PROCESS VALIDATION To define a procedure for validation of process to demonstrate its effectiveness and reproducibility including the preparation of protocols and report. It also outlines the personnel responsibilities and other qualification documents required for performing the validation activities. SCOPE: This SOP is applicable for execution of process validation activity. RESPONSIBILITY & ACCOUNTABILITY: RESPONSIBILITY: Quality … Read more
HANDLING OF DATA INTEGRITY PURPOSE: To lay down a procedure for the management of data generated through electronic and paper-based systems which should be Attributable, Legible, Contemporaneous, Original, and Accurate throughout the data lifecycle to ensure Data integrity. SCOPE: Data integrity management as described in the SOP applies to all manual, electronic, and paper-based data … Read more
Cleaning of Lifter Machine Objective : To lay down a procedure for the cleaning of Lifter Machine. Scope :This SOP is applicable for cleaning of Lifter Machine to warehouse of formulation plant Responsibility Operator / Technician – For cleaning of Lifter Machine. Warehouse personnel– For checking the cleanliness of the Lifter Machine. Accountability Department Head/In-charge … Read more
Operation of Vacuum Cleaner Objective :To lay down a procedure for the Operation of Vacuum Cleaner. Scope : This SOP is applicable for Operation of Vacuum Cleaner to warehouse of formulation plant. Responsibility Operator / Technician – For Operation of Vacuum Cleaner. Warehouse personnel– To maintain proper functioning of the equipment & procedure as per … Read more
Handling of Jewelry and Ornaments in the plant Objective ; To lay down a procedure for Handling of Jewelry and Ornaments in the plant. Scope : This Standard Operating Procedure is applicable for all the employees at the formulation plant of Pharmaceuticals Industries. Responsibility HR Department is responsible for the implementation of the procedure mentioned … Read more
Cleaning of Factory Footwear Objective : To lay down a procedure for Cleaning Factory Footwear. Scope : This Standard Operating Procedure is applicable for cleaning factory footwear in the formulation plant of pharma industries. Responsibility Housekeeping personnel is responsible to follow the procedure mentioned in the SOP. HR Department is responsible for the implementation of … Read more
Medical Examination Objective To provide a standard operating procedure for evaluating the health status of employees. As well as every year health check-ups will provide the health status of all employees. Scope This SOP is applicable to all the employees in the pharma industry. Responsibility HR Department shall be responsible to follow the procedure laid … Read more
Health & Hygiene Objective : To lay down a procedure for the description of Health and Personal Hygiene. Scope : This Standard Operating Procedure is applicable for all the employees at pharma industries. Responsibility HR Department is responsible for the implementation of the procedure mentioned in this SOP. It is the responsibility of all the … Read more
Spillage of Materials Objective :To lay down a procedure for Handling of Spillage of Materials to prevent contamination in surrounding areas and to avoid environmental hazards by any hazardous material. Scope : This Standard Operating Procedure is applicable in the facility for the handling of spillage of Material in the pharma industry. Responsibility Concerned Department … Read more
SOP for Drain Point Sanitization Objective : To lay down a procedure for Drain point sanitization. Scope : This SOP is applicable for cleaning and sanitization of drain points available in all sections of formulation plants of pharma industries. Responsibility Operator/Technician – To perform the procedure. Production personnel (Officers & above) to ensure the procedure … Read more