SOP on Personnel Qualifications

SOP on Personnel Qualifications
1.0 Purpose: This SOP describes the requirements for the minimum qualifications of personnel engaged in the manufacture, testing or holding of a drug product.
2.0 Scope: This SOP applies to all the personnel working in the manufacture, testing and holding of drug products. 
3.0 Responsibility:  Personnel Department to ensure that the procedure is followed.
4.0 Materials and Equipment: None.
5.0 Procedure: 
General – 
5.1 Each person engaged in the manufacture, processing, packing or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.
5.2 The working personnel should perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.
5.3 Initial screening select only those individuals who have such basic skills as reading, writing, and numeracy.
5.4 In addition to the basic skills by every employee, there are specific requirements for certain jobs e.g . Higher qualifications or specialization.
5.5 Once accepted for employment, the initial or induction training takes place. Basic training includes all the employee’s – new or working, during which the employee’s are fully trained in all relevant techniques associated with the equipment involved and fully understand the procedures to be followed, and must be aware of the  potential problems that can be created by nonadherence to these procedures
5.6 Education and training records must be maintained and kept current.

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