1.0 Purpose: The standard procedure; Aseptic Handling, Operation and Aseptic Connection apply to the aseptic technique which refers to the system of working while performing procedures that are to be carried out under sterile conditions. The aim is to prevent microbial contamination while media simulation, manufacturing products, blending procedures, and aseptic connection. 2.0 Applicable: This … Read more
1.0 Objective: To lay down a procedure for the Operation and cleaning of Fluidized Bed Drier.2.0 Scope: This SOP is applicable to the Operation and cleaning of a Fluidized Bed Drier in the production area.3.0 Responsibility: Operator, Officer, Executive- Production DepartmentManager- Production Department 4.0 Procedure for Operation and Cleaning of Fluidized Bed Drier:4.1 Machine setting: … Read more
Objective: To initiate, incorporate, approve and record changes to the master documents. Scope: This Sop is applicable for changes to the master documents. Responsibility: All the functional Heads. Accountability: Head – Quality Assurance. Filling procedure for Document Change Control DCC No: Document change control number is entered, and DCC No., will be allotted using the … Read more
1.0 Objective: To lay down a procedure for status labeling in the production department.2.0 Scope: This procedure is applicable to the Status Labeling of equipment, cleaning and disinfectant aids, lubricating aids, in-process materials, and excess packing materials in the production areas.3.0 Responsibility: Officer, Executive – Production DepartmentManager – Production DepartmentQA Officer – In the process … Read more
1.0 Objective: To lay down a procedure for the operation of the Blister Pack Machine.2.0 Scope: This procedure is applicable to the operation of the Blister Pack Machine in the production area.3.0 Responsibility: Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure for Blister Pack Machine: 4.1 Ensure the area and equipment are … Read more
1.0 Purpose: To lay down the procedure for handling, investigating, and reporting of Out of Specification (OOS) results obtained during laboratory testing. This procedure provides guidance to assure that the investigations are conducted in a timely manner with appropriate depth and are supported by the necessary documentation to perform root cause analysis as appropriate. 2.0 … Read more
1.0 OBJECTIVE: To lay down a procedure for making entries in the inward/outward register.2.0 SCOPE: This procedure is applicable to making entries in the inward/outward register in the production area. 3.0 RESPONSIBILITY:Officer, Executive – Production DepartmentManager – Production Department4.0 PROCEDURE:4.1.1 Inward entry is to be made when the material of a particular batch is transferred … Read more
1.0 OBJECTIVE: 1.1 To lay down the procedure for the Corrective and Prevention Action for non-conforming resultsin total microbial count in water samples 2.0 SCOPE: 2.1 This procedure is applicable to the utility department and all the production department 3.0 RESPONSIBILITY 3.1 Microbiologist3.2 Head – Microbiology3.3 Head – Production Block3.4 Head Engineering and Utility 4.0 … Read more
1.0 Objective: Media is the main source of growth of the microbial. To detect the microbes in the test samples we can follow some guidelines for the preparation of the Media. 2.0 Scope: This procedure is applicable to Microbiology Department. 3.0 Responsibility:The microbiology officer is responsible to implements this SOP.Head Department is responsible for overall … Read more
Standard operating procedure on Procedure for Hot Air Oven Operation & Calibration
1.0 Objective: To lay down a Procedure for the Usage, Control, and Storage of Change Parts for liquid orals.2.0 Scope: This procedure is applicable for the proper usage and control of change parts of the Bottle washing machine and Monoblock bottle filling & sealing machine in the liquid department. 3.0 Responsibility:Operator, Officer, Executive – Production … Read more
1.0 Objective: The purpose of this SOP is to lay down the procedure for the operation of the Pharmacode Reader. 2.0 Scope: This SOP is applicable for the operation of a pharmacode reader in the production area. 3.0 Responsibility: 3.1 The production officer/ sr.officer is responsible for the implementation of this sop. 3.2 The Head … Read more
1.0 Purpose: To lay down the procedure for the operation and cleaning of the decontamination autoclave.2.0 Aim: This Standard Operating Procedure is applicable for the operation and cleaning of the decontamination autoclave, at the Production facility.3.0 Responsibility:3.1 Officers/ Sr. Officers shall be responsible to do the process.3.2 Manager Production shall be responsible for the training … Read more
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
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
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