GMP – Good Manufacturing Practice

Last March and April Loccioni humancare experts gave an advanced, practical and theoretical course at Pharmacy of Ancona Hospital to the clinicians in charge of automatic compound of cytotoxic drugs.

 The class had the target to deepen the most complex procedures related to the automatic compound, the operator safety and the quality of the therapy.

The course was structured in three phases:
- Practical part treating the most complex procedures of APOTECAchemo and simulating some cases of problem solving regarding to functionalities introduced with the recent up-dates;
- Theoretical part where the GMP (Good Manufacturing Practice) and the international standards associated to the chemotherapic preparations were introduced. The focus was on the requirements introduced by the regulations, on their use in pharmaceutical and hospital sector, on the validation concept and as everything has been applied to the automated preparation.
- Theoretical part introducing the whole activity with its re-qualification results about the pharmacy ambient and APOTECAchemo system. This test phase has been done between September 2011 and March 2012 treating the chemical and microbiologic contamination in a methodic and exhaustive way.

The GMP is a group of rules which guarantees the quality of manufacturing (and storage) of pharmaceutical products in order to have an appropriated and predetermined quality necessary to use them respecting the intended use.

The Italian Pharmacopoeia XII Ed. treats the GMP normative for the requirements related to locals and devices used for the preparation of sterilized drugs in hospital pharmacies. The difference between hospital structures and pharmaceutical companies is very important as they have different contamination ambient classes and aseptic drugs production estimated by regulations.
The training day has been useful for the participants to clarify the different requirements necessary for the activity in the pharmaceutical and hospital sector.

Loccioni humancare considers the constant training in medical field as essential to maintain high the level of attention and to animate the discussion about the quality service dedicated to the patient and about the safety of clinicians involved into the whole oncologic workflow.

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