General Requirement of PASCB for Conformity Assessment Bodies:

1. The PASCB shall verify that the PASCB can demonstrate that all personnel involved in performing certification functions have the required competence.
2. The PASCB shall verify that the CB has defined its certification process and the intended results to be achieved for each certification function. The PASCB’s evaluation of the CB’s competence shall be based on:
   1. the CB’s documented process for determining competence criteria;
   2. the outcomes of the process for determining competence criteria;
   3. the CB’s evaluations of its personnel; and
   4. Taking account of the intended results of each certification function and whether, or not, these have been achieved.
3. The certification functions for which the PASCB shall verify that the CB has determined competence criteria, include, but are not limited to, the following:
   1. Application review (see example in 3.5 below);
   2. Establishing the audit program;
   3. Scheduling of audits;
   4. Allocation of audit teams;
   5. Auditing and reporting;
   6. Report reviews and certification decisions; and
   7.  Maintenance of certification.
4. The PAS shall verify that the CB has determined competence criteria for:
   1. Management overseeing the certification process;
   2. Members of its committee for safeguarding impartiality;
   3. Personnel performing internal audits; and
   4. Personnel responsible for evaluating and monitoring the competence and performance of personnel performing certification functions.
5. The PAS shall regard objective evidence of the CB achieving the intended results for all certification functions (see Annex A of this document) as an indication of the effectiveness of its processes for determining and evaluating competence. The PASCB shall regard objective evidence of the CB failing to achieve intended results for any certification functions as an indication that the processes for determining and evaluating competence may be ineffective.
   Note: The failure of the CB to achieve the intended results for a particular certification function could also be an indication that the CB’s procedures for that function are ineffective or have not been implemented.
   For example, in the case of the application review, to determine that the CB has competent audit team members, it can allocate and to determine the audit time, the PAS shall verify that the CB:
   1. has defined the intended results (see (d) below) for this function of the certification process;
   2. has defined effective competence criteria for the personnel performing this function
   3. can provide objective evidence that the staff performing this function have demonstrated that they meet the competence criteria; and
   4. that the output from this function of the certification process has achieved the intended results, by:
      • providing evidence that the technical area(s) of the organisation to be audited has/have been correctly allocated;
      • providing evidence that the assigned auditors have the required competence for the appropriate technical area(s); and
      • providing evidence that adequate time has been allocated for the audit, based on the review of information provided by the applicant/certified client and from previous audits.
6. The PAS shall assess the process and procedures established by the CB to determine competence criteria and to evaluate competence to verify that personnel evaluated as competent consistently achieve the intended results for all certification functions.
7. The PAS shall verify that the CB has appropriate records of the implementation of its processes for determining and evaluating competence and that the CB can demonstrate its evaluation methods are effective and achieve intended results consistently.

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ISO 15378:2011 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.

ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

ISO 15378:2006

Certification of your operation against the ISO 15378 standard, you mitigate your risks especially related to contamination, mix-ups and errors. Further, you ensure your customers of the compliance of your QMS.

PASCB provides reliable, independent ISO 15378 certification for your pharmaceutical packaging materials manufacturing operation. During your audit prior to certification we analyze your operation, identifying strengths and outlining the areas where improvement is necessary.  PASCB is a globally recognized leader in certification for the pharmaceutical sector. The PASCB global network of auditors understand your manufacturing processes and the precise meaning of all aspects of the standard. The ISO 15378:2006 standard includes a number of important QMS guidelines  for primary manufacturers of glass, plastic, rubber, aluminum and other materials used for medicinal packaging, including:

1. Compliance to legal requirements
2. Identification, reduction and control of risks including contamination and manufacturing errors
3. Improved efficiency and cost-effectiveness in your operation
4. Partner with PASCB when you need to demonstrate your ability to quality provide packaging materials for the pharmaceutical industry and help improve patient safety. Contact us today to learn more about ISO 15378 – Primary Packaging for Medicinal Products certification.

ISO 15378:2006 BENEFITS

Obtaining certification to this standard represents an enhancement that brings benefits manyfold:

Improvement in processes

1. cost minimization for certified organization
2. additional assurance of quality products to your customers
3. minimization or elimination instances of contamination
4. reduction in mistaken mix-ups
5. reduction of manufacturing errors
6. Evidence of adherence to legal requirements and contractual obligations
7. Reduction and control of risks
8. Clear statement of the organization’s competence
9. Creates competitive advantages
10. Improves quality capability
11. Saves time and costs

The ISO 15378:2006 includes important QMs guideline for primary manufacture of glass, plastic, rubber, aluminum and other medical packaging materials.

The standard also provide framework for legal compliance, identification, traceability, validation, reduction and control of risks (like contamination and our production defects).

Published first in 2006, the process-oriented ISO 15378 standard picks up this idea. 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. A certificate to ISO 15378, with its holistic approach to GMP and quality requirements, is recognized throughout the world. It provides manufacturers of primary packaging materials with a suitable qualification for customer approval – as well as improving the organization’s image in the eyes of the authorities. ISO 15378 applies to all manufacturers of packaging materials that come into direct contact with the medicinal product. The standard covers all of the usual materials, such as glass, rubber, aluminum, and plastics.