You purchased the handbooks from GMP Publications and now what?
1. Do you have the resources to conduct proper training against the Regulations based upon applicability?
2. Have you conducted a formal Gap Analysis against the Regulations?
If not, consider TurnKey QMS and The Auditing Group, together assisting firms to meeting and exceed GMP requirements.
Do you need to?
Consider your risks and liability if you decide to decline;
First, Understand the 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.