Procedure For Quality Risk Management

STANDARD OPERATING PROCEDURE Title: Procedure For Quality Risk Management Department: Quality Assurance OBJECTIVE  This SOP defines the approach to Quality Risk Management (QRM) of a GMP  site which may be used to facilitate the process and to aid personnel performing the assessment. SCOPE Applicable to any process at a GMP site that requires a Risk … Read more

Procedure for Operation & Calibration of  pH Meter

STANDARD OPERATING PROCEDURE Title : Procedure for Operation & Calibration of  pH Meter      OBJECTIVE This SOP describes the procedure for operation and calibration of pH Meter. SCOPE This procedure is applicable for operation and calibration of pH Meter in Quality Control Department. RESPONSIBILITY Officer / Executive-QC – responsible for Implementation of SOP. ACCOUNTABILITY … Read more

Procedure for Preparation, Standardization and Re-Standardization of Volumetric solutions

STANDARD OPERATING PROCEDURE Title : Procedure for Preparation, Standardization and Re-Standardization of Volumetric solutions         OBJECTIVE This SOP describes the procedure for Preparation, Standardization and Re-Standardization of Volumetric solutions. SCOPE This procedure is applicable for preparation and standardization of volumetric solutions in Quality Control. RESPONSIBILITY Officer / Executive-QC – responsible for Implementation of … Read more

Procedure For Internal Facility Audit

STANDARD OPERATING PROCEDURE Title : Procedure For Internal Facility Audit    OBJECTIVE To lay down the procedure for carrying out Self Inspection of various departments. SCOPE This procedure is applicable for carrying out the self inspection of all departments RESPONSIBILITY It is a joint responsibility of all self-inspection team members in coordination with Quality Assurance. … Read more

Procedure For  handling of returned goods

 STANDARD OPERATING PROCEDURE Title: Procedure For  handling of returned goods OBJECTIVE  To lay down a procedure for handling of returned goods. SCOPE This procedure is applicable for handling the retuned goods. RESPONSIBILITY Manager-Quality Control Manager-Warehouse ACCOUNTABILITY Manager-Quality Assurance PROCEDURE Returned goods in general belongs to: Recalled product in-case of product recall. Returned saleable finished goods. … Read more

Procedure For line clearance activities during processing of product

STANDARD OPERATING PROCEDURE Title : Procedure For line clearance activities during processing of product  OBJECTIVE To lay down the procedure for Line Clearance. SCOPE This procedure is applicable for line clearance activities during processing of product. RESPONSIBILITY Officer-Production Officer-IPQA/QA ACCOUNTABILITY Manager-Production Manager-Quality Assurance PROCEDURE Officer-Production should place the line clearance status board after ensuring the … Read more

Procedure For Internal Facility Audit

  STANDARD OPERATING PROCEDURE Title : Procedure For Internal Facility Audit Department : Quality Assurance OBJECTIVE  To lay down the procedure for carrying out Self Inspection of various departments. SCOPE This procedure is applicable for carrying out the self inspection of all departments. RESPONSIBILITY It is a joint responsibility of all self-inspection team members in … Read more

Procedure For Good Documentation Practices

STANDARD OPERATING PROCEDURE Title :  Procedure For Good Documentation Practices Department : Quality Assurance OBJECTIVE                                                       To lay down a procedure for good documentation practices. SCOPE This procedure is applicable for all Production, Quality Control, Quality Assurance, Warehouse, Engineering & utility and Personnel and Administration departments. RESPONSIBILITY Officer/Executive-QA. ACCOUNTABILITY Manager-Quality Assurance PROCEDURE Design and Preparation … Read more

Procedure for Surface Monitoring of Equipment by Swab

STANDARD OPERATING PROCEDURE Title : Procedure for Surface Monitoring of Equipment by Swab Department : Quality Control-Microbiology   OBJECTIVE To lay down a procedure for surface monitoring of equipment by swab. SCOPE This SOP is applicable for surface monitoring of equipment by swab in microbiology laboratory. RESPONSIBILITY Officer / Executive-QCM – responsible for Implementation of … Read more

Procedure for handling of cultures & contaminated material

 STANDARD OPERATING PROCEDURE Title :Procedure for handling of cultures & contaminated material Department:Quality Control-Microbiology OBJECTIVE To lay down a procedure for handling of cultures & contaminated material. SCOPE This SOP is applicable for handling of cultures & contaminated material in microbiology laboratory . RESPONSIBILITY Officer / Executive- QC M – responsible for Implementation of SOP. … Read more