All branches, relevant departments and units directly under the Provincial Bureau:
The newly revised Measures for the supervision and administration of pharmaceutical production (Order No. 28 of the State Administration of market supervision and Administration) (hereinafter referred to as the "production measures") will come into force on July 1, 2020. In order to further optimize the daily supervision of the production of Chinese herbal pieces, and in combination with the actual situation of our province, we hereby notify the following matters:
1、 From July 1, 2020, the supervision department of traditional Chinese medicine and cosmetics of the Provincial Bureau will no longer handle the registration of key facilities and equipment changes of Chinese Herbal Pieces production enterprises. If the key production facilities and equipment of the enterprise are changed, which belongs to the reconstruction or expansion of the workshop or production line, it shall be handled according to the provisions of Article 16 of the "production measures"; if it does not belong to the reconstruction or expansion of the workshop or production line, the enterprise shall complete the confirmation and verification according to the requirements of GMP before putting into use, and report it through the comprehensive drug supervision platform of Anhui Province.
2、 From July 1, 2020, the supervision and Control Department of traditional Chinese medicine and cosmetics of the Provincial Bureau will no longer handle the change record of the quality responsible person and the production person in charge of drug production enterprises. If the relevant personnel of the enterprise are changed, it shall be handled in accordance with Article 17 of the production measures.
3、 Manufacturers of Chinese herbal pieces should be equipped with sufficient testing instruments to ensure that the products can be fully inspected. For special inspection items such as heavy metals and harmful elements, arsenic salt inspection, pesticide residues, aflatoxin and other special inspection items, as well as inspection items involving large-scale instruments with less frequency of use, qualified units or pharmaceutical production enterprises in Anhui province that meet GMP requirements and have corresponding detection capabilities and have not found serious defects in the supervision and inspection of drug regulatory authorities in recent five years can be entrusted Inspection. If the enterprise needs to entrust the inspection, it shall be managed in strict accordance with the relevant provisions of GMP. The entrusted inspection contract, qualification certificate of the entrusted unit, certificate of competence, varieties and items of the entrusted inspection shall be submitted through the Anhui provincial drug comprehensive supervision platform and registered by the local provincial Bureau.
4、 If Chinese Herbal Pieces manufacturing enterprises of the same group company in the same park belong to the same quality management system and need to share testing instruments and equipment, the feasibility report of common instruments, names of common testing instruments and equipment, inspection items, etc. shall be reported through the comprehensive drug supervision platform of Anhui Province.
5、 Manufacturers of Chinese herbal pieces should establish and implement drug traceability system, give traceability marks to all levels of sales packaging units of drugs according to the regulations, implement drug traceability by means of information technology, timely and accurately record and save drug traceability data, and provide traceability information to drug traceability collaborative service platform.
Before the promulgation of policies and technical requirements on informatization traceability of Chinese Herbal Pieces issued by the State Drug Administration and the provincial administration, the information of relevant products shall be reported through the comprehensive supervision platform of Anhui Province in accordance with the requirements of the Provincial Bureau's Circular on opening the comprehensive drug supervision platform of Anhui Province (No. 15, 2020).
6、 If the production enterprise of traditional Chinese medicine decoction pieces stops production, it shall report to the local provincial Bureau in writing within 10 days from the date of the decision to stop production; if it has stopped production for more than 6 months, the Provincial Bureau branch shall report to the Provincial Bureau and issue a suspension announcement; during the period of production suspension, the Provincial Bureau branch shall verify the suspension situation on the spot every year. If a stop production enterprise resumes production, it shall report in writing to the local provincial Bureau 30 days in advance. The Provincial Bureau shall supervise and inspect the stopped enterprise. Only when it meets the requirements of GMP can it agree to resume production.
7、 The legal representative and main responsible person of an enterprise producing Chinese herbal pieces shall be fully responsible for the pharmaceutical production activities of the enterprise and strictly perform the five duties specified in Article 29 of the production measures.
The relevant departments, units directly under the Provincial Bureau and the branches of the Provincial Bureau shall include the compliance of the legal representative and the main responsible person of the Chinese medicine decoction pieces production enterprise with Article 29 of the "production method" into the key inspection contents, and urge them to implement the main responsibility of drug safety.
8、 The sub bureaus of the Provincial Bureau should strengthen the supervision of entrusted inspection and shared testing instruments and equipment, take the entrusted inspection and common inspection instruments and equipment as the key contents of daily supervision, and carry out extended inspection on the entrusted units of entrusted inspection when necessary. The drug regulatory authorities shall timely correct the entrusted inspection behaviors that do not conform to the provisions; those that violate the drug administration law, GMP and other relevant laws and regulations shall be dealt with in accordance with the relevant provisions.
9、 All branches of the Provincial Bureau should seriously study and study the content of the "production method", strictly implement the "production method" and the requirements of this circular, and do a solid job in the daily supervision of the production process of Chinese herbal pieces; they should strengthen the publicity, implementation and training of the production enterprises of Chinese herbal pieces, and timely convey the requirements of the "production methods" and this circular to the Chinese Herbal Pieces production enterprises within their jurisdiction, Urge enterprises to learn, understand and implement the spiritual essence and basic content of the "production method", urge enterprises to learn and watch the interpretation of the newly revised "drug production supervision and management measures" through the "food and Drug News" app of China food and drug network, strictly abide by the drug production quality management standards, establish and improve the drug production quality management system, and ensure the quality of Chinese herbal pieces from the source Quantity safety.
The problems encountered in the implementation of the "production method" shall be reported to the Provincial Bureau in time.
Office of Anhui Drug Administration
June 29, 2020
(Disclosure attribute: active disclosure)