Precision is one of the most important quality characteristics of an analytical method. It is a measure of how reproducible the results of the method are. Precision is important in method validation because it ensures that the method is producing consistent results. This is essential for ensuring the accuracy and reliability of the analytical…
Accuracy determines whether the product can be extracted using the solvent used in the test method. Assay: In drug manufacturing, it is crucial to accurately determine the concentration of the active pharmaceutical ingredient in the finished product. For example, if a tablet is claimed to contain 100 mg of a specific drug, the validated…
Analytical Instrument Qualification (AIQ) and system suitability testing (SST) are both important processes in the pharmaceutical industry that ensure the accuracy, reliability, and consistency of analytical instruments used for testing drug products. However, there are some key differences between these two processes. 1. Purpose: – AIQ: The primary purpose of AIQ is to establish…
Pre-treatment system 1- Pretreatment process contains traditional processes, such as Feed water storage tank，Heat exchanger heating device，Mechanical filtrater, activated carbon filtrater, softener,Precision Filter, dosing device, as well as ultra-filtration, residual chlorine removal UV, micro-filtration, etc. Residual chlorine removal UV system 1- Using residual chlorine removal UV system in pretreatment, instead of activated carbon…
1. Calibration This involves testing the accuracy of the pH meter by measuring solutions with known pH values. The pH meter should provide readings that are within an acceptable range of the known values. 2. Linearity This test determines if the pH meter provides consistent and accurate readings across a range of pH values….
1. Corrective action A systematic process undertaken to identify, analyze, and eliminate the root cause of a nonconformity or deviation in order to prevent its recurrence. 2. Preventive action Proactive measures taken to identify and eliminate potential causes of nonconformities or deviations before they occur. 3. Nonconformity Any deviation from established standards, procedures,…
The concept of the Qualified Person (QP), first established in 1975, is a unique regulatory requirement which applies within the European Union (EU). The only comparable situation exists within Member States of the European Economic Area (EEA) with whom the EU has reciprocal agreements. Each holder of an Authorisation to Manufacture products…
Test procedures for assessment of the quality levels of pharmaceutical products are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the USP Pharmacopeia and the National Formulary constitute legal standards. The cGMP regulations [21 CFR 211.194(a)] require that…
