Quality is our strength

A GMP and GLP based QA system is established at Biopharm. All work is performed in accordance with this system:

	Analytical tests of drugs and active substances in accordance with GMP (EU Directive 91/356/EEC for drugs intended for use in man; ICH Q7A for active substances)
	GLP studies in accordance with Appendix 1 to ChemG [Law on Chemicals] § 19 a of 8th May 2001 (GLP certificated since 1993)
	Validation of analytical methods in accordance with ICH Guideline Q2

Our QA system is defined in more than 150 SOPs. Compliance with these SOPs is continuously monitored by internal inspections performed by our QA department, which is deliberately not involved in performing the tests. In addition, we are regularly audited by the authorities and by our customers. Experience from these audits, together with the current requirements of the FDA and the European authorities are incorporated into our QA system, which is being developed all the time.

Quality assurance signifies comprehensive and thoroughly controlled documentation, which guarantees the traceability from receipt of the sample till conclusion of the analysis. Aside from the creation of the necessary documents, we regard the training of our employees as being of decisive importance. We are aware that a QA system does only function when it is lived. In addition, all work is performed with qualified instruments. There are current regulations for dealing with OOS results and deviations. Before their implementation, changes must be evaluated with respect to their quality impact; the corresponding measures must be laid down and processed. GMP/GLP documents are archived for at least 15 years.

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