SOP ON SWAB /RINSE SAMPLING PURPOSE: To lay down a procedure for sampling a swab or rinse sample from different equipment or areas. SCOPE: This SOP applies to sampling rinse or swabs from different equipment/parts/areas at various stages of product processing. REFERENCE: In-House CROSS-REFERENCE DOCUMENTS Quality Risk Management SOP on Investigation ATTACHMENTS: S.No. Attachment No. Attachment…
PRODUCT PROCESS QUALIFICATION (PPQ) PURPOSE: The purpose of this procedure is to provide a high degree of assurance of meeting all the predefined attributes and the process is capable of consistently delivering quality products. SCOPE: This SOP is applicable for Process Qualification activities of drug products manufactured. REFERENCE(S) ISPE, Volume 5, Commission & Qualification. Guidance for Industry:…
PROCEDURE FOR CLEANING, OPERATION AND CALIBRATION OF MICROMETER SCREW PURPOSE: To lay down a procedure for the Operation and calibration of a micrometer screw. SCOPE: This procedure is applicable for the Operation and calibration of micrometer screws. REFERENCE: In-House DEFINITION: MICROMETER SCREW: A Micrometer is a measuring device used for taking the exact measurement of an object. It…
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PROCEDURE FOR CLEANING, OPERATION AND CALIBRATION OF TACHOMETER PURPOSE: To lay down a procedure for Cleaning, Operation, and Calibration of the Tachometer. SCOPE: This procedure is applicable for the Cleaning, Operation, and Calibration of Tachometer screw in the Quality assurance Department. REFERENCE: In-House DEFINITION TACHOMETER: A tachometer is an instrument that is used to measure the speed of an…
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CLEANING, OPERATION, AND CALIBRATION PROCEDURE OF FRIABILITY TEST APPARATUS PROCEDURE OF CLEANING, OPERATION, AND CALIBRATION PROCEDURE OF FRIABILITY TEST APPARATUS: SAFETY/PRECAUTION OF CLEANING, OPERATION AND CALIBRATION PROCEDURE OF FRIABILITY TEST APPARATUS: Make sure that knob is properly fitted on the shaft to assure the drum is held in the position. Do not hold the drum while…
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PROCEDURE FOR OPERATION AND CALIBRATION OF STOPWATCH PURPOSE: To describe the procedure for the operation and calibration of the watch. SCOPE: This Standard Operating Procedure (SOP) shall be applicable at this company. REFERENCES: In House CROSS-REFERENCE DOCUMENTS Procedure for in-house & outside party calibration Preparation, review, approval, issuance & retrieval of standard operating procedures (SOPs) Documents…
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PROCEDURE FOR CLEANING, OPERATION AND CALIBRATION OF DIGITAL HARDNESS TESTER PURPOSE OF SOP: The purpose of this SOP is to provide a procedure for cleaning, operation, and calibration of the Digital Hardness tester. SCOPE OF SOP: This SOP applies to the quality assurance department for cleaning, operation, and calibration of the Digital Hardness tester. REFERENCE(S) Instrument…
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PROCEDURE FOR HANDLING AND CALIBRATION OF VERNIER CALIPER PURPOSE OF SOP ON PROCEDURE FOR HANDLING AND CALIBRATION OF VERNIER CALIPER: To provide the procedure for operating and cleaning the digital Vernier caliper. SCOPE OF SOP ON PROCEDURE FOR HANDLING AND CALIBRATION OF VERNIER CALIPER: This SOP is applicable for operating and cleaning the digital Vernier…
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PROCEDURE FOR ROUNDING OFF NUMERICAL VALUES AND REPORTING SYSTEM PURPOSE OF SOP ON REPORTING: To describe the procedure for rounding off numerical values and reporting system. SCOPE OF SOP ON REPORTING: This Standard Operating Procedure (SOP) shall be applicable for rounding off numerical values and reporting systems in Quality Control, Production, IPQA and Warehouse Departments….
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SOP ON MANAGEMENT REVIEW SYSTEM IN PHARMA PURPOSE OF SOP: To outline the procedure for Management Review of all systems. SCOPE: This procedure applies to the Management Review of all systems. CROSS-REFERENCE DOCUMENTS OF SOP Corrective action & preventive action (CAPA) ATTACHMENTS S.No. Attachments No. Attachment Title 1 Attachment-I Quality Management Review Report 2 Attachment-II Quality…
