shivpharma2016 SOP on Handling of Out-of-Specification and Out-of Trend Test Results Objective : To lay down a procedure for handling of Out-of-Specification and Out-of-Trend Test Results. Scope : This SOP shall be applicable for chemistry based testing of drug substances, excipients, components and drug products at formulation plant . The SOP is not applicable for the … Read more
SOP On Qualification procedure for External Calibrating Agency Objective : To lay down a procedure for qualification of external calibrating agency. Scope : This Standard Operating Procedure is applicable for qualification of external calibrating agency, for instruments /equipment for which in-house calibration facility is not available. Responsibility : Heads of Engineering, Quality Control and Quality Assurance departments or … Read more
SOP on Sampling of In process Materials and Finished Products Objective : To lay down a procedure for Sampling of In process materials and Finished products. Scope : This standard operating procedure is applicable to formulation plant for the sampling of In process materials and finished products for QC analysis. This SOP shall also be applicable for … Read more
SOP on In process Checks by IPQA Objective : To lay down a procedure for carrying In-process checks by IPQA personnel. Scope : This standard operating procedure is applicable at formulation plant of Panacea Biotec Limited, Baddi. Responsibility Officer /Executive IPQA shall be responsible to perform in-process checks as per this SOP. Head – QA or designee: … Read more
SOP on Review of Batch Manufacturing Record Objective : To lay down a procedure for review of Batch Manufacturing Record. Scope : This Standard Operating Procedure is applicable to Baddi formulation plant. Responsibility : Officer /Executive – IPQA shall be responsible for reviewing Batch Manufacturing Record including verification of every step recorded in it, right from beginning to … Read more
SOP on In-process Checks during Packaging Operations Objective : To lay down a procedure for In-process checks at different stages of Packaging Operations. Scope : This standard operating procedure is applicable for formulation plant. Responsibility : Production and IPQA personnel shall be responsible for Implementation of the procedure mentioned in this SOP. Heads, Production and Quality … Read more
SOP on Issue, Receipt, Storage and Destruction of Batch Manufacturing Records Objective : To lay down a procedure for issuance, receipt, storage and destruction of Batch Manufacturing Records. Scope : This Standard Operating Procedure is applicable for the issuance, receipt, storage and destruction of BMRs of products being manufactured and issuance of BMR to Contract acceptor, if … Read more
SOP on Management of Equipment Objective : To lay down a procedure for Management of Equipment. Scope : This standard operating procedure is applicable at formulation plant. Responsibility : Respective heads of user departments shall be responsible for implementation and compliance of this procedure. Abbreviations and Definitions Equipment: An instrumentality needed for an undertaking or to perform a … Read more
SOP on Product Quality Review Objective : To lay down a procedure of Product Quality Review for the products manufactured in the respective financial year. Scope : This Standard Operating Procedure is applicable for all products manufactured in formulation plants of for European Union, W.H.O, Geneva or for any specific customer requirement. Responsibility : Officer / … Read more
SOP on Preparation, Approval and Control of Corporate manuals Objective : To lay down a procedure for the preparation, approval and control of corporate manuals. Scope : This Standard Operating Procedure is applicable for the preparation and implementation of all corporate manuals prepared at various sites. Responsibility : Officer/Executive -Concerned department shall be responsible for preparing the … Read more