ASC GDP Services

Temperature-Controlled Pharmaceutical Logistics & GDP Consulting

Although the logistics industry is becoming more regulated, threats to pharmaceutical and high-value shipments continue to be a significant concern worldwide. Our team can provide guidance on the most effective logistics and supply chain security practices tailored to your specific needs. Whether it’s reducing the risk of supply chain theft, diversion, or counterfeit, we prioritize safeguarding your finished product, components, and APIs.

Compliant Pharmaceutical Logistics, best-in-class 

Our service is unique as we conduct a ‘Good Distribution Practice for Medicinal Products for Human Use’ (GDP) audit and a Security Vulnerability Assessment (SVA) simultaneously, which leads to a reduction in your costs and an increase in the audit scope. As the supply chain is becoming more complex, we audit every single step and ensure that all outsourced activities are compliant and secure. By combining both audits, we can guarantee compliance with your complete supply chain.

ASC GOOD DISTRIBUTION PRACTICE HEALTH CHECK

Our ASC GDP Health Check is designed to help companies improve their processes and facilities to meet the requirements for obtaining a Wholesale Dealers License and achieve GDP compliance per the regulations/guidelines. We offer a flexible Health Check that can be customized to meet your specific needs, including pre-audit scoping, a competency audit based on Good Distribution Practice Guidelines, a review of your entire Quality Management Systems, and an assessment of your pharmaceutical activities, warehouse and transport functions. Our Health Check also includes a thorough Gap Analysis and a detailed report that outlines suggested improvements to your business. After the assessment, we provide a debrief presentation of the results and support you with implementing the findings to ensure your company operates at its best.

We have extensive experience working with Manufacturers, Wholesalers, Freight Forwarders/Brokers, Airlines, 3PLs (third-party logistics providers) and GHAs (ground handling agents) to achieve their GDP Compliance. 

Expert Support when you need it
Are you looking for professional services to improve your business operations? 

We offer specialized services to enhance your GDP practices, including WDA (Wholesaler Dealers Authorization) support. We can also provide templates, write or review your SOPs (Standard Operating Procedures), and improve your QMS (Quality Management System) by designing, implementing, and training your staff. Our quality agreement writing and implementation services help you meet regulatory requirements, while our deviation management, CAPA design, review, and training services ensure that you can manage non-conformances and implement corrective actions effectively. We also provide change control services to help you comply with changing regulations.

Temperature-controlled Supply Chains 

Supply chains are not just about moving goods from one place to another. It’s about the patient receiving medicine that is effective. 

Pharmaceutical products are made in a highly regulated and controlled environment, and it is essential to maintain those standards throughout the supply chain to keep the products safe and effective for the end users. Even minor changes in temperature or humidity during shipment can damage sensitive medicines, making them unsafe or less effective. Therefore, every aspect of the supply chain, from the lab to the end-user, must be carefully planned and executed to ensure product integrity is maintained throughout the supply chain.

Supporting the pharmaceutical industry and the logistics companies that serve  them

We specialize in Temperature Controlled Logistics and have extensive experience assessing, improving, and maintaining the supply chain. Whether you are a manufacturer or a logistics company looking to provide a solution to the pharmaceutical industry we can help. Our services include Developing Compliant Pharmaceutical Supply Chain Programmes, Lane validations, Supply chain design for Temperature Sensitive and High-Value Goods, and Operational capabilities for handling temperature-sensitive products.