MC Pharma Successfully Audited by Pharmalane UK for GDP & Pharmacovigilance
- mcpharma01
- Dec 11, 2025
- 5 min read
Updated: Dec 18, 2025
Table of Contents
Introduction
On 11 March 2025, MC Pharma completed an audit by Pharmalane UK Ltd. covering Good Distribution Practice (GDP) and pharmacovigilance (PV).
A formal Audit Compliance Report was submitted in April 2025; corrective actions were accepted and the audit was officially closed.
For clients, this means independent confirmation that our distribution controls and safety systems meet internationally recognised benchmarks (EU GDP and EMA GVP) while aligning with SAHPRA requirements in South Africa.
About Pharmalane UK (and why their audits carry weight)
Pharmalane UK is a global GxP auditing provider (GMP, GDP, GPvP/GVP, GCP) with a ready audit-report library and the capacity to conduct new audits on request through a worldwide network of experienced auditors. Their model shortens supplier qualification by enabling stakeholders to procure an existing report or commission a fresh audit quickly. Reports are not public; they are provided on request to bona fide stakeholders (typically via their library or direct enquiry).
Why this helps you: for manufacturers, MAHs and distributors looking at MC Pharma as a partner in South Africa, a recent, independent GDP/PV audit by a recognised specialist can materially reduce qualification timelines and internal audit burden.
What Pharmalane UK audited and against which standards
The audit evaluated our distribution and safety-monitoring systems against internationally recognised frameworks and local requirements:
EU Guidelines on Good Distribution Practice (GDP) for medicinal products for human use — baseline expectations for quality systems, documentation, temperature control, segregation, deviations and CAPA across the supply chain.
EMA Good Pharmacovigilance Practices (GVP) — Module IV (Pharmacovigilance audits) — risk-based PV audit strategies, grading (critical/major/minor), reporting and follow-up.
Relevant ISO standards — supporting quality-management system effectiveness and continual improvement.
Local GDP regulations in South Africa — including SAHPRA Good Wholesaling/Distribution Practice expectations for wholesalers and distributors.
Other applicable international regulatory guidance — ensuring alignment with globally recognised best practice for distribution and pharmacovigilance.
Outcome (and why “audit closed” matters)
Audit conducted: 11 March 2025 (remote/desktop).
Compliance Response: Audit Compliance Report submitted in April 2025.
Status: Corrective actions accepted, audit closed.
“Closed” indicates that observations were addressed to the auditor’s satisfaction via CAPA - consistent with GDP and GVP audit principles and with SAHPRA’s inspection-response expectations. In practice, it shows our quality system is effective, documented and responsive to risk.
What this means for MC Pharma’s clients - Right Now
Proven distribution controls (GDP): Independent review against EU GDP provides assurance over storage, handling, traceability, temperature control, segregation and documentation - all key to product integrity and patient safety.
Robust safety governance (PV): Alignment with GVP confirms our pharmacovigilance system - case handling, signal oversight, governance and audit readiness - meets recognised best practice for MAH obligations.
Reduced due-diligence burden: A recent third-party GDP/PV audit streamlines supplier questionnaires, reduces duplicate audits and accelerates quality-agreement finalisation.
Local readiness, global standards: Compliance with SAHPRA Good Wholesaling/Distribution Practice and inspection-response guidance demonstrates local alignment while meeting EU/UK expectations - ideal for regional programmes running on global QMS frameworks.
Why this de-risks and strengthens future collaborations
Faster supplier qualification: Pharmalane UK's ready report library and ability to conduct new audits on demand materially shorten timelines for qualification.
Lower onboarding friction: With CAPA accepted and the audit closed, fewer gaps need remediation during tech transfer or market entry.
EU/UK-friendly frameworks: Reliance on EU GDP and GVP provides familiar benchmarks for QA, QP/RP/RPi oversight.
Execution in South Africa: Local GDP/GWP alignment supports compliant import, warehousing, distribution and PV operations for the SA market.
How to request the audit report
The report is not publicly available. Eligible stakeholders may request access via MC Pharma or procure via Pharmalane UK’s audit-report library (or request a new audit if needed). We’ll coordinate secure sharing with appropriate NDAs where required.
About MC Pharma
MC Pharma (Pty) Ltd is a South African regulatory-pharmaceutical consultancy (licensed under Section 22C), offering regulatory intelligence, pharmacovigilance/ADR support, imports/exports & distribution, and eCTD publishing & submissions, among other services.
Connect With Us
Manufacturers / MAHs:
Request the Pharmalane UK audit package and book a regulatory roadmap session to align GDP/PV expectations for South Africa and broader African market entry.
Distributors / Market entrants:
Talk to us about imports, warehousing, distribution, pharmacovigilance and ADR reporting support as a service tailored to your portfolio, backed by multiple approvals and independent audits
Frequently Asked Questions (FAQ)
Was this a GMP audit?
No. This specific Pharmalane UK assessment focused on Good Distribution Practice (GDP) and Pharmacovigilance (PV), not manufacturing (GMP). GMP requirements and audits are handled separately where applicable.
Why reference EU GDP/GVP for a South African company?
EU GDP and EMA GVP are widely recognised global benchmarks. Used together with SAHPRA guidance (for example, Good Wholesaling/Distribution Practice and inspection-response expectations), they provide a strong, internationally aligned framework for operating in South Africa while meeting the expectations of global QA, QP and regulatory teams.
What does “audit closed” actually mean?
“Closed” means findings were addressed through CAPA; the auditor has completed their review, accepted the company’s responses and formally concluded the audit process in line with GDP/GVP and SAHPRA inspection-response principles. In MC Pharma’s case, this sits alongside existing licences and approvals as another piece of external confirmation around systems that are already in routine use.
Can our QA team rely on this for supplier qualification?
In many organisations, yes. Independent GDP/PV audits are commonly used as part of supplier qualification to reduce duplicated effort and accelerate vetting. Pharmalane UK’s model — combining a ready report library with the option for new audits — is recognised by QA and QP teams globally and can be used alongside MC Pharma’s existing approvals and licences for a fuller picture.
Can anyone download the report?
No. Audit reports are not public. Access is limited to eligible stakeholders via MC Pharma or Pharmalane UK and is usually handled under appropriate confidentiality arrangements (for example NDAs) as part of supplier qualification or partnership discussions.
How MC Pharma Provides Services & Consulting
As a licensed Marketing Authorisation Holder (MAH) under Section 22C of the Medicines and Related Substances Act, MC Pharma offers end-to-end regulatory consulting and compliance support for both medicines and medical devices in South Africa.
Our services include:
Regulatory Affairs Consulting – Guiding clients through SAHPRA requirements, classification, and registration strategies.
eCTD Dossier Management – Compilation, publishing, submission, and lifecycle management of regulatory dossiers.
Pharmacovigilance – Monitoring, reporting, and managing adverse events to ensure ongoing safety compliance.
Borderline Product Support – Assisting with classification assessments and preparing submissions for SAHPRA determination.
Import & Export Logistics – Managing compliant movement of medicines and devices across borders, including post-importation quality testing.
Quality Management Systems – Developing, implementing, and auditing QMS to SAHPRA standards.
Why Choose MC Pharma?
MC Pharma combines over 26 years of regulatory experience with a deep understanding of the South African pharmaceutical and medical device landscape to deliver compliant, efficient, and market-ready solutions for local and international clients.
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