Shandong Kongshengtang Pharmaceutical Co., Ltd.

Kong Pharmaceutical has six dosage forms: granules, pills, tablets, capsules, oral liquid and dripping pills. The leading products are six national-level new drugs with independent intellectual property rights, such as Shuang Dan Granule, Yikang Capsule and Shuang Dan Dropping Pill, and nearly 100 kinds of over-the-counter Chinese patent medicines A and B for treating common and frequently-occurring diseases, such as Gardenia Jinhua Pill, Liuwei Dihuang Pill and Wuji Baifeng Pill.

"Shuang Dan Granule" is a national new drug jointly developed with Chinese Academy of Traditional Chinese Medicine to treat cardiovascular and cerebrovascular diseases. It has definite curative effect, is safe and reliable, has no toxic and side effects, has independent intellectual property rights, is exclusively produced in China, and is a protected variety of traditional Chinese medicine. It has entered the national medical insurance product catalogue, won the "first prize of scientific and technological progress" and was included in the national spark plan. Yikang Capsule, the fifth generation compound preparation of Ginkgo biloba leaves, is a patented health care product jointly developed with Wuhan Institute of Botany, China Academy of Sciences. Its technical standards exceeded the international standards of similar products and won the "Gold Award of Hong Kong International New Products and New Technologies Expo".

In September 2003, pills, granules and capsules of Shandong Kongshengtang Pharmaceutical Co., Ltd. passed the on-site inspection of the Certification Center of the State Pharmaceutical Products Administration for the first time and obtained GMP certification. In September 2008, the replacement certificate was passed. This indicates that the production quality management of Confucius has moved towards standardization, standardization and modernization.

According to GMP requirements, the enterprise has established and improved the organization of production and quality management. The functions and post responsibilities of each department are clearly defined in the document.

Enterprises have all kinds of technical personnel suitable for the production scale.

The workshop has a clean area of 300,000, which is a general production area. The workshop layout is scientific and reasonable, the production process is not circuitous, and the production processes are clearly distinguished, which do not cross and interfere with each other.

All kinds of warehouses have sufficient area and space suitable for production; Production has an intermediate station where intermediate products are placed.

The enterprise has formulated management regulations, including institutions and personnel, factories and facilities, equipment, materials, hygiene, verification, documentation, production management, quality management, quality inspection, self-inspection management, user complaint management and adverse reaction reporting, sales and recycling, etc.

The enterprise has established various records of production, quality management, equipment and health management.

The enterprise has established a management system for the classification and numbering of GMP documents, and standardized the drafting, revision, review, approval, cancellation, printing and storage of GMP documents.

Strictly implement the requirements of batch number management regulations in the production process. Avoid drug contamination and confusion. Before production, there will be quality inspectors to inspect the production site, and production can only be carried out after passing the inspection. The equipment and containers used in the production process have obvious status marks. After each batch of production in each process is completed. Clean up the site according to the standard operating procedures for cleaning up the site. And fill in the clearance record.

Process water meets the requirements of quality standards, and is regularly tested by the Technical Supervision Bureau, and a qualified report is issued. Purified water is prepared by reverse osmosis, which is checked once a month and recorded.

The technical research and development department of the enterprise is responsible for the quality management and inspection of the whole process of drug production. The quality department is directly led by the person in charge of the enterprise. The quality inspection center has all kinds of laboratories, places, instruments and equipment that can meet the production scale, variety and inspection requirements.

The technical research and development department is responsible for formulating and revising the internal control standards for intermediate products and finished products of materials; Responsible for formulating and revising the inspection operation procedures for intermediate products and finished products of materials; Formulate sampling and sample retention system; Formulate management measures for inspection equipment, instruments, reagents, inspection solutions, standard solutions and culture media; Determine the use of materials and intermediate products: review batch production records before product distribution; Decide on product sales; Review the handling procedures of non-standard products; Sampling, inspecting and retaining samples of semi-finished products and finished products, and issuing inspection reports; Monitor the clean room and the number of dust particles and microorganisms: evaluate the quality stability of raw materials, intermediate products and finished products, and provide data for determining the storage period of materials; Formulate the responsibilities of quality management and inspection personnel, and evaluate the quality system of major material suppliers together with the supply department; Organize quality analysis activities regularly; Responsible for recording, investigating and reporting adverse reactions; Responsible for the investigation, analysis, handling and reporting of quality accidents: testing the returned products and putting forward handling suggestions; Be responsible for summarizing and reporting quality reports; Responsible for organizing the activities of the quality management team of the whole plant; Responsible for supervising the drug recovery process when necessary; Responsible for the management of product quality documents; Responsible for quality management and quality inspection personnel training; Responsible for providing sampling methods of inspection procedures for verification, inspection and issuance of inspection reports; Responsible for the formulation and implementation of verification schemes such as equipment cleaning and product technology, and responsible for the supervision of unqualified drug treatment.

The enterprise has established an adverse reaction reporting procedure and a user quality complaint management procedure, and set up an after-sales service department, with a special person responsible for the investigation and handling of adverse reactions and quality complaints and making records.

The enterprise has set up a self-inspection team to regularly inspect personnel, factories, equipment, documents, production, quality management, drug sales, user complaints, product recycling and so on.

We deeply realize that passing GMP certification is only the starting point, and implementing GMP has a long way to go. We have the determination and confidence to persist in the implementation and continuous improvement of GMP in future production and operation, and make Kong Pharmaceutical bigger and stronger. Make new positive contributions to meet social needs.