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    Pharmaceuticals Quality Standards


    Quality Standards

    Our dedicated quality team ensures the implementation of uniform standards and processes for BASF production sites and all products worldwide as well as compliance with all relevant statutory requirements. Our active ingredients and excipients are produced by trained and experienced BASF employees in line with the required quality standards. All our sites comply with ISO 9001 at minimum.

    In line with quality requirements our services focus on the following quality standards
    IPEC-PQG GMP guide for all pharmaceutical excipients
    cGMP standards for APIs (ICH Q7)
    ISO 9001 certified production for raw materials and precursers

    Quality Services for APIs and Excipients

    Our productions sites are regularily inspected by relevant health authorities and have been granted GMP certificates for APIs and excipients as applicable. We provide key quality information needed to support your existing and new business.

    Moreover, 3rd party audits for individual excipients or APIs products are available at:

    Quality Management for Raw Materials & Precursors

    The Quality System of our Intermediates division is based on the following elements:

    • ISO 9001:2008
    • Quality, safety, health & environment - (QSHE) policy
    • Documented procedures audit plan

    It includes the following processes and procedures:

    • Procedure for handling “changes”
    • Non-conformance management (NCM) system
    • Definition of processes
    • Suitable and maintained buildings, facilities and process equipment
    • Process control during production

    All products of the Intermediates division are manufactured under ISO 9001 conditions.

    The Quality System of the Intermediates division is certified according to the international DIN ISO 9001:2008 standard.