Rapid Mixture Granulator(RMG); Working and Principle

Rapid mixture Granulator machine

A Rapid mixture granulator (RMG) is used in mixing, agitation, and shear mixing (to break internal molecular force). It is used in pharmaceuticals to make granules. The components of the RMG (impeller and chopper) are highly responsible for the wet granulation process. Components of RMG: Rapid mixture granulator components are as follows: The impeller and chopper are responsible … Read more

Multimill; Working and principle

Multimill

Multimill is used widely in pharmaceuticals (granulation section), cosmetics, chemicals, and bulk drugs for cutting granules into small particle sizes by using cutting, Pulverization, and hammering mechanisms. Components of multi-mill: 1. Hopper inlet The hopper is used to feed products to the mill. 2. Milling chamber The milling chamber contains a screen to reduce particle … Read more

Product Waste; Collection and Disposal

1.0 Purpose: To lay down the standard operating procedures for the Collection and Disposal of product waste.2.0 Scope: This scope is applicable to all the product waste generated during the following activities. 3.0 Responsibility:3.1 Officer concerned department is responsible for the Product Waste; Collection and Disposal.3.2 All concerned heads of the department and head of Quality Assurance are … Read more

Colloidal Mill; Working and Principle

Colloidal mill

A colloidal mill is used to break down a mixture that contains Suspended solid particles to make a homogeneous mixture. So it is used in a wide range of pharmaceuticals and other industries to make a suspension. Working Principle of Colloidal Mill: The colloidal mill works on Shearing by using a rotor/ stator. By using shearing force its … Read more

Disintegration Test Apparatus: Diagram, Principle, Types, Procedure, Calibration, Limit and Assembly

Disintegration Test Apparatus

Disintegration test apparatus is widely used in pharmaceuticals to identify the disintegration properties of various types of tablets and capsules. The DT apparatus decides whether or not tablets or capsules disintegrate within a recommended time once placed in a liquid medium. What are Disintegration and Principle Disintegration is defined as that state in which no residue of the … Read more

Top 10 Tablet Coating Problems and Remedies

The coating on tablets helps withstand the gastric environment and also has many advantages like masking the odor, color, and taste of a drug along with physical and chemical protection. Sometimes tablet’s quality may be improper if, the proper method and technique are not followed during the coating process. So to avoid these problems, we … Read more

SOP on Operation, cleaning of Leak Test Apparatus

SOP on Operation, cleaning of Leak Test Apparatus

Learn about Standard operating procedures on Leak Test Apparatus including Purpose, Scope, Responsibility, Procedure, How to perform Leak test for blister and containers and aluminum triplex, limit, Action on Failure of leak test for blister or strips, Frequency, Challenge test, Cleaning and calibration of leak test apparatus. 1.0 Purpose: To let down the standard operating … Read more

Water System Validation and Phases in 2024

Water System validation

Validation of the water system is important in the pharmaceutical industry. Water is extensively used in the manufacturing process at various stages. Throughout manufacturing, water is consistently generated and distributed, making it unusable to test and analyze every quantity used in production. To ensure consistent quality standards, it’s essential to validate the treatment, generation, storage, … Read more

Drugs and Cosmetics Rules 1945: All Schedules (A–Z) Explained with Examples

Drugs and Cosmetics Rules Schedule 1945

Quick Answer The Drugs and Cosmetics Rules, 1945 categorize drugs, cosmetics and medical devices under Schedules A to Y. Every schedule is for a particular purpose, application forms (Schedule A), lab fees (Schedule B), biological products (Schedule C), GMP for pharmaceuticals (Schedule M), GMP for ASU drugs (Schedule T), and labelling of narcotics (Schedule H, … Read more

SOP on Cleaning and Sanitization in Pharmaceutical

Pharmaceutical cleaning and sanitization SOP featuring a cleanroom technician sanitizing equipment in a GMP-compliant manufacturing area with hygiene and contamination control procedures.

This guide will provide you the Standard Operating Procedure (SOP) for Cleaning and Sanitization of pharmaceutical manufacturing facilities. This SOP includes the objective, scope, responsibility/scope of work, safety precautions for cleaning different zones with their cleaning and sanitization frequency/cleaning agents used/approved & documentation requirement along with its annexure does help maintain GMP compliance as well as avoid contamination prevention & hygienic production environment.

SOP on Training of Personnel in Pharmaceutical Industry with Formats

Pharmaceutical GMP training session with staff participating in an SOP training course and a trainer demonstrating training procedures and forms in a professional training hall.

Training of employees is one of the key aspects of pharmaceutical GMP compliance, as it ensures that employees possess the necessary knowledge, skills, and competency to perform their tasks effectively. This is an SOP Training of Personnel, which covers the induction training, departmental training, SOP training, evaluation, qualification and periodic retraining.