1.0 Purpose: To lay down the procedure for cleaning and storage of filling accessories.2.0 Aim: This Standard Operating Procedure is applicable to the cleaning and storage of filling accessories at the production department.3.0 Responsibility:3.1 Operator shall carry out the operation process.3.2 Officers shall be responsible to supervise the process.3.3 Head Production/ Designee shall be responsible … Read more
Pithampur is a town located in the Dhar district of Madhya Pradesh, India. There are several small and large-scale pharmaceutical companies located in Pithampur. Major pharmaceuticals like Cipla Ltd, Lupin Ltd. Glenmark Pharma, Torrent Pharma, and Alkem Lab produce a wide range of drugs and medicines. Some of the major Pharma companies in Pithampur are: … Read more
In the pharmaceutical industry, Engineering & Utility equipment is very essential components of manufacturing drugs. Pharmaceutical manufacturing in the production area requires technical equipment to produce drugs. The pharmaceutical manufacturing process controls various parameters such as temperature, pressure, and flow rate. Engineers develop and implement process control systems that ensure consistent product quality and safety. … Read more
1.0 Objective: 1.1 To describe the procedure for Bills Realization. 2.0 Scope: 2.1 This procedure applies to the Purchase department in Pharmaceuticals. 3.0 Responsibility: 3.1 Asst. Manager- Purchase 4.0 Accountability:4.1 General Manager – Purchase in coordination with respective Department Heads like QC and Stores. 5.0 Procedure for Bill Realization 5.1 The nature of deviations may … Read more
The sugar coating of tablets process involves building up layers of coating materials on tablet cores by repetitively applying a coating solution or suspension and drying off the solvent. Sugar coating insulates and masks the color and texture of the core of the tablet. Here in this article, you will learn about the steps of … Read more
The validation Protocol for the Hold time study of Garments has been done to ensure that the suggested method of the sterile garment is capable of being free from microbial contamination for daily use in the Sterile section. Aim: To validate the Hold time study for ‘STERILE GARMENTS’ and to establish documented evidence to ensure … Read more
Design Qualification Protocol Vertical Laminar Reverse Flow Powder Containment Station has the following Table of content: 1.0 OBJECTIVE of Design Qualification Protocol: To design, engineer, and supply the Vertical Laminar Reverse Flow Powder Containment Station, Model: (Modal Name) to assure that the machine is manufactured as per the URS and complies with the Scope of … Read more
1.0 Purpose: To lay down the procedure for the operation and cleaning of lyophilizer.2.0 Aim: This Standard Operating Procedure is applicable to the cleaning and operation of the Lyophilizer, located on the production floor.3.0 Responsibility:3.1 Officer Production3.2 Head Production 4.0 Safety considerations:4.1 Persons who are familiar with the basic safety and accident prevention regulations and … Read more
1.0 Purpose: To describe the procedure for auto-mode Sterilization of Piping System of blending Tanks.2.0 Aim: This Standard Operating Procedure is applicable to auto-mode Sterilization of Piping System of blending Tanks in solution preparation and formulation blending tanks. 3.0 Responsibility: 3.1 Officer/Executive line coordinator shall execute this SOP.3.2 Production Head/designee shall be responsible for implementation … Read more
1.0 Purpose: To lay down the procedure for manual visual inspection of filled vials.2.0 Aim: This Standard Operating Procedure is applicable for packing vaccines at the packing section. 3.0 Responsibility:3.1 Trained operators for visual inspection activities of vials.3.2 Officer is responsible for checking the activity.3.3 IPQA shall be responsible for compliance as per this SOP.3.4 … Read more
1.0 Purpose: To lay down the procedure for the operation of the particle counter2.0 Aim: This Standard Operating Procedure is applicable to the operation on the Production floor. 3.0 Responsibility:3.1 Line coordinators shall execute the process.3.2 Officer / Sr. Officer shall check & control the activity.3.3 Production Head shall be responsible for the execution of … Read more
1.0 Purpose: To describe the procedure for cleaning, sterilization, and operation of a Magnetic Stirrer.2.0 Aim: This Standard Operating Procedure is applicable for cleaning, sterilization, and operation of the Magnetic Stirrer.3.0 Responsibility:3.1 The line coordinator shall be responsible to carry out the procedure as per SOP.3.2 In-Charge/ Officer shall be responsible for checking and compliance … Read more
1.0 Objective: To describe the written standard procedure for the Operation & Calibration of HPLC LC- 2050C2.0 Scope: This SOP is applicable for the Operation & Calibration of HPLC LC-2050C3.0 Reference: In-House, Instrument Manual4.0 Responsibility: 4.1 Officers and Executive – F&D4.1.1 Proper Operation of HPLC, LC- 2050C4.1.2 Calibration as per frequency & method.4.1.3 To give … Read more
1.0 Objective: To lay down a procedure for the operation, calibration, and cleaning of the Electronic balance.2.0 Scope: This SOP is applicable for the operation & calibration of electronic balance in the Quality Control Department.3.0 Responsibility: Officer, Executive – Quality Control Department.Head – Quality Control Department 4.0 Procedure for Electronic balance:4.1 Operation4.1.1 Ensure the Calibration … Read more
The Weighing Balance Tolerance Limit of a pharmaceutical weighing machine refers to the maximum acceptable range of balance while material weighing that is considered acceptable for installed balance at the manufacturing area. Weighing Balance Tolerance limits are usually calculated by using a %age of the minimum and maximum capacity of the balance. For example, a … Read more
1.0 Objective: To lay down the procedure for Cleaning and Operation of the basket filter assembly.2.0 Scope: This procedure is applicable for the Cleaning and Operation of the basket filter assembly in Liquid orals. 3.0 ResponsibilityOperator, – Production DepartmentOfficer, Executive- Production and QA DepartmentManager – Production and QA Department 4.0 Procedure4.1 Cleaning4.1.1 Remove the “ … Read more