Inter-Harz GmbH

 

QUALITY MANAGEMENT

 

The legal basis of our Quality Management are documented processes (SOPs) according to the applicable German laws, Directives and Guidelines and EU-GMP-Guidelines …

 

AMG

German Medicines Act (Arzneimittelgesetzt) dated 24th August 1976 (in a version published on 12th December, 2005, BCGI. I S. 3394)

 

AM-HandelsV

Ordinance of 10th November 1987 on Wholesale Trade in Medicinal Products (Germany) (Verordnung über den Großhandel und die Arzneivermittlung (Arzneimittelhandelsverordnung) vom 10. November 1987 (BGBI. I S. 2370), in der jeweils aktuellen Fassung)

 

AMWHV

German Good Manufacturing Regulation (AMWHV- Arzneimittel- und Wirkstoffherstellungsverordnung) dated 3rd November 2006 (BGBI. I S. 2523)

 

EU-GMP-Guideline Part II

Guideline on Good Distribution Practice of medicinal products for human use dated 5th November, 2013 (2013/C 343/01)

 

EU-GMP-Guideline Part II

Guideline on the principles of Good Distribution Practice of active substances for medicinal products for human use vom 21st March, 2015 (2015/C 95/01)

We are registered according to § 67 of the German Medicine Act (AMG) at our competent Health Authority (LAsD in Kiel, Germany).

 

Warehouse/Storing   

Active Pharmaceutical Ingredients (APIs) will be stored in an EU-GDP-Guideline certified warehouse. The warehouse-IT is validated according to GAMP5, Annex 11. Permanent temperature control on all levels. Storing temperature 15 – 25 °C and in refrigerated areas (2 – 8 °C and – 20 °C).

 

Transport

APIs according to GDP-conditions in special trucks which are certified accordingly. Temperature controlled transports are possible in the ranges of …

  • – 20 °C
  • 2– 8 °C
  • 15 – 25 °C

 

Certificates