Primary packaging materials for medicinal products
Pharmaceutical companies need to ensure that their own supplier audits fulfill relevant legal requirements. This is why when selecting a supplier of packaging materials, particular attention needs to be paid to their ability to fulfill current GMP (Good Manufacturing Practices) requirements.
What is ISO 15378
GMP has been restated as a legal requirement in order to ensure the health of consumers by reducing risk, including contamination and/or mix-ups, in the pharmaceutical and food industries.
First published in 2006, the process-oriented ISO 15378 standard focuses on this perspective. Based on the internationally accepted ISO 9001 quality standard, it contains all of the GMP requirements relevant to primary packaging material, such as batch tracing, risk management, validation, and controlled environment. ISO 15378 applies to all manufacturers of packaging materials that come into direct contact with the medicinal product, e.g. glass, rubber, aluminum, and plastics.
ISO 15378 benefits
A certificate to ISO 15378, with its holistic approach to GMP and quality requirements, is recognized throughout the world.
- Evidence of adherence to legal requirements and contractual obligations
- Reduction and control of risks
- Clear statement of the organization’s competence
- Creates competitive advantages
- Improves quality capability
- Saves time and costs
Conformity and value generation
DQS was the first certification body to become accredited for ISO 15378 by the German Association for Accreditation (TGA) in July of 2007. With an independent and expert assessment of their management system, top management can be sure that the system is in conformance with the requirements of the standard. In addition, the auditors will focus on the identification of improvement potential. Finally, audits also result in an increased awareness of whether or not the management system is suitable for achieving the desired results. With value-generating audits, the ideal certification body will provide direction for decision making processes.
The process starts with the client’s needs and expectations. DQS wants to learn about the client’s organization, its management system, size and types of operation. Together both parties will define objectives for the assessment and/or certification, including applicable standards and specifications.
DQS will provide a detailed offer for assessment and certification services, tailored to individual client needs, based on the information provided initially. A written contract will specify all relevant deliverables as well as applicable assessment and certification criteria.
A pre-audit can serve as initial performance or gap analysis, identifying strengths and areas for improvement. For larger assessment and certification projects a project planning meeting provides a valuable opportunity for the client to meet the lead assessor and develop a customized assessment plan for all functions and locations involved. Both services are optional.
The assessment procedure itself begins with review and evaluation of system documentation, goals, results of management review and internal audits. During this process, it will be determined whether the client’s management system is sufficiently developed and ready for certification. The assessor will explain findings and coordinate any required activities to prepare for the on-site system assessment.
The assigned auditor team will audit the client’s management system at the place of production or service delivery. Applying defined management system standards and specifications, the assessment team will evaluate the effectiveness of all functional areas as well as all management system processes, based upon observations, inspections, interviews, review of pertinent records, and other assessment techniques. The audit result, including all findings will be presented to the client during the closing meeting. Required action plans will be agreed upon as necessary.
The independent certification function of DQS will evaluate the audit process and its results, and decide independently about issuance of the certificate. The client receives an audit report, documenting the audit results. When all applicable requirements are fulfilled the client also receives the certificate.
Either semi-annually or at least once per year, there will be an on-site audit of the critical components of the management system. Improvement potential will be identified, with a focus on continual improvement and sustained effectiveness.
A management system certificate is valid for a limited period of time, frequently for a maximum of three years. At the end of this cycle, a re-audit will be carried out to ensure the ongoing fulfillment of all applicable requirements. Subject to this fulfillment, a new certificate will be issued.
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