SELF INSPECTION CHECKLIST FOR DPI (DRY POEDWE INJECTION) CHANGE ROOM: General Area cleanliness Entry /Exit procedure & Pictorial diagram GENERAL AREA: General cleanliness Area differential pressure records Equipment status Labeling status Use of protective equipment’s (e.g. Hand gloves, nose masks etc.) Machine uses and clean log record Temperature and relative humidity record of the area … Read more
SELF INSPECTION CHECKLIST FOR ENGINEERING PREVENTIVE MAINTENANCE: Preventive Maintenance SOP & Planner availability. Preventive maintenance records of critical equipment’s of production Area Preventive maintenance records of Water System Preventive maintenance record of Air Handling Unit Preventive maintenance Status Label affixed on Area /Equipment /System /Utility. Preventive maintenance record of Nitrogen Generation System Preventive maintenance record … Read more
SELF INSPECTION CHECKLIST FOR QA Sampling procedure of intermediate / finished products and control sample Line clearance procedure Review of online batch records for checking of in-process results Handling of Batch record system Procedure DISPOSAL OF INPROCESS TEST SAMPLE DOCUMENT CONTROL: Authorization, issuance and control of Following documents SOP’S Specifications and testing procedures, Validation documents … Read more
SELF INSPECTION CHECKLIST FOR QC General Checklist: General cleanliness of department and cleaning records Storage condition of chemicals and solvents Labeling status on bench reagents / volumetric solutions /working standards and their preparation & utilization records Sampling procedure of raw materials / packaging materials as per SOP Labeling of raw material samples /packaging materials samples … Read more
SOP FOR SELF-INSPECTION PURPOSE: To lay down the procedure for Self-Inspection in order to monitor the implementation and compliance with the laid down procedures, cGMP practices and to propose necessary corrective measures. SCOPE: This procedure is applicable for Self-inspection of manufacturing, packing, holding and distribution areas and related functions associated with manufacturing. RESPONSIBILITY: Preparation of SOP: Officer/ Sr. … Read more
SOP FOR ACCEPTABLE QUALITY LEVEL (AQL) FOR VISUAL INSPECTION PURPOSE: To lay down a procedure for Acceptable Quality Level (AQL) for visual inspection. SCOPE: This procedure is applicable for the Acceptable Quality Level (AQL) for visual inspection of Cephalosporin Block. RESPONSIBILITY: Preparation of SOPs: Officer/Sr. officer. Checking and Review of the SOPs: Executive /Sr. Executive. … Read more
SOP FOR APPLY PERMISSION FOR MANUFACTURING OF NEW PRODUCT PURPOSE: To lay down the procedure for application for the permission for manufacturing of new product. SCOPE: This SOP is applicable to describe the procedure for application for the permission for manufacturing of new product. RESPONSIBILITY: Preparation of SOP: Officer/Sr. Officer of QA Personnel. Checking and … Read more
SOP FOR ACCELERATED STABILITY AND SHELF-LIFE CALCULATION PURPOSE: To lay down a method for accelerated stability and to find out the shelf life of the product for Cephalosporin Block. SCOPE: This SOP is applicable for the standard operating procedure pertaining to all departments. RESPONSIBILITY Preparation of SOPs: Officer/ Executive of Concerned Departments Checking and Review of the … Read more
SOP FOR CALIBRATION OF EQUIPMENT/ INSTRUMENTS FROM OUTSIDE AGENCY PURPOSE: To lay down a procedure for calibration of equipment’s /instrument by outside agency SCOPE: This sop applicable to all the equipment’s/ instruments. RESPONSIBILITY: Preparation of SOPs: Officer/ Executive of Concerned Departments Checking and Review of the SOPs: Next Level of the Concerned Department Approval of the SOPs: … Read more
SOP FOR MANAGEMENT REVIEW MEETING PURPOSE: The purpose of this SOP is to lay down the procedure for regular Quality management review meeting to determine the performance and effectiveness of in product development, regulatory approval, dossier compliance and GMP scenario during routine and associated documentation. SCOPE: This SOP is applicable for product development, regulatory approvals, … Read more