Quality Control

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

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

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

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.

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

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 »

SOP For Operation, Maintenance And Calibration Of Ultrasonic Water Bath

The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for Operation, maintenance and Calibration of Ultrasonic Water Bath. PROCEDURE: PRELIMINARY CHECK: Fill the Water bath with water up to height of minimum 7cm from bottom of tank. Whenever the Ultrasonic Water Bath is required with specific temperature then heater to

SOP For Operation, Maintenance And Calibration Of Ultrasonic Water Bath Read More »

SOP for Handling of Laboratory Reagents

Standard Operating Procedure (SOP) for Receipt, Storage, and Handling of Laboratory Reagents, Buffers, Solvents, Glasswares and other consumables in QC. Receipt, Storage, and Handling of Laboratory ReagentsPurpose : The purpose of this SOP ( Standard Operating Procedure) is to describe the procedure for the receipt, storage, and handling of laboratory reagents. Scope : This procedure

SOP for Handling of Laboratory Reagents Read More »

Acceptable Quality Level (AQL) – SOP and Chart

OBJECTIVE: To define the procedure for Acceptable Quality Level sampling for Tablets and Capsules during bulk approval. SCOPE: This procedure is applicable to bulk approval of manufactured Tablets and Capsules at pharmaceutical product manufacturing location.     REFERENCES: ISO 2859-1:1999(en) Sampling procedures for inspection by attributes SOP for Event Reporting and Investigation. DEFINITIONS OF TERMS:

Acceptable Quality Level (AQL) – SOP and Chart Read More »

SOP on Operation and Calibration of Melting Point Apparatus

Standard Operating Procedure (SOP) for Operation and Calibration of Melting Point Apparatus used for analysis / identification  of starting materials (Raw Material – API & Excipient) in Quality Control Laboratory. Operation and Calibration of Melting Point Apparatus 1.0   PURPOSE: The purpose of this SOP is to describe the procedure for operation, calibration and maintenance of

SOP on Operation and Calibration of Melting Point Apparatus Read More »