Quality Management and Compliance Content Hub
Our Quality Management and Compliance (QMC) team is involved in all aspects of the Product Lifecycle from innovation to commercialisation providing strategic consultancy related to compliance in every stage from development to product withdrawal. From early innovation, we guide our clients through all stage gates towards and beyond commercialization, consulting with them on anything that will impact the quality and compliance of the final product
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Blog & Article
- 29th April 2024
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
Blog & Article
- 12th April 2024
Contract Manufacturing, both foreign direct investment (FDI) and local, is the new norm. The advancement of this diverse and complex activity plays a vital role in the supply chain and encompasses multiple facets of the pharmaceutical and medical technology business — including research, development, clinical, manufacturing, testing, batch release, post-market surveillance, and beyond. On Thursday the 29th February 2024, the PDA Ireland Chapter hosted a sold out event on Contract Manufacturing, which was facilitated by industry leaders, experts, and pharmaceutical company representatives. The event was enhanced with informative stands by multiple sponsors and enriching connections and conversations which occurred
Blog & Article
- 9th April 2024
Introduction With the EU GMP Annex 1 “Manufacture of Sterile Medicinal Products” [1], which came into effect as of August 2023, companies are now being inspected by the regulatory authorities against the guidelines and are receiving observations in cases of non-compliance. Although the revision seeks to remove ambiguity and inconsistencies, there are still open-ended questions and challenges for both industry and regulators. These were addressed during the ISPE Annex 1 Workshop event in Waterford, Ireland. During the seminar, participants heard from industry experts and regulators about their experiences with regulatory inspections, typical issues, associated challenges, and possible solutions for
Blog & Article
- 12th March 2024
Successful regulatory inspection outcomes require preparation and communication. While inspections are challenging, having the process run smoothly is achievable with proper preparation. Inspection readiness is about continuous improvement and ensuring the team is ready to navigate the complexities of a regulatory audit with confidence. Not being ready to meet the regulator’s requirements during the inspection process is a huge risk, since an unsuccessful inspection will add significant time to a company’s strategic goals. To successfully prepare for an inspection, organizations should consider adopting best practices. This article explores eight invaluable tools for inspection success. 1. Be properly prepared
Journal Article
The COVID-19 pandemic exposed significant challenges in the pharmaceutical global supply chain, leading to severe shortages of drugs and vaccines worldwide. This resulted in a pronounced inequity in distribution, particularly disadvantaging the Global South. This disparity is largely due to the dependency of low- and middle-income countries (LMICs) on pharmaceutical manufacturing in more industrialized nations. To mitigate this inequity and ensure supply of medicinal products across the globe, manufacturing of medicinal products needs to be decentralized through the establishment of manufacturing sites in LMICs.
Journal Article
Londa Ritchey’s expertise in quality operations, oversight, and management has been integral to PharmaLex’s success. Leveraging her strong background in microbiology and biostatistics, she effectively manages operational plants, supervises global manufacturers, and navigates complex challenges, ensuring the highest standards in the pharmaceutical sector. In an interview with Pharma Tech Outlook Europe, Londa shared her positive outlook on emerging pharmaceutical manufacturing trends and the promising uptake of rapid micro methods, enabling swift responses to challenges.