UAB "Biotecha"

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EMPROVE®

EMPROVE® program – easier risk assessment

As a supplier of raw materials and industrial materials for the pharmaceutical and biopharmaceutical industries and medicinal formulations, Merck pays great attention to the compliance of the supplied products with the latest regulations and for ensuring uninterrupted operations of its customers. With increasingly stringent risk assessment guidelines and directives applied for these industries, the updated EMPROVE® program of Merck and the structure and content of the dossier of suppliers meets the latest regulations, to accelerate clients’ processes in the control and supervisory labyrinths.

All EMPROVE® products are supplied with comprehensive documentation, to reduce the costs for qualification and registration processes, and to help accelerate the integration into the market. Using EMPROVE® raw materials you will have everything necessary for the successful registration of medicinal products.

EMPROVE® program covers about 400 raw and industrial materials, including excipients (additional substances), chemicals used in production and active pharmaceutical ingredients (API) used in medicinal preparations.

Program and structure of the dossier

EMPROVE® classified products are grouped by degree of risk. The documents of each EMPROVE Essential and EMPROVE® Expert product are divided into three possible options of the dossier. This facilitates product qualification, risk assessment and process optimization. For active pharmaceutical ingredient EMPROVE® API gives access for documentation (DMF ASMF, CEP) approved by relevant authorities.

The recent EMPROVE® program upgrade enabled the selection of raw materials and industrial materials according to application, depending on the degree of risk:

  • EMPROVE® Essential products for medium-risk category applications.
  • EMPROVE® Expert raw materials and production materials for the applications of higher degree of risk, with extremely critical low microbial and endotoxin contamination levels. The manufacturing process of our products is designed so that we can ensure low microbial and endotoxin contamination levels of our suppliers.
  • EMPROVE® API products are delivered with quality confirmations and other documents complying with the legal provisions, required for active pharmaceutical ingredients. Substances are produced in Europe in accordance with the ICH Q7 Directive, the products meet the GMP requirements.

 

 Material qualification dossier¹Quality management dossierOperating activities dossierDMF, ASMF, CEP
Emprove® EssentialXXX 
Emprove® ExpertXXX 
Emprove® API   X

¹ Material qualification dossier: former Main dossier. 

2018.10.19 23:10 Atspausdinta iš UAB "Biotecha" tinklalapio.
Adress: http://www.biotecha.lt/