OBJECTIVE: The purpose of this SOP is to lay down a procedure for sending sample for analysis to external laboratory. SCOPE: This SOP is applicable to Quality Control Department at manufacturing facility. RESPONSIBILITY: Analyst or his designee shall be responsible for follow the SOP. The Head of Quality Control Department or his designee […]
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OBJECTIVE: The purpose of this SOP is for Receiving of current updates on Pharmacopoeias in Quality Control Department. SCOPE: This SOP is applicable to Quality Control Department at manufacturing facility . RESPONSIBILITY: Authorized designee of Quality Control department shall be responsible for Receiving / reviewing of current updates on Pharmacopoeias. The Head of Quality
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OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to describe the operation and Calibration of the Cold Chamber. SCOPE: This SOP is applicable to Quality Control Department at manufacturing facility. RESPONSIBILITY: Officer/ Executive shall be responsible for the effective handling, operation, maintenance, calibration and validation of
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OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for naming of method, program and sequences in chromatographic analysis. SCOPE: This SOP is applicable to chromatographic analysis performed on HPLC and GC. RESPONSIBILITY: Analyst or his designee shall
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OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Operation and Calibration of UV-Visible Spectrophotometer Make: SHIMADZU, Model: UV-1800 SCOPE: This SOP is applicable to UV-Visible Spectrophotometer in Quality Control Department at manufacturing facility. RESPONSIBILITY: Analyst / Section Head or his designee shall be responsible for follow
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OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is To describe the procedure for checking of analytical reports and raw data for correctness. SCOPE: This SOP is applicable to the procedure for checking of analytical reports and raw data for correctness at Quality Control
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OBJECTIVE : Data integrity verification is performed as the data/record/report being generated electronically and is than further analyzed /calculated as per respective test procedure / calculation sheet to verify and then result linkages are established between respective equipments software, log book and records calculation sheet as per respective test procedure and specification. SCOPE :
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OBJECTIVE: This procedure outlines the procedure for operation of Water Purification System. Make : ADRONA-SIA Model : Q-Front SCOPE: This SOP is applicable to Quality Control Department at manufacturing facility. RESPONSIBILITY: Analyst / Section Head or his designee shall be responsible to follow the SOP. The Head of Quality Control Department or his designee shall
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Indiana Chem-Port MARCS-CMS 618173 — FEBRUARY 02, 2022 February 02, 2022 WARNING LETTER Delivery Method:Via EmailProduct:Drugs Recipient:Indiana Chem-Port 349 GIDC Industrial Estate Makarpura, Vadodara Gujarat IndiaIssuing Office:Center for Drug Evaluation and Research | CDER United States Warning Letter 320-22-11 AMENDED February 2, 2022 Dear Mr. Desai: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Indiana
USFDA Warning Letter of Indiana Them-port 2022 Read More »
Aurobindo Pharmaceutical Limited MARCS-CMS 618091 — JANUARY 12, 2022 January 12, 2022 WARNING LETTER Delivery Method:VIA UPSProduct:Drugs Recipient:Mr. Narayanan GovindarajanAurobindo Pharmaceutical Limited Floor No.’s 22, 23 & 24 Galaxy Plot No-1, Survey No: 83/1, Hyderabad Knowledge City Raidurg Panmaktha, Ranga Reddy DistrictHyderabad 500081 Telangana IndiaIssuing Office:Center for Drug Evaluation and Research | CDER United States Warning Letter 320-22-10 January 12,
USFDA Warning Letter of Aurobindo Pharmaceutical Limited 2022 Read More »
