Engineering

Operational qualification protocol cum report shall consist of minimum contents but not limited to. Overview Purpose Background Responsibility Requalification System Description HANDLING, MANAGEMENT, AND INVESTIGATION OF DEVIATION Operational Qualification Procedure Training Date Calibration Review Key Functionality Safety Features SOP verification Preventive maintenance procedure verification Operational testing Deficiency (if any) and …

Operation cum performance qualification protocol cum report shall consist of minimum contents,but not limited to. TITLE Pre Approval Overview Purpose Background Responsibility Requalification System Description FBD Machine Operational Qualification Procedure Training Date Calibration Review Key Functionality Safety Features SOP verification Preventive maintenance procedure verification Operational testing Performance Qualification Results Deficiency …

Performance qualification protocol cum report shall consist of minimum contents but  not be limited to TITLE Pre Approval Overview Purpose Background Responsibility Requalification System Description Performance Qualification Procedure Training Date Performance Qualification Results for Run-1 Performance Qualification Results for Run -2 Performance Qualification Results for Run-2 Deficiency (if any) and …

Operation & time verification of digital clock Digital Clock: A digital clock is a type of clock that displays the time digitally (i.e. in numerals or other symbols) as opposed to an analogue clock. Digital clocks are often associated with electronic drives but the “digital” description refers only to the …

The compressed air system in Pharma The Moisture free Compressed Air system comprises of state-of-the-art Vertical single cylinder reciprocating air-cooled compressor with a “V” Belt arrangement, starter cum control panel, safety devices, interconnecting piping, cabling, etc. and accessories duly mounted on a rigid steel deck. These packages are provided with …

Accident Management To establish procedures to be followed at the time of any accident during production operation. RESPONSIBILITY: Department in charge –Implementation of SOP & Documentation. Production Supervisor  (Present at the time of the accident) – To take the necessary action as per SOP. S&E Person – Clearance from S&E aspects. ACCOUNTABILITY: Production HEAD …

PROCEDURE FOR QUALIFICATION/ REQUALIFICATION OF SYSTEM/ EQUIPMENT/ UTILITY/ INSTRUMENTS PURPOSE To describe the procedure for preparation of qualification protocols, and reports and provide the guidelines for execution of qualification activity and related documentation. SCOPE This SOP shall be applicable for the qualification of all newly procured and upgraded systems/ equipment/utilities …

Temperature mapping protocol A well-designed protocol will help ensure that the mapping study is correctly carried out. To cover the full range of temperature regimes, a standard protocol can be used to map any storage area in the facility The mapping protocol should contain the following sections: a. Approval page …

Temperature Mapping report template The mapping report should include the following sections: a. Introduction: a description of the objectives of the mapping study. b. Summary: a summary and discussion of the results organized in the sequence set out in the mapping protocol, including a summary of deviations (if any). c. …

Electronic data logging monitor (EDLM): A small portable device that measures and stores temperature readings at predetermined time intervals by means of an electronic sensor. They have programmable alarm capabilities, and integrated displays, and can create reports and graphs which may be permanently stored, shared, and analyzed via proprietary hardware, …