Surviving a GMP Audit

LAS VEGASWith GMPs now a reality for most dietary supplement companies, the prospect of facing a GMP inspection and audit by FDA can be daunting. In a Nov. 12 seminar at SupplySide West, Amy Caplette, Nutrilite, and Andrew Shao, Ph.D., Council for Responsible Nutrition (CRN), looked at the most important areas of the GMP regulations and provided recommendations for those companies that are required to follow the regs and are likely to face an audit.

Caplette, group leader of quality assurance for Nutrilite/Amway, told a packed room at SupplySide West 2009 of her company's experience in dealing with FDA auditors. A certified quality auditor herself, Caplette is well-versed in inspections from such regulators worldwide. In a nutshell, she told the audience to expect FDA auditors to ask for loads of records and documents, take about 60 to 70 hours to audit the facility and generate a report up to 90 days later. Based on her experience in such an audit, she said there are many preparation tips companies can undertake now that will help them during an audit.

However, she also shared her thoughts in the video below about the future of the process.

Above all, Caplette stressed becoming familiar with the regulation (21 CFR Part 111) is beyond crucial. Good preparation means having written procedures and establishing specifications, sampling testing and retention. Master manufacturing records, batch records and material review board are important pieces to this puzzle, as is documentation, which includes standard audit info, copies and accessibility of records. To better prepare personnel, Caplette suggested identifying one lead person for any audits and training everybody in the company on how to handle the inspection and any requests or questions made during the audit.

Shao reiterated the major areas of concern in GMPs are record-keeping, analytical methods and supplier qualification. On records, he stressed, If its not written down, it did not happen. For companies aiming to peek at reports for inspections already completed, Shao said there is currently limited access to existing information on inspection reports, as the Freedom of Information Act (FOIA) requests are slow and often unreliable.

On testing he noted no company has gained an exemption from 100-percent identity testing. Further, analytical methods present a potential problem for manufacturers, as it is not required they use official validated methods, but scientifically valid methods, a situation which poses potential for the misapplication of methods.  Shao suggested some ways to verify a method would be appropriate for a given product/application.

However, the bulk of his presentation covered supplier qualification, including the relevant regulations, FDA's expectations, and the joint SIDI (standard information on Dietary Ingredients) initiative bringing together various trade associations and industry members. Stressing the importance of such qualification, he noted many suppliers dont provide a quality certificate of analysis (CofA), if they supply one at all.