Quality and Compliance - INTERPHARMA PRAHA, a.s.

Quality and Compliance

Quality and Compliance

Providing products of guaranteed quality is the fundamental goal of our company. The Quality Assurance (QA) system in Interpharma Praha, a.s. (IPP) has been firmly established and has been regularly certified since the 1990s.

 

IPP is a manufacturer of active pharmaceutical ingredients (APIs), the production of which is governed by the rules of Good Manufacture Practice (cGMP) following the regulations of the European Union. The compliance with the GMP requirements is regularly inspected by the relevant regulatory authority, the State Institute for Drug Control.

 

IPP has also been audited in the past by foreign drug agencies such as US FDA and the Japanese PMDA.

 

Each year IPP hosts numerous customer audits by both domestic and international clients. And IPP regularly audits its own qualified suppliers and external service providers.

Quality Management

Quality Management

Interpharma Praha, a.s. (IPP) is a cGMP compliant, full scale manufacturing facility with its own state-of-the-art quality control laboratories.

 

Our cGMP system encompasses all activities including the receipt of raw materials, production, packaging, labeling, quality control, release, storage and distribution of active pharmaceutical substances. A single quality assurance system governs both the production of active pharmaceutical substances and the production of nutraceuticals and cosmetic products.

 

Compliance with cGMP requirements is monitored and enforced by three departments:

  • QA department (Quality Assurance)
  • RA Department (Regulatory Affairs)
  • QC Department (Quality Control Laboratory)

IPP has been certified in accordance with the cGMP rules since 1994. cGMP certificates are valid for three years and a current copy can be provided upon request.

 

The Quality Control (QC) department in IPP includes both classical and instrumental analytical sections, as well as a microbiology laboratory. The modern instrumentation includes HPLC, GC and GC-Headspace instrumentation, titration equipment, and other instrumentation necessary to perform quality control testing to meet pharmacopeial and in-house standards for our products. The QC department also performs stability studies to meet regulatory requirements for all regulated products.