Pharmaguidances

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

SOP FOR ANNUAL PRODUCT QUALITY REVIEW PURPOSE: To lay down the procedure for preparation, review and approval of annual product quality review (APQR). SCOPE: This SOP is applicable is applicable to APQRs for products manufactured. RESPONSIBILITY: Preparation of SOPs: Officer QA Department Checking and Review of the SOPs: Officer QA Department Approval of the SOPs: … Read more

SOP FOR PROCEDURE FOR ASEPTIC PROCESS SIMULATION (MEDIA FILL) PURPOSE: To define the procedure to be followed for validation of aseptic processes by process simulation   study through a media fill. Process simulation study provides a way- To demonstrate the capability of the aseptic process in producing the sterile drug product. To qualify the personnel involved … Read more

SOP FOR INVESTIGATION OF MEDIA FILL FAILURE PURPOSE: To lay down a procedure for Media fill failure Investigation.  SCOPE:  This Standard Operating Procedure is applicable for Media fill failure Investigation. RESPONSIBILITY: Preparation of SOP: Officer QA Department Checking and Review of the SOP: Executive QA Department Approval of SOP: Executive QA Department Authorization of SOP: Head … Read more