NIH Seeks to Turn Drug Compounding Unit Into cGMP Facility
The National Institutes of Health is working quickly to correct major lapses in its drug compounding unit so officials will be able to ask the FDA to register it as a cGMP manufacturing facility subject to periodic regulatory inspections.
A May 19 to 29 FDA inspection resulted in a 17-observation Form 483 and an announcement on June 4 that NIH was suspending all operations in its Pharmaceutical Development Section and the Clinical Center Pharmacy.
Investigators found flaws in the air filtering system, deficiencies in monitoring environmental conditions and cleaning sterile processing areas, buildings not being able to facilitate proper cleaning and inadequate quality control, the Form 483 says.
NIH plans to retain a consulting firm to conduct a comprehensive evaluation of the PDS facility, its operations, procedures and processes, and quality assurance and quality control systems. Additionally, NIH has set a series of strict timelines for ongoing projects.
Dynamic airflow studies of the hoods in the pharmacy’s ISO 5 sterile areas will begin by July 1 and results will be processed as soon as they are available. Similar studies will be conducted every six months.
A plan to redesign the pharmacy’s facilities to prevent contamination is expected by July 15. All PDS personnel will be retrained using GMP-specific courses by Aug.14, and new standard operating procedures will be in place by Sept. 1.
Going forward, NIH officials will establish a senior advisory committee of GMP, facility management, clinical research, engineering and regulatory experts to oversee the entire process.