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
SOP FOR REPORTING OF INVESTIGATION PURPOSE: To lay down a procedure for reporting of investigation. SCOPE: This SOP is applicable to for the quality related failures of product, which do not meet the acceptance criteria. RESPONSIBILITY: Personnel of concern department are responsible for the Quality Related failures of product. Concern-HOD or designee shall investigate and … Read more
SOP ON BATCH CONVERSION PURPOSE: To lay down the procedure for Batch Conversion. SCOPE: This SOP is applicable for Batch Conversion Procedure. RESPONSIBILITY: Preparation of SOP: 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 Head Production shall be responsible for initiating conversion … Read more
SOP ON BATCH RELEASE SYSTEM OF FINISHED PRODUCT PURPOSE: To lay down a procedure for release of finished products for distribution. SCOPE: This SOP is applicable for release of finished product manufactured. RESPONSIBILITY: Preparation of SOP: Officer/ Sr. Officer. Checking and Review of the SOP: Executive/Sr. Executive Approval of SOP: Head of Department/ Assistant Manger Authorization of … Read more