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 ...

1. Good Manufacturing Practice (GMP) GMP ensures that pharmaceutical products are consistently produced and controlled according to quality standards. This includes guidelines for facilities, equipment, personnel, documentation, and processes. 2. Good Laboratory Practice (GLP) GLP ensures the reliability ...

GxP is a set of regulations and quality guidelines formulated to ensure the safety of life sciences products while maintaining the quality of processes throughout every stage of manufacturing, control, storage, and distribution. GxP is a general abbreviation for the “good practice” quality ...

GMP audit is a process by which an external or internal individual or team verifies that a manufacturer is following its documented Good Manufacturing Practices. GMP audit of any pharmaceutical industry is very critical and important in the terms of its business. Therefore, the preparations for the audit ...

Data integrity requirements are not new. FDA, MHRA, and WHO have generated additional guidance to clarify requirements. Why? Numerous violations have been found in recent years that have led to warning letters, import alerts, and consent decrees. Data Integrity Issues • Data integrity issues can happen ...

Corrective and preventive action (CAPA) noncompliance is one of the top reasons the FDA issues a noncompliance warning. The purpose of a CAPA report in pharmaceutical industry is to document the actions taken to address the issue and prevent it from happening again in the future. This is a systemic ...

21 CFR Part 11 is a regulatory framework designed by the FDA to guide drugmakers on how to create, manage, and maintain electronic records and electronic signatures. It also says under what conditions drug makers become eligible for compliance with this regulation. The term comes from Title 21 of the ...

Root Cause Analysis is a useful process for understanding and solving a problem. As an analytical tool, Root Cause Analysis is an essential way to perform a comprehensive, system-wide review of significant problems as well as the events and factors leading to them. Root Cause Analysis (RCA) is a technique ...

Principle 1 Customer focus: organizations depend on their customers and therefore should understand current and future customer needs; meet customer requirements and strive to exceed customer expectations. Principle 2 Leadership: leaders establish unity of purpose and direction of the organization. They ...

Currently, the FDA is the only national authority tasked with enforcing and issuing policies on cGMPs. As a rule, a drug is considered adulterated if the facility used to manufacture it and the packaging and processing do not conform to cGMPs. So during inspection, CGMP regulations ensure product safety, ...