GMP Compliance

Looking to get GMP compliance? Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. Core Compliance has FDA industry expertise in-depth knowledge of cGMP regulations from clinical development through post-approval drug and biotech product manufacture.

See FDA facts about current good manufacturing practices–

GMP Road Map to Compliance

Core Compliance provides a clear road map GMP compliance. We assess your systems to ensure proper design, monitoring, and control of manufacturing processes and facilities to meet FDA requirements. We create customized training courses designed specifically for your manufacturing organization, personnel, lead & internal auditors, and field service staff. Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologic, and devices) are known as current good manufacturing practices (CGMP’s). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act). 

 GMP road map includes:

• Training of staff expectations best practices
• Requirements and objectives
• CFR record proposed rules, final rules of -FDA 21 Code of Federal Regulations Part 210 & 21 Code of Federal Regulations Part 211
• Instructional design
• Testing and/or evaluation of effectiveness  

Amazon Sellers receive GMP COA Certificates

Are you an Amazon seller looking to get GMP, COA certificates? If you have provide supplements, beauty, or skin care products through Amazon, you may be required to get cGMP (Good Manufacturing Practice) FDA registered (Orange Application number) COA (Certificate of Analysis) among other requirements. Sellers can be required to provide documentation or a certificate for topical approval for any of the following:

• GMP (Good Manufacturing Practices) 
• COA (Certificate of Analysis)
• FDA Orange Book Application Number
• Labeling Bar-Code requirements (UPC Exemption)

How do I start the process for GMP Compliance?

Core Compliance will evaluate/determine what category your Amazon products belong and if they are gated category restrictions. We will build a road map to compliance, in developing a management system and issuing the relative GMP, COA, FDA requirements based upon the category for topical approval.   

Consulting Services GMP Compliance

Manufacturing facilities are heavily regulated by the FDA, Core Compliance will provide Consulting services GMP compliance to evaluate your current state for the following: 

• Build Road Map to GMP Compliance (Quality Assessment) 
• Training & Expertise to Validate Activities
• –    Process validation
  –    Cleaning and sanitation validation
  –    Computer system validation
  –    Analytical method validation
• Training & Performance of staff expectations best practices to FDA/GMP Requirements
• Design a compliant management system of controls, documentation, records and labeling
• Testing and/or evaluation of effectiveness
• GMP COA, FDA (Issue Certificates)

ISO Standards