ISO 15378(2011版)培训课件-1

Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
Important additional requirements to ISO 9001
The organization’s overall policy, intentions and approach to validation shall be documented (4.2.1.1)
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primary packaging materials Annex C (informative) Guidance on risk management for primary packaging
materials
Brief introduction
This International Standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. The realization of GMP principles in production and control of primary packaging materials within organizations is of great importance for the safety of a patient using the medicinal product, because of their direct product contact. The application of GMP for pharmaceutical packaging materials should ensure that these materials meet the needs and requirements of the pharmaceutical industry.
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Important additional requirements to ISO 9001
• Electronic records shall be subject to the same controls as those required for other records (4.2.4.1)
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(4.2.1.1)
Important additional requirements to ISO 9001
The organization shall define the period for which at least one copy of obsolete, controlled documents shall be retained (4.2.3.2)
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Important additional requirements to ISO 9001
If electronic signatures are used on documents, they shall be controlled to provide equivalent security to that given by a hand-written signature (4.2.3.3)
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Important additional requirements to ISO 9001
• The organization shall define the quality critical processes and parameters where a double-check is necessary for the release of a batch. If either check is carried out electronically this shall be clearly defined. Each quality critical stage and parameter in production and control processes shall be identified and shall be double-checked (Double Check) (4.2.4.3, 4.2.4.4)
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Important additional requirements to ISO 9001
For each batch of primary packaging material the organization shall establish and maintain a record that provides traceability and identifies the quantity manufactured and quantity approved for distribution.(4.2.4.5)
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Important additional requirements to ISO 9001
• All manufacturing, control, testing, distribution and investigation records shall be retained for at least five years after the date of manufacture or as agreed with the customer, or at least one year after the expiration date of the primary packaging material assigned by the organization, unless agreed otherwise with the customer (4.2.4.8)
A key objective of this International Standard is to define harmonized primary packaging material requirements
This International Standard is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.
Important additional requirements to ISO 9001
GMP in this International Standard and regulatory requirements shall be communicated, as appropriate, to each level of the organization. (5.5.3.1)
Brief introduction
ISO 15378 First edition ISO 15378:2006 ISO 15378 Second edition ISO 15378:2011, minor revision to adapt to ISO 9001:2008
Stand alone standard, Text of ISO 9001:2008 is integrated Structure equal to ISO 9001:2008, additional GMP requirements
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Important additional requirements to ISO 9001
• Entries in records shall be clear, indelible, made directly after performing the activity (in the order performed), dated, initialled or signed by the person making the entry. Corrections for entries shall be dated, initialled or signed and, where appropriate, explained, leaving the original entry still legible.(4.2.4.2)
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Important additional requirements to ISO 9001
effectiveness of training must be an input information of the management review (5.6.2)
ISO 15378:2011
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Brief introduction
ISO 15378:2011
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Important additional requirements to ISO 9001
The organization shall maintain a current record of signatures of responsible persons (5.5.1.1) ඪŝּ"‫ ݖ‬ந * 0 ౐ (5.5.1.1)
Important additional requirements to ISO 9001
Describe the overall policy, intentions and approach to assurance of product quality (4.1.g)
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3 Appendixes Annex A (normative) GMP requirements for printed primary packaging materials Annex B (informative) Guidance on verification and validation requirements for
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Important additional requirements to ISO 9001