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?