Recently, an expert panel from the Anhui Provincial Center for Drug Evaluation and Inspection conducted a three-day combined on-site GMP inspection of Anhui Poly Pharmaceutical Co., Ltd. This inspection simultaneously carried out the GMP compliance inspection of Gadobutrol API as requested by the company and a routine drug GMP compliance inspection as part of regulatory duties, covering multiple API production lines in a single effort. It was a comprehensive examination characterized by broad scope, strict standards, and high requirements.
It is worth noting that this regulatory GMP compliance inspection was, for the company, essentially an unplanned "flying inspection." On top of the Gadobutrol GMP compliance inspection, the expert panel added on-site inspections of three other API varieties at short notice. Faced with this sudden, compound challenge and high-intensity arrangement, all colleagues at the company responded calmly, drawing on solid daily fundamentals and efficient collaborative teamwork, and successfully completed the inspection task, demonstrating the team's outstanding overall competence.
Faced with the complex situation of a combined "application-based inspection" and a sudden "duty-mandated inspection," the quality management system the company has built over the years quickly demonstrated its highly efficient response capability. A coordinated mechanism composed of key personnel from multiple departments — including Quality, Technical, Production, Equipment Assurance, and Planning & Materials Control — was immediately set into efficient operation. Thanks to rigorous daily document management and process organization, during the inspection, no matter what documents the expert panel requested, the relevant positions were able to achieve "minute-level" precise response and seamless coordination. This is a true reflection of the company's "whole-company-as-one" quality collaboration system.
It is precisely because of the company's long-standing emphasis on quality management and all employees' in-depth practice of the quality philosophy — from rigorous daily process control and meticulous document organization to regular personnel training and systematic risk assessment — that the company has always placed quality and safety first, making compliant production and standardized management a conscious action for every employee. In the core areas of production, QC, and warehouse, employees won the recognition of the expert panel during the inspection with absolutely standardized operations, a clean and orderly workplace, and confident, professional responses. When asked about complex processes and technical details, colleagues from the relevant departments were able to quickly form an "ad-hoc expert team," providing clear and rigorous professional explanations from multiple perspectives.
The composure, seamless coordination, and profound professionalism demonstrated by the team throughout the inspection powerfully confirmed the outstanding capability of this team. This calm performance convincingly proves one thing: only through day-after-day solid accumulation and沉淀 can we handle sudden challenges with ease and composure.
The company has always regarded every external inspection as a valuable opportunity to learn from top industry experts. During the inspection, the team cooperated fully with an open and candid attitude. Immediately after the inspection concluded, the company organized a dedicated meeting, led by the Quality Department in coordination with all relevant departments, to systematically review the expert panel's guidance and recommendations, and promptly set about formulating a rectification and improvement plan covering the entire system — determined to fully transform the gains from this inspection into even more solid foundations for the company's quality edifice.
The smooth execution of this high-standard, high-intensity combined on-site GMP inspection (including the unannounced "flying inspection" portion) serves as a powerful dual confirmation of both the effectiveness of the company's existing quality management system and the team's emergency response capabilities. It fully demonstrates that Anhui Poly Pharmaceutical possesses a professional team that is solidly grounded, quick to respond, capable of fighting tough battles, and worthy of trust.
Anhui Poly Pharmaceutical Co., Ltd., founded in 2018, is located in the Anqing National High-tech Industrial Development Zone. It is a professional supplier of active ingredients, providing high-quality specialty raw materials through chemical synthesis and biosynthesis to the global pharmaceutical, healthcare, and skincare industries.
Anhui Poly Pharmaceutical has a strong and efficient R&D and production team, is equipped with modern production facilities, and has established a rigorous cGMP quality system for high-end APIs in Europe and the US, along with a high-standard EHS system. While providing customers with high-quality APIs and intermediates, the company also offers CDMO services and process improvement. At present, the company has 3 API production workshops compliant with GMP standards of Europe, the US, and China, 10 production lines, and 357 pieces of multi-functional equipment.
Leveraging its strong R&D capabilities and technology transformation capacity, the company has completed the commercial R&D and production of a series of products, including:
Contrast agents: Gadoteric acid meglumine, Gadoteridol, Gadobutrol, Iomeprol, Iopromide, Iohexol, Iopamidol, Iodixanol, etc.Synthetic biology: Semaglutide, Ectoine, Salidroside
Anti-tumor: CyclophosphamideOther APIs: Magnesium hydroxide, Apremilast, Crisaborole, Voriconazole, Memantine hydrochloride.Other pharmaceutical excipients: DOTA, SNAC, Sulfobutyl ether beta-cyclodextrin sodium, Calcium carteridolate, Cobutrol calcium
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