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
1.0 Purpose: The purpose of this SOP for cleaning the glassware.2.0 Scope: This standard operating procedure is applicable to glassware in the Quality Control department at pharmaceuticals.3.0 ResponsibilityOfficer to implement this procedureHead QC/Executive – Responsible for overall compliance with this SOP.4.0 AccountabilityIn charge – Quality Control 5.0 Procedure5.1 Send the used glassware for cleaning after … Read more
Objective: To lay down procedures for validation of Analytical Procedures to be followed in the laboratory. The AMV (Analytical method Validation) aims to demonstrate that it is appropriate for the purpose.Scope: This SOP is applicable in Analytical Research and Development Laboratory (ADL) for validation or verification of analytical procedures at the Pharmaceutical Quality control laboratory. … Read more
The accelerated Stability Study method is developed to predict the stability and shelf life of products under normal or recommended storage conditions by different guidelines. These recommended methods are used to carry out a study of products under different accelerated conditions by using temperature, moisture, and light. As can say an accelerated stability study is … Read more
1.0 PURPOSE: The purpose of this Standard operating procedure is to provide an operating procedure for the fire extinguishers.2.0 SCOPE: The procedure is relevant for Fire Extinguishers in industries.3.0 RESPONSIBILITY: Safety department, EHS department, and Security department.4.0 ACCOUNTABILITYHead – Engineering/Environment and Health Safety 5.0 PROCEDURE:5.1.0 Fire is classified into four types based on its usage:5.1.1 … Read more
1.0 Purpose: The purpose of this SOP is to provide instruction for the Retesting and Resampling of raw materials and intermediates.2.0 Objective: To provide a documented procedure for Retesting and Resampling of raw materials and intermediates.3.0 Scope: This procedure is applicable for the Retesting and Resampling of raw materials and intermediates in the QC department.4.0 … Read more