What is ISO 15378?
The ISO 15378 – Primary Packaging Materials for Medicinal standard was developed by stakeholders in the pharmaceutical sector to provide a quality management system (QMS) for suppliers of materials intended to be used as packaging for medicinal products.
What is ISO standards?
ISO (International Organization for Standardization) is an independent, non-governmental, international organization that develops standards to ensure the quality, safety, and efficiency of products, services, and systems. ISO standards are in place to ensure consistency.
What is ps9000?
• PS 9000 is an application standard written by the PQG for suppliers of. pharmaceutical packaging materials that integrates ISO 9001 and ISO. 9004 together with additional Good Manufacturing Practices (GMP)
What is ISO in pharmaceuticals?
The International Standards Organization (ISO) as a whole aims to ensure that products and services are safe as well as reliable by producing standards that can be incorporated into any organization — large or small, complex or simple in the nature of the products/services offered.
What is ISO PDF?
ISO 32000-2, Document management – Portable document format – Part 2: PDF 2.0, specifies a digital form for representing electronic documents, enabling users to exchange and view electronic documents independent of the environment in which they were created, viewed or printed.
Why line clearance is important in pharma?
Line clearance is useful to ensure the cleanliness of the manufacturing area. It is good manufacturing practices requirement to prevent the mix up and cross contamination in pharmaceutical products.
How the printed packaging material is disposed off in pharmaceutical industry?
5.3. 6 The Printed packing material and alu foil are destroyed by shredding or cutting. 5.3. 7 After the destruction activity, Debit the excise duty of the destructed material with proper entries in excise records and reverse the Cenvat.
What is the latest ISO 15189?
ISO 15189:2012 specifies requirements for quality and competence in medical laboratories. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
What is the difference between ISO 17025 and ISO 15189?
A. It is an international standard, based on ISO/IEC 17025 and ISO 9001, that specifies requirements for competency and quality that are particular to medical laboratories. ISO 15189 focuses on the continuum of care directly connected with improved patient safety, risk mitigation and operational efficiency.