Part VIII: Establishing a Production and Process Control System

Introduction
Setting a production and process control system requires several facets of control involving all stages of the manufacturing process. This system intends to ensure quality products through the use of verified components that meet defined specifications. It is also intended to provide a balance between running an efficient quality control system and confirming the test quality of manufactured ingredients for finished dietary supplements. To ensure cGMP compliance, the FDA requires all those who manufacture, package, label or hold dietary supplements to follow these standards when establishing their production and process control system.

Guidelines for Production and Control System: General
All manufacturers must implement a system that covers all stages of the manufacturing process including packaging, labeling and holding of the dietary supplement in order to ensure the quality and its labeling in the master manufacturer record
There must be established component specifications for each material used in the manufacturing of a dietary supplement

Guidelines for Production and Control System: Component Verification
Established specifications are required for the identity, purity, strength and composition of components used in the manufacturing process
Each component must have limits on types of contamination that could adulterate the quality of the finished dietary supplement
Conduct at least one appropriate test or exam on each component to ensure the identity of the dietary ingredient
Components must meet all specifications of the dietary ingredient test
If tests are not conducted; manufacturers may rely on the supplier’s certificate of analysis
Suppliers first need to be qualified by verifying the reliability of the COA through the confirmation of the supplier’s tests on ingredients
Supplier’s COAs must contain descriptions of the tests, limits of the tests and actual test results
Documentation on how the supplier was qualified must be maintained and manufacturer should periodically reexamine the supplier’s COA
Quality Control personnel must continuously review and document qualification of supplier’s dietary ingredients

Guidelines for Production and Control System: In-Process Specifications
In-process specifications must be established for any point, step or stage of the manufacturing process
Documentation for why the in-process specifications are needed to verify identity, purity, strength and composition of the dietary supplement
Quality control personnel must review and approve in-process documentation as well as reject processes if needed

Guidelines for Production and Control System: Packaging and Labeling
Packaging and labeling from supplier must be fully identifiable and consistent with the purchase order
Detailed packaging and labeling or different specifications are required for finished dietary supplements
A material review and disposition decision needs to be done for any packaged and labeled dietary supplement that does not abide by required specifications
All containers and closures must match the descriptions on the supplier’s invoice, guarantee or certification
Dietary supplements must be visually examined to make sure the labeling and packaging meet established specifications

Guidelines for Production and Control System: Addressing unfulfilled specifications
If any specification for a component, dietary supplement or ingredient, packaging or labeling is not in accordance with requirements, it must be rejected and go through a treatment process to ensure the quality of the finished supplement
Rejected dietary supplements must go through new treatments and processes and comply with all specifications before being released or distributed