Quality Assurance

SITE MASTER FILE Site Master File that is useful to the regulatory authority in planning and conducting GMP inspections. The… Read More

QUALITY MANUAL  QUALITY MANUAL describes one comprehensive model for an effective pharmaceutical quality system that is based on the quality… Read More

SOP ON CAPA (CORRECTIVE ACTION AND PREVENTIVE ACTION) PURPOSE: To lay down the standard operating procedure for Corrective Action and… Read More

SOP OF PRODUCT RECALL PURPOSE: This procedure covers transmission of information by means of a Rapid Alert between the different… Read More

SOP on Cleaning, Maintenance and Calibration of Stability Chamber Objective: To lay down a procedure for cleaning, maintenance and calibration of… Read More

SOP FOR INCIDENCE HANDLING PURPOSE: To lay down a procedure for reporting, investigation and disposition of Incidents. SCOPE: this procedure… Read More

SOP FOR HANDLING OF OUT OF CALIBRATION PURPOSE: To lay down a procedure for handling of out of calibration of… Read More

SOP on writing & approval of Qualification and validation protocol & reports Objective: To describe the procedure for writing & approval… Read More

SOP FOR CLEANING VALIDATION PURPOSE: To describe the procedure for Cleaning Validation studies to be followed for equipment/ accessories used in… Read More

SOP FOR HANDLING OF ON-LINE REJECTIONS PURPOSE:  To lay down the procedure for On-line rejected materials. SCOPE: This SOP is applicable… Read More