By Donald E. Hagman, N/A
The Food and Drug Act was established to protect the public health and safety, and complying with it has become a major emphasis for pharmaceutical companies.
At one level, FDA compliance dominates the entire physical aspect of the industry, from the manufacturing facility and process to the final distribution and use of the end product. However, its effect reaches even farther. Good compliance practices can lead to faster, easier product approvals, allowing a company to beat the competition to market. Poor compliance may cause the agency to refuse or delay approval of a product, or there could be legal action, seizure of products or closure of the company's manufacturing operation. For this reason, a good regulatory history is an absolute must for a contract manufacturer.
Theory and Practice
In theory, guiding a project to the final commercial state is no more difficult for one company than for another. In practice, however, there are considerations that may reflect differences in compliance expertise. For example, guidelines and regulations do not tell how to do something. Rather, they tell what the ultimate result should be. This leaves them somewhat open to interpretation. This interpretation can evolve, and it is important for the manufacturer to be flexible. The contractor may have to quickly change course as interpretations change. Also, contractors and their clients may disagree in their interpretation of a regulation. A good contractor can negotiate the difference. Does the manufacturer's record demonstrate this ability?
The complexity of the product manufacturing process can also complicate the compliance process. This point underlies all judgments of a manufacturer's regulatory history: it is not how a contractor handles the ordinary, but how it handles the extraordinary.
There are other considerations when rating a contractor on compliance.
- Document management. How well do they handle documentation? Compliance is a document-intensive endeavor, and good document management is a fundamental need. However, it is no easy task. There are about 1,000 document control SOPs alone in a small business environment, and every product has batch records and specification sheets for all raw materials. Master files must be maintained with various regulatory agencies. Can the documents, and the actions they reflect, be easily traced?
- Knowledge. Has it kept pace with the information explosion? We are now in a global business atmosphere and must keep up-to-date not just with the U.S. agencies, but with regulatory bodies from around the world. They are all different and manufacturers have to know requirements, guidelines and regulations for each. Does the contractor have the global knowledge and experience to keep the path smooth?
- Flexibility. Is the contract manufacturer flexible, comfortable with compromise and change?
- Controls. How does the contractor ensure that the manufacturing and services are controlled? Every good manufacturer will have verifiable and documented systems to guarantee that the product will meet its intended specifications and meet the requirements for safety.
- Checking the record. With appropriate safeguards for client confidentiality, a contractor should communicate openly on regulatory history. Reviews and audits should be open. Good manufacturers, for example, conduct an annual review of operations to ensure compliance. The results, complete with corrective actions taken, should be open to interested parties. Most often, manufacturers will also provide audits and information based on government inspections. Customer audits may be offered up for review, depending on confidentiality agreements.
For those who need legal assistance in securing records, all the information on compliance for U.S. applications is available through the Freedom of Information Act.
As companies evaluate contractors' regulatory history, they should be aware that good compliance practices, with their fundamental advantages, cost money. The manufacturer with the better regulatory record may submit quotes a little higher than quotes from someone with a not-so-good history. Obviously, one manufacturer has put capital into the physical operation and invested in training employees in their personal attitude and knowledge. This is why an ongoing commitment by management is key to a successful compliance effort.
About the Author
Donald E. Hagman is executive vice president and a principal of N/A. He has operating responsibilities for regulatory, quality and development activities. Hagman has extensive management experience in the pharmaceutical industry in the areas of research and development and quality control assurance. He earned his M.S. and Ph.D. in Industrial Pharmacy from Purdue University and his B.S. in Pharmacy from Massachusetts College of Pharmacy. Hagman is a member of the American Pharmaceutical Association, Parenteral Drug Association, and the American Society for Quality Control.
For more information: Donald E. Hagman, Executive Vice President, SP Pharmaceuticals LLC, 4272 Balloon Park, NE, Albuquerque, NM 87109. Tel: 505-345-0500. Fax: 505-761-9229.