Validation is the established document evidence or proof that provides a high degree of assurance. A particular method can systematically produce a product that meets its predetermined specifications and quality attributes. Process validation is also a component of the validation, which is explained below. Introduction to Pharmaceutical Validation: The Importance of Validation in Pharmaceutical Validation … Read more
Standard Operating Procedure for Coding and Calibration of Standard Weight, Scope, Responsibility, Precautions, Frequency, Procedure, and Yearly Calibration of Analytical Weight and Standard Weight. 1.0 Scope: The SOP is applicable for the Coding and Calibration of Standard Weight including analytical balance in the various departments at the plant. 2.0 Responsibility: 3.0 Precautions:3.1 Check the validity of the calibration … Read more
Standard Operating Procedure for Acceptable Quality Level (AQL) includes; Purpose, Scope, Responsibility, Precautions, Procedure, Classification of Defects for AQL, and AQL Charts. 1.0 Purpose: To lay down the standard procedure for an acceptable quality level for semi-finished tablets to evaluate physical attributes before packing. 2.0 Scope: This sop is applicable to all tablet products manufactured at the … Read more
Compression machines are used to compress the powder or granules into uniform size and weight. The machine and its tools are key in this process. Therefore, taking good care of and lubricating these tools is extremely important in the pharmaceutical industry. You may also read: about Tablet defects, Capsule defects, and Solid dosage form Different … Read more
The penetration of steam in all parts of the autoclave is essential for achieving and holding sterilization time. A Bowie dick test is done to know steam penetration within the autoclave with the help of the Bowie test pack. While the dense bubble in the load might block steam from getting in, the bowie dick test ensures … Read more
Fumigation and fogging are commonly used in pharmaceuticals to control microbial contamination in a controlled area. Fumigation is the gaseous sterilization process that kills microorganisms and prevents microbial growth in the air or on the surface of the wall/floor. Fumigation agents, like chemicals such as formaldehyde and potassium permanganate, are often used to control micro-organisms. This technique … Read more
Water is widely used in pharmaceuticals as an ingredient, solvent for processing, analytical reagents, and Manufacturing of pharmaceutical products. So, according to pharmacopeia, different types of water are recommended as per the official book and chapter <1231>. Note: Information in this Article doesn’t change the existing guidelines and regulations. It helps users to understand or … Read more
Sometimes issues happen during the manufacturing process of tablets, and we call them tablet manufacturing defects. Below is a Detailed discussion on Tablets Manufacturing Defects and Remedies that help to encounter these situations. So to provide and maintain the quality of products, tablets should be free from such visual defects. A pharmaceutical company that manufactures … Read more