Koteze, Sokola 1 st., 83-200 Starogard Gdanski, Poland
Phone/Fax: (+48) 58 531 02 59
Phone: (+48) 606 93 82 51
On 13 August 2014, the European Commission published revised versions of Chapter 3: Premises and Equipment and Chapter 5: Production of the EU GMP Guide. The new chapters will become effective on 1 March 2015. Chapter 3: Premises and Equipment The revision concerns section 3.6 as part of the improved guidance on prevention of cross-contamination involving
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According to an Article 46(f) of Directive 2001/83/EC as amended for medicinal products for human use, the holder of a manufacturing authorization shall at least be obliged: “to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with
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