Quality Assurance
At Apotech, we have worked with a
huge range of clients all around the world.
With consultants and teams present in 30 key life science markets, we have successfully executed projects in over 110 countries and helped a large number of innovative medical devices and products enter the market with complete regulatory compliance.
Keep reading to discover some of our most recent case studies.
GMP QA Consulting
GMP QA Consulting Introduction Global API Manufacturer The client was an API manufacturer, with a need for some support to cope with a deviation backlog. Apotech consultant: Two QA Consultants, with backgrounds in sterile devices. Types of Audits GMP Tools: Ishikawa, 5M Audit Locations Europe Scope of work Under the QA director supervision, our consultant…
Batch Release as EU Qualified Person
Batch Release as EU Qualified Person Introduction Our client is a vertically integrated company in chemical synthesis and manufacturing of generic Active Pharmaceutical Ingredients and Drug Products. Standards and references Scope of work Remote batch certification and release of medicinal products Provide regulatory expertise as requested Review Marketing Authorisation variations Perform training with impacted…
What Is A Notified Body & Key Differences With Other Conformity Assessment Bodies
Written by Claudia Rose-Mastrobuoni – Quality & Regulatory Manager What is a notified body? A notified body is an independent organization designated by a European Union (EU) Member State to assess whether certain regulated products, most notably medical devices and in vitro diagnostic devices (IVDs), comply with applicable EU legislation before they are placed on the EU market. For manufacturers based in the United States,…
10 CAPA Metrics and KPIs Every Quality Team Should Track
By Imane Nohair, GxP Audit manager at Apotech Corrective and Preventive Actions (CAPAs) are a fundamental element of quality management across the pharmaceutical & biotechnology industries. When designed and executed effectively, CAPAs do more than address isolated non-conformities. CAPA processes strengthen quality systems, reduce regulatory risk, and support sustained compliance across global regulatory frameworks. Across…
From Audit Non-Conformities to CAPA: A Systematic Approach
By Imane Nohair, GxP Audit manager at Apotech An organized method from audit non-conformities to CAPA overview is key for operational efficiency and compliance in the pharmaceutical industry. Continuous improvement, product quality, and long-term compliance can be assured when these non-conformities are successfully addressed through a Corrective and Preventive Action (CAPA) procedure. This article describes…
How to Make Sure Your CAPA Process Actually Works?
By Imane Nohair, GxP Audit manager at Apotech If you work in quality management, you know how important the CAPA (Corrective and Preventive Action) process is. It helps identifying problems, fixing them, and preventing them from happening again. But here’s the real challenge: how do you make sure those fixes actually work? Many companies put…
2024 Pharmaceutical Inspections: Risk-Based, Remote-Ready, and Globally Harmonized
Staying audit-ready is no longer optional, it’s strategic! Based on EFPIA’s 2024 Inspection Survey, pharmaceutical manufacturers must align with increasingly global and risk-based inspection models. At Apotech, we help clients confidently meet these evolving expectations. Inspection compliance is consistent: no matter the type Whether a Pre-Approval Inspection (PAI), routine check, for-cause investigation, or surveillance audit,…
ALCOA+ Principles in Pharma: The Next-Gen Standard for Data Integrity
ALCOA+ and the modern data integrity landscape Data integrity underpins regulatory compliance and patient safety. And as pharmaceutical and biotech organizations adopt increasingly digital systems, automated workflows, and globalized supply chains, regulators including the FDA, EMA, and MHRA have intensified their focus on how data is generated, captured, and maintained. The ALCOA+ principles form the…
What is QMSR vs QSR? Understanding The FDA Final Rule and ISO 13485 Harmonization
The Quality Management System Regulation (QMSR) is the U.S. Food and Drug Administration’s (FDA) new rule replacing the Quality System Regulation (QSR) for medical devices. Finalized in February 2024, QMSR updates 21 CFR Part 820 by incorporating ISO 13485:2016 by reference, aligning U.S. quality system requirements with the internationally recognized medical device standard while retaining certain FDA-specific obligations. The…
How To Master The CAPA Process Step-by-Step: From Identification to Implementation
The Corrective and Preventive Action (CAPA) process is a core mechanism within Pharmaceutical and Biotech quality systems, designed to identify, address, and prevent issues that may impact compliance, product quality, and most importantly, patient safety. In regulated environments, CAPAs are not isolated actions but structured responses embedded within a wider quality management framework. CAPAs are commonly triggered by internal…