Clean and sterile environments are of the greatest importance in the pharmaceutical field. One of the more important factors that contribute to it is differential pressure. What is Differential Pressure? It is the pressure difference between the cleanroom or manufacturing areas and adjacent areas, which usually include corridors or airlocks. This pressure difference ensures control…
As a Stability Assessor at the Egyptian Drug Authority, I frequently review CTD files, and I’ve noticed recurring mistakes in the Analytical Method Validation section. These oversights not only delay regulatory approvals but also question the reliability of the data presented. Here are some common pitfalls to avoid: 1. Incomplete Validation Reports: Failing to address…
In the pharmaceutical industry, the Q value is a key parameter in dissolution testing that ensures the quality and performance of solid oral dosage forms like tablets and capsules. But what exactly does it mean? The Q value represents the minimum percentage of the active pharmaceutical ingredient (API) that must dissolve in a specified time…
Pass boxes are an essential component of a cleanroom environment, preventing the transfer of contaminants from one area to another. Selecting the appropriate type of passbox will depend on various factors, such as the type and volume of materials being transferred, the level of contamination risk, and the specific requirements of the application. A passbox…
A Contract Manufacturing Organization is a third-party company that provides comprehensive services in the manufacturing of pharmaceutical and biotechnology products. CMOs are integral to the drug development process, as they allow companies to outsource various stages of production, enabling them to focus on other core areas like research, development, and marketing. Key Services Offered by…
In pharmaceutical HVAC systems, filters are crucial for maintaining clean air quality and ensuring compliance with Good Manufacturing Practices (GMP) and other regulations. The filters used in these systems can be categorized based on their efficiency and application in different cleanroom environments. Here’s a detailed breakdown of the common filter types, their integrity tests, and…
In the pharmaceutical industry, quality is more than a goal—it’s a responsibility. At the heart of this responsibility lies the Quality Management System (QMS). A well-designed QMS ensures that every product is safe, effective, and compliant with regulatory standards. Key QMS tools driving success in pharma include: Risk Management Quality Risk Management is a systematic…
In the pharmaceutical industry, training management is a cornerstone of regulatory compliance and a strong quality culture. A robust training program not only meets regulatory standards but also fosters a commitment to quality across all roles. Regulatory and Quality Standards Importance of Training Key Approaches in Training Management Role-Specific Training Onboarding Programs Blended Learning Approach…
