Securing the drug supply chain is a legal requirement, but why is it important, and what is involved?
As a participant in the clinical trial supply chain, we understand that quality and regulatory compliance can never be compromised. First and foremost, supply chain security protects patients and consumers. From a legal and / or insurance perspective, the regulatory requirements define standards that govern the end-to-end supply chain. By complying with these guidelines, companies conducting clinical trials or selling commercially approved pharmaceuticals protect their reputation and receive insurance / liability protection.
In addition to company-specific compliance and quality guidelines, specific regulations and laws that drive security in the clinical supply chain include:
- Good Manufacturing Practices & Good Distribution Practices (cGMP & GDP)
- Drug Supply Chain Security Act (DSCSA)
In the context of a clinical trial, DSCSA and Serialization apply primarily to sourced commercial product (e.g. comparator, rescue meds, co-meds). The more over-arching guideline for the clinical trial supply chain is GDP - a quality system that covers the movement of goods from manufacturer to point of supply to the patient. In fact, GDP guidelines extend beyond the patient, incorporating final accountability and disposal / destruction of materials. In our experience, many sponsors are unaware that this final step, which often involves reverse logistics, is part of GDP compliance.
GDP guidelines address:
- Quality systems
- Temperature monitoring
- Supplier qualifications
- Storage and segregation
- Expired Materials
- Controls for pick, pack, shipping, segregation, supply, export, complaints, returns, recalls, etc
- Following labeled storage conditions
- Accountability and Destruction
Is it strictly the pharmaceutical company that is responsible for compliance? Absolutely not. The end-to-end supply chain involves numerous parties, including: Contract Drug Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), 3rd party packaging and labeling suppliers, and logistics organizations that offer storage and distribution to include transportation of materials to and from investigator sites. To be fully compliant, each of these providers must be held to the same high standard as the pharmaceutical manufacturer.
Ensuring end-to-end compliance requires a commitment to robust training at the site, investigators, doctors, nurses and even patients. Well written documentation must be developed to govern the process, including Standard Operating Procedures (SOPs), Job Aids, dosing instructions, study closeout procedures including drug accountability, returns and destruction. External partners must be subject to competitive bidding that includes comprehensive qualification processes and audits.
Maintaining the highest possible standard requires a corporate quality culture. At Fisher Clinical Services, each of us has internalized this simple fact: We are part of a critical team serving the patient, supplying hope.