In Indonesia You Need
ELPRO Can Help.
In Indonesia You Need GMP/GDP Compliance.
ELPRO Can Help.
As a professional in the pharma, life science, healthcare or medical device industry, it is mandatory to comply with Good Distribution Practice (GDP) to ensure quality standards across your entire supply chain. Find out more today.
This FREE guide covers key topics like:
What is GDP and why does it matter?
How temperature excursions can compromise drug safety and efficacy
Utilizing data loggers and monitoring systems to ensure compliance
Establishing reliable cold chain shipping and storage protocols
Best practices for supply chain visibility and risk mitigation
The laws and regulations are specific to each country and typically include a national or international authority like the FDA (Food and Drug Administration) in the United States; EU (European Union) in Europe; or Swissmedic in Switzerland; all coordinated by the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).
In addition to official regulations, there are a number of important associations issuing guidance documents supporting and detailing the regulations and their application in specific situations. Some of the most influential organizations relevant to the pharmaceutical supply chain industry are the ISPE (International Society for Pharmaceutical Engineering), the USP (United States Pharmacopeia), the PDA (Parental drug Association) and the WHO (World Health Organization).
The regulatory framework is therefore a living organism which changes almost daily with new laws becoming effective and new guidance documents being published.
Pharma Quality and Logistics Leaders Worldwide Trust ELPRO
We had a really fruitful collaboration with ELPRO concerning our Qualification and mapping of our new GMP/GDP warehouse. All steps until the authority inspection were attended professionally and finally we had no issues.
Did You Know?
If you store or transport pharmaceutical products you have to comply to GMP and GDP guidelines.
- Products must be produced, handled, stored, and transported in qualified facilities.
- Temperature and/or humidity must be monitored at all times by a compliant monitoring system (with an audit trail).
All sensors monitoring temperature., humidity, etc., must be calibrated regularly.