GQMS Certifications

Pharmaceuticals

Advancing Health, Ensuring Quality.

Pharmaceuticals Industry Challenges

  • Regulatory Compliance:
    • Navigating complex and evolving regulations.
    • Ensuring quality and safety standards.
  • R&D Costs:
    • High costs and lengthy processes for drug development.
  • Market Access:
    • Securing market approval and reimbursement.
  • Supply Chain Management:
    • Ensuring a reliable and resilient supply chain.
  • Technological Advancements:
    • Integrating new technologies in drug discovery and production.
  • Healthcare Costs:
    • Balancing innovation with affordability.

Scope Identified for Pharmaceutical Industry

Regulatory Compliance
  • Utilize compliance management software.
  • Implement rigorous quality control systems.
R&D Efficiency
  • Invest in advanced technologies like AI and machine learning for drug discovery.
  • Foster partnerships and collaborations to share R&D costs.
Market Access
  • Develop strategic market access plans.
  • Engage with stakeholders early in the drug development process.
Supply Chain Resilience
  • Diversify supply sources.
  • Implement advanced supply chain management systems.
Cost Management
  • Focus on value-based pricing models.
  • Improve operational efficiencies to reduce costs.
Supply Chain Resilience
  • Diversified Suppliers
  • Risk Management: strategies to anticipate and mitigate supply chain disruptions.

Standard Certifications

ISO 9001

Helps pharmaceutical companies enhance product quality and regulatory compliance.

ISO 14001

Assists pharmaceutical companies in reducing their environmental impact and ensuring regulatory compliance.

ISO 45001

Aims to ensure a safe and healthy working environment for employees in the pharmaceutical sector.

GMP cGMP

Vital for ensuring the safety and efficacy of pharmaceutical products.

ISO 13485

Crucial for pharmaceutical companies involved in the production of medical devices to ensure product quality and regulatory compliance.

ISO 27001

Important for pharmaceutical companies to protect sensitive data and ensure cybersecurity.

Lean Six Sigma

Focuses on reducing waste and improving efficiency in pharmaceutical manufacturing and operations

ISO 50001 Energy

Helps pharmaceutical companies optimize energy usage and reduce costs.

ISO 27017

Ensures the security of cloud-based systems used by pharmaceutical companies.

ISO 27018

Ensures pharmaceutical companies comply with data privacy regulations when using cloud services.

WHO

Ensures pharmaceutical products and services meet international health standards.

ISO 10002

Helps pharmaceutical companies manage customer feedback and improve service quality.

SA 8000

Promotes ethical practices and good working conditions in the pharmaceutical sector.

ISO 21001

Enhances the quality of educational and training services provided by pharmaceutical companies.

GLP

Important for pharmaceutical companies conducting research and development in laboratories.

HACCP

Hazard Analysis and Critical Control Points, a systematic preventive approach to food safety.

Kosher

Important for pharmaceutical companies producing products that are kosher-certified.

HALAL

Essential for pharmaceutical companies producing products that are halal-certified.

Benefits of GQMS Certification

  • Enhanced Product Quality:
    • Consistent standards ensure high-quality drugs.
  • Operational Efficiency:
    • Streamlined processes reduce costs and time to market.
  • Regulatory Compliance:
    • Ensures adherence to global standards.
  • Risk Management:
    • Identifies and mitigates risks in drug development and production.
  • Market Access:
    • Builds trust with regulators and payers.
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