Robinson Pharma audit confirms cGMP compliance

The audit, performed by Specialized Technology Resources (STR), grants the company continued certification under the Retail Qualification Program (RQP). These standards were originally established to assure the safety, purity and label claim compliance of supplements sold in a major national retail chain.

According to Robinson Pharma’s vice president of marketing Kenn Israel, the firm’s investment in quality has already allowed it to expand into the private label market.

“Partnering with STR, along with other key strategic initiatives, has facilitated the transformation of RPI from a contract manufacturer to a competitive private label supplier of some of the leading marketers of dietary supplements in the United States and other international markets,”​ he said.

Quality review​

The STR audit – which confirms the purity, safety and labeling of products – tested Robinson Pharma’s standard operation procedures, staff qualifications and staff training program. It also evaluated facility adequacy and cleanliness.

Aspects of the manufacturing process that were reviewed include receipt and authentication of ingredients, the production process, post production product analysis, product handling, packaging, storage, and record keeping, said RPI.

The firm first committed to the Retail Qualification Program last year.

Investment​

Certified quality standards are now becoming indispensible in all levels of the supplement manufacturing industry after the introduction of new quality regulations last year.

FDA’s good manufacturing practices (cGMPs) for supplements, designed to ensure quality, safety and consistency, have already been adopted by large manufacturers in the US (over 500 employees). Mid-size companies are expected to comply by June this year, while small firms (less than 20 employees) have until June 2010 to comply.

Robinson Pharma, which can produce 12bn soft gel capsules per year, said it has made “significant investments”​ in manufacturing systems that ensure constant monitoring of all aspects of its production process.

It said it has designed systems for ingredient receipt and testing, pharmacy and pre-production processing, manufacturing, post production testing and packaging.

Much of this work was conducted in partnership with STR, which RPI said provided “guidance and objective perspective”​ on its progress and execution.