Validations: Biologics, ATMP & Viral Safety Validation
Sterility Assurance for ATMP: EM & Media Fills The assurance of sterility within Advanced Therapy Medicinal Products (ATMPs) is crucial in the realm of biologics. This comprehensive guide outlines a step-by-step tutorial for understanding sterility assurance, particularly focusing on environmental monitoring (EM) and media fills. The focus on viral clearance validation, spiking studies, and the application of aseptic controls as…
Tech Transfer to Hospital Sites: PPQ/CPV Hooks Tech Transfer to Hospital Sites: PPQ/CPV Hooks The process of tech transfer to hospital sites for biologics and Advanced Therapy Medicinal Products (ATMP) brings unique challenges and requirements, especially regarding Process Performance Qualification (PPQ) and Continued Process Verification (CPV). In this guide, we will cover essential aspects of PPQ and CPV tailoring for…
Sampling Plans in Advanced Therapy Medicinal Products (ATMP): Small n, Rare Events, Real Data Introduction to Sampling Plans in ATMP Sampling plans play a crucial role in the validation of Advanced Therapy Medicinal Products (ATMP), specifically focusing on ensuring the safety and efficacy of biologics and advanced therapies. In the context of regulatory compliance under the US FDA, EMA, MHRA,…
Acceptance Criteria in ATMP: Attribute vs Variable Advanced Therapy Medicinal Products (ATMPs) present unique challenges and opportunities in the pharmaceutical development landscape, particularly regarding validation protocols. With a regulatory environment governed by stringent guidelines from authorities such as the FDA, EMA, and MHRA, understanding the distinction between attributes and variables within Acceptance Criteria (AC) is pivotal for professionals involved in…
Bridging Development to PPQ for ATMP In the complex landscape of Advanced Therapy Medicinal Products (ATMP), the integration of viral clearance validation into Process Performance Qualification (PPQ) is critical. This comprehensive guide outlines the essential steps for pharma professionals in navigating the regulatory maze associated with PPQ, focusing on viral safety, spiking studies, closed systems, and single-use systems, as per…
Chain-of-Identity Links to PPQ Execution Chain-of-Identity Links to PPQ Execution Pharmaceutical validation is a cornerstone of good manufacturing practices (cGMP) and a crucial element for ensuring patient safety. This tutorial focuses on the application of chain-of-identity (COI) to process performance qualification (PPQ), specifically in the context of advanced therapy medicinal products (ATMP). The integration of viral clearance validation, spiking studies,…
CPV Tailoring for ATMP: Signals and Windows CPV Tailoring for ATMP: Signals and Windows In the evolving landscape of biologics and advanced therapy medicinal products (ATMPs), effective process validation is critical for ensuring the safety and efficacy of therapeutic products. This tutorial provides practical guidance on Process Performance Qualification (PPQ) and Continuous Process Verification (CPV) tailored specifically for ATMPs. With…
Case Library: COI/COC Issues and Resolutions Case Library: COI/COC Issues and Resolutions Introduction to Chain-of-Identity and Chain-of-Custody in Biologics In the context of biopharmaceuticals, ensuring the integrity and traceability of products is paramount. This article serves as a comprehensive guide addressing Chain-of-Identity (COI) and Chain-of-Custody (COC) issues encountered during the manufacturing processes of Advanced Therapy Medicinal Products (ATMPs) and biologics….
COI/COC Governance for Multi-Site Programs COI/COC Governance for Multi-Site Programs Introduction to COI/COC in Biologics and Advanced Therapy Medicinal Products (ATMP) The governance of Chain-of-Identity (COI) and Chain-of-Custody (COC) is paramount in the field of biologics and ATMP validation. These processes ensure the proper tracking and safeguarding of biological materials throughout their lifecycle, from collection to patient administration. As global…
3rd-Party Platforms for COI/COC: Due Diligence 3rd-Party Platforms for COI/COC: Ensuring Due Diligence in Biologics and ATMP Validation Introduction to Chain-of-Identity and Chain-of-Custody in Biologics As the demand for biologics and advanced therapy medicinal products (ATMPs) rises, the need for rigorous validation processes within the pharmaceutical landscape becomes increasingly critical. Chain-of-Identity (COI) and Chain-of-Custody (COC) are essential frameworks that safeguard…