cGMP in Toll Processing: Insights for Food & Pharmaceutical
Tammy Sammeli, Feb 19, 2020 10:32:00 AM
Trust. It can be so difficult to build and so easy to lose.
When it comes to toll processing for food and pharmaceutical applications, trust is paramount. Knowing that a toll processor takes every effort to stay up-to-date with current regulations is really the first step to building trust within the manufacturing process.
Current Good Manufacturing Practices (cGMP) is a set of quality assurance principles and procedures that helps ensure products are consistently manufactured and controlled to appropriate quality standards.
Established by the FDA, cGMP standards are especially vital for businesses in heavily regulated industries such as pharmaceuticals, food, and dietary supplements. Without this guidance, for instance, medicine could fail to have the intended therapeutic effect or unintentionally contain toxic substances.
With cGMP covering all aspects of manufacturing — from raw materials to equipment to personal hygiene — you may think getting certified would be complex and time-consuming. It’s not.
Once a manufacturer selects a certification standard (GMP, organic, etc.), a reputable third-party certifier supplies guidelines to follow prior to an audit at the facility. Results of the audit include a timeline in which to make corrections to nonconformances, including a scheduled time for a second, and hopefully final, review.
“If it isn’t documented, it didn’t happen.” That classic training tenet helps reinforce how incredibly important documentation is within cGMP. There are detailed, written procedures on every process that could affect the quality of the end product. There are also management systems to provide documented proof that correct procedures are followed.
Whether hand-written or electronic, documentation helps resolve problems, conduct investigations, make corrective actions, or simply prompt being proactive, using preventive controls to avoid potential issues.
The 10 Principles of cGMP
- Write detailed, step-by-step operating procedures — these are the roadmap for controlled and consistent performance
- Follow written procedures — instructions are the key to product quality (prevent contamination and reduce errors)
- Document work — compliance and traceability is only possible with prompt and accurate documentation
- Validate work — prove that systems do what they’re designed to do
- Properly construct facilities and equipment — integrate productivity, product quality, and employee safety into their design
- Maintain facilities and equipment — everyone has the responsibility to follow maintenance schedules
- Design, develop, and demonstrate job competence — clearly state what every individual job should be accomplishing
- Protect against contamination — make cleanliness a lifestyle habit to ensure product quality
- Control components and product-related processes — manufacturing, packaging, labeling, testing, distribution, and marketing all build quality into a product
- Conduct planned and periodic audits — this helps evaluate your progress toward living up to cGMP standards
cGMP Differences Between Pharma and Food
Because there are so many ways to put safety practices into place when manufacturing food, cGMP offers guidelines to follow (to help meet FDA regulations). For every product, however, a hazard analysis must be completed to ensure the consumer is consuming a safe product.
The food defense program is an important requirement of the FDA with shared responsibilities from manufacturer to manufacturer throughout the supply chain. From trailer seals to tamper-resistant packaging, minimizing food vulnerability with the right processes and facilities is key.
For pharma, 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 an 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” in cGMP. Being “current” with FDA regulations is simply a must in this industry.
Is a Dedicated Food Grade Processing Facility Needed for cGMP?
With so many regulations needing to be followed for cGMP, it wouldn’t be surprising for the FDA to require a dedicated food grade processing facility. But they don’t.
A toll processor doesn’t need to conduct pharma/food blending and milling processes in separate buildings away from other toll processing functions. Good manufacturing processes can exist in the same building with non-cGMP processes. However, the top toll processors in the industry do take that extra step.
A dedicated facility, while seen by some as an “above and beyond” measure, is a huge step toward mitigating cross-contamination and the effects of allergens. So, many pharmaceutical and food manufacturers now look specifically for this level of quality control.
Any experienced toll processor that knows various processes — blending, milling/grinding, drying, extraction, etc. — understands the demands of cGMP and is cGMP-compliant.
Learn more about selecting a toll processor for pharma ingredients with our Blending for Pharmaceuticals Guide. Just click the link below to download your copy. And when you’ve read through it, feel free to contact us if you have questions.