3) Written procedures listing the basic hygiene requirements should be made available. 4) Personnel must be protected from contact with irritants and potentially allergenic plant materials by means of adequate protective clothing. 4.4 Change control 1) In case any change will be made in the manufacturing procedure, etc. which could affect the quality of the products, the manufacturer shall have the person designated beforehand to conduct the following duties in accordance with the documented procedure: to evaluate effects on the quality of the products due to such change; — to be approved by the manufacturing manager with respect to the change being made — based on the results of the evaluation; to establish and maintain records of the evaluation and approval. — 2) The manufacturer shall conduct to revise relevant documents, to train the personnel and to take other necessary actions in case where any change is made upon approval of the manufacturing manager. 4.5 Deviation Control 1) In case any deviation from the manufacturing procedure, etc. has occurred, the manufacturer shall direct the person designated beforehand to evaluate effects on the quality of the products due to the deviation. 2) The manufacturing manager shall approve the designated person to take proper actions based on the results of the evaluation. 3) The manufacturer direct the designated person to establish and to maintain records of the evaluation. 4) The manufacturer shall conduct to revise relevant documents, to train the personnel and to take other necessary actions. 4.6 Self-inspections The manufacturer, etc. shall have the person designated beforehand to conduct the following duties: to conduct the self-inspections periodically on the manufacturing control and quality — control of the products in their manufacturing site, and to establish and maintain records of it; to report in writing the results of the self-inspections to the manufacturing manager; — to take necessary actions in case where improvements are necessary for correcting, — and to establish and maintain records of such actions.
3) Written procedures listing the basic hygiene requirements should be made available. 4) Personnel must be protected from contact with irritants and potentially allergenic plant materials by means of adequate protective clothing. 4.4 Change control 1) In case any change will be made in the manufacturing procedure, etc. which could affect the quality of the products, the manufacturer shall have the person designated beforehand to conduct the following duties in accordance with the documented procedure: — to evaluate effects on the quality of the products due to such change; — to be approved by the manufacturing manager with respect to the change being made based on the results of the evaluation; — to establish and maintain records of the evaluation and approval. 2) The manufacturer shall conduct to revise relevant documents, to train the personnel and to take other necessary actions in case where any change is made upon approval of the manufacturing manager. 4.5 Deviation Control 1) In case any deviation from the manufacturing procedure, etc. has occurred, the manufacturer shall direct the person designated beforehand to evaluate effects on the quality of the products due to the deviation. 2) The manufacturing manager shall approve the designated person to take proper actions based on the results of the evaluation. 3) The manufacturer direct the designated person to establish and to maintain records of the evaluation. 4) The manufacturer shall conduct to revise relevant documents, to train the personnel and to take other necessary actions. 4.6 Self-inspections The manufacturer, etc. shall have the person designated beforehand to conduct the following duties: — to conduct the self-inspections periodically on the manufacturing control and quality control of the products in their manufacturing site, and to establish and maintain records of it; — to report in writing the results of the self-inspections to the manufacturing manager; — to take necessary actions in case where improvements are necessary for correcting, and to establish and maintain records of such actions.
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