Trend Analysis – Tools for Risk Based Thinking
The biggest concern in this Regulatory Challenging Environment is to apply risk-based thinking for implementing, deploying and maintaining a quality management system with limited resource There is a significant concern…
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 the year 2018. In totality MHRA Inspectorate audited 286 facilities across the globe in the year 2018 and made total 6209 deficiencies…
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…
Media fill aseptic processing
A media fill aseptic processing 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…
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…
SOP on Technology Transfer
PROCEDURE ON TECHNOLOGY TRANSFER Objective of this procedure is to provide a guideline on the transfer of technology from R&D to the manufacturing site and from one manufacturing site to…