The Food and Drug Administration (FDA) clarified it no longer requires the QPIRA (Qualified Person in Industry Regulatory Affairs) training or certification to issue a License to Operate (LTO) to manufacturers.
Oscar G. Gutierrez, Jr., OIC-director of the Policy and Planning Service of the Food and Drug Administration (FDA), made this clear at a recent webinar on the agency’s efforts to simplify FDA requirements and procedures for processed food products.
He said the agency “did away” with the QPIRA training and now only requires the company to provide the qualified person or persons.
This new policy, Gutierrez said, is in line with the Department of Health’s Administrative Order (AO) No. 2020-0017, or the Revised Guidelines on the Unified Licensing Requirements and Procedures of the FDA.
The AO seeks to simplify the requirements and processes for initial, renewal and variation of LTO applications.
To apply for an LTO with the FDA, a manufacturer should know the food manufacturing or processing business inside out, reminded Gutierrez. This means the company is required to hire a qualified person or persons.
As defined in the AO, a qualified person is an organic or full-time employee of the establishment who possesses technical competence in the establishment’s activities and health products because of his or her profession, training or experience.
Moreover, the qualified person must comply with the technical requirements of the FDA or discuss or clarify matters with the FDA when submitting technical requirements or to engage the FDA officials when conducting inspection or post-market surveillance activities.
Gutierrez said that under the revised guidelines, the qualified person should have the right education, experience and training on the operation of the business, be it in food, drug, cosmetic or medical device production.
As an example, he said a drug manufacturing company will require a registered pharmacist to act as its liaison or regulatory officer. For food products, the company needs qualified people like a food technologist or a nutritionist.
“So the QPIRA training or certification will no longer be required by the FDA. All we need the company to submit is a qualified person,” he stressed. During inspection the qualified person should be present to answer the technical part of the inspection.
“So hindi na requirement ang QPIRA certificate in order to get an LTO. Hindi na rin requirement ang QPIRA [training] for companies to hire qualified persons. We simplified it,” he said.
Asked if small enterprises could afford to hire such a specialist, Gutierrez pointed out that under AO 2020-0017, the qualified person may also be the duly authorized person of the establishment.
The authorized person “refers to the owner, president, chief executive officers (CEO) or its equivalent, or any organic or full-time employee representing the establishment in an authorized or official capacity,” states the AO.
Thus, “the qualified person can also be the owner, so why hire? If you are small and you want to run your business then you have to get the proper training,” said Gutierrez.
To help businesses get such training is the FDA Academy, the agency’s education platform that conducts QPIRA trainings for FDA employees, the students, the industries it regulates and other stakeholders.
Gutierrez said the academy will continue to provide training on a voluntary basis, sometimes for a fee and sometimes for free. Through the academy, the qualified person, be it the owner or a company hire, can apply for the course or topic and get himself or herself properly trained.
The official mentioned that the FDA Academy recently conducted a webinar on drug outlets for those who wanted to set up this business, and that more webinars will be forthcoming.