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At AJES "Quality is our top Priority": At AJES quality and product performance are the only priorities.  We constantly reinvest in our facility and staff, because our customers prefer working with a company comprised of scientists and experts who develop and test the products rather than companies that invest in trade show booths and advertising firms. 

 

Our 25,000 square foot manufacturing facility is cGMP compliant and fully modernized for the nutritional supplement industry with our brand-new Gummy production line.  This added capability sets AJES apart from most manufacturers since few are capable of developing the complicated product form.

 

Our in-house analytics lab is a good place to improve and invest.  AJES’s cGMP approved facility examines every aspect of your product using:

 

  • HPLC – High Performance Liquid Chromatography
  • Gas Chromatography
  • Ultraviolet-Visible Spectrophotometers
  • FTIR Spectrophotometers
  • ICH Guideline Stability Chambers
  • USP Disintegration
  • USP Dissolution
  • Tablet Hardness
  • Powder Properties
  • Organoleptic Testing
  • pH Testing
  • Monograph Testing
  • Conductivity Testing
  • Precise Temperature Cold Storage
AjesPharma

 

Our Analytical Lab oversees all stages of the manufacturing process.  Starting with Raw Material delivery we QC all ingredients sent from vendors, then continuing during in-process testing we ensure nothing has been accidentally compromised and ending with finished product testing and stability studying.  Our QA roles in the analytical lab never ends as we continually assess and perfect our methodology and common practices.  
 
Following cGMP protocols is not a one-step process and is not limited to the actual manufacturing of the products.  These guidelines extend to include all paperwork cataloguing and the layout of your facility. To guarantee everyone gets what they pay for the process begins with raw material delivery and continues through in-process testing and ultimately ends with final product testing and storage.  
 

Raw Material Stage

  • Raw materials need to be separated and inspected prior to entering the facility.
  • These inspections include identity testing as well as potency testing to ensure what was ordered and requested was actually delivered.

In-Process Stage

  • During the manufacturing of your product, samples must be analyzed to ensure there has been no compromising of the product or nutrient’s integrity.

Final Process Stage

  • When your product is finally completed there will be a host of additional tests to ensure purity and potency.
  • These tests will vary depending on product form. Tablets and capsules will undergo dissolution and dissolvability tests so that we know the nutrients will be released when intended. Enteric coated pills will need to breakdown slower than others. Liquids will need to ensure there is no separation of ingredients. Powders will need to prove their capability to dissolve completely.
  • After these tests are completed products will be stored and retested months after production to determine their long-term survivability. Additionally, in the unlikely event of a product recall or FDA inspection batch samples must be kept to reassess the reasons and problems caused by the formulation and production.

Paperwork and Facility Stage

  • For every test performed there must be a physical paper stating and documenting results and details of such test.
  • A GMP facility will need to have every step of the manufacturing process in segmented rooms to ensure no stage is mixed with the next and that paperwork/testing is completed before moving to the next stage.