Our Products

Global Regulatory Compliance

Our pharmaceutical Quats are manufactured in accordance with the cGMP Guide ICH Q7 for Active Pharmaceutical Ingredients, the highest available standard. We analyze according to multicompendial pharmacopoeias (BP, Ph.Eur., USP/NF and JP), and can provide all relevant regulatory documentation to ensure global compliance.


You can see which documents and services are available for each product of our standard assortment by clicking on a product name to the left.


Regular grade products not currently available in the pharmaceutical grade, are available for upgrade. Contact us to discuss your requirements.

Difference between Regular and Pharmaceutical Grade

 

  Regular Grade Pharmaceutical Grade
Non-cGMP (ISO 9001 only) cGMP (ICH Q7) and ISO 9001

  Production Documentation

  

None

Specific pharma process journal
Instructions

  Facilities

  

No clean room
 

Clean room filling
Qualification of facility
(DQ + IQ + OQ + PQ)

  Validation Documentation

  

Analysis spec. & Analysis instruction
Only BP pharmacopoeial
compliance for few items

Validation master plan (VMP)
Quality risk assessment
Process validation (PV) incl. 3 PV batches
Technical cleaning report

  Analysis Documentation

  

None

Analysis spec. & Analysis instruction
Full BP, Ph.Eur.
USP/NF and JP compliance
Analysis validation
Stability and stress studies
Water analysis and bacterial count

  Regulatory affairs

  

None

CEP/DMF
GMP certificate
Audits
Statements
Questionnaires

Standard Operating Procedures (SOP)

Did you know

  • We offer Global Regulatory Compliance
    Read more
  • What is the difference between pharmaceutical and regular grade?
    Read more

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