Quality Assurance

SOP on Cleaning, Maintenance and Calibration of Stability Chamber Objective: To lay down a procedure for cleaning, maintenance and calibration of stability chamber. Scope: This SOP is applicable for the cleaning, maintenance and calibration of stability chamber. Responsibility: QC Chemist or above AND Electrician or above Accountability: Head – Quality Control & Head – Engineering Procedure: Cleaning: Chamber shall be cleaned … Read more

SOP FOR INCIDENCE HANDLING PURPOSE: To lay down a procedure for reporting, investigation and disposition of Incidents. SCOPE: this procedure is applicable to the reporting of investigation and disposition of unplanned, uncontrolled incidents either directly or indirectly associated with Manufacturing/Packaging, or Analytical operations. RESPONSIBILITY: Observer / Concerned Department Officer shall report the Incident. Observer / … Read more

SOP FOR HANDLING OF OUT OF CALIBRATION PURPOSE: To lay down a procedure for handling of out of calibration of instruments. SCOPE: This SOP is applicable for all the instruments available. RESPONSIBILITY Preparation of SOP: Officer /Sr. Officer QA Department. Checking and Review of the SOP: Officer /Executive QA Department. Approval of the SOP: Executive … Read more

SOP on writing & approval of Qualification and validation protocol & reports Objective: To describe the procedure for writing & approval of qualification and validation protocols & reports. Scope: This SOP is applicable to all type of qualification and validation protocol & report for all department to Formulation plant. Responsibility: The officer / executive / section in-charge … 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 to all Raw and packing materials. RESPONSIBILITY Production officer or Executive shall be responsible to initiate online rejection note QA personnel shall issue online rejection note. IPQA personnel shall verify online rejection note. QA head/ … Read more

SOP FOR PROCEDURE FOR NUMBERING, CLEANING AND SANITIZATION OF DRAIN POINTS PURPOSE:  The purpose of this Standard Operating Procedure is to provide guidance for numbering, cleaning and sanitization of drain points.        SCOPE: This procedure is applicable for numbering, cleaning and sanitization of drain points of all department. RESPONSIBILITY: Preparation of SOP: Officer/ Sr. Officer … Read more

SOP FOR PROCEDURE FOR CLEANING AND DISINFECTION OF AREA PURPOSE: To lay down the procedure for cleaning and disinfection of area. SCOPE: This procedure is applicable for cleaning and disinfection of classified and unclassified area. RESPONSIBILITY: Respective user department shall be responsible to prepare the disinfectant and clean the area according to the procedure defined in the SOP. … Read more

SOP FOR OPERATION AND CALIBRATION OF FRIABILITY APPARATUS PURPOSE: To lay down a procedure for operation and calibration of friability apparatus. SCOPE: This procedure is applicable for operation and calibration of Tablet friability apparatus.    RESPONSIBILITY: IPQA Person/ Officer: Production to follow SOP accordingly & Documentation. Officer/Executive QA: To ensure Implementation of SOP. ACCOUNTABILITY: Head Quality … Read more

SOP FOR OPERATION AND CALIBRATION OF VERNIER CALIPER PURPOSE: To lay down a procedure for operation and calibration of vernier caliper. SCOPE: This SOP is applicable in Quality Assurance. RESPONSIBILITY: Preparation of SOP: QA Officer/ Sr. Officer Checking and Review of the SOP: Executive/Sr. Executive Approval of SOP: Head of Department/ Assistant Manger Authorization of SOP: Head QA/Designee Following … Read more