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 If you like the contents of this site and think that it will be useful for you and for other Pharmaceutical Industry persons then can donate (even small amount also acceptable). Chandrasekhar Panda-7008217254 (Gpay) & Phonepe & jpanda1983@gmail.com for Paypal account Good Laboratory Practices (GLP) was first introduced in New Zealand and … 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 →

What is Recall of Product : A product recall is a request from a manufacturer to return or removal of a  marketed product after the discovery of safety issues or product defects that might endanger the consumer or put the maker/seller/ manufacturer at risk of legal action. The manufacturer not only has  to pay  the … Continue reading What is the Difference between Recall & Mock recall in Pharmaceutical →

What is Document: A piece of written, printed, or electronic matter that provides information or evidence or proof of any activity that serves as an official record. Why Good Documents are Required in Pharmaceuticals : 1.If it isn’t documented, it didn’t happen & we document to provide written proof that something happened. 2.For regulatory requirements … Continue reading Good Documentation Practices (GDP) in Pharmaceuticals →

Data Integrity Principles : Data Integrity as per United states Foods & Drugs Administration (USFDA) : Data integrity refers to the completeness, consistency, and accuracy of data. Complete,consistent and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy and accurate (ALCOA). Data Integrity as per Medicines and Healthcare products Regulatory Agency … Continue reading Data Integrity Principles ALCOA & ALCOA PLUS in Pharma →