Pharmaguidances

SOP on Control of Master Formula Records (MFRs) Objective : To lay down a procedure for preparation and updating of Master Formula Records (MFRs). Scope : This Standard Operating Procedure is applicable to Master Formula Records of all the products manufactured or marketed. Responsibility : Executive/Officer Quality Assurance shall compile, maintain and update the Master Formula Records … Read more

SOP on Correction of Documentation Errors Objective : To lay down a procedure for correcting the errors in documentation. Scope :  This Standard Operating Procedure is applicable for correction of all documentation error in written procedures (SOPs, Specifications, STPs, or TDs etc.) and records (Batch Manufacturing Records, Raw Data, Log Books, etc.) prepared. Responsibility : Each employee … Read more

SOP on Annual Product Review Objective : To lay down a procedure of Annual Product 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 US, Domestic market, Rest of the World (ROW) or for any specific customer requirement. Responsibility … Read more

SOP on Assigning Manufacturing and Expiry date to the Finished Products Objective : To lay down a procedure for assigning manufacturing and expiry date to the finished products manufactured. Scope : This procedure shall be applicable to all products manufactured. Responsibility : Executive / Officer Production shall be responsible for assigning manufacturing and expiry date to batch of … Read more

SOP on Issue of Batch Manufacturing Records for Contract Manufacturing Locations Objective : To lay down a procedure for issue of Batch Manufacturing Records to contract manufacturing locations. Scope : To lay down a procedure for issue of Batch Manufacturing Records to contract manufacturing locations. Responsibility : Executive / Officer of the Quality Assurance department is responsible for … Read more

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 … Read more