SOP FOR REPORTING OF INVESTIGATION PURPOSE: To lay down a procedure for reporting of investigation. SCOPE: This SOP is applicable to for the quality related failures of product, which do not meet the acceptance criteria. RESPONSIBILITY: Personnel of concern department are responsible for the Quality Related failures of product. Concern-HOD or designee shall investigate and … Read more
SOP ON BATCH CONVERSION PURPOSE: To lay down the procedure for Batch Conversion. SCOPE: This SOP is applicable for Batch Conversion Procedure. RESPONSIBILITY: Preparation of SOP: Officer/ Sr. Officer Checking and Review of the SOP: Executive/Sr. Executive Approval of SOP: Head of Department/ Assistant Manger Authorization of SOP: Head QA/Designee Head Production shall be responsible for initiating conversion … Read more
SOP ON BATCH RELEASE SYSTEM OF FINISHED PRODUCT PURPOSE: To lay down a procedure for release of finished products for distribution. SCOPE: This SOP is applicable for release of finished product manufactured. RESPONSIBILITY: Preparation of SOP: Officer/ Sr. Officer. Checking and Review of the SOP: Executive/Sr. Executive Approval of SOP: Head of Department/ Assistant Manger Authorization of … Read more
SELF INSPECTION CHECKLIST FOR WAREHOUSE RAW MATERIAL STORAGE AREA: General cleanliness Temperature and relative humidity measurement records Raw material receipt procedure Quantity verification of Raw material against purchase order Physical inspection of incoming goods for physical aspects Storage of materials as per the approved list of storage condition Weather freezer available for material stored at … Read more
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 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
