ISO 15378 Certification Consultancy in India for Medical Packaging Material Manufacturers

ISO 15378 Medicinal Product - requirements for a quality management system for the manufacturers of pharmaceutical and medical device primary packaging materials. This process-oriented ISO 15378 certification Standard was first published in 2006. It is, incorporated in a single document on the basis of the ISO 9001 quality management system requirements together with the Principles of Good Manufacturing Practice (GMP). These requirements and practices are 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, aluminum containers/components, films, foils and laminate containers. As these materials come in direct contact with the medicinal products, they need to comply with the 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 practices (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 ISO 15378 standard delineates GMP principles and specifies QMS requirements applicable to the primary packaging materials for medicinal products. An ISO 15378 consultant can help you in meeting all requirements and achieving ISO 15378 certification.

ISO 15378:2015 Certification

An ISO 15378:2015 Certification is issued by the Certifying body, which is accredited to provide the certificate under the ISO 15378:2015. The certificate is issued for the period of 3 years after successful completion of pre-assessment, registration and (Final) assessment. The ISO 15378 certification 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 on the nature and size of the Organization. Upon completion of 3 years, a renewal audit is done for the upcoming (new) 3 years' cycle.

Benefits of ISO 15378:2015 System Certification

As a trusted ISO 15378 consultant, we provide you the following benefits along with a quick ISO 15378 certification. Our ISO 15378 certification system:

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

Steps for Effective ISO 15378 Consultancy Service:, a leading ISO 15378 Consultant in India, has a vast industrial experience in the implementation of ISO 15378:2015 for all types of Pharmaceutical and medical devices manufacturers. Punyam implements the ISO 15378 certification system for its customers in the following manners;

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

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