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Quality
Gemini’s highly trained and experienced Quality Assurance Department has only one mission – ensuring that all products made by Gemini meet or exceed FDA cGMP requirements.

Product Development
Before beginning any project, Gemini’s Sales, Quality, Regulatory, Labeling and Operations Teams meet with our customers to develop detailed formulation and manufacturing procedures that are presented to our Gemini R&D Team only after all details are approved and signed off by our customers to ensure no items are overlooked or mistakes made.

Raw Materials
All raw materials are sourced from qualified vendors who have been approved and audited by our Quality Assurance team. Each raw material is tested multiple times to ensure we are providing the highest quality ingredients for our customer’s products.

Manufacturing
Every process has standard operating procedures that are required to be followed to meet our customer’s specifications and our internal requirements. A Master Manufacturing Record is created for the specific product. Every step of the production process is documented and tracked by the Quality Assurance team as evidenced by detailed Batch Records. These and other records are reviewed by production and Quality Staff at each step of the production cycle. The Batch Record is available for review at any time, and annual product reviews are perfored to trend our practices and to gain efficiencies.

Testing
Gemini has a fully equipped and staffed Quality Control analytical testing laboratory on site. All raw materials are identity tested using the latest techniques, equipment and methods. All in process testing and finished product testing is agreed to with our customers and are performed using scientifically valid methods which include USP, BP, AOAC and other industry accepted methodology. Equipment used includes the latest model ULPC, HPLC, HP-TLC, ICP-MS, and our computerized testing database lets us Gemini issue Certificates of Analysis with every lot we produce.

Finished Products
All finished products undergo a detailed inspection followed by Quality Assurance doing a thorough review of batch paperwork. Once testing is completed by the Quality Control laboratory and the manufacturing is finished, Quality Assurance conducts a final review of all paperwork and product so a Certificate of Analysis can be issued for each lot. This review usually requires the participation of no less than a dozen trained quality team members for every lot to ensure all specifications are met and the product meets our customer’s requirements. Additionally, items are regularly introduced into our stability program, demonstrating the quality of our product over the entire dating period.

Gemini Pharmaceuticals is an FDA inspected facility that has achieved recognition for cGMP compliance from

  • NSF International
  • Therapeutic Goods Administration (TGA) of Australia
  • Health Canada

Gemini also produces items under the authority of the Kosher Orthodox Union (OU) and IFANCA ( Halal) as requested by our customers.

For a full list of Gemini’s Registrations and Certifications, please see the Certifications Tab on the Home page.

Quote:
“Gemini stands behind its products as we offer complete solutions from product concept through item development and line extensions, effectively accelerating our customers’ time to market.”

– Mike Finamore
CEO Gemini Pharmaceuticals, Inc.