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 ...

Chapter 1: Quality Management – Principles – Quality Assurance – Good Manufacturing Practice – Quality Control – Audits – Quality Evaluation Audits – Critical Procedures Chapter 2: Organisation and Personnel – Principles – Responsibilities of Key ...

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 ...

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, ...

GMP stands for Good Manfufacturing Practice and GLP stands for Good Laboratory Practice. Though both are ensuring the quality of pharmaceutical products they have also few differences. GMP vs. GLP GMP covers whole manufacturing facility. GLP covers only quality control laboratory. Good Laboratory ...

The designated location of buildings and facilities must be appropriate to the processes performed and products handled. The design must permit all necessary cleaning, maintenance and proper access to the process. The design of the building and facility must conform to all Health & Safety internal ...

All pharmaceutical companies have established strict guidelines and regulations according to current good manufacturing (cGMP) guidelines. These guidelines help the manufacturers to ensure the quality of manufactured pharmaceutical products. Despite these efforts by the companies, there are a lot of ...

According to GMP inspections by various regulatory agencies, more than 100 types of GMP violations are found in Indian pharmaceutical manufacturing facilities. Some frequently found violations are as follows. 1. Data Integrity Data integrity issues are the most common GMP violations found in Indian ...

Mohammad Abdul Motalib Momin: GMP refers to the Good Manufacturing Practices promoted by the WHO GMP Guidelines, implemented by the pharmaceutical manufacturers and monitored by the regulations promulgated by the Drug Regulatory Authorities (DRA); the document was published in 1975. The GMP regulations ...

GMP audit of any pharmaceutical industry is very important and crucial in its business. Therefore, before the audit, the preparation of the audit must be done properly. We can plan any GMP audit in the following ways: 1. Documents reviewed: A list of all documents related to the audit should be prepared. ...