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
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
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
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
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
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
Standard operating procedure on Procedure for Hot Air Oven Operation & Calibration
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
Aggregation and Disaggregation is an important aspect of pharmaceutical industries to get a product to be serialized. Aggregation in a simple way is the process of making Groups bundles of serialized Products. A Group bundle contains information about the products throughout the supply chain. This process makes forms a hierarchical, parent-child relationship through the process … Read more