Introduction This report presents a high-level assessment of the Form FDA 483 issued to Sun Pharmaceutical Industries Ltd., Halol, dated June 13, 2025, following a comprehensive inspection by the United States Food and Drug Administration (USFDA). The inspection revealed eight major observations related to deficiencies in aseptic practices, process validation, equipment maintenance, data integrity, and […]
Terminal sterilization is the reliable process to assure the sterility of the product. Regulators more relay on the Moist heat terminal sterilization process than aseptic processing. In terminal sterilization product sterilized in the final container. Terminal sterilization should be utilized when the product and container/closure system are able to withstand the terminal sterilization process. Note: Kindly […]
A Review Article on Visual Inspection program for sterile injectable product- A complete solution for manual inspection process
For companies registered with the FDA, you can check the FDA’s inspection database to see the specific firms compliance status (NAI, VAI, or OAI) – https://www.fda.gov/iceci/inspections/ucm222557.htm. I prefer starting here as it gives me a picture of their status over time. You can also go to the FDA ORA FOIA electronic reading room and can find […]
Now a days the topic “Data integrity and non compliance” is the hot topics. Lots of references available online that deals with the Data integrity issue. One of the major example am going to give today, that can be control by the management only. Extended shift/working hour or over time:We know that “Human error” is the […]
Why inspection ? • To assess & evaluate the ability of a facility to manufacture quality products which consistently meet specification and regulatory requirements. • To confirm and assure the validity of: Identification, traceability and integrity of lots Manufacturing & packaging procedures Analytical methods • Confirm that the procedures, processes and methods described in registered […]
We know the available elements of ALCOA. We will discuss latter on the ALCOA topic. But currently we want to emphasis on the issue why we are getting this issues? Data integrity no only the problem of a specific organization, reflects how country are acting on the integrity issue. It will give very bad impact […]
Interview for the position of manager position in QA for aseptic formulation plant: 1. What is the interpretation between Re-Qualification and Performance re-qualification? Re-Qualification considered with again qualify the system/equipment in terms of IQ, OQ and PQ. Performance Re-qualification means revisit or re-verification of established limit within specified periodic interval. 2. Other […]
Audit is always additional headache for Pharmaceutical industry. People from lower level to higher management are afraid for any regulatory audit. But facing of audit is not like a rocket science. As we are working for our organization same way auditors are working for their regulatory authority. We are the knowledgeable fellow of our organization, […]
What is a DMF? Ans- A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Important facts regarding DMFs It is submitted to FDA […]
