Edge Runner Mill: Principle, Construction, Working, Merit, Demerit

Edge Runner Mill is widely used in industries till now, if talk about its usage centuries ago, the manual mortar and pestle was the traditional tool for accomplishing size reduction, and it is still frequently used on a modest basis. Compression size reduction may also be done on a small scale with end-runner mills and … Read more

SOP on Cleaning and Operation of Blister Pack Machine

1.0 Objective: To lay down a procedure for the operation of the Blister Pack Machine.2.0 Scope: This procedure is applicable to the operation of the Blister Pack Machine in the production area.3.0 Responsibility: Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure for Blister Pack Machine: 4.1 Ensure the area and equipment are … Read more

Procedure for investigation of Out of Specification (OOS) and SOP Formats

1.0 Purpose: To lay down the procedure for handling, investigating, and reporting of Out of Specification (OOS) results obtained during laboratory testing. This procedure provides guidance to assure that the investigations are conducted in a timely manner with appropriate depth and are supported by the necessary documentation to perform root cause analysis as appropriate. 2.0 … Read more

Granulation Technique in tablet manufacturing

Granulation Technique

In today’s Pharmaceutical industries, the Granulation Technique is highly employed to get better Quality granules. Granulation is the act or process of forming or crystallizing into grains. Granules typically have a size range between 0.2 to 4.0 mm, depending on their subsequent use. Synonym “Agglomeration“: Agglomeration processes or, in a more general term, particle size … Read more

SOP on Making Entries in inward/outward Register

1.0 OBJECTIVE: To lay down a procedure for making entries in the inward/outward register.2.0 SCOPE: This procedure is applicable to making entries in the inward/outward register in the production area. 3.0 RESPONSIBILITY:Officer, Executive – Production DepartmentManager – Production Department4.0 PROCEDURE:4.1.1 Inward entry is to be made when the material of a particular batch is transferred … Read more

Change Management System in Pharmaceuticals

Change is driven by innovation, continuous improvement, process performance and product quality monitoring, and CAPA. A firm must have an effective change management system in place in order to effectively review, authorize, and execute these changes. The complexity of change management processes before the original regulatory submission and after submission, where revisions to the regulatory … Read more

Calculation for Capacity of Tablet Coating Machine With Example

In order to achieve effective coating results, a sufficient amount of tablets must be placed in the coating pan. To get a consistent coating, the coating machine pan’s capacity should be estimated. Different coating issues may result from using insufficient amounts of tablets to coat inside the coating pan. so let’s understand how to calculate … Read more

Fluid Energy Mill; Working, Principle, and Construction

Fluid energy mill: A fluid energy mill is used for size reduction in the pharmaceuticals, cosmetics,s and food industries. the fluid mill works on impaction and attrition. Principle: Fluid mills operate on the principle of impact and attrition. Working of fluid energy mill: Start the fluid energy mill and pass the feed through the inlets … Read more

Difference Between Positive and Negative Control

Learn About the difference between Positive and Negative Control in microbiology. A positive control is a control group where if you change the dependent variable you’re expected to see a positive response whereas, in a negative control group, whenever you change the dependent variable you would expect a negative response. This demonstrates that the changes … Read more

Hammer Mill; Usage, Construction, Working Principles, and Types

A Hammer Mill machine is widely used in the Pharmaceuticals and Food industries to cutting Materials into small fragments or small pieces (Also called Size Reduction). The main component of a hammer mill is a row of hammers that are hinged on a central shaft and contained in a strong metal container. Size reduction is … Read more

Sop on Non-conforming Results in Total Microbial Count in Water Samples

1.0 OBJECTIVE: 1.1 To lay down the procedure for the Corrective and Prevention Action for non-conforming resultsin total microbial count in water samples 2.0 SCOPE: 2.1 This procedure is applicable to the utility department and all the production department 3.0 RESPONSIBILITY 3.1 Microbiologist3.2 Head – Microbiology3.3 Head – Production Block3.4 Head Engineering and Utility 4.0 … Read more

List of Quality Control Equipment in Pharmaceuticals

Quality control equipment is widely used in pharmaceuticals for the testing of drugs as per given standards. The subject of analytical instruments has grown more complex recently. In order to get more precise results, personal computers and microcontrollers have been added to analytical equipment in modern times. A chosen few of these instruments are also … Read more

SOP for Storage and Preparation of Media and Culture

1.0 Objective: Media is the main source of growth of the microbial. To detect the microbes in the test samples we can follow some guidelines for the preparation of the Media. 2.0 Scope: This procedure is applicable to Microbiology Department. 3.0 Responsibility:The microbiology officer is responsible to implements this SOP.Head Department is responsible for overall … Read more

Responsibilities of the Validation Team to Meet the cGMP Compliance

Purpose: The purpose is to describe the responsibility and functions of the validation team to meet the cGMP complianceResponsibility: It is the responsibility of all concerned departments to follow the procedure. The QA manager is responsible for compliance. Procedure: Validation CoordinatorAll validation activities through the different progress steps should be coordinated by one person, preferably … Read more