GDP Auditing Services with Precision & Trust
GDP auditing services are the insurance that pharmaceutical and biotechnology companies, distributors, and freight forwarders need to remain compliant, protect integrity, and maintain regulatory requirements.
We at Inglasia Pharma Solutions offer over a decade of professional expertise to help organizations strengthen Good Distribution Practice (GDP) compliance with precision, consistency, and confidence.
Book a Call NowWhy Do GDP Auditing Services Matter in Pharma & Biotech?
One failure of compliance can suspend distribution, postpone product launches, and even jeopardize patient safety.
Regulators across the globe require strict compliance with GDP norms to maintain medicinal products in a good state by storing, transporting, and handling them properly.
Companies risk:
- Suspension or delays in licenses.
- Recalls or fines that are expensive.
- Damage to their reputations in global supply chains.
GDP auditing services assure that your records, processes, and systems conform to GDP regulations and reveal hidden vulnerabilities before they become regulatory matters.
Inglasia’s Methodology in Providing GDP Auditing Services
Since 2011, Inglasia has been an authoritative consultancy partner for pharma and biotech customers worldwide.
What sets us apart is our philosophy: the seven pillars of Quality — Question, Understand, Accept, Liaise, Inform, Trust, You. These aren’t just tags; they’re at the very heart of how we conduct every audit and inspection.
Our auditing services are distinct in that we:
- Provide tailored assessments specifically for your operations, not generic templates.
- Offer flexible engagement models, from one-off audits to serving as your external Quality Department.
- Deliver comprehensive regulatory knowledge, including GDP and GMP auditing within an equilibrium compliance strategy.
- Guarantee purity, transparency, and patient focus in every recommendation.
What Do Our GDP Auditing Services Include?
Our audits aren’t token box-ticking exercises; they’re meaningful tests designed to uncover risks, identify areas for improvement, and bolster compliance culture.
Distribution & Transport Audits
Verification of conditions in warehouses, storage sites, transportation routes, and carriers to satisfy GDP regulations.
Documentation & Record Audits
Verification of appropriate SOPs, training files, and shipment documentation in accordance with regulatory requirements.
Supplier & Partner Audits
Third-party distributors, forwarding operators, and contractors audited for GDP compliance.
Temperature Control Audits
Verification of equipment utilized for handling cold-chains, monitoring equipment, and data integrity.
Licensing & Certification Support
Helping businesses be prepared for inspection by regulatory agencies and assisting with certification processes.
Internal vs. External GDP Audits
While internal audits are helpful, external GDP auditors like Inglasia provide an unbiased perspective regulators trust. Our external audits benchmark your systems against industry best practice and spotlight areas of non-compliance that may pass beneath the radar internally.
Internal Audits
- Conducted by in-house staff.
- Help monitor routine compliance.
- Useful for early issue detection.
- May miss blind spots due to familiarity.
External Audits (Inglasia)
- Unbiased and independent perspective.
- Trusted more by regulators.
- Benchmarking against global best practices.
- Spot hidden gaps internal teams may overlook.
The Benefits of Partnering with Inglasia
When you select Inglasia’s GDP auditing services, you’re not merely checking off a compliance box — you’re making an investment in operational assurance.
Regulatory Confidence
Be audit-ready around the clock with documented compliance.
Operational Integrity
Validate systems throughout warehousing, transport, and documentation.
Risk Reduction
Identify and rectify compliance problems before regulators even see them.
Time & Cost Savings
Stay out of delays, fines, and repeat audits by doing it right initially.
Personalized Advice
Tailored advice according to your company’s size, phase, and product category.
Common Issues in GDP Compliance and How We Overcome Them
Compliance is not about avoiding mistakes — it’s about anticipating risks beforehand. Across the pharma supply chain, we see common challenges — and we bring clear solutions.
Common Issues
Inaccurate temperature monitoring undermines cold chain integrity.
Outdated SOPs that do not reflect revised GDP guidelines.
Poor supplier management exposes companies to compliance threats.
Insufficient training leaves teams unclear on responsibilities.
How We Overcome Them
Implementing risk-based monitoring plans to strengthen cold chain assurance.
Updating documentation and SOPs to align with current regulations.
Auditing partners and freight providers to safeguard your distribution chain.
Delivering staff training that embeds compliance into daily operations.
GDP Auditing Services Across the Pharma Supply Chain
GDP requirements don’t stop at warehouse doors; they extend across every partner in the supply chain. That’s why our services cover:
- Pharmaceutical Businesses: Trials to commercial supply, we ensure your products reach safely.
- Biotech Businesses: Biotech-specific audits for emerging biotech businesses expanding their operations.
- Freight Forwarders & Distributors: Compliance audits ensuring safe handling, storage, and export shipping of pharmaceuticals.
Whether you are a biotech startup preparing for your first distribution license or an overseas manufacturer handling multi-country shipments, our GDP auditors have the appropriate expertise for your needs.
Why Inglasia is the Best for GDP Auditing Services?
With regulatory compliance not negotiable, you require auditors familiar with the letter of the law and the needs of day-to-day operations. That is where the balance of Inglasia’s experience and flexibility comes into play.
Proven Track Record
A decade of pharma and biotech compliance support with consistent results.
Flexible Engagement
Choose between ad-hoc audits or ongoing Quality Department outsourcing.
Patient-Centric Philosophy
Every recommendation is designed with patient safety as the ultimate objective.
Values-Based Approach
Guided by our seven pillars of Quality, built on trust and transparency.
While others produce generic audit checklists, we deliver principle-based audits that align compliance with your operational reality.
Ready for Your Next GDP Audit?
Regulators are not waiting, and compliance issues do not resolve themselves. Whatever your requirement, one-off external audit or regular compliance partner, Inglasia’s GDP audit services provide the guidance, adaptability, and assurance your business needs.
Move forward now, and strengthen your GDP compliance with Inglasia Pharma Solutions.
Arrange a free consultation today.
Frequently asked questions
The frequency of audit relies on the complexity of your operations, product risk levels, and regulatory needs. Internal audits are done annually for most firms, although higher-risk operations such as cold-chain distribution may require more frequent review. Inglasia often recommends supplementing planned audits with risk-based reviews to always be ready for regulation inspection.
Yes. Different classes of products present unique risks and regulatory requirements. Our GDP audits are built around the products you are shipping, whether that means verifying temperature monitoring systems for biologics, security protocols for controlled substances, or stability record checks for sensitive medications.
Our auditors possess strong GDP and GMP compliance experience, backed by pharmaceutical science, quality management, and regulatory affairs qualifications. They are certified in international GDP guidelines and have hands-on experience of audits across Europe, the UK, and international supply chains.
Most GDP audits can be completed in one to three days, depending on complexity. We work with your team to minimize disruption, focusing on records, systems, and procedures, and scheduling interviews or inspections at convenient times.
Inglasia provides full support for corrective and preventive action, from revising SOPs and documentation to staff training. Our aim is to leave your organization properly equipped, not just with an audit report, but with working solutions and knowledge transfer that strengthen compliance long term.