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Guide
GMP/GSDP verification guide
Operational and documentation requirements for compliance in Kenya. This guide outlines key GMP and GSDP requirements for manufacturers, importers, and distributors, supporting internal audits, supplier qualification, and PPB inspection readiness.
GMP / GSDP
Core requirements
GSDP requirements for distributors
Controlled storage conditions
Temperature monitoring & excursion management
Cleanliness & pest control
Segregation of rejected and quarantined goods
Documented receiving & dispatch procedures
Transport validation
Security & access control
GMP requirements for manufacturers
Validated manufacturing processes
Qualified equipment
Controlled documentation
Batch manufacturing records
Change control & deviation management
Environmental monitoring
Quality control testing
Stability programme compliance
Supplier qualification
Qualification is a process, not a certificate on file
A supplier certificate proves a point in time. Qualification proves you are still watching.
Supplier questionnaires Scope, capability and compliance posture captured in writing.
Audit reports Findings and their closure reviewed, not just received.
GMP/GSDP certificates Checked against site, scope and expiry — not filed unread.
Risk-based evaluation Depth of qualification proportionate to what the supplier handles.
Ongoing performance monitoring Tracked across the relationship, with re-qualification triggers defined.
Common non-conformities
Five findings that account for most of the remediation work
None of these are exotic. All of them are avoidable with a verification checklist run on a schedule rather than in response to an inspection notice.
Missing calibration records
Poor documentation control
Incomplete temperature logs
Unqualified suppliers
Inadequate CAPA management
Verification checklist
The full guide is available as a PDF for use in internal audits and supplier assessments. Download it below, or talk to us about applying it to your own sites.
VeroMed — Regulatory · Quality · Intellectual Property
