SOP FOR PROCEDURE FOR ASEPTIC PROCESS SIMULATION (MEDIA FILL) PURPOSE: To define the procedure to be followed for validation of aseptic processes by process simulation study through a media fill. Process simulation study provides a way- To demonstrate the capability of the aseptic process in producing the sterile drug product. To qualify the personnel involved … Read more
SOP FOR INVESTIGATION OF MEDIA FILL FAILURE PURPOSE: To lay down a procedure for Media fill failure Investigation. SCOPE: This Standard Operating Procedure is applicable for Media fill failure Investigation. RESPONSIBILITY: Preparation of SOP: Officer QA Department Checking and Review of the SOP: Executive QA Department Approval of SOP: Executive QA Department Authorization of SOP: Head … Read more
SOP ON INPROCESS CONTROLS PURPOSE: To lay down a procedure for in process control in dispensing area, oral preparation (Tablets, Capsules & Dry Syrup) and in Dry powder Injection. SCOPE: This SOP is applicable for the Tablet Capsule dry syrup orals dosage Forms and Dry powder Injections for different products manufactured RESPONSIBILITY: Preparation of SOP: Officer/ … Read more
SOP ON GAP ASSESSMENT PURPOSE: The purpose of this Standard Operating Procedure is to lay down the procedures for periodic review of respective standard operating procedures, Validation Procedure and other activities to find out the possibilities of improvement. SCOPE: This SOP is applicable for review and updating of standard operating procedure, Validation Procedure and other activities … Read more
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