cannabis it is not always easy to know who to trust, in a sector where improvised expertise is still common. Since 2023 we have followed one path, grounded in professional judgment and technical competence, applying those standards to ourselves first and putting our name and face behind the work every day.
Riccardo Longato
GMP Pharmaceutical Quality Systems Lead Auditor
CQI and IRCA Certified GMP Pharmaceutical Quality Systems Lead Auditor Course (PR325)
RSSL, 2026
GMP and GxP supplier and CMO audits, GACP to EU GMP readiness assessments, CAPA follow-up
Asia, Africa and Europe
PQS design, supplier qualification and audit-readiness support
Medical cannabis and regulated active-substance supply chains
ISO 9001:2015 Management System Auditor training
Implementation and internal-audit experience across ISO 9001, ISO 14001 and ISO 45001
Production-process sampling training
60 hours
The team behind the scenes
Clear is built around complementary expertise. Alongside our pharmaceutical-quality work, Fabrizio leads the management-system side of the business outside the pharmaceutical sector, helping industrial organisations build practical systems and reach the certifications they are aiming for.
Fabrizio Longato
Quality consultant, co-founder of Clear S.r.l. Società Benefit and managing partner of Clear Italia
Over twenty management systems implemented across ISO 9001, ISO 14001 and ISO 45001
QMS and integrated management systems designed for industrial organisations of different sizes and sectors
Internal-audit experience across quality, environmental and occupational health and safety management systems
Management-system work focused on operational efficiency, risk reduction and stronger governance
Qualified ISO 9001 Management Systems Auditor, with foundational GMP training
From pre-audit review to the final report,one engagement covers the complete supplier-audit cycle.
Single-site supplier audit
Our most requested service
Every audit is quoted on its own. What moves the figure is the scope, the standard it is audited against, and where the site is.
Request a quotationIncluded in the engagement
Pre-audit review & planning
Scoping call, supplier PQS review and audit planning
On-site audit execution
Systems, processes, interviews, records and objective evidence
Conclusions & formal audit report
Findings classified, the report issued, and CAPA follow-up where in scope
Travel arrangements
Travel is quoted separately, and nothing is booked without your approval.
Professional work performed during travel is billed separately and is never double-counted as travel time.
Travel time is billed by the hour
Capped at eight hours per one-way journey.
Expenses at cost
Pre-approved, itemised and without mark-up.
You control the booking
Booked directly, or reimbursed against receipts.
12-hour arrival buffer
For journeys over 5 hours or across 3 time zones or more.
Would you rather talk it through first?
Questions clients ask us before commissioning an audit.
Yes. The report provides independent, traceable evidence for your qualification file. Your Quality Unit retains the approval decision, supplier status and any conditions under your Pharmaceutical Quality System.
Yes. Where you have your own procedures, checklists and report format, the audit is run against them and delivered in them. Where you do not, ours are used and handed over with the report.
The criteria are agreed with you in the scoping call and written into the audit plan: EU GMP and its annexes, GACP, the relevant GxP, your own quality agreement, or a combination of them. Nothing is assessed against a standard that was not agreed first.
Yes, once you have introduced us. Requests, the agenda and the document exchange run through one channel agreed with you, and you are copied throughout. Nothing is asked of the supplier that you have not seen.
Each finding is classified as critical, major or minor, stated with the objective evidence behind it and the requirement it refers to, and presented to the supplier at the closing meeting. Nothing in the report arrives as a surprise.
The date is fixed with you in the scoping call and written into the audit plan alongside the deliverables, so it is agreed before the audit rather than after it. If it has to fit a qualification schedule, that is the conversation to have first.
Yes, when it is in scope. The supplier’s corrective actions and the evidence behind them are reviewed, and you are told whether each finding has been adequately addressed or remains open.
It is recorded as a limitation of scope, in the report, against the part of the audit it affected. The report says what could not be assessed and why, so your decision is taken on what was actually seen.
Answers are kept short here. Detailed scope and contractual points are confirmed before the engagement.