Within all aspects of pharmaceutical manufacturing operations, maintaining a rigorous level of quality assurance is of critical importance. Urging greater focus on contractor quality, the United States Food and Drug Administration (FDA) issued new guidance in May that provides specific strategies for manufacturers to ensure drug quality from third parties.

The new FDA document maps ways to define and document the responsibilities of all parties involved in commercial production of human and animal drugs, biotechnology products, combination products and active pharmaceutical ingredients (APIs).

“A main theme is that the owner of a new drug application is ultimately responsible for any failings or shortcomings by contractors,” PharmTech reported last month. “While all parties to a contract must prevent adulteration or misbranding, FDA emphasizes that owners cannot escape responsibility by pointing to vendor failings.”

The FDA has issued various guidelines in the past addressing quality management principles related to contract manufacturing operations and recommended the use of Quality Agreements (QAs) to facilitate compliance with current Good Manufacturing Practice (cGMP) requirements, but the new draft guidance is significant for its focus on the importance and the details of written QAs.

In the draft guidance, the FDA recommends that a QA not only stand separate from commercial contracts but also clarify which of the cGMP activities are to be carried out by each party and track the basic subparts of the cGMP regulations or guidelines. At a minimum, the QA should cover the following basic topics: purpose/scope; terms (including effective date and termination clause); dispute resolution; responsibilities (including communication mechanisms and contacts); and change control and revisions (including subcontractors).

Health Care Law Matters has noted that “areas of responsibility include Quality Unit, facilities and equipment, materials management, product-specific requirements and responsibilities, laboratory controls and documentation.”

As manufacturers work to produce safe and reliable prescription drugs, maintaining clear and effective relations with contractors to balance the demands of meeting regulations and production costs is of the utmost importance.

Beyond a sense of restoring national pride, the recent resurgence of American-made goods makes economic sense again for manufacturers in the United States. Today, as economic conditions drive many overseas manufacturing operations back to the U.S., a new film explores the history of American manufacturing and its impact.

The feature-length documentary, titled American Made Movie, reflects on the glory days of U.S. manufacturing and also examines the factors that have contributed to the decline of the American manufacturing workforce, including technology and globalization.

While the documentary explores the decline of America’s manufacturing workforce, it also looks at people and families who have adapted and thrived, as well as successful companies that have prospered, showing the positive impact manufacturing jobs have on national and local economies.

Even more, the directors of American Made Movie, Vincent Vittorio and Nathaniel Thomas McGill, illustrate the integral role consumerism may play in getting the economy back on track, showing the relationship between people and what they buy. The film demonstrates how each American consumer can make a difference in the future of U.S. manufacturing.

In a recent 32-city, 32-day bus tour, Vittorio and McGill aimed not only to promote the film (which hits theaters nationwide Aug. 30), but also to educate and encourage people to purchase American-made products. Ultimately, the film asks who will be responsible for the resurgence of American manufacturing, and answers: Americans.

Approximately 65 percent of American consumers are willing to pay more for 10 key product categories – including electronics, appliances and apparel – as long as these goods were made in the United States, according to a late-2012 study from the Boston Consulting Group (BCG).

The findings are part of a research project known as “Made in America, Again,” which shows that the U.S. is becoming increasingly attractive as a location for making certain products for the domestic market, as well as becoming a base for global exports.

Buyers’ preferences for American-made products may be indicative of a broader trend that is making the U.S. more competitive with China, whose overwhelming manufacturing cost advantage over the  U.S. is shrinking rapidly and, ultimately, changing cost considerations.

Yet labor costs are only part of the picture, according to earlier BCG findings on the changing economics that are starting to favor the manufacturing of certain goods in the U.S.A. growing number of U.S. companies are considering reshoring, or shifting previously offshored operations back to the U.S., to also improve product quality, ease of doing business and proximity to customers. Relatively affordable energy is also making “Made in America” more attractive to businesses.

The results are consistent with evidence that the great migration of manufacturing offshore is beginning to reverse. According to findings published by Accenture last summer, approximately two-thirds of large U.S. manufacturers have moved factories in the past two years, with the most popular destination being the U.S.

This trend is expected to reach a tipping point over the next few years, as the total landed cost gap between the U.S. and China continues to shrink, driven in part by rising wage inflation inChina and continued productivity improvements in the U.S.

DeMarco Industrial Vacuum Corporation is proud to be Made in the USA. This is one of our core beliefs.