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…
1) Raw material sourcing and testing The raw materials for tablet manufacturing are typically sourced from approved suppliers who have been vetted for quality and reliability. The raw materials are tested for quality and purity before being used in the manufacturing process. This is to ensure that the tablets are safe and effective. 2)…
What is Regulatory Affairs? Professionals in this field implement regulations from local, state and federal governing bodies to ensure compliance. They also stay up to date on the latest policy changes and recommend new organization protocols as necessary. RA professionals work in Bio pharmaceutical, pharmaceutical and medical devices industries What is Quality Assurance (QA)?…
Innovator An innovator in the context of drugs refers to the original developer or manufacturer of a new pharmaceutical product. – Example: Astellas is the innovator of Veozah, as they researched, developed, and brought the drug to market first. Generic Drug Generic drugs are generic versions of a pharmaceutical product that are approved as…
Black Spots Black-colored specks or dots on the tablet surface. Causes of Black Spots: Remedies for Black Spots: Inconsistent Thickness Variations in the tablet thickness within a batch or across different tablets. Causes of Inconsistent Thickness: Remedies for Inconsistent Thickness: Hardness Variation Inconsistency in tablet hardness across a batch or within…
