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ISO 15378


ISO 15378 Certification: Enhancing Pharmaceutical Packaging Standards

What is ISO 15378 Certification?

ISO 15378 Certification defines the requirements for a quality management system specific to the production of primary packaging materials for medicinal products. This standard ensures that pharmaceutical packaging is conducted under controlled and consistent processes, meeting stringent quality and safety standards.

When is ISO 15378 Certification Required?

Pharmaceutical companies and manufacturers of packaging materials for medicinal products seek ISO 15378 Certification to adhere to international standards governing the production of primary packaging. It is crucial for businesses involved in the pharmaceutical supply chain to ensure the safety, integrity, and traceability of packaging materials.

Importance of ISO 15378 Certification:

  1. Product Safety: ISO 15378 emphasizes the safety of packaging materials, reducing the risk of contamination and ensuring the integrity of pharmaceutical products throughout their lifecycle.
  2. Global Compliance: Certification aligns businesses with international regulations and standards, enhancing market access by demonstrating a commitment to quality and safety.
  3. Risk Mitigation: The standard provides a framework for risk management in packaging processes, helping businesses identify and mitigate potential risks associated with medicinal product packaging.
  4. Customer Confidence: ISO 15378 Certification instills confidence in customers, regulators, and stakeholders regarding the reliability and safety of pharmaceutical packaging materials.

Criteria for ISO 15378 Certification:

  1. Quality Management System: Organizations must establish and maintain a robust quality management system that aligns with ISO 15378 requirements.
  2. Product Traceability: The standard mandates traceability throughout the production process, ensuring that each batch of packaging materials can be traced back to its source.
  3. Change Control Procedures: ISO 15378 requires documented procedures for handling changes to the production process, ensuring that modifications do not compromise the quality or safety of packaging materials.

How to Apply for ISO 15378 Certification:

  1. Preparation: Familiarize yourself with ISO 15378 requirements and assess your existing processes against the standard.
  2. Documentation: Develop comprehensive documentation outlining your quality management system, traceability measures, and change control procedures
  3. Internal Audit: Conduct an internal audit to identify areas for improvement and ensure alignment with ISO 15378 criteria.
  4. Certification Body Assessment: Engage with an accredited certification body to undergo an assessment, which may include document reviews and on-site inspections.
  5. Certification Approval: Upon successful assessment, the certification body grants ISO 15378 Certification, acknowledging your commitment to producing pharmaceutical packaging materials of the highest quality.

How Business Badhega Will Help:

  1. Guidance Through Standards: Business Badhega offers expert guidance on understanding and implementing ISO 15378 standards, ensuring a smooth certification process.
  2. Documentation Support: We assist in preparing comprehensive documentation, helping organizations showcase their commitment to quality pharmaceutical packaging.
  3. Internal Audit Assistance: Our team supports companies in conducting internal audits, identifying areas for improvement, and ensuring readiness for certification assessments.
ISO 15378 in Mumbai, Delhi, Chennai, Kolkata, Hyderabad, Bangalore, Kerala, Pondicherry, Bhuvneshwar, Orissa, Assam, Pune, Nagpur, Nashik, Ahmedabad, Surat Vadodara, Chandigarh, Ladakh, Jammu & Kashmir, Haryana, Gurugram, Noida, Varanasi, Kanpur, Lucknow, Bhopal, Indore, Ujjain, Jaipur, Agra, Himachal Pradesh, Andaman & Nicobar, Lakshadweep, Patna, Ranchi

All types of Business Compliances by Business Badhega – India’s Compliance Platform | Bharat Ka Compliances Platform. Pan India Services | Comply India Grow India | Built in India Built for the WorldEnsure the safety and integrity of medicinal products, comply with international regulations, and contribute to the growth of the pharmaceutical industry in India.