ISO 15378 Certification Consultancy in India for Medical Packaging Material Manufacturers

ISO 15378 Medicinal Product - requirements for a quality management system for manufacturers of pharmaceutical and medical device primary packaging materials. This process oriented ISO 15378 Standard, first published in 2006 incorporates in a single document based on the quality management system requirements of ISO 9001 together with the Principles of Good Manufacturing Practice (GMP) relevant to the design, manufacturing and supply of primary packaging materials for medicinal products. Pharmaceutical and medical device primary packaging materials include glass, rubber, plastics, aluminium containers/components, films, foils and laminate containers. As these materials come in direct contact with medicinal products, they need to comply with safety, efficacy and reliability requirements. Suppliers of primary packaging materials have to meet the expectations of medicinal product manufacturers and demonstrate compliance with expected quality levels by integrating quality management systems (QMS) and good manufacturing practice (GMP) in their production processes. These organizations require demonstrating their capability to constantly meet client requirements, including regulatory requirements and international standards applicable to primary packaging materials for such medicinal products. The standard delineates GMP principles and specifies QMS requirements applicable to primary packaging materials for medicinal products.

ISO 15378:2015 Certification

ISO 15378:2015 Certification is issued by Certifying body, which is accredited to provide certificate under the ISO 15378:2015. The certificate is issued for the period of 3 years after successful completion of pre-assessment and registration (Final) assessment. The certificate is valid till 3 years from the date of issue. Surveillance audits are conducted by the Certifying body within the period of 3 years at the interval of 6 Months, 9 Months or 12 Months depending upon the nature and size of the Organization. Upon completion of 3 years, renewal audit is done for new 3 years cycle.

Benefits of ISO 15378:2015 System Certification

  1. Helps organizations in the pharmaceutical and medicinal primary material packaging products manufacturing sector to minimize or eliminate instances of contamination, mix-ups, and manufacturing errors.
  2. Provides guidance on risk management and validation.
  3. Improves efficiency and cost effectiveness of your business operations.
  4. Ensures consistently meet customer requirements, including regulatory requirements.
  5. Additional assurance of quality products to your clients.
  6. Enhancement in processes.
  7. Evidence of adherence to legal requirements and contractual obligations.
  8. Clear statement of the organization's competence.
  9. Creates competitive advantages.
  10. Saves time and costs in day to day practice as per GMP guidelines.

Steps for Effective ISO 15378 Consultancy Service:, leading ISO 15378 Consultancy in India, is having vast industrial experience in the implementation of ISO 15378:2015 for all types of Pharmaceutical and medical device manufacturer. Punyam implements the ISO 15378 system for its customers in the following manners;

  1. Micro-level survey for each and every medicinal products of the pharmaceutical and medical device and preparation of detail Gap analysis report,
  2. Preparation of applicable documents required by ISO 15378:2015 based on detail study of all activities of the medical device, such as;
    • ISO 15378 Quality Manual,
    • Quality Procedures for ISO 15378:2015 Certification (Mandatory procedures required by the standard),
    • Standard Operating Procedures (SOPs) for inspection of various activities as well as operation and calibration of identified equipments used in the inspection,
    • Formats to establish the objective evidence of implementation and to ensure control over all the inspection parameter.
      • Preparation of Quality assurance plan for maintaining and assuring quality of inspection services provided to its customer.
      • ISO 15378 training to all levels of employees within the medical device.
      • Helps in effective implementation of system by periodic visit till accreditation.
      • Conduct internal audit for ISO 15378 system to check readiness for the accreditation.
      • Conduct management review meeting in presence of Top Management to guide the Inspection bodies for effective implementation on all the issues related to management requirements and technical requirements.

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