1.0 Objective: To lay down a procedure for the Operation and cleaning of Fluidized Bed Drier.2.0 Scope: This SOP is applicable to the Operation and cleaning of a Fluidized Bed Drier in the production area.3.0 Responsibility: Operator, Officer, Executive- Production DepartmentManager- Production Department 4.0 Procedure for Operation and Cleaning of Fluidized Bed Drier:4.1 Machine setting: … Read more
The Limit Test for Sulphate is designed to determine the allowable limit of Sulphate contained in a sample. Principle: The principle for the limit test of Sulphate is based on the reaction of soluble Sulphate with barium chloride in the presence of dilute hydrochloric acid to form barium Sulphate which appears as turbidity with a … Read more
A limit test for chloride is done to identify the impurity in the compounds by comparing the test solution against the standard solution. The chloride limits test is only designed to identify and control the impurity present in the compounds. Limit Test for Chloride Principle The limit test for chloride is based on the reaction … Read more
The limit test for iron refers to a type of analytical chemistry test used to determine the concentration of iron in a sample. This test is often performed in the laboratory as part of a larger suite of tests to determine the chemical composition of a substance.In a limit test for iron, a known volume … Read more
In pharmaceutical analysis, a limit test is a type of analytical test used to determine impurity in a substance whether a substance is present in a sample at a concentration above or below a specified limit. Limit tests are often used to ensure that a substance meets certain quality standards or regulatory requirements. Definition The … Read more
Objective: To initiate, incorporate, approve and record changes to the master documents. Scope: This Sop is applicable for changes to the master documents. Responsibility: All the functional Heads. Accountability: Head – Quality Assurance. Filling procedure for Document Change Control DCC No: Document change control number is entered, and DCC No., will be allotted using the … Read more
1.0 Objective: To lay down a procedure for status labeling in the production department.2.0 Scope: This procedure is applicable to the Status Labeling of equipment, cleaning and disinfectant aids, lubricating aids, in-process materials, and excess packing materials in the production areas.3.0 Responsibility: Officer, Executive – Production DepartmentManager – Production DepartmentQA Officer – In the process … Read more
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
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
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
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
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 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
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: 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
A Ball Mill is used to grind the materials to get a course or fine powder. Ball mill is also known as the tumbling mill and pebble mill. Principle Ball mill principle work on Impact and Attrition. Both are responsible for size reduction, rapidly moving balls are used for reducing the size of brittle materials. … Read more