Validations: Chain-of-Identity/Chain-of-Custody

Digital Systems for COI/COC: Part 11/Annex 11 Hooks Digital Systems for COI/COC: Part 11/Annex 11 Hooks Ensuring the integrity of biologics production, particularly in advanced therapy medicinal products (ATMP), encompasses a myriad of regulatory requirements and best practices. Among these, the concepts of Chain of Identity (COI) and Chain of Custody (COC) are paramount. This tutorial will guide you through…

Labeling & Serialization for Patient-Specific Batches Labeling & Serialization for Patient-Specific Batches The pharmaceutical landscape is continuously evolving, particularly in the domains of biologics and Advanced Therapy Medicinal Products (ATMPs). Central to these advancements is the rigorous validation of processes that include cold chain management, viral clearance validation, and the meticulous handling of patient-specific batches. This article serves as a…

Shipment & Storage: Cold Chain with COI/COC Controls In the realm of pharmaceutical and biologics validation, ensuring the integrity of products throughout the cold chain is paramount. The cold chain represents an unbroken series of storage and transport conditions that maintain medications at specific temperature ranges, particularly critical for biologics and advanced therapy medicinal products (ATMPs). This article serves as…

Exception Handling in COI/COC: Investigations That Work Exception Handling in Chain-of-Identity/Chain-of-Custody: Investigations That Work In a biopharmaceutical environment, the integrity of the Chain-of-Identity (COI) and Chain-of-Custody (COC) is paramount for ensuring that a product’s lineage and quality are traceable throughout its lifecycle. This article provides a step-by-step tutorial on handling exceptions in COI/COC through effective investigations essential for compliance with…

Chain-of-Identity vs Chain-of-Custody: What Each Proves Chain-of-Identity vs Chain-of-Custody: What Each Proves The concepts of Chain-of-Identity (COI) and Chain-of-Custody (COC) are increasingly critical in the pharmaceutical industry, especially for biologics, Advanced Therapy Medicinal Products (ATMPs), and viral safety validation. Understanding these principles is essential for ensuring that products meet regulatory standards set out by entities such as the US FDA,…