Seoul

SOP on Preparation, Approval and Control of Technical Directions for Bulk Drug Preparation Objective : To lay down a procedure for the preparation, approval and control of Technical Directions for manufacture of bulk drug preparation at contract manufacturing locations. Scope : This Standard Operating Procedure is applicable for preparation and implementation of Technical Directions for all APIs … Read more

SOP on Batch Numbering Objective : To lay down a procedure of the batch numbering system for the products. Scope : This standard operating procedure is applicable for assigning batch number to all the different formulations to be manufactured at different locations. Responsibility : Officer, Quality Assurance department shall be responsible for assigning of the batch number Head, … Read more

SOP on Product Recall and Handling of Recalled Products Objective : To lay down a procedure for product recall and handling of recalled products Scope : This Standard Operating Procedure is applicable for recall of drug products and handling of recalled drug products manufactured or marketed. Responsibility : Head, Quality Assurance/ designee shall be responsible for the … Read more

SOP on Handling of Product Complaints Objective : To lay down a procedure to investigate, document and respond to the product complaints. Scope : This Standard Operating Procedure shall be applicable to all pharmaceutical drug products (formulations) manufactured or marketed. Responsibility Head, Marketing of the concerned division shall be responsible for forwarding the complaints received from sales … Read more

Internal Audit and Self Inspection Objective: To lay down a procedure for periodic internal audit and self-inspection, to ensure current Good Manufacturing Practices compliance. Scope : This Standard Operating Procedure is applicable to all departments of all formulation plants of Panacea Biotec Limited. Responsibility : Audit Team : Auditing the facility and to prepare audit report … Read more