GDP Auditing Service
HTF Associates’ GDP auditing service is designed to help clients ensure the safety, integrity, and compliance of medicinal products throughout their supply chain.
HTF’s specialist audit team can focus on overarching or specific aspects, including Quality Management Systems (QMS) and supply chain processes across internal and / or external stakeholders, such as contract storage sites and transport providers. The solution can be tailored to meet requirements. HTF’s comprehensive approach identifies compliance gaps and areas for improvement. HTF can also provide guidance and support mitigation planning to ensure robust GDP adherence.
Our Services Include.
HTF’s audit team can build bespoke auditing solutions to meet business needs, including development of any required mitigation strategies, with either internal or external parties.
How we can help.
HTF’s auditors have a wealth of experience in the GDP Supply Chain with collectively ~ 150 years in industry as RP, RPi, Quality Management and Operations and ~ 100 years as GDP auditors. This knowledge expands across GDP supply chain implementations, the full scope of WDA operations, Controlled Drug licences, API Registration for distribution and Freight Forwarding.
HTF’s knowledge also extends to GMP manufacturing operations, GMP secondary packaging, component printing and ISO 9001; auditors having been named as QC and / or QPs on numerous Manufacturing Import Authorisations are available to support GMP audits.
All HTF auditors have undertaken external training in conducting and reporting on audits which is supplemented with continual professional development in-house at HTF.
HTF standard processes and templates are available, alternatively client-specific controlled documentation can be used in order meet requirements.
A process that starts at any point.
No two clients or products are the same and everything we do for a client is bespoke, making use of the wide variety of our team’s previous experiences.
Contact us
From an initial meeting, we can often understand in broad terms what is needed and what part we can provide. There is no cost or obligation to use HTF at this stage.
You have your own team at HTF
Each client has access to a knowledgeable team of auditors with proven industry experience.
Adapt and evolve our service
We can adapt our services to suit, providing increased (for example; audit response management) or decreased services (audit report issuance only) as required by you.
Longstanding relationship built
We often partner with our clients for many years, flexing our services as their situation changes.
Customised Solutions.
Comprehensive report and action plan:
- Receive detailed reports with actionable recommendations to enhance your QMS and maintain compliance.
Training and support:
- Providing training for your staff on GDP requirements and best practices. We can support development of your own auditors through co-auditing if required.
Continuous improvement:
- Ongoing support to help you address non-conformities, maintain compliance and identify opportunities for continual improvement to address inefficiencies.
Let’s talk.
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Connect with HTF Associates for expert pharmaceutical solutions and client-focused guidance. Explore tailored services in Good Distribution Practice (GDP) and discover why we are your flexible global partner.