How CGMP Certified Toll Manufacturing Supports Food & Pharma Success

Justin Klinger, Apr 7, 2022 10:32:00 AM

cGMP in Toll Processing

Trust can be tough to build, and it’s so easy to lose. 

That’s true whether it’s a customer’s trust in a contract manufacturer or a consumer’s trust in a product — especially when food or pharmaceuticals are involved. Few products get the same scrutiny as those consumers choose to ingest. After all, a consumer can’t detect whether a food or drug was correctly produced just by sight, smell, taste, or touch.

That’s why it’s so important for food and pharma manufacturers to know their toll manufacturing partners are up-to-date and compliant with all current regulations, especially Current Good Manufacturing Practices (CGMP).

Along with food products and pharmaceuticals, dietary supplements are also subject to CGMP regulations. The U.S. Food and Drug Administration (FDA) holds all parties involved in manufacturing, packaging, labeling, or engaging contractors in these processes responsible for CGMP compliance. 

At every point in your business relationship, it’s essential to establish and uphold trust that your toll processor is performing services in full compliance with CGMP regulations.

What are Current Good Manufacturing Practices (CGMP)?

CGMP refers to principles and procedures established and enforced by the FDA to help ensure that products are consistently manufactured and controlled to quality standards.

CGMPs cover process and facility design, monitoring, and control. Companies that adhere to CGMPs assure that they make what they claim to make. Following CGMPs helps prevent quality deviations, mix-ups, product failure, contamination, and other failures.

If manufacturers in these industries were not held to CGMP guidelines, medicines could fail to have the intended therapeutic effects, or could end up containing toxic or unwanted substances. Foods could be contaminated through contact with other materials in the processing, packaging, or handling environment.

That’s why it’s so important for CGMP manufacturers to work with vendor partners to ensure that processes and facilities used for services like wet milling pharmaceuticals, jet milling incipients, micronization, and pharma blending are fully CGMP compliant.

How hard is it to establish trust in a CGMP processor? Fortunately, it’s pretty simple.

Once a manufacturer selects a certification standard (such as CGMP, organic, etc.), a reputable third-party certifier supplies up-to-date guidelines for the pharma or food contract manufacturer to follow in advance of an on-site facility audit. This allows the toll processor to create and document compliant processes.

After the audit, results include a timeline for corrections to nonconforming processes, as well as a scheduled time for a second review to demonstrate corrected processes.

“If it isn’t documented, it didn’t happen.” This tenet explains the importance of documentation. Every process that could affect the quality of the end product has its own detailed, written procedures. Management systems provide documented proof that those procedures are followed.

Whether hand-written or electronic, documentation helps resolve problems, make investigations easier, make corrective actions simpler, and perhaps more important, prompt the use of preventive controls to prevent issues in the first place.

10 Principles of CGMP

  1. Write detailed, step-by-step operating procedures: these are the roadmap for controlled and consistent performance
  2. Follow written procedures: instructions are the key to product quality (prevent contamination and reduce errors)
  3. Document all work: compliance and traceability is only possible with prompt and accurate documentation
  4. Validate work: prove that systems do what they’re designed to do
  5. Properly construct facilities and equipment: integrate productivity, product quality, and employee safety into facilities design
  6. Maintain facilities and equipment: everyone has the responsibility to follow maintenance schedules
  7. Design, develop, and demonstrate job competence: clearly state what every individual job should be accomplishing
  8. Protect against contamination: make cleanliness part of your company culture and employee lifestyle to ensure product quality
  9. Control components and product-related processes: manufacturing, packaging, labeling, testing, distribution, and marketing all build quality into a product
  10. Conduct periodic audits: this helps evaluate how well you live up to CGMP standards

Differences in CGMP Regulations for Food and Pharmaceuticals

Because there are so many ways to put safety practices into place when manufacturing food, CGMP offers guidelines for all manufacturers and processors to follow. But a hazard analysis must be completed for every product to help ensure the consumer is consuming a safe item.

The food defense program is a set of FDA requirements that outlines shared responsibilities from manufacturer to manufacturer throughout the supply chain. From trailer seals to tamper-resistant packaging, every requirement plays an important role in minimizing food vulnerability using the right processes and facilities.

For pharmaceuticals, CGMP is regulated and enforced, mostly due to the product’s potential to cause harm if manufactured incorrectly. Identity, purity, strength, and composition are vital to process control so every end product is consistent and reliable.

Pharmaceutical manufacturers qualify suppliers as part of their overall quality systems. Staying up to date in pharma emphasizes the importance of the “C,” which stands for “current,” in CGMP.

Do CGMP Regulations Require Dedicated Food Grade Processing Facilities?

Because CGMP regulations are so many and so in-depth, it wouldn’t be surprising if the FDA required a dedicated food grade processing facility for compliance. But they don’t.

A toll processor is not required to conduct pharmaceutical or food blending, milling, drying, or other processes in separate buildings away from other toll processing services. Good manufacturing practices can exist in the same building with non-CGMP processes, such as industrial micronizing and blending. 

That said, the best toll processors in the industry take that extra step.

A dedicated facility, while seen by many as an “above and beyond” measure, is a huge step toward preventing cross-contamination risks, as well as the potential effects of allergens. So, many pharmaceutical and food manufacturers now look specifically for this level of quality control.

After all, your contract manufacturing relationship is built on trust. Any experienced toll processor that knows various processes — blending, milling and grinding, drying, extraction, and more — embraces the principles of cGMP and demonstrates cGMP-compliance.

Learn more about finding and choosing a trusted toll processor for pharma ingredients when you download our free guide, Milling Methods for Food and Pharma. Click below to claim your personal copy today. 

Guide to  Milling Methods for Food & Pharma  [Claim Your Copy]

Posted in:PharmaceuticalcGMP