Manufacturing hygiene

Cotton manufacture—Hygienic aspects—Congresses. 2. Byssinosis—Congresses. 3. Cotton manufacture—Dust control—Congresses. 

Manufacturing Control Standard Code and Manufacturing Hygienic Control Standard Code... 

To confirm that the manufacturing control is properly performed by the documents of storage, receipt and distribution, as well as manufacturing hygienic control, and report the results in writing to the product security pharmacist. 

The manufacturer shall have the manufacturing control manager perform appropriately the following duties related to manufacturing control in accordance with the product master formula, manufacturing control standard code or manufacturing hygienic control standard code ... 

To retain records of manufacture, storage, receipt, distribution, and manufacturing hygienic control for 3 years after the date of recording [in the case of the recorded drug necessitated to bear a term of shelf life (including the shelf life the same hereinafter), the shelf life plus one year]. 

For ensuring proper fulfillment of manufacturing and quality control of drugs, the manufacturer should make and maintain the manufacturing control standards, master formula, manufacturing hygiene control standards and quality control standards. 

Manufacturing hygiene control standards should include the following particulars ... 

The production manager who is responsible for the management of the manufacturing processes, manufacturing hygiene and storage, should carry out the following particulars ... 

Maintenance of manufacturing control standards, master formula and manufacturing hygiene control standards in order to carry out proper management of manufacturing. 

To ensure whether the manufacturing hygiene and storage management are carried out as stipulated by the standards. 

Control of manufacturing hygiene should be done as follows ... 

Persons suffering from any illness which may adversely affect drugs should not be instructed and trained of manufacturing hygiene. 

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