What happens when a firm obtains out of specification results?
21 CFR 211.192 states:
All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.… more
On July 10, 2018 FDA issued a health care alert for products compounded by Ranier’s Pharmacy do to a lack of sterility assurance. Rainer’s inspection history includes:
In the warning letter, the FDA recommended:
FDA strongly recommends that your management first undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, materials, and systems for the production of human and animal drugs. … more
SCADA (Supervisory Control and Data Acquisition) software vendors have historically served industries that require tight controls over system configurations and data records. As a result, modern SCADA software systems have evolved to provide a robust set of tools intrinsically designed to prevent the intentional or unintentional undetectable alteration of system data. … more
One of the more interesting and novel cancer therapies is the genetic engineering of the patients T-cells, where the cells are modified to target a specific protein expression on the cancer cell. However, this is a paradigm shift in manufacturing moving from a centralized manufacturing (what we see today at large pharmaceutical companies, or 503B Outsourcing Facilities) to a patient point-of-care or decentralized manufacturing model. … more
One of the tools FDA has to enforce laws and regulations are injunctions which may leed to a consent decree. These tools are goverened by FDA Policy. Injunctions are managed through the Office of the Chief Counsel (OCC) per FDA policy. … more
As identified in a recently posted FDA warning letter during the inspection, the FDA investigator requested the firm to provide all deviations from environmental monitoring limits. The firm reported that they had no results outside limits for over a year prior to the inspection date…
However, during the inspection the FDA investigator found containers storing environmental and personnel monitoring microbiological samples, dated August 30 and 31, 2017.… more
Did you know that 503B Outsourcing Facilities are tracked under CDER Strategic Area 2 – Drug Quality and Compliance on the CDER Dashboard.
Section III identifies Inspections and Enforcement of Compounders. This CDER Dashboard identifies by fiscal year the number of compounds that recalled products, the number of warning letters issued, the number of state referral letters, the number of injuctions/consent decrees, and the total number of regestered outsoursing facilities. … more
In the first 6-months of 2018, fiftteen 503B Outsourcing Facilities were cited for smoke study issues. Airflow is critical in maintaining sterile conditions, as described in the FDA Guide on Aseptic Processing
In an aseptic process, the drug product, container, and closure are first subjected to sterilization methods separately, as appropriate, and then brought together. … more
Aseptic manufacturing facilities have many critical qualification activities that rely heavily on high-quality data collection. One such activity is critical airflow visualization – commonly referred to as a smoke study. Smoke studies are used to demonstrate “laminarity and sweeping action over and away from the product under dynamic conditions” (FDA draft guidance “Sterile Drug Products Produced by Aseptic Processing”).… more