cGMP quality systems, SOPs, batch records, environmental monitoring and building a quality culture.
Quality Systems Matter for the Emerging Supplement Manufacturer For the Emerging Supplement manufacturer, overlooking Regulatory & Compliance as a dietary supplement marketer can be a costly mistake. Overlooking Regulatory & Compliance as a dietary supplement marketer can be a costly mistake. Regulatory Risk = Business Risk. In today’s environment, it’s easy to view regulatory oversight…
Smaller and emerging dietary supplement manufacturers face challenges in seeking their way to cGMP certification. I understand this well. As a Quality Management Systems specialist, our planned monthly virtual meeting with the leadership team is often postponed. And if you are a manufacturer, you are well aware of the reasons. Most often, it is simply that…
Here are the major requirements. Leadership Production Team Taking Ownership of the Rules Quality Assurance Team enforcing the Regulatory Code Ongoing cGMP training The leader is responsible for driving the process, and it falls under the responsibility of the QA/QC team. It can often be a challenge to get the production team members on board,…
What is environmental monitoring in cGMP for Dietary Supplements? Environmental monitoring (EM) is a process that determines the quality of a controlled environment via microbial data collection. Data comes from air samples, surfaces, and personnel in a clean space. It is a significant infraction in 3rd party cGMP audit for dietary supplements. Monitoring the production environment…
Part 1 of a series. Attaining cGMP status requires dedication to five (5) essential components: Discipline to detail and performance among all personnel. (2) Ongoing cGMP training with units involved in the manufacturing processes. (3) A leader/driver knowledgeable and proficient in the code’s documentation requirements and physical management as outlined in current CFR 21 parts…
If you are a small manufacturer of dietary supplements, hemp oil derivatives, or functional foods, here’s how I can help you. I create a document management system for cGMP compliance that is low cost and high quality. I will create standard operating procedures (SOP’s), Master Manufacturing Records, and a complete management system to comply with…
Standard Operating Procedures are the backbone of a certifiable document management program for Food or Dietary Supplements manufacturers. The entrepreneurial smaller manufacturing companies In the hemp derivative sector are at a competitive disadvantage without a cGMP document system. The real issue here is the actual expense and investment required to hire a 3rd party regulatory…
The U.S. CBD market depending on which research house data one uses is ballparked to be a massive 5 billion USD at the end of 2019 (Brightfield Group) and it is esitimated to grow perhaps to as large as 23 billion USD by 2024. Even if these numbers are off substantially, the growth is there….
Currently in the CBD Oil processing space there is a need for those companies to create SOP’s to structure and ensure the safety of their finished product. There are over 15 sections or chapters that need to be written to comply with the standards set by the FDA here in the U.S. as well as…