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
Pharmacode primary function is to confirm that the pharmaceutical product in a package is the correct product, as well as the relevant associated documentation. It is a packing control system that is intended to eliminate packing errors. Scanning Direction and Pharmacode Numbers Pharmacode is only intended to be scanned in one direction. Scanning it from … Read more
1.0 Objective: To lay down a Procedure for the Usage, Control, and Storage of Change Parts for liquid orals.2.0 Scope: This procedure is applicable for the proper usage and control of change parts of the Bottle washing machine and Monoblock bottle filling & sealing machine in the liquid department. 3.0 Responsibility:Operator, Officer, Executive – Production … Read more
1.0 Objective: The purpose of this SOP is to lay down the procedure for the operation of the Pharmacode Reader. 2.0 Scope: This SOP is applicable for the operation of a pharmacode reader in the production area. 3.0 Responsibility: 3.1 The production officer/ sr.officer is responsible for the implementation of this sop. 3.2 The Head … Read more
The Cleaning Validation Protocol is an essential part to execute the cleaning validation process. Title of Contents Objective Scope Responsibility Procedure Sampling Plan Sampling Points Test/Method Acceptance Criteria ANNEXURE A – Cleaning Validation Test Request Form ANNEXURE B – Cleaning Validation Test Report ANNEXURE C – Cleaning Validation Test Report 1.0 OBJECTIVE To assure that … Read more
Pharmaceutical organizations required Standard grads equipment for the different sections to carry out processes or manufacturing of products. A new pharma manufacturer doing a hard struggle to find and prepared a list of Pharma equipment to purchase as per their capacity requirement. So the common list of pharma equipment is given below for the different … Read more
Way to Improve Investigation Report in Pharmaceuticals: It becomes very important for organizations to write an investigation report while getting any observations during routine audits or external audits. As before FDA had issued more than a hundred of 483 observations during the last few years. The organization gets a chance to comply with the observation … Read more
Human bodies are natural hosts to harmful bacteria, and if we’re sick or infected, dangerous viruses and fungi are as well. We also constantly shed tons of hair and skin cells and breathe out a plume of various microorganisms. So following the Gowning procedure in CleanRoom becomes an important task for working persons. Today Life … Read more
1.0 Purpose: To lay down the procedure for the operation and cleaning of the decontamination autoclave.2.0 Aim: This Standard Operating Procedure is applicable for the operation and cleaning of the decontamination autoclave, at the Production facility.3.0 Responsibility:3.1 Officers/ Sr. Officers shall be responsible to do the process.3.2 Manager Production shall be responsible for the training … Read more