Pharmaguidances 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
ASSESSMENT OF CONTRACT ANALYTICAL LABORATORY FOR QUALIFICATION PURPOSE: To lay down the procedure for Assessment of Contract Analytical Laboratory for qualification. SCOPE: This Standard Operating Procedure is applicable for qualification of Contract Analytical Laboratory for analysis of samples for which in-house testing facility is not available. RESPONSIBILITY: Preparation of SOP: Officer/Sr. Officer QA Department Checking and … 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 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 Post Views: 577
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