An Analysis of GxP Audit Procedures and FDA Inspection Readiness Strategies
GxP audits are necessary in the pharmaceutical industry to ensure that operations comply with global regulatory standards, especially those established by the U.S. Understanding audit procedures and inspection readiness is essential for organizations involved in or supporting pharmaceutical manufacturing and R&D to ensure compliance and prevent costly enforcement actions.
The Importance of GMP Audits in Ensuring Product Safety and Quality
Regardless of the industry, maintaining high standards of quality and assuring product safety is paramount to perform successfully, make profit and avoid mistakes. In the pharmaceutical sector protecting the patient’s safety and credibility requires performing Good Manufacturing Practices (GMP) audits. GMP custom made audits are equally fundamental for ensuring legal compliance as they protect the patient’s safety, nurture and maintain brand reputation, and foster compliance with more than minimal standards.
The Egyptian Drug Authority begins today to activate the electronic payment service through its official website
The Egyptian Drug Authority announced the start of activating the electronic payment service through the official website of the Authority, as part of its continuous efforts towards digital transformation and enhancing the efficiency of the services provided, which contributes to facilitating procedures and providing more effective service to customers.
Egypt Joins EDQM’s OMCL Network as an Associated Member: A Leap Forward for Global Medicines Quality Control
Masuu Global is proud to highlight a significant milestone in international pharmaceutical collaboration: The BIO INN Laboratories of the Egyptian Drug Authority (EDA) have joined the General European OMCL Network (GEON), co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM), as an associated member. After Morocco, it is the second African official medicines control laboratory (OMCL) to become part of this network. The network is now counting 69 laboratories from 43 countries among its members.
Effective Preparation for Pharmacovigilance Inspections: Key Steps for MAHs
Pharmacovigilance (PV) inspections are a crucial part of ensuring public health safety within the European Union (EU). These inspections are conducted by national competent authorities in cooperation with the European Medicines Agency (EMA) to verify that marketing authorisation holders (MAHs) are meeting their pharmacovigilance obligations.
