Before beginning an on-site audit, the following Check List for Visitors points should be considered: Using the WHO-GMP Document Checklist can help you understand the requirements during visits to the premises. Document Check List for Visitors Format-B: Product summary sheet Conclusion: A Good Manufacturing Practice (GMP) audit checklist is one of the most effective methods … Read more
1.0 Purpose: To lay down the procedure for Repacking Of Finished Product.2.0 Aim: This Standard Operating Procedure is applicable to the repacking of the finished product on the production floor. 3.0 Responsibility:3.1 Asst. Manager/ Sr. Officer / Officer of the production department shall execute this SOP.3.2 Manager / Sr. Manager Shall supervise that the process is … Read more
Check the following list of Standard operating procedures (SOPs) in the Tablets section of the production
1.0 Purpose: To lay down the procedure to carry out the Fogging at the Production and Service floors.2.0 Aim: This Standard Operating Procedure is applicable to carry out Fogging process on the Production Floor and the service floor of pharmaceuticals. 3.0 Responsibility:3.1 Trained Line coordinators shall be responsible for carrying out the processes.3.2 Sr. officer/officer shall be responsible for supervising … Read more
Pharma SOPs is used as a tool for providing a proper and systematic way to follow all rules and regulation under controlled manners in pharmaceutical industries. The quality assurance department reviews all SOPs before the distribution to the department. Read here the list of all Quality Assurance SOPs. List of all SOPs Related to Quality … Read more
1.0 Purpose: To lay down a procedure for the operation of the pouch sealing machine.2.0 Aim: This Standard operating procedure applies to Pouch Sealing machines located on the production floor.3.0 Responsibility: 3.1 The line coordinators trained in cleaning and operation processes shall carry out the process.3.2 Officers/ Sr. officers shall supervise the process.3.3 Production Manager shall … Read more
Bhiwadi is situated in Rajasthan India. At Bhiwadi, there are lots of Pharmaceutical manufacturing companies involved in the manufacturing of medicines. Bhiwadi is 70 kilometers from Delhi and 200 kilometers from Jaipur and 40 kilometers from Gurugram. The top pharmaceuticals in Bhiwadi like Kusum Healthcare Ahlcon Parenteral India Ltd (B. Brawn group) and is also … Read more
1.0 Objective: To lay down the procedure for Sanitizing Solution Preparation in the manufacturing area.2.0 Scope: This standard operating procedure applies for Sanitizing Solution Preparation in the production area.3.0 Responsibility: Housekeeping personnel, Officer, Executive – To follow this procedureManager – To execution this procedure 4.0 Procedure: 4.1 Safety Precautions4.1.1 Use proper safety apparel such as gowns, rubber hand … Read more
pH meter is used to measure the acidity and alkalinity of a solution by measuring Hydrogen ion concentration in a solution. pH Meter Calibration is required at regular intervals or as per the defined frequency to maintain its accuracy. Here, we will discuss the pH meter principle, ph meter electrode, Range of pH, Calibration, Key … Read more
1.0 Objective: To lay down a procedure for the operation of Auto Coater.2.0 Scope: This procedure is applicable to the operation of Auto Coater in the production area.3.0 Responsibility: Officer – for implementation of this procedureManager production is responsible for overall compliance with this procedure. 4.1 Machine Setting Operation Of Auto Coater: 4.1.1 Ensure that the equipment and … Read more
IPQA Person plays a very important role in the quality of drugs or products during manufacturing. She/ He is responsible for carrying out all the processes as per standard operating procedures during manufacturing to ensure quality. The line clearance stage is the very crucial stage before starting a product. So the role of the IPQA … Read more
1.0 Objective: To lay down a procedure for the operation of the strip pack machine.2.0 Scope: This standard operating procedure is applicable to the operation of the strip pack machine used in the production department.3.0 Responsibility: Officer and Executive – for implementation of this procedure.Manager Production is responsible for overall compliance with this procedure. 4.0 Procedure: 4.1 Machine Setting:Ensure … Read more
Six Sigma is an extremely disciplined activity that focuses on growing and giving close to excellent products and services. Six Sigma focuses on what’s necessary for the client. It reduces method variation defects, so nearly all the product or services provided meet client expectations. Six Sigma has been utilized by some of the world’s most … Read more
1.0 Objective: To lay down a procedure for the operation of Colloidal Mill.2.0 Scope: This standard operating procedure is applicable to the operation of Colloidal Mill in the production area.3.0 Responsibility: Officer, Executive – To implement this procedureHead of Department – To overall compliance with this procedure 4.0 Procedure:4.1 Operation of colloidal mill:4.1.1 Ensure cleanliness … Read more
Good Laboratory Practice (GLP) is a set of guidelines that helps ensure the quality and reliability of pharmaceutical laboratory data. These GLP guidelines are important because they help to prevent errors and they also ensure that data collected during laboratory testing is accurate and consistent. Understanding GLP guidelines in Pharmaceuticals: Good Laboratory Practice (GLP) guidelines … Read more
1.0 Objective: To lay down a procedure for the operation of Multimill.2.0 Scope: This procedure is applicable to the operation of Multimill located in the manufacturing area.3.0 Responsibility:Officer, Executive – To the implementation of this procedureManager – For overall compliance with this procedure 4.0 Procedure:4.1 Machine setting4.1.1 Ensure that the machine is cleaned before setting.4.1.2 … Read more