NSF/ANSI 455-2 Good Manufacturing Practice for Dietary Supplements Standard Training

The purpose of this training is to understand the intent of the requirements for the NSF/ANSI 455-2 Good Manufacturing Practice (GMP) for Dietary Supplements Standard. For those wondering "what is GMP?" or "what does GMP stand for?", GMP full form is Good Manufacturing Practice. GMP encompasses a set of guidelines that ensure consistent quality and safety in product manufacturing. This GMP standard, which aligns with Current Good Manufacturing Practice (cGMP) and good manufacturing practices in the dietary supplement industry, is based on FDA regulations, specifically 21 CFR Part 111 requirements, other regulations (normative references), retailer criteria, and industry best practices. The criteria in this standard were structured to follow a seven (7) systems approach to ensure comprehensive GMP compliance in the dietary supplement industry. In this training, we will discuss how to prepare for an audit at your dietary supplements manufacturing facility.

We will not be discussing the need for documented procedures and evidentiary records in depth as this is well documented within the standard as well as the prerequisite Dietary Supplement GMP Training and is always best practice for quality assurance and quality control.

The training is divided into two sections:

Section 1

• Context of the organization – this includes requirements for implementing a quality management system (QMS) as well as regulatory requirements
• Leadership – this includes requirements for management to demonstrate commitment to the QMS, such as assigning roles and responsibilities throughout the organization to ensure good manufacturing practices
• Planning, which includes requirements for planning the ongoing function of the QMS and maintaining GMP compliance
• Support – includes requirements for management of resources for the QMS. This includes, buildings and infrastructure, human resources, and control of documents
• Operation – includes requirements on planning and creating of the product
• Performance evaluation – includes requirements for monitoring the QMS and evaluation of the product
• Improvement – includes requirements for taking corrective action for product or process nonconformities, and actions to make the QMS better over time

Section 2

• Support – includes requirements for management of resources for the QMS. This includes, buildings and infrastructure, human resources, and control of documents
• Operation – includes requirements on planning and creating of the product
• Performance evaluation – includes requirements for monitoring the QMS and evaluation of the product
• Improvement – includes requirements for taking corrective action for product or process nonconformities, and actions to make the QMS better over time

• You will learn the structure of the NSF/ANSI 455-2 Good Manufacturing Practice for Dietary Supplements Standard, with a detailed overview of each section of the standard.
• You will learn the requirements of NSF/ANSI 455-2 Good Manufacturing Practice for Dietary Supplements Standard and how they relate to FDA cGMP regulations.
• You will understand the intent of the required programs and elements of the 455-2 standard from the NSF/ANSI 455-2- ARG – Audit Requirements Guidance for Good Manufacturing Practices for Dietary Supplements.
• You will learn best practices on how to implement the required programs and elements of the standard.
• You will learn what documentation is necessary to demonstrate compliance with the standard at your facility.

Attend this training if you work in:

• Management
• Manufacturing processes
• Quality control/assurance
• Packaging operations
• Marketing
• Laboratory operations
• Auditing
• Suppliers and distributors
• Regulatory affairs