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Last publication: 30/10/2014
Basic GMP requirements are as follows
I - Any manufacturing procedure is clearly defined and systematically revised in the light of experience acquired; it must be demonstrated that the process is capable of repeatedly producing medicines that meet their specifications;
I - The critical stages in manufacturing and any significant modifications are validated;
III - All the resources required for GMP implementation are provided, including:
IV - The instructions and procedures are written in an appropriate style using clear and unambiguous vocabulary, particularly adapted to the resources provided;
V - Operators receive training to correctly implement the procedures;
VI - During manufacture, readings are taken manually or with automated equipment or manually and with automated equipment; they prove that every stage required by procedure has been completed and that the product complies with its specifications both qualitatively and quantitatively. Any significant deviation is recorded in detail and examined.
VII - Manufacturing files and in particular distribution files (for market sales) are drawn up to provide a complete traceable history of a batch; they are written in a clear style and are easily accessible.
VIII - The distribution of medicines involves minimum risk to their quality.
IX - A reminder system is put in place in the case of a product batch recall.
X - Complaints concerning products released on the market are examined, the causes of manufacturing faults investigated and appropriate measures taken, not only in terms of the faulty product itself but also to prevent any recurrence.
Good manufacturing practices - Consistent quality