Quality Management and Compliance Hub

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.  ullamcorper malesuada. Duis convallis convallis tellus id interdum.

Blog & Article
One of the most widely discussed concepts within the revised Annex 1 is a contamination control strategy, or CCS[1]. The guidelines require the implementation of a CCS across manufacturing facilities to manage any potential contamination risks. Fundamentally, the CCS is about establishing a tight focus on patient safety by thoroughly assessing all the different areas where contamination can happen, and what controls are in place to prevent such from happening. The CCS comprises a repository of documents that provide a high-level overview of how the company controls and prevents contamination of microbial particulates, microbial byproducts such as endotoxins and
Blog & Article
The National Institute for Bioprocessing Research and Training (NIBRT) and Cencora PharmaLex collaborated on an event to discuss the EU GMP Annex 1 requirements and how to navigate the road to a successful Annex 1 inspection. The event took place at the NIBRT facility in Dublin on Thursday 9 May 2024. The sold-out event was led by industry leaders, experts, regulators, and pharmaceutical company representatives and was attended by professionals from across Ireland as well as overseas. Annex 1 came into force in August 2023 and remains a hot topic within the industry[i]. Discussions during the event centered on
Video

Annex 1 – Navigating the road to a successful inspection

Blog & Article
Authentic management oversight and active engagement is an important determinant for an effective and robust CAPA process. Senior management support for a quality culture should begin with investment in training, awareness that quality is everyone’s responsibility, and the importance of reporting issues and the mechanisms for reporting. It should be made easy to report potential issues e.g., “good catch programs” 1 , 2 and recognize and reward the behavior for highlighting such issues. Invest time and effort in targeted CAPA Workshops reviewing regulatory requirements, supplemented with examples of practical applications from real-life occurrences at the organization and strengthen the
Blog & Article
Corrective and preventive actions (CAPAs) are often met with fear and trepidation. Many organizations simply see these as a regulatory requirement, yet the reasons why health authorities require them are equally reasons the business will benefit from them. Manufacturers are required to have a robust quality management system (QMS) and meet the ISO 9001 global standards[1] for their QMS. An intrinsic element in the QMS is the establishment of CAPA processes[2]. According to the US Food and Drug Administration (FDA), the purpose of a CAPA subsystem is “to collect information, analyze information, identify and investigate product and quality problems,
Blog & Article
Pharmaceutical companies bringing a product to market in Europe are sometimes not entirely comfortable with the local affiliate requirements they must address in key markets. One of the more complex and poorly understood is the legal framework of the “Exploitant” in France[1]. The Exploitant is defined under the French Public Health Code as the organism responsible for drugs “exploitation”1, under the responsibility of a Responsible Pharmacist[2] “Exploitation” refers to any activity that applies to the commercial operation of medicinal products in France, including advertising, information, pharmacovigilance, storage and distribution (including batch follow up and recalls)1. Indeed, the French Health
Scroll to Top