Quality & regulatory corner

ARMOR PHARMA™ main objective is to ensure quality, sustainability and safety so as to comply with the most stringent regulatory requirements. Our Quality and Regulatory Affairs Departments work closely together to stay up-to-date on all regulatory changes. 

This "Quality and regulatory corner" is intended to :

- facilitate your access to the latest versions of our quality documents

- provide you with all necessary information for carrying out your product risk assessment,

 

Note : Regulatory and quality documents are available to registered users.

  • Discover all coverd items and find answer to your questions

    • Lactose risk profile
      • Oral solid dosage forms
      • Inhalation route
    • Storage and transportation
      • Storage / transportation conditions
      • Supply chain complexity
      • Stability
      • Packaging integrity evidence
      • Change control
    • Environmental control
      • General
      • Air process
      • Water quality
      • Pest control
    • Risks associated with the Excipient contamination potential
      • Potential for viral contamination
      • Potential for microbiological contamination
      • Potential for endotoxin contamination
      • Potential for impurities generated as part of the process and carried over
    • Risks associated with nature of the excipient
      • Composition
      • Origin
      • Allergen risk
      • GMO risk
      • TSE/BSE risk
    • Regulations
      • Certifications
      • Pharmacopoeia
      • Other regulation