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…
Ever wondered about the difference between a completely new drug (NDA) 505(b)(1)and a hybrid drug (NDA)505(b)(2)? Let’s explore the contrast between these two pathways! A 505(b)(2) New Drug Application (NDA) is a regulatory pathway in the United States that allows for the submission and approval of certain new drug products. The name “505(b)(2)” comes…
Hazard and Risk are two important concepts in the pharmaceutical industry, but they have distinct meanings and implications. Here is a comparison between hazard and risk in the context of the pharmaceutical industry: 1. Definition Hazard: A hazard refers to any potential source of harm or danger that can cause adverse effects on human…
The main similarities and differences between Quality Control (QC) and Quality Assurance (QA) are as follows: Similarities 1. Both quality control and quality assurance are essential components of the pharmaceutical industry. 2. Both aim to ensure that pharmaceutical products meet the required standards and regulations. 3. Both involve monitoring and evaluating processes to identify any…
