BSP Quality System has been designed to be in compliance with FDA and EMEA regulations for medicinal and clinical products.

BSP Quality is involved in the implementation of Quality System from the early stage of development and integration of quality practices to pharmaceutical development to commercial production.
Strong teamwork among quality units (Quality Assurance, Quality Control and Regulatory Affair), product and process development, technology transfer and production departments are our key to producing high quality products through optimized processes using new technologies and a continuous improvement approach.



BSP Pharmaceuticals site is approved to manufacture and control Medicinal Products for human use including Biotechnological Medicinal Product for both commercial and clinical.

The facility has been successfully audited by EMEA.
EMEA Inspection: July 2-7, 2008
Authorization number aM – 136/2008 of September 12, 2008

EMEA Inspection: November 3-10, 2008
Authorization number aM – 33/2009 of February 16, 2009

Part 1: Production activities (for commercial and clinical products)

1.1 Sterile Products:
- Lyophilised vials
- Sterile liquids aseptically filled
- Sterile liquids aseptically filled and terminally sterilized

1.2 Non Sterile Products:
- Capsules
- Tablets

1.3 Biological Medicinal Products:
- Biotechnological products

The facility is audited on a regular basis by our clients.