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
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
SOP FOR OPERATION AND CALIBRATION OF HARDNESS TESTER PURPOSE: To lay down a procedure for operation and calibration of hardness taster. SCOPE: This procedure is applicable for operation and calibration of Tablet disintegration test apparatus. RESPONSIBILITY: IPQA Person/ Officer: Production to follow SOP accordingly & Documentation. Officer/Executive QA: To ensure Implementation of SOP. ACCOUNTABILITY: … Read more
SOP FOR ASSIGNING OF MANUFACTURING AND EXPIRY DATE TO A FINISHED PRODUCT PURPOSE: To lay down the procedure to assign manufacturing and expiry date to a finished product. SCOPE: This SOP is applicable to assign expiry date to a finished product. RESPONSIBILITY: Preparation of SOP: QA Officer/ Sr. Officer Checking and Review of the SOP: Executive/Sr. Executive Approval … Read more
SOP FOR PREPARATION, APPROVAL, REVISION, CONTROL OF LISTS PURPOSE: To lay down a procedure for Preparation approval revision and control of lists. SCOPE: This procedure is applicable to all type of lists prepared. RESPONSIBILITY: Preparation of SOP: Officer Quality Assurance Checking and Review of the SOP: Officer QA Approval of the SOP: Executive QA/ Designee Authorization of … Read more
