SELF INSPECTION CHECKLIST FOR DRY SYRUP CHANGE ROOM: General cleanliness Entry /Exit procedure GRANULATION AREA: General cleanliness Area differential pressure records Equipment status Labeling status Use of protective equipment (e.g. Hand gloves, nose masks etc.) Machine use and clean log record Temperature and relative humidity record of the area Status of batch record of the … Read more
SELF INSPECTION CHECKLIST FOR CAPSULE CHANGE ROOM: General cleanliness Entry /Exit procedure BLENDING AREA: General cleanliness Area differential pressure record Equipment status Labeling status Identification of utility services Temperature and Relative Humidity record Process activities as per BMR/SOP Cleaning of Filter GRANULES – QUARANTINE AREA: General cleanliness Labeling status on containers Balance calibration status CAPSULE … Read more
SELF INSPECTION CHECKLIST FOR TABLET CHANGE ROOM General cleanliness Entry /Exit procedure GRANULATION AREA: General cleanliness Area differential pressure records Equipment status Labeling status Use of protective equipment’s (e.g. Hand gloves, nose masks etc.) Machine use and clean log record Temperature and relative humidity record of the area Status of batch record of the product … Read more
SELF INSPECTION CHECKLIST FOR DPI (DRY POWDER 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 HR House Keeping Record of the various department Drain cleaning record Procedure for emergency handling Induction training of newly recruited employees Training procedure and records Pest control record Rodent control records Employees medical examination report Eye checking reports Employee health and hygiene
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