These tests are designed to confirm the identity of the active pharmaceutical ingredient (API) and other components in a drug formulation. The identification of pharmaceuticals is a fundamental step in quality control, as it helps prevent errors in manufacturing and ensures that the final product meets the required specifications. Here are some common identification tests…
Bubble point integrity testing is a method used to evaluate the largest pore size in a filter or membrane. This test is based on the principle that when a liquid is forced through a filter, it will flow through the larger pores first. As the pressure increases, the liquid will eventually penetrate the smaller pores,…
XRD stands for X-ray diffraction. It’s a technique used to analyze the crystal structure of materials by examining how X-rays are diffracted as they interact with the atomic lattice of a sample. Instrumentation XRD instruments typically consist of an X-ray source, a sample holder, and a detector. The X-rays are directed onto the sample,…
1. Preparing the media: The first step is to prepare the media, which involves selecting the appropriate growth media, sterilizing it, and ensuring it is properly mixed and free from contamination. 2. Filling equipment preparation: The ampule line and filling equipment need to be properly cleaned and sterilized before the fill process begins. This…
1. Purpose: The user requirements specification document outlines the needs and expectations of the end-users or stakeholders, focusing on the functionalities and features required from a system or product. On the other hand, the design qualification document describes the design solution, including technical specifications and implementation details. 2. Content: A user requirements specification…
The main steps involved in the Corrective and Preventive Action (CAPA) process: 1. Identification: The first step is to identify the issue or non-conformance that needs to be addressed. This can be done through various means, such as audits, inspections, customer complaints, or internal quality control. 2. Evaluation: Once the issue is identified, it’s…
Process and procedure are two important terms in quality management and ISO 9001 standard that are often used interchangeably. However, there are some key differences between the two terms. 1. Definition: – Process: A process is a set of interrelated or interacting activities that transform inputs into outputs. – Procedure: A procedure…
Terminal sterilization refers to the process of sterilizing a product or substance at its final stage of packaging, usually using heat or radiation. In the pharmaceutical industry, there are several methods of terminal sterilization employed, each with its own advantages and disadvantages. Here are some commonly used methods: 1. Autoclaving – Advantage: Autoclaves…
