COVID-19 (Corona Virus) and Unethical Business
On one side, China & other countries across the world are struggling with the infection of COVID-19 (Corona Virus) and on the other side, some selfish people are selling unapproved products…
5 ways to reduce Human Error
"The great majority of reported defective medicinal products has resulted from human error or carelessness, not from the failure of technology" Source: MHRA, Orange Guide 2002 As stated by Orange Guide…
Statistical Evaluation (Analysis) of MHRA 2018 GMP Inspection’s Deficiencies
MHRA published its GMP Inspection Deficiency Data for year 2018. In totality MHRA Inspectorate audited 286 facilities across the globe in the year 2018 and made total 6209 deficiencies EU…
Quality Oversight – FDA warning letter
Food and Drug Administration issued a warning letter to the Chinese Drug Manufacturing facility where Inspector found Oversight concerning the Quality. There are numbers of pharmaceutical industries received FDA 483s…
Aseptic Process Simulation by Media Fill
A media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to…
How to implement Good Documentation Practices
In a pharmaceutical or healthcare GMP environment, implementation of Good documentation practices is very much required as it is directly affecting the product quality, safety, efficacy. If any document related…
HPLC Troubleshooting & Its Data Integrity Assessment
HPLC (High Performance Liquid Chromatography) is a chromatographic technique used to separate a mixture of compounds between Mobile phase and stationary phase. The technique is widely used in industrial area…
Handling of consumables in pharmaceutical industries
If I am talking about material management system, we do all the thing to comply the regulatory requirement; Raw material supplier qualification, raw material technical evaluation, testing etc. but to…
Technology Transfer Procedure
PROCEDURE ON TECHNOLOGY TRANSFER Objective of this procedure is to provide a guideline on the transfer of technology from R&D to manufacturing site and from one manufacturing site to another manufacturing…
Microbial Contamination in Pharmaceutical products
What is Microbes?The microorganism or microbes is a microscopic organism which may exist in single celled form or in a colony. Single celled microorganism were in the first form of…