Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) Audit Services
GMP and GDP audits support the quality, compliance and operational control of pharmaceutical manufacturing, storage and distribution activities, helping organisations ensure products are manufactured, handled and supplied in accordance with applicable regulatory requirements.
Tower Mains provides independent GMP and GDP audit support across development, manufacturing and commercial environments, assessing facilities, suppliers, quality systems, processes and documentation to identify risks, strengthen oversight and support inspection readiness.
Our experienced GMP/GDP auditors provide practical, risk-based assessments of manufacturing sites, contract manufacturers, suppliers, laboratories, storage and distribution facilities, quality systems and regulatory documentation.
Why GMP/GDP audits matter
A robust GMP/GDP audit programme helps organisations maintain product quality, strengthen supply chain oversight and ensure manufacturing and distribution activities meet global regulatory expectations. Without appropriate GMP/GDP oversight, organisations may face:
Quality system weaknesses affecting product compliance and patient safety.
Insufficient supplier qualification and oversight across the supply chain.
Manufacturing, storage or distribution process gaps.
Data integrity, documentation or traceability concerns.
Regulatory findings, supply disruption or increased corrective action requirements.
Tower Mains helps organisations proactively identify and address these risks through independent GMP/GDP audits, providing clear insight and practical recommendations to strengthen quality systems, supplier oversight and regulatory readiness.
Our GMP/GDP audit services
Tower Mains provides flexible GMP/GDP audit solutions to support pharmaceutical organisations throughout the product lifecycle, from development through commercialisation. Our audits are tailored to your requirements and delivered using a risk-based approach aligned with global regulatory expectations.
Vendor Audits from Development to Commercial
- Manufacturing
- Storage & distribution centres
- Test laboratories
Marketing Authorisation Applications / Common Technical Document Submissions
Our GxP audit process
Tower Mains applies a practical, risk-based approach to GxP auditing, ensuring each audit is delivered by a specialist with the appropriate technical expertise and regulatory knowledge.
1. Understanding your requirements
We begin by understanding your objectives, audit needs, timelines and key areas of focus.
2. Selecting the right GxP auditor
We assign an auditor with relevant GxP expertise, industry experience, technical knowledge and an understanding of your specific requirements.
3. Preparing for your audit
Your auditor prepares the audit plan, agenda and documentation requirements.
4. Conducting the audit
Audits are performed remotely or on-site through interviews, document reviews and assessment of relevant systems, processes, facilities, suppliers or studies.
5. Delivering clear audit outcomes
You will receive a comprehensive audit report, prepared using your preferred format or our own template, detailing observations, findings and practical recommendations for improvement.
6. Follow-up and ongoing support
Where required, we provide follow-up activities including CAPA review, re-audits and additional quality assurance support.
Why choose Tower Mains?
Global GxP Expertise
Access experienced auditors, quality professionals and subject matter experts across the GxP landscape, from clinical and laboratory environments to manufacturing, devices and research. We bring industry experience and specialist insight to help you address quality and compliance priorities.
Regulatory and Technical Insight
Our team brings extensive, real-world experience across global regulatory frameworks, including ICH, FDA, EMA and MHRA requirements. We help organisations interpret regulatory expectations, focus on what matters, assess risk and make informed quality decisions with confidence.
Flexible Quality Solutions
From single audits and annual audit programmes to vendor oversight, QA support and inspection readiness, we provide the right support for your objectives and risk profile. Services can be delivered in person, remotely or through a hybrid approach.
Practical. Proportionate. Collaborative.
We believe quality should enable your organisation, not add unnecessary complexity. Working alongside your teams, we bring an objective perspective, provide constructive challenge and help strengthen quality systems through sustainable improvements.