GMP Compliance

Do you sell supplements, beauty, or skin care products? Are you looking for GMP Compliance ? Sellers can be required to provide documentation or a certificate for 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)

Requirements of you as a seller of cosmetic, health & personal care products additional requirements to provide transparency to reflect customer concerns about product quality, product branding, and consumer safety.

How do I start the process for GMP Compliance?

Core Compliance will evaluate/determine what category your 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.

GMP Certificate Road Map Compliance

 Core Compliance provides a clear road map for manufacturers and sellers of supplements, cosmetics, beauty/skin care products to become FDA GMP compliant. We evaluate your current systems and 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. Sellers/Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. 

 Identify Product Category

 Core Compliance will guide manufacturers and distributors to receive the required GMP, COA, FDA Orange Book certificates with creating a clear road map for compliance/approval. Establish FDA pre-market submission strategy. 

Identify Product Certificate Requirements

• GMP (Good Manufacturing Practice) –provide for amazon FDA compliance that systems that assure proper design, monitoring, and control of manufacturing processes and facilities
• COA (Certificate of Analysis)-The certificate of analysis (COA) for each product (accessible via QR labels on packaging)
  • Testing performed on Products
  • Creation process of Products 
  • Ingredient origins
  • FAQ or Q&A addressing customer concerns (Including testing (charts, warnings, pesticides, herbicides)
• FDA Orange book application number –Approved Products with Therapeutic Equivalence Evaluations identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. Orange Book-Search by Proprietary Name, Active Ingredient or Application Number

Steps to FDA Approval

The steps to FDA approval-Core Compliance provides gap analysis of the following: (Facility, Equipment, Ingredients Raw Materials, Production, Laboratory Controls, Records, Labeling, and Complaints)

• Registration of the products with the FDA 
• FDA, Certificate of Registration (showing the Seller has registered with the FDA)
• FDA, New Dietary Ingredient (NDI) Notification
• Product testing document or safety assessment
• Business certification document that shows they registered their business
• Documentation- How the product is created
• Ingredients Origins
• Q&A addressing customer concerns 
• Receipt/Invoice (manifest) guidance and approval
• Product vendor research.
• Instructional correspondence
• Product images
• Certificate of Analysis
• Good Manufacturing Practices
• FDA Orange Book application number

Consulting Services GMP Compliance

  Manufacturing facilities for medical device and pharmaceuticals are heavily regulated by the FDA, Core Compliance will provide Consulting services GMP compliance to evaluate your current state for the following: Facility, Equipment, Ingredients Raw Materials, Production, Laboratory Controls, Records, Labeling, and Complaints.

• 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)