GMP

High Quality

in Ibn Hayyan Pharmaceuticals

 

In Ibn Hayyan Pharmaceuticals we care about human health, and work continuously to produce perfect medicines helping to cure patients, and make them happy, hence we are achieving doctor’s trust and satisfaction. We always perform the best production quality control, so we were trying insistently to achieve certification of the best international accreditation bodies approving our high quality good manufacturing practice.

Ultimately, after several years of hard work and collaboration with European Experts, our efforts were rewarded by European GMP accreditation for all our production lines. On 06-05-2009, His Excellency the Minister of health, and his highness the Dutch Ambassador handed out Ibn Hayyan Pharmaceuticals Euro GMP Certification, so our products are considered now similar to medicines that are manufactured in European Union. And we became a member of an international network exchanging information and experience relating to up-to-date advancements in this field. The main issue we have to answer now, “what does Good Manufacturing Practice – GMP mean”. It is well known that every drug must have 3 mean specifications to be high quality:
• Safety.
• Efficacy.
• Acceptance (patients good feeling about what he\she taking from all aspects).

The Syrian Pharmaceuticals industries had undergone nonstop developments since the beginning of the 20th century, and high quality meaned that the final product is tested only for the acceptable limits of the active material only. To make it short, and not mentioning all the historical developments that took place during the past century, we will now enlist only the up-to-date European concepts regarding Good Manufacturing Practice. The following issues must be fulfilled to achieve GMP in Pharmaceutical products: Enough Building space and facilities (water, air conditioning…). Human resources (qualified, trained, and committed). Equipments (for production and control). The good approved formulae. A meticulous filing and follow up system.

It is not enough nowadays for a medicine to have the required quantity of the active material, for many reasons including:
1. The medicine might be contaminated bacteriologically or chemically, a case which may cause harm more than the benefits expected from.
2. If the drug is really containing the appropriate and declared quantity of the active material, it is necessary for the active material to reach the target organ; however it is essential to test the inactive materials, and if bioequivalece and bioavailability tests is not undertaken (on volunteers and in specialized research centers), we cannot be sure that the expected effects will be achieved from the appointed drug dose.
3. If excepients are not chosen correctly, and manufacturing conditions were not appropriate, the drug may lose a large part of its efficacy, or we can say that it is not a stable from a scientific point of view.

Having this accreditation from European Good Manufacturing Practice means that Ibn Hayyan Pharmaceuticals had undergone close and meticulous inspection on all aspects of Medicine Quality (buildings, equipments, personnel, raw materials, manufacturing processes, testing and control systems, accurate documentation…..). And it has been revealed that all these factors are accomplished. So it is clear that quality in Ibn Hayyan Pharmaceuticals medicines is not a chance encounter, but it is a result of a comprehensive system yielding a consistent good quality today and tomorrow, for all patches and products.

Of course, it was not easy at all to have Euro GMP, because High Quality Requirements are increasing year after year in Europe, and may be month after month. And we had to comply with all that increasing requirements. In deed those requirements compelled us to stuck to an enormous effort over more than three years of reconstructing all our firm buildings, building new ones, new production lines, new production systems, and to enhance staff education for all our personnel through condensed training courses held by European Experts from several countries.

Albeit the great amount of efforts and money paid, we are really satisfied and happy with our achievements, because we look at medicines we manufacture as a necessity for humans not just as a product for sale and profit, and to produce and hand out a safe and efficacious medicine to patients is an ultimate goal that exceeds any financial profit.