Annexure for Decontamination Autoclave

The autoclave is most commonly used for the decontamination of the laboratory. It works on killing the micro-organism by applying high-temperature steam per predetermine criteria. The attached annexure for the different processes is given below: Equipment:    Decontamination Autoclave                                  Process:   Vacuum leak test Annexure-1 Set parameters 1 Pre Vacuum -0.700 2 Delay before hold 3 Min … Read more

SOP on Cleaning and Operating of ZEBRA Printer

1.0 Objective: To lay down a procedure for Cleaning and Operating of ZEBRA Printer.2.0 Scope: This sop is applicable to the formulation plant Make/Model: ZEBRA3.0 Responsibility: 3.1 Trained worker / Operator shall be responsible for cleaning and operating the machine as per this SOP.3.2 Production Supervisor / Officer shall be responsible for the implementation of … Read more

Procedure for Operation of 37 Stations Double Rotary Compression Machine

1.0 Objective: To lay down a procedure for the operation of 37 stations double rotary compression machine.2.0 Scope: This procedure is applicable to the operation of 37 station double rotary compression machines in the production department.3.0 Responsibility:Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure:4.1 Ensure that the equipment and area are cleaned and … Read more

Procedure for Issuance, Use, and Retrieval of Punches and Dies

1.0 Objective: To lay down a Procedure for Issuance, Use, and Retrieval of the Punches and Dies.2.0 Scope: This procedure is applicable to the issuance, use, and retrieval of the punches and dies used in the production department.3.0 Responsibility:Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 Issuance of dies and punches:4.1.1 Issue … Read more

SOP on Procedure for Making Entries in Equipment Usage Log Book

1.0 OBJECTIVE: To lay down a Procedure for Making Entries in Equipment Usage Log Book. 2.0 SCOPE: This Procedure for Making Entries in Equipment Usage Log Book in the production department. 3.0 RESPONSIBILITY:Officer, Executive – Production DepartmentManager – Production Department 4.0 PROCEDURE:4.1 Record the usage, cleaning, and preventive maintenance activity of idle time in the … Read more

SOP on Operation of 35 Station Double Rotary Compression Machine.

1.0 Objective: To lay down a procedure for the operation of 35- a station double rotary compression machine.2.0 Scope: This procedure is applicable to the operation of 35- a station double rotary compression machine in the production department.3.0 Responsibility: Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 Ensure that the equipment and … Read more

SOP on IR Moisture Balance, Operation, and Calibration

1.0 Objective: To lay down a procedure for operation calibration and cleaning of IR Moisture Balance.2.0 Scope: This procedure is applicable to operation calibration and cleaning of IR Moisture Balance in the production department.3.0 Responsibility:Operator, Officer, and Executive – Production DepartmentManager – Production Department4.0 Definitions:NA 5.0 Procedure for IR Moisture Balance :5.1 Setting:5.1.1 Adjust the … Read more

Sop for Destruction of Rejected Dies and Punches

1.0 Objective: To lay down a procedure for the destruction of rejected dies and punches.2.0 Scope: This procedure is applicable to the destruction of rejected dies and punches used in the production department. 3.0 Responsibility:Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure:4.1.1 Assemble all the defective punch sets, defective upper punches, lower punches, … Read more

SOP on Destruction of Rubber Stereos

1.0 OBJECTIVE: To lay down a procedure for the destruction of rubber stereos.2.0 SCOPE: This procedure is applicable to the destruction of rubber stereos in the Production department.3.0 RESPONSIBILITY:Officer, Executive – Production Department, Quality assurance DepartmentManager – Production Department 4.0 PROCEDURE :4.1 Collect the used stereos after completion of packing. Verify that the quantity is … Read more

SOP on Indent and Approval of Rubber Stereo for Overprinting

1.0 OBJECTIVE: To lay down a procedure for indent and approval of rubber stereo for overprinting of batch details on printed packaging material.2.0 SCOPE: This procedure is applicable to indenting and approval of stereo for overprinting of packing material in the production department.3.0 RESPONSIBILITY: Officer, Executive – Production DepartmentManager – Production Department 4.0 PROCEDURE:4.1 Stereo … Read more

SOP on Cleaning of Coating Solution Preparation Tank

1.0 Objective: To lay down a procedure for cleaning of coating solution preparation tank. 2.0 Scope: This SOP is applicable to the cleaning of the coating solution preparation tank in the production department. 3.0 Responsibility:Operator responsible for cleaning Officer, and Executive – Production Department to ensure activity as per given procedureManager – Production Department for … Read more

SOP to Initiate, Incorporate, Approve and Record Changes to the Master Documents

Objective: To initiate, incorporate, approve and record changes to the master documents. Scope: This Sop is applicable to the Credence Pharmaceuticals for changes to the master documents. Responsibility: All the functional Heads. Accountability: Head – Quality Assurance. Documentation:Document Change Control -D083ARevision History -D084AFilling procedure for Document Change Control -(D083A)DCC No: Document change control number is … Read more

SOP on Transfer of Finished Products to Finished Goods Stores

1.0 OBJECTIVE:   To lay down a procedure for the transfer of finished products to finished goods stores. 2.0 SCOPE:   This procedure is applicable for the transfer of finished products to finished goods stores in the production department. 3.0 RESPONSIBILITY:   Officer, Executive – Production Department Manager – Production Department In charge – Stores … Read more

SOP on Indent, Inspection, and Maintenance of Punches and Dies

1.0 Objective: To lay down a procedure for indent, inspection, and maintenance of punches and dies.2.0 Scope: This procedure is applicable to indent, inspection, and maintenance of punches and dies used in the production department.3.0 Responsibility:Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure:4.1 Indent of dies and punches:4.1.1 For ordering a new … Read more

SOP on Disintegration Test (DT Apparatus ) Cleaning, Operation, and Calibration

1.0 Objective: To lay down a procedure for cleaning, Operation, and Calibration of Disintegration test apparatus.2.0 Scope: This procedure is applicable to the cleaning, operating, and calibration of the Disintegration test apparatus used in the production department. 3.0 Responsibility:Officer, Executive – Production DepartmentManager – Production Department, QA Officer – In the process 4.0 Procedure:4.1 Cleaning4.1.1 … Read more

SOP on Cleaning, Operation of the Automatic Dosing Cap Pressing Machine

1.0 OBJECTIVE: To lay down the procedure for Cleaning and Operation of the automatic dosing cap pressing machine.2.0 SCOPE: This procedure is applicable for the Cleaning and Operation of the automatic dosing cap pressing machine in the liquid department. 3.0 RESPONSIBILITYOperator, Officer, Executive – Production DepartmentManager – Production Department 4.0 PROCEDURE4.1 Cleaning4.1.1 Batch-to-Batch change over … Read more