2022

USFDA Warning letter for Biotek India

FDA Warning Letter

Biotek India MARCS-CMS 613295 — MAY 13, 2021 WARNING LETTER Delivery Method:VIA UPSProduct:Drugs  Recipient:Biotek India  919/2 First Floor, Conmet Cross Road, Makarpura GIDC Vadodara 390010 GujaratIndiaIssuing Office:Center for Drug Evaluation and Research United States Warning Letter 320-21-45 May 13, 2021 Dear Mr. Arora: Your facility is registered with the United States Food and Drug Administration (FDA) as a […]

USFDA Warning letter for Biotek India Read More »

SOP For Operation and Calibration of Refrigerator.

Quality Control

  OBJECTIVE:  The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Operation and Calibration of the Refrigerator.   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

SOP For Operation and Calibration of Refrigerator. Read More »

SOP For Operation and Calibration of Bursting Strength Apparatus

Quality Control

OBJECTIVE:             The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Operation and Calibration of Bursting strength apparatus. SCOPE:             This SOP is applicable to Bursting Strength Apparatus at manufacturing facility. RESPONSIBILITY:  Analyst/Section Head or his designee shall be responsible

SOP For Operation and Calibration of Bursting Strength Apparatus Read More »

SOP For Management of Reference Standard and Reference Solution

Quality Control

OBJECTIVE: The purpose of this SOP is to lay down a procedure Management of Received, handling, storage and usage of reference standard and reference solution. SCOPE:  This SOP is applicable to reference standard and reference solution used at quality control department. RESPONSIBILITY: Analyst or his designee shall be responsible for follow the SOP. The Head

SOP For Management of Reference Standard and Reference Solution Read More »

SOP For handling, Operation, maintenance and Calibration of Suppository Tester Apparatus

Quality Control

OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for handling, Operation, maintenance and Calibration of Suppository Tester Apparatus. SCOPE: This SOP is applicable to Suppository Tester Apparatus (Make: ELECTROLAB, Model No.: ESDT – 3) in Quality Control Department at manufacturing facility of XXX.   RESPONSIBILITY:    Analyst / Section

SOP For handling, Operation, maintenance and Calibration of Suppository Tester Apparatus Read More »

SOP For operation and Calibration of Disintegration Tester Apparatus

Quality Control

OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for handling, Operation, maintenance and Calibration of Disintegration Tester Apparatus. SCOPE: This SOP is applicable to Disintegration Tester Apparatus in Quality Control Department at manufacturing facility of XXX. RESPONSIBILITY:    Analyst / Section Head or his designee shall be responsible for

SOP For operation and Calibration of Disintegration Tester Apparatus Read More »

SOP For Operation and Calibration of Bulk Density Apparatus

Quality Control

OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Handling, Operation, and Calibration of Bulk Density Apparatus. SCOPE: This SOP is applicable to Bulk Density Apparatus in Quality Control Department at manufacturing facility of XXX.     RESPONSIBILITY:  Analyst / Section Head or his designee shall be responsible to

SOP For Operation and Calibration of Bulk Density Apparatus Read More »

SOP for Certificate of Analysis (COA) of Finished Product in Microsoft world.

Quality Control

OBJECTIVE: To describe the procedure for preparation of Certificate of Analysis (COA) of Finished Product.      SCOPE: This SOP is applicable to control Certificate of analysis of Finished Product in Quality Control Laboratory at manufacturing facility of XXX.     RESPONSIBILITY: 3.1 The Analyst/Executive/Asst. Manager-QC shall be responsible for preparing the COA in Microsoft

SOP for Certificate of Analysis (COA) of Finished Product in Microsoft world. Read More »

SOP for operation and cleaning of Ultrasonic Water Bath

Quality Control

OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for Operation, maintenance and Calibration of Ultrasonic Water Bath. SCOPE: This SOP is applicable to Ultrasonic Water BatH) in Quality Control Department at manufacturing facility of XXX.  RESPONSIBILITY: Analyst / Section Head or his designee shall be responsible for follow

SOP for operation and cleaning of Ultrasonic Water Bath Read More »