The Auditing Group, Inc. (TAG) - Provides extensive Auditing, Training and Remediation services supporting FDA regulated industries working under the various standards (cGMP, cGCP, cGLP, Systems) with one goal, to provide reliable Auditing, Remediation, Validation, Consulting, Training, and Quality Assurance services that efficiently provide the assistance needed to help our clients succeed. Our Scope of Audit Objectives

FDA Thinking;

If products, or services, or any action, in whole or in part, which may impact either directly or indirectly, is distributed, adhered, affixed, consumed, or used by a Consumer or Patient, either by Use, Ingestion, Injection, Inhalation, and/or Permeation, they must follow GMPs, or…

If a product is manufactured, or services rendered which greatly benefits the safety, health or welfare of a consumer or patient, directly, and/or indirectly, or…

If a Product or Data which may influence, form a decision for, or create an adverse reactionary event to the health, safety, welfare of a Consumer or Patient, directly or indirectly;

You must comply to the GMPs!

So, what is a Product? What are Services? What are Data? What is direct and/or Indirect impact?

Your applicability to the Federal Regulations is based upon the Product, Service or Data that you provide. And the question is, what is your applicability, directly and/or indirectly?
And this is the hardest concept to understand.

The 3 Step Approach for GMP Compliance - ART

1) Audit, (with Certificate of Audit)

2) Remediate, (with Certificate of Compliance) and,

3) Training (with Certificate of Attendance)