WHO IS CDSCO : The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines agency of the European Union, the Japan, the Foods & Drugs Administration of the United states and the Medicines and Health care products Regulatory agency of the united Kingdom. The Central Drugs Standard Control Organization (CDSCO) is the Central Drug … Continue reading Central Drugs Standard Control Organization (CDSCO) and Its Function →

In the earlier blog we have discussed about Falsified Medicines Directive (FMD) of Europe & Track & Trace System of USA . Below are the difference between these two.......... Related Topic https://pharmaceuticalindustrydotblog.wordpress.com/2019/01/27/importance-of-track-and-trace-system-for-pharmaceutical-packaging/ Related Topic : https://pharmaceuticalindustrydotblog.wordpress.com/2018/12/27/what-is-fmd-falsified-medicines-directive-in-pharmaceuticals-packing/ FMD vs Track & Trace

What is Self Inspection : Self Inspection or Internal Audit is a Quality System to check whether activities followed by all departments are according to the written approved procedures and complying with the cGMP and Regulatory Requirements. What are the Objective of Self Inspection : Promote awareness for Quality and CGMP  within plantProactive approach to … Continue reading Self Inspection or Internal Audit and its requirement in Pharmaceuticals →

What is Track & Trace System : Track and Trace is the operation in which the past and current status information of each drug product is recorded. All the drugs in the market are tracked on the basis of packages using keys of GS1 (Global Standards One) standards. The ability to track each drug unit is provided … Continue reading Importance of Track and Trace system for pharmaceutical and other industry packaging →

What is Quality Assurance : Quality Assurance is a deep concept covering all matters that individually or collectively influence the quality of a product. It is the complete & whole of the arrangements made with the object of ensuring that manufactured products are of the quality required for their intended use. As per Oxford Reference … Continue reading Responsibility of Quality Assurance personnel in Pharmaceuticals →

FDA New Dat Integrity Guideline In recent years, CGMP violations related to data integrity was increased during FDA inspections. In order to protect the public health it is the responsibility of manufacturer/firms to ensure the safety, efficacy, and quality of drug products. As a result of data integrity-related CGMP violations many manufacturer/firms has got regulatory … Continue reading USFDA New Data Integrity and Compliance Guideline at a Glance →

As we know that water is the most essential part of different pharmaceutical preparations & is used for the cleaning of machines, equipment's and other accessories during manufacturing hence directly & indirectly it plays an vital role in building of product quality. Why Water System Validation is Important : 1.The purpose of carrying out water … Continue reading Purified water System Validation →

Quality Control Laboratory Photo Good Laboratory Practices (GLP) was first introduced in New Zealand and Denmark in 1972, and later in the US in 1978. It was followed a few years later by the Organization for Economic Co-operation and Development (OECD) Principles of GLP in 1992 & the OECD has since helped promote GLP to many countries. … Continue reading Good Laboratory Practices (GLP) for Pharmaceuticals and other Quality Control Laboratories →

Validation is a concept that has been develop gradually since its first formal appearance in United States in 1978. The concept of validation was first proposed by two Food and Drug Administration (FDA) officials, Ted Byers and Bud Loftus, in 1979 in USA, to improve the quality of pharmaceuticals. In 1996 GMP guidelines were published by WHO for the validation … Continue reading Validation and its Importance in Pharmaceuticals →