Audits are an integral part of supplier qualification irrespective of the services or products sourced. Any activity covered by the GMP and GDP guidelines that is outsourced should be appropriately defined, agreed, and controlled in order to avoid misunderstandings which could result in a product or operation of unsatisfactory quality.
Experienced and qualified auditors at Billev Pharma East:
Audit types (both on-site or remote/virtual):
* Manufacturers/distributors/brokers of active pharmaceutical ingredients (API’s), manufacturers of excipients, consumables, primary and secondary packaging materials, manufacturers of finished medicinal products (FDF), quality control laboratories, …
** GMP / GDP relevant