Quality Policy

Siemsgluss Ibérica complies with the GMP/GDP guidelines by a carefully designed Quality System which involves the whole organization and is the basis of all our activity.

Our aim is that our products and services meet quality needs and expectations with an absolute commitment to the environment, health and safety of all those involved in our processes.
 
 
Applus

Management model

The different stages of the process guarantee the quality, effectiveness and safety of the operations and a total traceability of the product at any point of the supply chain.

Siemsgluss Ibérica has established the basis of a management model which complies with protocols of assessment and satisfaction reports thus strengthening the capability of understanding and very often planning ahead for the needs of each customer.

Certifications

Siemsgluss Ibérica meets all the quality standards required by health authorities, and constantly updates its operational processes to guarantee the compliance with new safety and revised quality standards thus obtaining the corresponding certifications.

Laws and legislation

  • Guidelines on Principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)
  • Guide of Rules for the Correct Manufacturing of Medicines for Human and Veterinary Use PART II – Basic requirements for active substances used as starting materials.
  • Rule UNE-EN-ISO 9001:2015.
  • Directive 2001/83/EC of the European Parliament and the Council, of November 6 2001, which establishes a comunitary code on medicines for human use (modified by the Directive 2004/27/EC).
  • Directive 2001/82/CE of the European Parliament and the Council, of November 6 2001, which establishes a comunitary code on veterinary medicines (modified by the Directive 2004/28/EC).
  • Directive 2011/62/UE of the European Parliament and the Council, of June 8 2011, which modifies the Directive 2001/83/CE, which establishes a comunitary code on medicines for human use regarding the prevention of the incoming forged medicines in the legal suply chain.
  • Directive 824/2010, of June 25, which standarises pharmaceutical laboratories, manufacturers of active ingredients of pharmaceutical use and the foreign trade of medicines and medicines in investigation process.
  • Regulation 183/2005 (CE) of January 12 2005, which establishes the requirements regarding feed hygiene.