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
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
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
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
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
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
1.0 Objective: To lay down a procedure for disposal in the tablet department.2.0 Scope: This procedure is applicable to disposal in the production department.3.0 Responsibility:Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure Disposal in Tablet: 4.1 All used polythene bags (used for granules, raw materials, compressed and coated tablets, etc.) are collected in … Read more
1.0 Objective: To lay down a procedure for footwear Cleaning.2.0 Scope: The procedure is applicable to the cleaning of footwear used in the production department.3.0 Responsibility:Housekeeping personnelOfficer, Executive – Production DepartmentManager – Production Department 4.0 Procedure:The frequency of cleaning shoes is once a week4.1 Collect all the footwear from the male and female change room … Read more
The autoclave is playing a vital role in the Microbiology department. Before testing any material, except the sample, all preparations including glassware must be autoclaved for sterilization of the preparations ( free from microbial load ). 1.0 Objective: To lay down standard operating procedure on operation and calibration of autoclave 2.0 Scope: This procedure is applicable to … Read more
1.0 Objective: To lay down a procedure for the movement of material from one stage to another.2.0 Scope: This procedure is applicable for the movement of material from one stage to another stage during various processes in the production department.3.0 Responsibility:Operator, Officer, and Executive – Production DepartmentManager – Production Department4.0 Definitions:NA 5.0 Procedure:5.1 Store to … Read more
1.0 Objective: To lay down the procedure for operation of Filter Press. 2.0 Scope: This procedure is applicable for the operation of the Filter Press in the liquid oral department. 3.0 Responsibility:Production Officer, Production Executive. 4.0 Procedure:4.1 Assembling: 4.1.1 The filter press consists of 9 sets of filter plates, mesh, and non-woven filter pads alternating … Read more
1.0 Objective: To lay down a procedure for monitoring temperature, relative humidity, and differential pressure in the production area.2.0 Scope: This procedure is applicable to the monitoring of temperature, relative humidity, and differential pressure in the production area.3.0 Responsibility: Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure:4.1 Recording of Temperature and relative humidity:4.1.1 … Read more
1.0 Objective: To lay down a procedure for Inventory and storage of sieves, screens. 2.0 Scope: This procedure is applicable to Inventory management and storage of sieves, screens. 3.0 Responsibility: Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 Inventory4.1.1 On intimation of receipt from stores, collect all the sieves/screens from the … Read more
1.0 OBJECTIVE: To lay down a procedure for cleaning of new equipment/machinery / in-process product containers/accessories received. 2.0 SCOPE: This procedure is applicable to the cleaning of new equipment/machinery / In-process product containers/accessories in the production department. 3.0 RESPONSIBILITY:Officer, Executive – Production DepartmentManager – Production Department 4.0 DEFINITION(S): Accessories: Sieves, screens. Spatulas, scoops SS jugs, … Read more
1.0 OBJECTIVE: 1.1 To define SOP on Change Control to be made in the authorized documents, validated methods, process, procedures, facilities, and equipment. 2.0 RESPONSIBILITY2.1 Assistant / Chemist / Executive – To initiate the Change Control Form.2.2 Respective Department Head – To evaluate and justify the required change.2.3 Other Departments Heads – To review and … Read more
1.0 OBJECTIVE: To lay down a procedure for handling products during a power failure in the production area.2.0 SCOPE: This procedure is applicable to the handling of products during a power failure in the production area.3.0 RESPONSIBILITY:Officer, Executive – Production Department, Quality AssuranceManager – Production Department, Quality Assurance4.0 DEFINITION(S):NA 5.0 PROCEDURE: 5.1 Action to be … Read more