Several reasons can lead to the rejection of a pharmaceutical batch: Microbial Contamination: Presence of harmful bacteria, fungi, or other microorganisms, especially in sterile products. Out-of-Specification (OOS) Results: Test results, such as potency, dissolution, or assay, falling outside the set quality parameters. Deviations in Manufacturing Process: Unplanned changes or errors during production, such as incorrect…
GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) are both quality assurance systems that are crucial in the pharmaceutical manufacturing industry. While they share some similarities, there are also notable differences between the two concepts. Standards: 1. GMP: GMP focuses on ensuring that pharmaceutical products are consistently produced and controlled according to quality…
1. Pre-inspection planning This involves determining the scope and objectives of the inspection, identifying the specific areas to be inspected, and gathering relevant information about the foreign facility. 2. Notification The regulatory authority or agency conducting the inspection notifies the foreign facility about the upcoming inspection, providing details such as the date, time, and…
Obtaining GMP authorization for a new pharmaceutical facility entails a detailed process to ensure regulatory compliance and safe product production. Here’s a comprehensive overview of necessary activities: 1. Facility Design and Construction: – Develop layout adhering to GMP, zoning different areas. – Construct with materials preventing contamination. 2. Cleanroom Design and Qualification: –…
To ensure the quality of the drugs produced, strict guidelines and regulations shall be in place and followed by the pharmaceutical companies. What are Good Manufacturing Practices Violations? GMP stands for Good Manufacturing Practices and it is a set of regulations that must be followed when manufacturing pharmaceuticals. There are a few different types…
GMP stands for Good Manufacturing Practices in pharmaceuticals, it means to follow the regulatory standards during manufacturing of pharmaceutical products. There are several guidelines for good manufacturing practices worldwide like WHO , FDA and EU. These guidelines have recommendations for almost all departments of pharmaceutical companies like manufacturing, quality control, storage and distribution. …
