Significato Quality Agreement
Anche se queste possono sembrare domande ovvie, la risposta non-pué essere trovata solamente nel buonsenso dei contraenti ma deve avere un preciso riferimento nel technical agreement a tutela de contraienti, della quality del prodotto e soprattutto dell`utilizzatore. Si é avuta una lunga discussione sull`uso dei termini owner e contract facility. In alcuni commenti ricevuti, si chiede di utilizzare i termini contract giver e contract acceptor, ma FDA afferma che questi vocaboli non sono in linea con lo scopo di mostrare come the party possano lavorare insieme per definire, stabile e documentare gli agreement per definire the attint Quality requirements set by the manufacturer for raw materials should be discussed and coordinated with suppliers. Appropriate aspects of manufacturing, control and control, including handling, labelling, packaging and distribution, claims, recalls and refusal procedures, should be recorded in a quality agreement or formal specification. [5.28] “Da una prospettiva cGMP, gli elementi pié critici di un quality agreement sono le sezioni che delineano the responsibility delle parti e la discussione sul change control.” Excipients and suppliers of excipients should be properly monitored on the basis of the results of a formal quality risk assessment, in line with the European Commission`s formalised risk assessment guidelines, to determine appropriate good manufacturing practices for medicines for human use. I proprietari e le contract facilities possono bassono basarsi sui principi di quality management per realizzare il contratto definendo, stabilendo e documentando le att volte ad assicurare la compliance alle cGMP e quality, sicurezza ed efficaci dei prodotti. Manufacturers of intermediate products and/or APIs should have a system for evaluating suppliers of critical materials. [7.11] Materials must be purchased by a supplier or supplier approved by the quality unit, against an agreed specification. [7.12] If the supplier of a critical material is not the manufacturer of that material, the intermediate manufacturer and/or API must know the manufacturer`s name and address. [7.13] Changes to the source of critical raw materials must be dealt with in accordance with the control of the amendments. [7.14] FDA raccomanda che i Abbiano al loro interno quality agreements, such as minimo: selection, qualification, approval and maintenance of raw material suppliers, should be documented as part of the pharmaceutical quality system. The level of monitoring should be proportionate to the risks inherent in different materials, taking into account their origin, their manufacturing process, the complexity of the supply chain and the end-use for which the material is introduced into the drug. Staff involved in these activities should have current knowledge of suppliers, the supply chain and the risks involved.
Where possible, raw materials should be purchased directly from the raw material manufacturer. [5.27] I requisiti di quality stabiliti dal produttore per la materia prima devono essere discussi e concordati con il fornitore. Tutti gli aspetti della produzione devono essere documentati in a quality agreement. Contract manufacturing allows a company to sell a product under its brand without working with the production process itself. As a result, they do not need to invest in expensive plants, hire staff, close equipment and even organize their packaging and distribution.