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
1.0 Purpose: To define the SOP for the Operation of a Stainless Steel Reactor.2.0 Scope: This procedure is applicable to the Operation of all stainless steel Reactor in the Production Department.3.0 Responsibility:Officer/Executive – Production.4.0 Accountability:Head – Production 5.0 Procedure:5.1 Check the “CLEANED” label is affixed to Reactor.5.2 Before starting the operation Check the calibration tags … Read more
1.0 Purpose: To lay down the procedure for cleaning and operating the Automatic strapping (banding) machine.2.0 Aim: This Standard Operating Procedure is applicable to the cleaning and operation of the automatic strapping (banding) machine Production floor. 3.0 Responsibility:3.1 The Line coordinators will carry out the cleaning and operation of the banding machine.3.2 Officer of the … Read more
FIFO, FEFO, and LIFO are three different methods used in inventory management, warehouse management, and Pharmacy management to determine the order in which items are sold or used. Let’s understand the difference between FIFO, FEFO, and LIFO. What is FIFO FIFO Principle stands for “First In, First Out,” meaning that the first item that was … Read more
1.0 Objective: To lay down the procedure for Sanitization of the Storage tank and Distribution Loopline and cleaning of DM and RO water storage tank.2.0 Scope: This procedure is applicable for the Sanitization of the Storage tank and Distribution Loopline and cleaning of DM and RO water storage tank in liquid oral department.3.0 Responsibility: 3.1 … Read more
1.0 Purpose: To describe the procedure for operation and cleaning of mobile SIP unit2.0 Aim: This Standard Operating Procedure is applicable for the operation and cleaning of mobile SIP unit.3.0 Responsibility: 3.1 The operator is responsible for operation and cleaning as per SOP.3.2 Officer/Executive shall supervise the process.3.3 Production manager for implementation of SOP.3.4 Head … Read more
1.0 Purpose: To lay down the procedure for the operation and cleaning of tray loading machine.2.0 Aim: This Standard Operating Procedure is applicable to the cleaning and operation of tray loading machine, located on the production floor.3.0 Responsibility:3.1 The line coordinators shall carry out the process.3.2 Officers/Executives shall be responsible to supervise the process.3.3 Production … Read more
1.0 Purpose: To lay down a procedure for the operation of Box Cutting and Vial loading.2.0 Aim: This Standard Operating Procedure is applicable to the operation of Box Cutting and Vial loading.3.0 Responsibility: 3.1 Trained operators shall be responsible for Box cutting and vials 3.2 Officers/Sr. Officer for working operation of Box Cutting and Vial … Read more
1.0 Purpose: To describe the procedure for tub handling of prefilled syringes of filling machine.2.0 Aim: This Standard Operating Procedure is applicable for tub handling of prefilled syringes of filling machine at Production.3.0 Responsibility:3.1 Officer Production3.2 Head Production4.0 Safety considerations:4.1 Handle the tubs with care while transferring them from one place to another place.4.2 Ensure … Read more
1.0 Purpose: To describe the procedure for cleaning and operation of vacuum scrubber.2.0 Aim: This Standard Operating Procedure is applicable to the cleaning and operation of vacuum scrubber present at the Production facility. 3.0 Responsibility:3.1 Officer / Sr. Officer & line coordinator shall execute this SOP.3.2 Head production to ensure implement this SOP.3.3 Head-QA shall … Read more
1.0 Purpose: To describe the procedure for the transfer of semi packed material to warehouse.2.0 Aim: This Standard Operating Procedure is applicable to the transfer of semi packed material from production to the warehouse.3.0 Responsibility:3.1 Officer Production3.2 Head production4.0 Safety considerations:4.1 Always keep the PFS tubs/vials in an upright position.4.2 Transfer the material immediately after … Read more
1.0 Purpose: To lay down a procedure for the preparation of rubber bungs.2.0 Aim: This Standard Operating Procedure is applicable for the preparation of rubber bungs. 3.0 Responsibility:3.1 Operator/ Sr. Operator is responsible for carrying out the operation process.3.2 Officers/Executives shall be responsible to supervise the process.3.3 Production-Head/Manager shall be responsible for the implementation of … Read more