Regaining cGMP Compliance and Attracting New Clients

At an Over-the-Counter (OTC) Drug Contract Manufacturer, tumultuous ownership history with 4 owners in 7 years created high employee turn-over, reduction of corporate knowledge, and loss of cGMP compliance.

And, the Contract Manufacturer was no longer able to attract new customers in large part because of the poor level of cGMP compliance.

Executives at both the contract manufacturer and the parent company viewed an FDA facility inspection at the Contract Manufacturer's site as a threat to the Contract Manufacturer's very existence, the parent company's reputation, and bottom line financial performance.

Coming Back from the Brink

Over a period of intense months, QualPro Consulting developed a user-friendly Quality Management System, trained the Contract Manufacturer's team, and validated production processes to put the contract manufacturer back within cGMP compliance.

The Contract Manufacturer did receive the once dreaded FDA inspection - a one investigator, 4 day inspection. It only resulted in two annotated observations (observations corrected during the audit).

No official action was required. The FDA Investigator told the Contract Manufacturer that their Quality Management System was one of the best she had ever seen.

With cGMP compliance established, the executives got the Contract Manufacturer back on track, regained their ability to attract new customers, and started to grow at a rate not experienced in years.

From Recall to Entering New Markets Within 18 Months

A company sales representative at a medical device company specializing in orthopedic implants discovered a package with a broken sterility seal.

Sterility had been compromised and further evaluation revealed that the broken seal was not an isolated event. The scope of the problem was widespread, involving the company's top two products which comprised 70% of company revenues.

The business itself was at risk.

Jim Dunning, who would later founded QualPro Consulting, was hired as head of quality assurance and immediately took charge of the recall.

The root cause of the problem was quickly determined as a faulty sealing process at a contract manufacturer. With open and clear communications to all stakeholders including the FDA the problem was fixed and managed.

An alternate contract manufacturer was qualified. Production capacity was doubled within 100 days from the day the packaging problem was discovered so that replacement product was provided while the recall was in-process.

Closing the Recall and Entering the European Market

The US FDA was informed of recall progress monthly and the recall was officially closed without on-site verification by the FDA. No illness or injuries were attributed to the problem. No customer accounts were lost due to the recall.

Immediately after the recall was resolved, the increased production capacity and the validations helped the products enter new markets. A CE Mark was acquired for both products and a successful European launch of both products was achieved.

Less than two years from recall initiation, the company was purchased by a much larger medical device company, at a price of more than five times earnings.

Meeting Regulatory Requirements Quickly to Make Distribution Schedules

A nutraceuticals company gained the rights to distribute a new product line in the U.S. and Canada. They bet the relationship and their sales quarter on a timely and successful launch.

The product labeling was designed by a foreign manufacturer for the Australian market. The Company had to make sure the labeling met regulatory requirements for the U.S. and Canada. And they had to do it in a hurry.

QualPro Consulting was hired to review and revise all labeling for the new products. The labeling was reviewed and label proofs were generated within 5 days. In addition, detailed citations for the required changes were provided to the U.S. distributor.

In short, the product licensing and distribution deal was a big success and the company had a great sales year.