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
SOP ON INPROCESS CONTROLS PURPOSE: To lay down a procedure for in process control in dispensing area, oral preparation (Tablets, Capsules & Dry Syrup) and in Dry powder Injection. SCOPE: This SOP is applicable for the Tablet Capsule dry syrup orals dosage Forms and Dry powder Injections for different products manufactured RESPONSIBILITY: Preparation of SOP: Officer/ … Read more
SOP ON GAP ASSESSMENT PURPOSE: The purpose of this Standard Operating Procedure is to lay down the procedures for periodic review of respective standard operating procedures, Validation Procedure and other activities to find out the possibilities of improvement. SCOPE: This SOP is applicable for review and updating of standard operating procedure, Validation Procedure and other activities … Read more
