In order to comprehensively promote the research on the Risk Assessment of Quality Safety of Raw Materials and Excipients for Pharmaceutical Manufacturing Enterprises in Guangdong Province which is governed by Guangdong Medical Products Administration(MPA), then further improve the quality management of pharmaceutical manufacturing in Guangdong Province, so as to ensure the quality safety of drugs, on August 22, 2022, TITAN Pharmaceutical, invited by the Guangdong MPA and Guangdong Provincial Pharmaceutical Association Committee, undertook and held the “Special Meeting of Qualified Persons of Pharmaceutical Manufacturing Enterprises in Guangdong Province”.

The leaders attending the meeting were Mr. Fang Wei, Deputy Director of the Guangdong MPA, Ms. Luo Yubing, Director of the Medical adminnistartion First office of MPA, key members of the First office and the Guangdong CDE. Mr. Wang Shaofeng, Deputy Secretary General of Heyuan Municipal Government, Mr. Xu Xuezhang, Director of Heyuan Municipal Market Supervision and Administration Bureau, and Mr. Meng Lixin, Deputy Director of Heyuan Municipal Market Supervision and Administration Bureau, attended the meeting on behalf of Heyuan Municipal Government. A total of 30 persons from 20 pharmaceutical companies in Guangdong Province, including Sinopharm Group, GPC, Baiyunshan Pharmaceutical, Livzon Group, Xinlitai Pharmaceutical, and Zhuhai Union, were invited to the meeting.

Mr. Wang Shaofeng, Deputy Secretary-General of Heyuan Municipal Government, delivered a speech on behalf of Heyuan Municipal Government at the beginning of the meeting. He extended a warm welcome to the arrival of the pharmaceutical experts, and expressed thanks to the leaders of the provincial bureau and colleagues in the pharmaceutical industry for their full affirmation of TITAN Pharma. He said that Heyuan City, as a mountainous city, the drug supervision work has also achieved remarkable results in recent years under the correct leadership of the Guangdong MPA. The quality safety of raw materials and excipients, as the first pass of drug quality safety, has always been the focus of the Heyuan Drug Administration. In the future work, Heyuan City will make all efforts to follow the provincial bureau’s decisions and deployments, and continue strengthening the supervision of technical guidance and supervision of pharmaceutical manufacturing enterprises.

Subsequently, Ms. Luo Yubing, Director of the Medical adminnistartion First office of MPA, explained the purpose of the meeting. The review meeting of the audit templates for raw materials and excipients was held in order to discuss and decide comprehensive audit templates for drugs raw materials and excipients, so that the enterprises can refer to them when conducting audits, thus jointly promoting the quality supervision of raw materials and excipients manufacturers by regulatory authorities and pharmaceutical manufacturing enterprises.

The audit templates for quality safety risk assessment of raw materials and excipients were divided into 4 categories, including APIs, excipients, fermented products and traditional Chinese medicine extracts. The templates were formulated according to the drug production supervision and management standards, GMP and related appendices, Chinese Pharmacopoeia and APIC audit guidelines, and compiled into different chapters and systems in the form of and questionnaires, with comprehensive and wide-ranging contents.

During the meeting, the members of the expert group basically approved the formulation and form of the audit templates, and expressed their opinions on the clauses in the templates in turn. In terms of the applicability of the templates, some experts pointed out that the templates were mainly used as a reference for pharmaceutical manufacturing enterprises to audit suppliers, the ultimate purpose of the audit was to ensure the product quality, so the pharmaceutical manufacturing enterprises should not rely too much on the standardized templates and ignore some key risk points in the auditing process. At the same time, some experts suggested that we should pay attention to some high-risk points, or professional contents in the pharmaceutical industry.

At the end of the meeting, Mr. Fang Wei, Deputy Director of the MPA, made a summary of the review meeting. He first affirmed the efforts made by TITAN Pharma in the development of APIs in Guangdong Province. Especially in the current epidemic, it was not easy to maintain the stable development of the enterprise. At the same time, he expressed thanks to TITAN Pharma for its strong support for this meeting. He pointed out that the improvement of drugs quality has always been purpose of the joint effort of the MPA and the pharmaceutical industry. The audit templates were only for reference for the pharmaceutical manufacturing enterprises to better supervise the raw and Excipient material suppliers, and the enterprises should make judgments based on their own considerations on quality risks, audit method, and the final audit results. Only by better familiarizing with the properties of the raw materials and excipients produced by their suppliers, can they better control their own products quality.

In addition, Mr. Fang Wei also pointed out that the qualified person system had been implemented by the MPA for a long time. He sincerely hoped that the qualified person of each enterprise can keep finding out new ideas to solve problems and improve the quality management of enterprises, thus constantly promoting the healthy development of the pharmaceutical industry in Guangdong province.