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3. If you selected products or product corrections
occupiers agency products or those who have been entrusted to exclude products that can be used in
.Production process. From products that do not comply with the requirements. Save a good amount of waste extraction.
Notice of Department quality control checks and leave through a good product. Prior to use in PM.MAN
(movement.4) for products that must be destroyed, follow the steps for task
"waste management" quality assurance manager carried out monitoring operations and sign the above
.Agency owner, a product that does not comply with the requirements to identify the cause. Risk analysis, and how to prevent
not according to the definition in the Act on what the suspect did not comply with the requirements.
(F.QA.29) quality assurance Manager track corrective action against ready-to save the track in order that the product operation
suspect does not meet (F.QA .29) and sends it to
.Director of parts factories and agents to be aware of the management.
If it is a duplicate of the production process (Reprocess and Rework), follow SOP.QA .31
route duplication
. In the case of a lot of drugs, a new editor comes back with another medication mixed with lot (Recovery), specify the lot in the Recovery F.QA
.29, clear and save the changes (Change control request) (F.QA .62) of
.Pharmaceutical production newly lot from reused (Recovery), as well as conduct stability studies
.
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