Welcome to Mitchell GMP Consulting
Many sections of the Current Good Manufacturing Practice or “CGMP” regulations are purposely vague in content. This approach provides the Industry flexibility to implement programs they believe address the intent of the CGMPs. However, if the firms interpretation of the regulatory intent differs from that held by the FDA compliance issues may exist.
I have experience in dealing with the FDA during audits as well as interaction with many other quality professionals in the industry allows me to better interpret regulatory intent. This experience results in more accurate and reasonable compliance recommendations that -result in minimizing future compliance challenges.
Experience in the following areas:
CGMP Audits per 21 CFR Part 111 and 117
Audit of Firms own Manufacturing, Packaging and Testing Facilities
These audits allow for an independent assessment of the firms processes and procedures and provide an opportunity to learn quality systems being utilized by other firms.
Third Party Contract Manufacturers
If a firm outsources a Manufacturing and or Packaging process, the FDA holds the outsourcing firm responsible for CGMP compliance of the Contract Manufacturer.
Third Party Contract Laboratories
If a firm outsources raw material or finished product testing, the FDA holds the outsourcing firm responsible for CGMP compliance of the Third Party Laboratory.
Raw Material Suppliers
The CGMPs require all ingredients used in Dietary Supplements to be “qualified” by verifying the Certificate of Analysis (COA) is reliable and performing an on-site compliance audit.
Generation of Standard Operating Procedures (SOPs)
For all Quality Systems from Receiving through Distribution
Written procedures (SOPs) must be generated for all aspects of a firm’s activities. These SOPs must be approved by the Quality Unit and documentation must exist to show all personnel have been trained and the procedures have been implemented as written.
Generation of Raw Material and Finished Product Specifications
CGMPs require that firms establish testing specifications that are necessary to ensure the purity, strength and composition of both raw materials and finished product.
Generation of Master Manufacturing Records (MMRs), Production Batch Records (PBRs) and Master Packaging Records (MPRs)
CGMP regulations require that an MMR is generated for each batch size of a Dietary Supplement manufactured including the specific item number for each raw material to be used. PBRs must reflect the formulation and manufacturing directions contained in the MMR and list all ingredient lot numbers utilized to manufacture the finished product which allows traceability of each ingredient back to the raw material supplier.
A MPR is similar to an MMR but has to reference the Bulk Lot Number being packaged and Item Numbers that reference the packaging components used as well as the specific label that is to be applied. As with the PBR component lot numbers need to be listed to allow traceability of the packaging components to the component suppliers
CGMP Training Programs
Part 111 regulations require CGMP training to be performed at least annually. This training needs to be documented and include subject matter and identification of employees trained.
Although not specifically stated the FDA generally requires a firm to document that the training was effective. The effectiveness of the training can be determined through the administration of a test to all attendees.