CleaningValidationWHO培训.pptVIP

* Cleaning validation protocol: The protocol should be written before the experimental section of the work commences. It should be seen as the written description of the experiment, as is often taught in the first year of high school chemistry (Aim, Method, Equipment, Results, Conclusions). It should include: Objective of the validation. What is the experiment trying to do? Responsibility for performing the validation study: Who are the people and what are their responsibilities? It is extremely important that the person signing off the work, for example, has adequate qualifications and experience. In some situations, some inspection agencies have found the person to be not adequately qualified, trained or experienced and so all of the work was invalidated and the process deemed to be out of control. Description of equipment to be used. This is where the list of equipment is needed which should include make, model and serial number or some other unique code. * Cleaning validation protocol: (Contd.) Should include: Interval between end of production and cleaning, and commencement of cleaning procedure. To take into account the maximum period that equipment will be left dirty before being cleaned. There may also be a need for the manufacturer to establish the time after cleaning and before use. This may be especially important for control of micro-organisms. Cleaning procedures to be used for each product, each manufacturing system or each piece of equipment. Reference to the standard operating procedure is required here. Cleaning process must already be documented in an SOP. Note that some cleaning agents are incompatible with the drug. For example, removal of chlorhexidine residues (cationic) with an anionic surfactant will result in intractable, sticky residues. Any routine monitoring equipment used. This includes conductivity meters, pH meters, and Total Organic Carbon analyzers. The number of cleaning cycles to be