Quality assurance is important in any industry, but in the medical manufacturing and pharmaceutical industries, it takes on an even greater role.
Not only do manufacturers have an ethical duty to provide products that are safe and effective, but they also must comply with stringent legal regulations, which are frequently updated.
The pharmaceutical industry in the United States is set to grow over $150 billion over the next four years, with a compound annual growth rate of nearly six percent.
A key ingredient in pharmaceutical applications that will support that growth is safe and pure white mineral oil. One way manufacturers can create products that meet or exceed medical industry standards is by using USP Verified white mineral oil.
3 Best Practices for Quality and Safety
Especially when producing at scale, safety, quality, and consistency throughout the entire product line are of the utmost importance for pharmaceutical manufacturers.
By adhering to certain basic principles, manufacturers can minimize the risks to their reputation and their bottom line that can come from a subpar product.
Here are some tips for how to maintain the standards of quality and safety that medical product consumers depend upon, all of which are essential characteristics of a USP Verified white mineral oil supply source.
1. Implement a Quality Management System
Quality management systems (QMS) are frameworks that help companies ensure consistently high quality in their products.
A QMS encourages and gives guidance on practices such as:
- Setting specific standards,
- Establishing clear and effective organizational structures,
- Keeping and maintaining thorough records,
- Taking corrective and preventative action,
- Employee training, and
- Sourcing and managing quality material from suppliers.
One of the largest and most widely recognized QMS frameworks is the ISO 9000 family of standards. These include the general standard ISO 9001, as well as industry-specific applications such as ISO 13485 for medical devices.
The ISO framework also serves as the basis for other important quality assurance frameworks such as SQF (Safe Quality Food) which are used for specific product classes. This is a GFSI (Global Food Safety Initiative) approved framework.
By working with white oil suppliers that have a strong QMS in place, particularly one that supports a USP Verified product, medical manufacturers can demonstrate a strong commitment to quality and consumer safety.
2. Keep Up To Date With Regulations
The FDA is the federal body tasked with regulating the quality and consistency of pharmaceuticals in the United States. The primary regulatory standard that the FDA enforces is known as Current Good Manufacturing Practice (CGMP).
These regulations address the design, monitoring, and control of the pharmaceutical production process to maintain high standards and ensure safety.
But the “C” in CGMP is important. Machines and organizational structures that might have been effective in the past may become outdated. To ensure that U.S. pharmaceutical manufacturers are up to the most recent standards, the CGMP is regularly updated.
It’s crucial to work with excipient suppliers that are FDA-compliant. To keep up to date with changing regulations, manufacturers can find the FDA’s newest regulations in the Federal Register or on the FDA’s website.
3. Maintaining Effective Documentation
Part of what makes a quality management system effective is clear and measurable goals. Thorough record-keeping is how your organization can be sure it is meeting these goals, or determine how to course correct to meet them.
Documentation is also essential for accreditation or compliance purposes. When other organizations and regulatory bodies seek to verify your claims of quality and consistency, consistent recordkeeping can prove that your business practices what it preaches.
Consistent, detailed recordkeeping also enables continuous quality improvement. A standardized review process should reveal opportunities to build more cost-saving efficiency into procedures such as product handling, quality assurance, and transportation.
Partner With Renkert Oil for USP Verified White Mineral Oil
Part of maintaining high standards of quality is working with suppliers that demand the same level of consistency and purity in their products as you do.
For manufacturers in the medical industry, Renkert Oil’s USP Verified white mineral oils check all the boxes quality assurance. We are also:
- SQF (Safe Quality Food) certified,
- Kosher, Pareve, and Halal certified,
- REACH registered,
- FMSA (Food Modernization Safety Act) compliant, and
- CGMP (Current Good Manufacturing Practice) compliant.
We take quality assurance seriously so that our customers in the food and medical industries can have unparalleled confidence in the safety and purity of our white oil products.
To learn more, contact Renkert Oil today!
