Sampling in the pharmaceutical industry has become normalized, how should relevant enterprises respond?

【Pharmaceutical Network Market Analysis】In order to strengthen drug quality supervision and ensure the safety of public medication, local drug administration bureaus are actively conducting random inspections of drug quality in the production, operation and use of drugs in the province
.
Sampling in the pharmaceutical industry has become normalized, how should relevant enterprises respond? (Image source: Pharmaceutical Network) Frequent pharmaceutical sampling inspections in various places, a large number of enterprises and products were notified On November 7, the Zhejiang Provincial Food and Drug Administration issued the second phase of drug quality sampling inspection in
2022.
The announcement shows that after inspection, 25 batches of unqualified drugs were found, including motherwort granules, three yellow tablets, rhubarb laxative tablets, isotretinoin gel, lotus fragrance zhengqi water, six flavors of rehmannia capsules, chicken bone grass, Wujia peel, angelica, etc
.
Among them, it is worth noting that many pharmaceutical companies have had multiple batches of drugs unqualified, such as Jiangxi Deshang Pharmaceutical Co.
, Ltd.
has 4 batches of rhubarb laxative tablets [check] soil rhetyside is unqualified
.
At present, the Provincial Drug Administration has requested the relevant prefecture and city market supervision and administration departments to dispose of
the unqualified drugs found in random inspection according to law.
Coincidentally, on November 6, the Guangdong Provincial Drug Administration also issued a notice on drug spot check and inspection information (Issue 7, 2022).

Among them, the compound aminophenolamine tablets of Shanghai Beijie Group Guandong Pharmaceutical Co.
, Ltd.
, the konbu of Jiangxi Hongjie Chinese Medicine Pieces Co.
, Ltd.
, and the loofah of Jiangxi Qi Rentang Chinese Medicine Pieces Co.
, Ltd.
were notified
due to unqualified traits and weight differences.
Prior to this, the Anhui Provincial Food and Drug Administration also issued a drug production supervision and inspection information notice
.
According to the content of the circular, the provincial bureau has carried out routine inspections, rectification and re-inspections, and cause-based inspections of 45 pharmaceutical companies
.
Among them, 36 meet the requirements, and 8 basically meet the requirements and need rectification
.
At present, most of the rectification has been completed; One enterprise that does not meet the requirements is Anhui City Pharmaceutical Co.
, Ltd.
, and the provincial bureau has ordered it to suspend production, warn and rectify
.
.
.
.
.
.
.
Under the normalization of sampling inspections, how should pharmaceutical companies respond Frequent sampling inspections mean that pharmaceutical safety has become the focus
of attention in the industry.
So in this context, how should pharmaceutical companies respond? In this regard, analysts said that all pharmaceutical companies need to further strengthen self-discipline, and strictly follow the requirements of the new version of the pharmacopoeia, do a good job in planting, production, processing, circulation and other links of the check, to promote the overall quality of the pharmaceutical industry
.
In addition, because the advanced pharmaceutical process will also directly affect the quality and yield
of drugs.
Therefore, relevant enterprises also need to accelerate the standardization of drug production to further ensure the safety of the production process and ensure the quality of
drugs.
It should be noted that since Chinese medicine pieces still account for the majority of unqualified drugs, more attention needs to be paid to
the control and production process of raw materials.
In addition, because Chinese medicine pieces are Chinese medicine products
that are processed by a certain process.
Therefore, Chinese medicine enterprises can also use modern advanced digital technology and equipment to carry out digital transformation and upgrading to improve production quality and better ensure the safety of
Chinese medicine pieces.
It is understood that more and more enterprises are vigorously using digital technology to promote the development
of Chinese medicine pieces in the direction of intelligence, flexibility, precision and production standards.
For example, pharmaceutical machinery companies have created a series of intelligent Chinese medicine pharmaceutical equipment
, including a full intelligent package traceability production line, a fully intelligent Chinese medicine formula granule bottling production line, and a full intelligent canning packaging line.
It is reported that these equipment can reduce work intensity, reduce labor time, while strengthening the quality of equipment packaging, and meet the requirements
of GMP control.
Of course, in addition to pharmaceutical companies, with the landing of the Regulations on the Supervision and Administration of Medical Devices, medical device manufacturers have also ushered in an era of
strong supervision.
In this context, industry insiders proposed that medical equipment companies should also strictly control the procurement of raw materials, screen good suppliers, ensure product quality from the source, and prevent the risk of product quality problems; At the same time, it is necessary to strictly implement and supervise product release and control procedures, and do a good job in data collection, analysis and utilization
.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.