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
SOP on Certification of Trainer Objective : To lay down a procedure for Certification of Trainers. Scope : This procedure is applicable for all formulation plants/operations. Responsibility : Head Quality Assurance shall be responsible for compliance of this SOP and certification of trainer. Plant Head shall be responsible for checking suitability of the trainer and its certification. … Read more
SOP on Training Procedures Objective: To lay down a procedure to conduct training of working personnel and its evaluation. Scope: This Standard Operating Procedure is applicable for the training of personnel working in all pharmaceutical formulation plants/operations. Responsibility: Head, QA or his/her designee for co-ordination on training of the personnel. Head of every department or training coordinator … Read more
SOP on Preparation & Handling of Un-blinding Envelopes Objective : To lay down a procedure for preparation and handling of un-blinding envelopes meant for un-blinding of patient kits of Clinical Trial Study. Scope : This standard operating procedure is applicable for formulation plants. Preparation of un-blinding envelopes shall involve the following Procurement of packaging material required for … Read more
SOP on Management of Clinical Supplies Objective : To lay down a procedure for the management of the clinical supplies of the pharmaceutical products. Scope : This standard operating procedure is applicable for formulation plant. Management of Clinical Supplies shall involve the following: Procurement of reference drug. Unpacking and repacking of reference drug. Manufacturing and packing of … Read more
SOP on Artwork Design and Approval Objective : To lay down a procedure for artwork design and approval (of Printed packaging materials). Scope : This Standard Operating Procedure is applicable to all drug products manufactured and marketed. Responsibility For Artwork development and approval system of Export markets Head Marketing/Business Development shall be responsible for providing the Packaging … Read more
SOP on Utilization of Biaxially Oriented Polypropylene (BOPP) Tapes Objective : To lay down a procedure for the selection of different colours of Biaxially Oriented Polypropylene (BOPP) tapes and their usage. Scope : This Standard Operating Procedure is applicable to drug products (formulations) manufactured or marketed. Responsibility : Officer / Executive – Packaging Development shall be responsible for … Read more