The APIC Audit Programme tb final comments 5 Oct 06

The Revised APIC Audit Programme Standardised Audits Cost Reduction APIC-certified Auditors GMP Compliance Evaluation A Third Party Audit Programme for MA Holders and API Manufacturers Coordinated by API Compliance A sector group of Institute www.api-compliance.orgNecessity for API Manufacturers to Comply with cGMP for APIs - Legal Background - According to the revised EU legislation ‘the holder of a manufacturing authorisation shall at least be obliged to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials’ (Directive 2001/83/EC as amended, article 46(f)for Human Medicinal Products and Directive 2001/82/EC, article 50(f) for Veterinary Medicinal Products). The competent authorities expect that the manufacturing authorisation holder will carry out an audit of the manufacturers/distributors of the active substances concerned. One of the primary means by which the competent authorities will determine whether manufacturing authorisation holders are in compliance with the above requirements will be the ‘examination, by inspectors, of the audit programmes used by authorisation holders for conducting regular audits (every 2-3 years), including review of ...