International Compliance & QMS Optimization
The Quality Management System (QMS) is mentioned in almost all supply chain guidelines and is considered as a regulatory must globally. The system defines how the firm is going to act responsibly, how standards will be deployed and also outlines the quality aspects that will shape the company’s compliance and logistics strategies. The absence of a quality management system is unlikely in today’s industry and a flawed QMS could cause the potential recall of a product due to a lack of verification and validation along the chain. Every member of the downstream process in a drug supply chain who has a responsibility to the drug in question should have access to the QMS.
The system is also a vital tool for audits. The defining factor of a QMS lies in whether the system is thorough enough to satisfy pharmaceutical regulatory bodies and shippers. Regulatory focus wants the QMS to act as a standard which both encourages and documents the effective leadership and governance throughout the transit of a pharmaceutical. Cold Chain IQ contributor Kevin O’Donnell notes:
“Broadly speaking, it’s being able to document what you do, [to] do what you document and then being able to prove that you’ve operated to that standard. Also to improve what you’re doing so there’s this constant progression towards continuous improvement.” In addition to this, there is increasing regulatory emphasis in inspections upon data integrity.
Inevitably, this system needs to be frequently refined to reflect regulatory changes, updates and newsworthy developments, so the methods the system endorses are not only compliant but as advanced as possible.
Last year at the 13th Cold Chain GDP & Temperature Management Logistics Global Forum, Dave Ulrich, QA Director of Supply Chain Compliance at Abbvie, discussed the subject of blending GMP, GDP and other compliance efforts into a Quality Management System.
In light of this subject, Cold Chain IQ consulted a selection of experts to discover the latest methods being deployed to navigate today’s regulatory challenges in regards to GMP, GDP GCP compliance and QMS integration. Also, we acquired insight on what compliance changes are on the horizon to impact the temperature controlled logistics market.
Subjects covered in this ebook:
- Good Manufacturing Practices
Quality Technical Agreements with Solution Providers
Insight from: Mahsa Alaee, Deputy Director, Site Quality Operations at Sanofi Pasteur Ltd.
- Good Distribution Practices
Recent and upcoming international advancements
How to Prepare for a GDP Audit
- Good Clinical Practices
Recent international advancements regarding GCP requirements
New USP Guidelines for Investigational Medicines
Insight from: Jeffrey M. Carrico, Director of Pharmacy at Investigational Drug Service Florida Hospital & USP Packaging & Distribution Expert Committee
- QMS Integration and Optimization
Quality Management System Best Practice Measures
Insight from: Russel Maschek, Manager, Supply Chain Quality at Mallinckrodt Pharmaceuticals
Source: Pharma Logistics IQ