David Trosin, director, global business development, dietary supplements at NSF International, discusses the Top 10 GMP Audit Findings at Dietary Supplement Manufacturing Facilities in 2016.
As the global leader in dietary supplement GMP facility registration, NSF International conducts GMP audits at hundreds of dietary supplement manufacturing facilities annually—including many contract manufacturers.
According to NSF International audit data, many supplement manufacturers struggled with the following GMP requirements in 2016:
1. Ensuring the batch production record follows the master manufacturing record and each step is performed appropriately.
2. Establishing procedures to prevent pests and animals from entering the facility (installation of screens and barriers, rodent traps, insect traps, lights, etc.)
3. Properly using equipment and utensils to protect components and dietary supplements from contamination from any source.
4. Establishing appropriate roles and responsibilities for quality control personnel.
5. Ensuring walls, floors and ceilings can be adequately cleaned and kept in good repair.
6. Maintaining, cleaning and sanitizing all equipment, instruments, utensils and contact surfaces as necessary.
7. Taking necessary precautions to prevent contamination, such as microbial, filth, chemical and foreign material contamination, throughout the manufacturing process.
8. Establishing adequate precautions against contamination by microorganisms, chemicals, filth, or other extraneous materials.
9. Establishing supplier qualification procedures, including procedures for initial qualification, periodic examination (re-qualification) and disqualification.
Establishing procedures and programs for maintenance of equipment.