Gansu promoted the implementation of the new version of pharmaceutical GMP

Business Club May 18 News Recently, the Gansu Food and Drug Administration issued a notice to make arrangements and arrangements for the implementation of the new version of the drug GMP in the province.

According to the above notification, the food and drug supervision department of Gansu Province will increase the supervision and guidance on the implementation of the new version of pharmaceutical GMP by drug manufacturers, and communicate the requirements for the implementation of the new version of pharmaceutical GMP to each drug manufacturer. The Bureau will organize new editions of GMP training for related companies and urge related companies to scientifically and reasonably formulate implementation plans based on their own characteristics, conduct hardware transformation and software upgrades in a realistic manner, and gradually meet the requirements of the new version of pharmaceutical GMP within the prescribed time limit.

During the transition of the new drug GMP implementation, the Gansu Provincial Bureau will strengthen the supervision and inspection of the drug production site, and will supervise and urge enterprises to carry out rectification in accordance with the requirements of the new version of the drug GMP. The Gansu Provincial Bureau requires that reviewing and accrediting agencies should strengthen the construction of their own inspection and certification capabilities in accordance with the requirements of the new version of pharmaceutical GMP. The Bureau will evaluate the certification and inspection capabilities of the review and certification center.

In addition, Gansu Province will strengthen the organization and management of the on-site inspection work of the “Drug GMP Certificate” for the validity period to ensure the quality of on-site inspection work during the transition period. The Bureau will do a good job in the application of the new drug GMP certification application for the drug manufacturer in the province and the extension of the existing "Drug GMP Certificate" validity period. The new situation and new problems encountered in the implementation process will be studied and resolved in a timely manner, and efforts will be made to promote it. The successful implementation of the new version of drug GMP.

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