GMP self-inspection
Author:汉德编辑 Time:2018-08-01 10:09 Click:
GMP self-inspection
After the relocation of company, Hande had launched GMP self-inspection. Now, we had finished the first self-inspection. (The inspection included the following contents but not limited within these beneath parts)
♦ The management of hygiene, identification, pest control and so on in the production, testing, storage, computer and machine room site.
♦Calibration, verification and identification of plant, public facilities, equipment and instruments.
♦ Health and training of staff.
♦ Management of material and product retention, stability test, re-inspection, etc.
♦ The implementation of all kinds of verification, certification and validation.
♦ The progress of deviation, change, risk assessment and CAPA.
♦ Recent developments of document management and records management.
♦ Product sales and product release management.
♦ Follow up on drug administration and regulatory filing.