How to Manage Deviation Backlog?
Every pharmaceutical manufacturer must have and implement suitable processes for dealing with devia…
Every pharmaceutical manufacturer must have and implement suitable processes for dealing with devia…
GMPs are minimum requirements that companies must meet in the development and execution of acceptab…
Put together an Inspection Team that will be responsible for dealing with the inspection when the F…
Have you ever wondered how pharmaceutical companies ensure the consistency and quality of their tab…
1. Always wear appropriate personal protective equipment (PPE) such as gloves, lab coat, and safety…
1. Pre-inspection planning This involves determining the scope and objectives of the inspection, id…
Precision is one of the most important quality characteristics of an analytical method. It is a mea…
Accuracy determines whether the product can be extracted using the solvent used in the test method…
Analytical Instrument Qualification (AIQ) and system suitability testing (SST) are both important p…
Pre-treatment system 1- Pretreatment process contains traditional processes, such as Feed water sto…
1. Calibration This involves testing the accuracy of the pH meter by measuring solutions with known…
1. Corrective action A systematic process undertaken to identify, analyze, and eliminate the root c…
The concept of the Qualified Person (QP), first established in 1975, is a unique regulatory require…
Test procedures for assessment of the quality levels of pharmaceutical products are subject to vari…
Filtration can have significant effects on the results of analytical method validation, particularl…
Most relevant interview questions for freshers and experienced candidate applying for Regulatory Af…
Obtaining GMP authorization for a new pharmaceutical facility entails a detailed process to ensure …
Discovering straightforward tips for success in optimizing HPLC methods: 1. Use the appropriate col…
Ever wondered about the difference between a completely new drug (NDA) 505(b)(1)and a hybrid drug (…
Managing deviations and investigations efficiently is critical to ensuring product quality, complia…