Quality Management

The quality management system of Pharmpur is process-oriented and is based on the standards ISO 9000 and ISO 13485. Today it comprises all elements necessary to produce medicinal and medical products. By incor­po­rating business-management elements, energy management, environ­mental and risk management, it fulfills an important control function for the entire organi­sation. The system’s efficiency is monitored by frequent inspec­tions by numerous national and foreign regulatory autho­rities.

Quality Policy

Our department of quality control realises the overall potential of our company in order to produce products with the highest possible degree of safety and conformity while conti­nuously observing market condi­tions; at the same time, the management follows ethical principles for dealing with all stake­holders. The entire Pharmpur team is committed to the high ethical standards that charac­terise the production of medicinal and medical products.

Major standards

Aseptic working EN ISO 13408
Biocom­pa­ti­bility EN ISO 10993
Clean rooms EN ISO 14644
Steri­li­sation EN ISO 17664
Medical Products EN ISO 13485
ICH Guide­lines Q1 – Q12

Elements of quality policy

Staff

  • high training standards
  • deep scien­tific-technical under­standing
  • conti­nuous GMP training
  • strict hygiene
  • health care

Processes

  • efficiency verifi­cation
  • valida­tions
  • risk management
  • dense network of in-process controls

Resources

  • prudent use of raw materials and energy
  • environ­mental protection
  • control of emissions and pollution

Site Master File

The Site Master File of Pharmpur GmbH is struc­tured in accordance with the EU GMP Guideline part III and PIC/S PE 008-4. Learn more?

Certi­fi­cates

Medical products
  • Notified body DQS Medizin­produkte GmbH 0297
  • EN ISO 13485:2012 + AC: 2012
  • Council Directive 93/42/EWG
Medicinal Products
  • Super­visory authority government of Upper Bavaria

  • DE_BY_04_MA_2017_0051/ROB-53.2-2677.Ph_2_245

Are you interested in colla­bo­rating with us and do you need current certi­fi­cates?