Alto Ingredients announces certifications for ICP facility

By Erin Voegele | February 12, 2021

Alto Ingredients Inc., formerly Pacific Ethanol Inc., announced on Feb. 3 its Illinois Corn Processing facility is now ICH Q7 certified. The following day, the company announced the same facility is now 2017 EXCiPACT Good Manufacturing Practices (GMP) certified.

According to Alto Ingredients, the International Council for Harmonization guideline is intended to provide guidance regarding GMP for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.

The company explained that this guideline applies to the manufacture of APIs for use in human drug (medicinal) products. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile.

“Our commitment to provide our customers the absolute best quality products is reflected by this significant achievement,” said Mike Kandris, CEO of Alto Ingredients. “In October of 2020, we obtained our ISO 9001 certification, the world's most widely recognized standard for quality management systems. Now with our internationally recognized ICH Q7 certification, our alcohol is certified for use as an active pharmaceutical ingredient. Markets for our alcohol include use in beauty and oral care products such as foundation and mouthwash, in addition to other uses within the pharmaceutical and personal care product industries. Our dedication to quality required to attain ICH Q7 allows us to safely and consistently serve our domestic markets as well as a growing export market.

“We thank our customers for assisting us in developing our quality program and providing support through the successful completion of our ICH Q7 audits,” he continued. “Attaining this certification deepens our existing customer relationships and also opens the door to new opportunities. With our ICP facility now ISO 9001 and ICH Q7 certified, we can more effectively meet anticipated customer demand for our specialty alcohols and essential ingredients.”

Regarding the EXCiPACT certification, Alto Ingredients explained that regulators require excipient users to qualify their suppliers based on GMP/GDP audits. Regulators have indicated that third-party auditing of suppliers is acceptable if a creditable certification body issues certificates and audit reports by employing qualified auditors who are demonstrably credible in suitable GMP/GDP standards and in the needs of the pharmaceutical industry. EXCiPACT is a non-profit organization that owns and manages oversight of such an independent, high quality, third-party certification program available to pharmaceutical excipient manufacturers and distributors worldwide.

“A key component of our growth strategy is broadening our access to additional ethyl alcohol markets,” Kandris said. “In conjunction with our recently announced ISO 9001 and ICH Q7 certifications, our EXCiPACT certification accomplishes that goal. EXCiPACT is an independent, globally recognized certification standard for the use of excipients in the pharmaceutical industry. Excipients are the inactive components of a drug or medication, such as solvents, carriers or tinctures. We attained these quality certifications with the assistance of our customers who expect high quality, safe ingredients for use in their formulations. These certifications demonstrate our commitment to meeting those expectations.”