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 111 & 117 (HACCP). (4) secure, cleanable, and environmentally secure buildings and equipment within the code. (5) The working capital necessary to achieve 3rd Party certification with globally recognized entities.
The overarching goal of cGMP for supplement manufacturers is simply put; “ To produce products that consistently meet the Product Specification.”
If you want to obtain better customers that will provide you with larger orders and more stable receivables, having a cGMP program in place can get you there. These more established customers require your facility to be cGMP.
Also, at the same time, you are reducing your regulatory risk because, at any time, an FDA or state agency can show up or make initial contact with you without warning. This is where the headaches and heartaches can begin. I have seen enough surprise FDA 483’s issued in my 30 years in this space. Next, “ About Your Batch Record.”
