The Cleaning Validation Protocol is an essential part to execute the cleaning validation process. Title of Contents Objective Scope Responsibility Procedure Sampling Plan Sampling Points Test/Method Acceptance Criteria ANNEXURE A – Cleaning Validation Test Request Form ANNEXURE B – Cleaning Validation Test Report ANNEXURE C – Cleaning Validation Test Report 1.0 OBJECTIVE To assure that … Read more
Pharmaceutical organizations required Standard grads equipment for the different sections to carry out processes or manufacturing of products. A new pharma manufacturer doing a hard struggle to find and prepared a list of Pharma equipment to purchase as per their capacity requirement. So the common list of pharma equipment is given below for the different … Read more
Way to Improve Investigation Report in Pharmaceuticals: It becomes very important for organizations to write an investigation report while getting any observations during routine audits or external audits. As before FDA had issued more than a hundred of 483 observations during the last few years. The organization gets a chance to comply with the observation … Read more
Human bodies are natural hosts to harmful bacteria, and if we’re sick or infected, dangerous viruses and fungi are as well. We also constantly shed tons of hair and skin cells and breathe out a plume of various microorganisms. So following the Gowning procedure in CleanRoom becomes an important task for working persons. Today Life … 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
Air changes in pharmaceutical cleanrooms play a significant role in maintaining the cleanroom quality as per ISO CleanRoom Classification through the HVAC system. Air change per hour is the number of total replacements of any room air in one hour. if the supply of air by the HVAC system in one houres is equal to … Read more
ISO CleanRoom Classification is done to define the limit of particles as per the standardized or predetermined criteria. A cleanroom is one where the viable count and particle count are kept within predetermined and standardized ranges. These rooms must always be kept at the specified level of cleanliness, as their name suggests, and cleaning is … 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
Markers for Liver Function Liver function tests also called hepatic panels, are blood tests used to monitor liver function and damage. These tests provide insights into several aspects of liver health, notably. the liver’s ability to synthesize enzymes and proteins, the liver’s ability to process bilirubin and secrete bile, and the extent of liver damage. … Read more
SCADA stands for Supervisory Control and Data Acquisition. It is a collection of software and hardware components that enable local and remote plant monitoring and control. Furthermore, the SCADA analyzes, collects, and processes data in real-time. SCADA Functions Users can communicate with field devices such as pumps, valves, motors, sensors, and more using human-machine interface … 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
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
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
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
In Pharmaceuticals it is very important to maintain the area as per the products or requirements of GMP. so what if the area where the product is not manufactured? So Based on activity Pharmaceutical industries divided areas into classified and non-classified areas/ Unclassified. The few concepts while Understanding the basic difference between Classified and Non-classified … Read more