MASTER FORMULA RECORD AMOXICILLIN AND POTASSIUM CLAVULANATE TABLETS BP Purpose: To provide instructions for the preparation of Master formula Record. For Amoxicillin Trihydrate and Potassium Clavulanate 625 mg Tablets BP. Objective: To provide a documented procedure for the preparation of Master formula record is that standard manufacturing/packing record which gives complete details of materials used … Read more
STANDARD OPERATING PROCEDURE Title : Procedure for handling of Microbiology Area Department : Quality Control-Microbiology OBJECTIVE To lay down a procedure for handling of microbiology area. SCOPE This SOP is applicable for handling of microbiology area. RESPONSIBILITY Officer / Executive-QCM – responsible for Implementation of SOP. ACCOUNTABILITY Manager – Quality Control Manager – … Read more
Issuance, Preparation, Storage, Usage and Disposal of Disinfectant Solution in Pharma Industry Objective To lay down a procedure for issuance, preparation, storage, usage and disposal of disinfectant solution in Pharma Industry. Scope This SOP is applicable for issuance, preparation, storage, usage and disposal of disinfectant solution in manufacturing area in Pharma Industry. Responsibility GMP coordinator … Read more
Corrective and Preventive Action (CAPA) In Pharma Industry Objective To lay down a procedure for the Corrective and Preventive Action so as to eliminate the causes of potential non-conformities and /or encountered non-conformities in order to prevent their occurrence and / or recurrence In Pharma Industry. Scope This Standard Operating Procedure shall apply to all … Read more
Organogram in Pharma Industry in Pharma Industry Objective To describe the procedure for preparation of Organogram in Pharma Industry. Scope This procedure is applicable for preparation of organograms of all the departments in Pharma Industry. Responsibility P&A Department is responsible for preparation of organogram. Head – User department is responsible for review of respective Organograms. … Read more
Cleaning Policy of Area and Equipment in Pharma Industry Objective To lay down the procedure for Cleaning Policy of Area & Equipment in Pharma Industry. Scope This Standard Operating Procedure is applicable to all the departments at the formulation plant in Pharma Industry. Responsibility Production Operator/ Technician shall be responsible for cleaning. Production & … Read more
STANDARD OPERATING PROCEDURE Title : Procedure for autoclave validation Department : Quality Control-Microbiology OBJECTIVE To lay down a procedure for autoclave validation. SCOPE This SOP is applicable for autoclave validation in microbiology laboratory . RESPONSIBILITY Officer / Executive-QC – responsible for Implementation of SOP. ACCOUNTABILITY Manager – Quality Control PROCEDURE … Read more
STANDARD OPERATING PROCEDURE Title : Procedure For Dispensing of Packing Materials OBJECTIVE This SOP describes the procedure for dispensing of packing material. SCOPE This procedure is applicable to Warehouse department for dispensing of packing material. RESPONSIBILITY Officer / Executive-WH – responsible for Implementation of SOP. ACCOUNTABILITY Manager-Warehouse PROCEDURE After receiving batch requisition from … Read more
PURPOSE: This MFR is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form. SCOPE: This procedure is performed and is applied during the manufacturing of dosage form. RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Assistant Manufacturing Chemist to follow and adhere to this MFR. The Production Pharmacist, QC/QA Manager are accountable … Read more
STANDARD OPERATING PROCEDURE Title : Procedure For Handling of Market Complaints OBJECTIVE To lay down the Procedure for Handling of Market Complaints. SCOPE This Procedure is applicable for handling of market complaints received from wholesaler, Distributor, Retailer, Customer, Physicians, Patients, field staff etc. at Pharmaceutical Company. RESPONSIBILITY It is a joint responsibility of Manager-Marketing and Manager-Quality Assurance in coordination with Quality Assurance. It is a … Read more