SOP on Sampling of Raw Material Objective: To lay down the procedure for sampling of raw material. Scope: This procedure is applicable for sampling of raw material Responsibility: Chemist or above Accountability: Head – Quality Control Procedure: Sampling of Raw Materials: Raw material sampling shall be initiated after receiving the “GRN” from warehouse. Ensure that material is received from … 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
CHECKLIST FOR PREVENTIVE MAINTENANCE OF COMPRESSION MACHINE Equipment code: ___________________________ Frequency: Quarterly Open and clean the panel internally and externally using vacuum cleaner/air blower. Visually check the tightness of cable termination at MCCB incoming and outgoing side and at outgoing MCB. Check the operation and setting of all machine interlocking. Check all terminations for overheating. … 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 CLEANING VALIDATION PURPOSE: To describe the procedure for Cleaning Validation studies to be followed for equipment/ accessories used in manufacturing. SCOPE: This SOP is applicable for documented evidence and actual experimental data that the procedure being followed for cleaning of equipment and accessories is effective and removes all residues of previous product up to … 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
