illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.

Audits

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:

  • Will provide the knowledge, skills and expertise to ensure your sustainable compliance with applicable legislation;
  • Have supported a large number of inspections from multiple regulatory agencies throughout the world;
  • Will perform external audits as well as internal audits against most recognised pharmaceutical standards;
  • Can execute audits that are completely scaleable, ranging from a single specialised audit to full management and execution of a company’s annual audit plan, regardless of location;
  • Will handle every step of the process for you – agenda planning, scheduling, communication, and more;
  • Have access to in-house IT support to assist audit execution and monitoring as needed.


Audit types (both on-site or remote/virtual):

  • Due digilence audits
  • Mock Regulatory audits (inspection readiness) and GAP analyis audits
  • Supply chain audits (vendors / suppliers / contract manufacturers *)
  • External service provider audits **
  • »For cause« audits
  • Self-inspections / internal audits
  • Bespoke process/system/IT audits

* 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

illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.
medicine

I think it is quite remarkable how we as humans have improved in the pharmaceutical and medical fields in the last 100 years. I am sure that we will remain courageous and continue to innovate!

Martina

Božíková

MASTER'S in PHARMACY REGULATORY AFFAIRS & PHARMACOVIGILANCE OFFICER