SOP on Preparation, Approval and Control of Technical Directions for Bulk Drug Preparation

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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

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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

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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

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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

SOP on Internal Audit and Self Inspection

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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 … Read more

SOP ON PROCEDURE FOR HANDLING E-WASTE

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SOP ON PROCEDURE FOR HANDLING E-WASTE OBJECTIVE : To lay down a procedure for handling e-waste. SCOPE : This SOP is applicable for handling e-waste. RESPONSIBILITY :  Officer and above shall responsible for preparation of SOP and create numbering system of computer and accessories. Executive and above shall responsible for Reviewed/Checked of SOP. Head QA shall … Read more

SOP ON RECOVERY OF ELECTRONIC DATA

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SOP ON RECOVERY OF ELECTRONIC DATA OBJECTIVE : To lay down a procedure for installation of Recovery of electronic data. SCOPE : This SOP is applicable for installation of Recovery of electronic data. RESPONSIBILITY : Officer and above shall responsible for preparation of SOP and create numbering system of computer and accessories. Executive and above shall responsible … Read more

SOP ON SELECTION AND EVALUATION OF VENDOR FOR INFORAMTION TECHNOLOGY (IT) EQUIPMENT

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SOP ON SELECTION AND EVALUATION OF VENDOR FOR INFORAMTION TECHNOLOGY (IT) EQUIPMENT OBJECTIVE : To lay down a procedure for selection and evaluation of vendor for Information Technology (IT) equipment. SCOPE : This SOP is applicable for selection and evaluation of vendor for Information Technology (IT) equipment. RESPONSIBILITY : Officer and above shall responsible for preparation of … Read more

SOP ON ELECTRONIC DATA BACKUP MANAGEMENT SYSTEM

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SOP ON ELECTRONIC DATA BACKUP MANAGEMENT SYSTEM OBJECTIVE : To lay down the procedure for all SOP on Electronic Data Backup Management System. SCOPE : This SOP is applicable for all SOP ON electronic data backup MANAGEMENT SYSTEM. RESPONSIBILITY : Officer and above shall responsible for preparation of SOP and create numbering system of computer and accessories. … Read more

SOP ON USER PASSWORD POLICY FOR ALL USER/HPLC

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SOP ON USER PASSWORD POLICY FOR ALL USER/HPLC OBJECTIVE :  To lay down a procedure for all computer user password policy. SCOPE : This SOP is applicable for all computer user password policy. RESPONSIBILITY : Officer and above shall responsible for preparation of SOP and create numbering system of computer and accessories. Executive and above … Read more