GMP Consulting Services
Offering the GMP Compliance Program

When it comes to quality assurance, especially in the pharma space today, companies seem to not have a solid foundation for their production and process control systems. As a result, quality assurance groups fail to keep an intimate understanding of such systems, leading to compliance-related complexities. Changes to the production systems must be fully examined to ensure that the changes do not cause a failure of the integration built into the system originally.

That’s where GMP Consulting Services can help.

GMP Consulting Services offers innovative services to help businesses meet and exceed Federal Regulations and provide technical support in the formulation and processing of drug and dietary supplement products. The company’s inclusive program provides all of the standard procedures that cover everything from the receipt of materials to the finished product. The standard procedures walk a company through how to create the specifications for each raw material, packaging component, in process material, and finished product.

“We provide the templates for these specifications which include the test results based on the company’s established specifications. It is up to the company to establish the test methods and equipment to be used,” says Gary Callahan, the President and CEO of GMP Consulting Services. “That said, we consult companies on the best methods for certain basic tests such as identity, microbials, heavy metals, and contaminants.”

Callahan started his career more than five decades back in the pharmaceutical manufacturing industry. His comprehensive knowledge of the regulations and inner workings of manufacturing liquids, powders, and solid dosage form products is the key to GMP Consulting Services’ success.

GMP Consulting Services has helped many companies with FDA citations and warning letters. In a few cases, the company has also acted as the liaison between the clients and the FDA.

Recently, Callahan was included in a conference call with one of his clients and the FDA while the FDA investigator was conducting an audit. Over the phone, the investigator cited several areas that the client was not in compliant with. Several times, the investigator stated that he was going to issue a 483-observation report. Fortunately, in the end, no such 483 was issued. The client believes that it was Callahan’s knowledge of the regulations that saved him from receiving the 483-observation report.

“We were the very first to offer targeted consulting to dietary supplement manufacturers and our start-up date was the same as the printing and release of the GMPs for Dietary Supplements. We also issued certificates of compliance to dietary supplement manufacturers,” states Callahan. “We ensure that our program will stand up to FDA scrutiny and the result of following our program leads to higher standards of quality and reduced customer complaints as well as increased productivity and profitability.”