Furthermore, GMP requires proof of the process steps which lead to a product or the result expected from each step. This proof is referred to in the pharmaceutical industry as qualification and validation.

This means:

• The standard operating procedures (SOPs) lay down precisely which measures are taken to produce and analyse the API

• An independent examination is conducted to ensure that the APIs are only produced and tested as set out

• Each production and analysis measure carried out is exactly documented

• Specifications are set out for each starting material, intermediate product and end product

• Each machine employed is proven to be qualified, and the production and analysis measures are documented in writing

• A system is introduced to capture and monitor process changes and deviations

• A training programme is established for all employees to ensure that every employee understands and correctly adheres to all GMP requirements

These steps demanded significant investment from BioSpring GmbH in terms of space, personnel and time. As our customer, you benefit through the certainty that the APIs produced by BioSpring GmbH meet all GMP requirements and you thereby save time and financial resources when getting your future medications approved.

We were supported in the implementation of the GMP system by Dr Klaus von Jan, Compliance and Regulatory Services, Herrmannstrasse 117, 35037 Marburg. You can find additional information at www.compliancesystems.de under GMP Consulting.

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BioSpring GMP Oligonucleotides

GMP certificate
Clean room (movie)
GMP manufacturing
Good Manufacturing Practice
Analysis and quality assurance

Sanofi and BioSpring cooperate on the field of therapeutic oligonucleotide manufacturing
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