Enterprise rectification self-inspection report 1 Based on the Drug Administration Law, the Regulations for the Implementation of the Drug Administration Law, the Implementation Standards for the Acceptance of Pharmaceutical Retail Enterprises in Zhejiang Province and other relevant materials. Through self-inspection, the enterprise basically meets the requirements of gsp tracking inspection. The self-inspection work is summarized as follows:
I. General situation of the enterprise
The name of this enterprise is xx Daxi Yingkang Pharmacy, which was established in June of 1992 1 and changed on September 29th of 20xx. Now the registered addresses of Jiang Xiuzhen, the person in charge of the enterprise, and Jiang Xiuzhen, the person in charge of quality, are No.81/KLOC-0, Pan Lang Road, Daxi Town, xx City, and the warehouse address of our store is No.5.
The main facilities and equipment of the enterprise include air conditioner, refrigerator, ventilator, thermometer and electronic scale. To ensure the quality of drugs displayed and stored.
Scope of business: Chinese medicine (decoction pieces) (limited variety supply), Chinese patent medicines, chemical preparations, antibiotics, chemicals and biological products, dealing in about 300 kinds of western medicines. Last year1February sales100000 yuan, profit and tax 3500 yuan.
Second, the quality management system self-inspection.
(1) personnel
There are 3 employees in this enterprise, and the person in charge of the enterprise and the person in charge of quality comply with the provisions of Articles 76 and 83 of the Drug Administration Law (including quality management personnel 1 person, prescription reviewer 1 person, acceptance maintenance personnel 1 person and sales personnel). All three pharmacists participated in the physical examination of that year and established employee files.
Enterprises regularly organize employees to carry out training and study on laws, regulations and professional knowledge, and establish files.
(2) Places and facilities
The business area of this enterprise is 45 square meters, the warehouse area is 40 square meters, the surrounding environment is clean and pollution-free, and the business place is separated from the warehouse, office and living area. Business premises, business shelves and counters are complete, and the signs of cabinets are eye-catching. Prescription drugs and over-the-counter drugs are displayed in categories, with corresponding guidance signs and warnings, and counters for antibacterial drugs, easily-smelled drugs and detachable drugs are set up. The ground and walls of the warehouse are flat and clean, equipped with shelves to ensure the normal storage of drugs, and the ground has certain padding. Equipped with air conditioner, exhaust fan, refrigerator, thermometer, etc. Business premises and warehouses have been equipped with dust-proof, moisture-proof, insect-proof, rat-proof, mildew-proof and other equipment, and the measuring instruments have been calibrated by the metrological supervision department.
(3) Quality management system and management responsibilities
According to the relevant laws and regulations and the requirements of gsp tracking inspection, the enterprise has set up 1 quality supervisor and full-time quality administrator, who are specifically responsible for the quality management of the enterprise, formulated the post responsibilities of various personnel and various quality management systems, and made specific provisions on the procurement, acceptance, display, storage, maintenance, storage and sales of drugs, and regularly inspected and assessed the implementation of the systems, and established files.
(4) Procurement and acceptance
When purchasing drugs, enterprises strictly implement the Drug Administration Law, the Quality Management Standard for Drug Trading and other relevant requirements, strictly review the legitimacy of the initial enterprises, and sign a procurement contract or quality agreement with clear quality terms. For purchased drugs, inspectors should carefully check the appearance quality, packaging, labeling and other items of drugs in batches according to relevant regulations, and make various quality records.
(5) Display and storage
Drugs displayed in the store are classified and stored, and drugs and non-drugs, prescription drugs and over-the-counter drugs, internal drugs and external drugs are displayed in separate cabinets; Smelly drugs, disassembled drugs and antibacterial drugs are displayed in the counter. The drugs stored in the warehouse should be classified, and the drug stack should be 30cm away from the wall and not less than 10cm away from the ground. Delivery execution? First production, first production in the near future? The principle of.
The drug maintenance warehouse shall be inspected once every quarter, and the business premises shall be inspected once a month. The inspection period shall be shortened for drugs with short-term effects and drugs prone to mildew and deliquescence.
(6) Sales and after-sales service
Enterprises insist on engaging in drug business activities? Customer first, quality first? The policy is to set up a service convention in the store and set up a consultation desk for resident pharmacists to list the consultation services. All prescriptions are reviewed and strictly controlled by resident pharmacists. Each prescription is signed by the audit and deployment personnel, and the store announces the supervision telephone number. Accept customers' criticisms and quality complaints at any time to improve and improve the business service quality of this enterprise.
Third, the existing problems and corrective measures
(1)xx The gsp certification of the US Food and Drug Administration conducted on-site inspection of defective products, and the gsp certification of this enterprise found 5 defective products through on-site inspection on September 1 1 day of 20xx.
Rectification measures:
A. rectification time: starting from September 20xx 1 1.
B. Responsible person for rectification:
C, rectification results
1, (6006) The enterprise has not established a quality file containing drug quality standards. Set up full-time quality management personnel, responsible for establishing the quality files of drugs handled by enterprises and bringing them into the quality standards.
2.(60 1 1) Enterprise managers collect drug information but do not analyze it. Arrange special personnel to establish files and analyze drug information.
3.(6806) The enterprise drug storehouse lacks mousetraps and screen doors. Buy a mousetrap and install the screen door immediately.
4.(720 1) The quality assurance agreement signed by the enterprise in Zhejiang Chuntian Pharmaceutical Co., Ltd. indicates the validity period. Contact the contact person of Zhejiang Chuntian Medicine Co., Ltd. in time, re-sign the warranty agreement, and indicate the validity period.
5.(7802) The enterprise did not shorten the maintenance period of drugs that are easy to mildew and have short-term effects as appropriate. Set up full-time personnel to re-maintain the drugs that are easy to mildew and have near-effect and shorten the maintenance period as appropriate.
(II) xx On August 2, 20xx, the US Food and Drug Administration found the following three bad items in its daily supervision.
Rectification measures:
A. The rectification time: 20xx starts on August 2nd.
B. Responsible person for rectification: Jiang Xiuzhen
C, rectification results
1, (2, 3, 8) This year, the enterprise did not carry out continuing education and did not establish training files. Immediately carry out continuing education and establish files in time.
2.(2, 10, 7) No prescription registration was found at the site, so the group could not provide it. Set up full-time staff to register prescriptions in time.
3.(2), (4) and (8) Honeysuckle dew is non-drug and is not placed in the non-drug area. Honeysuckle dew should be placed in the non-drug area in time, and strictly placed with drugs and non-drugs in the future.
Four, gsp tracking inspection results.
Through gsp follow-up inspection and self-examination, compared with gsp certification on-site inspection and evaluation standard 109 for pharmaceutical retail enterprises, this enterprise involves 99 items (our store does not handle special drugs or Chinese herbal pieces), and the reasonable missing items are (5 items do not handle special drugs: 680 1, 7007, 7402 and 703). There are five reasonable deficiencies in not dealing in Chinese herbal pieces: 6807, 7508, 7707, 7708, 8 1 1). After self-examination, we believe that it basically meets the exchange evaluation standard, and now we apply to xx US Food and Drug Administration for gsp tracking inspection.
Enterprise rectification self-inspection report II. The first is to improve the working mechanism and system construction.
Our unit has set up a leading group for information disclosure (government affairs disclosure) of xx Provincial Local Taxation Bureau, which is headed by the party secretary and single leader. Set up the office of the leading group for institutional information disclosure (government affairs disclosure). Institutional information disclosure (government affairs disclosure) leading group is responsible for the deliberation and decision-making of the overall planning, major issues and important documents of the institutional information disclosure of the local tax system in the province, and comprehensively promote, guide, coordinate and supervise the institutional information disclosure of the local tax system in the province. The office of the leading group for institutional information disclosure (government affairs disclosure) specifically undertakes the daily work of the leading group. At the same time, all units in the bureau have arranged full-time and part-time personnel to serve as liaison officers for institutional information disclosure, responsible for information collection, information release and comprehensive coordination. Local taxation bureaus of cities and States have also set up local taxation bureaus, which are headed by J? Led by the leading group for institutional information disclosure for a long time, the information disclosure work of local institutions was arranged and guided in a unified way, and a work pattern with clear responsibilities and implementation at different levels was formed in the system.
Our unit has established and improved the system of information disclosure from the aspects of involving the vital interests of the masses, earnestly safeguarding the interests of taxpayers, easily generating unhealthy practices and breeding corruption. A series of rules and regulations have been formulated, such as Guide to Information Disclosure of Local Taxation Bureau of xx Province, Catalogue of Information Disclosure of Local Taxation Bureau of xx Province, Working Rules for Information Disclosure of Local Taxation Bureau of xx Province upon Application, and Measures for Confidential Examination of Information Disclosure of Local Taxation Bureau of xx Province. Organize relevant information on institutional information disclosure, compile the Compilation of Institutional Information Disclosure and Administrative Efficiency Construction System, and issue it to all units of the Bureau. In the business training of municipal bureaus and pilot counties and cities, the disclosure of institutional information is the key training content.
Second, broaden distribution channels and improve information quality.
Vigorously strengthen the information construction of internal and external networks. Internal and external websites are important carriers for the local tax system to disclose institutional information. The whole system uses the intranet information assembly platform in a unified way, and the special person is responsible for editing and auditing, which realizes the timely assembly, submission and release of information of provincial bureau offices, municipal bureaus and pilot counties and bureaus with expanded power, ensures the timeliness of information work and improves the quality and efficiency of information work. Complete the revision of the external network, open a column of institutional information disclosure, and timely and comprehensively disclose institutional information closely related to taxpayers and the public. As of July 3, 20xx1day, 870 pieces of various information have been published on the external network.
Proactively submit special information. Focus on the key work concerned by the provincial party committee, provincial institutions and State Taxation Administration of The People's Republic of China, and actively reflect the work dynamics of the local tax system to the higher authorities. According to the new requirements of information work in the new situation and combined with work practice, we should actively explore new ideas, methods and ways of information work to enhance the initiative and creativity of work. Improve the way of information service, increase the intensity of information signing, and actively seek and dig information clues from meetings, documents, news, leaders' speeches and instructions. Attaching great importance to the details of information editing, we should not only strictly control the quality of information editing, but also improve the format, punctuation and printing to improve the overall quality of information work. As of July 3, 20xx1day, * * * has reported 130 to provincial party committees, provincial institutions and State Taxation Administration of The People's Republic of China special newspapers. Among them, the State Council adopted 1 information, and provincial institutions adopted 33 special newspapers.
Self-inspection report on enterprise restructuring in 3-20xx years, the company has achieved certain results in saving energy, reducing consumption, tapping potential and increasing efficiency through a series of positive measures. The annual energy-saving work is summarized as follows:
First, strengthen the leadership and management mechanism and pay close attention to energy conservation and emission reduction.
Company leaders regard energy conservation and emission reduction as the top priority of the enterprise, and often hold special meetings to study energy conservation and emission reduction; The company has identified a competent leader who is responsible for energy conservation and emission reduction; Established energy consumption reduction standards, unified electrical equipment standards for each pit, and implemented the target responsibility system for environmental protection, energy conservation and emission reduction; For plant selection and production units, energy saving, cost control and monthly wage distribution are closely linked, and rewards and punishments are clearly defined.
Second, strengthen power management and reduce power consumption.
Since 20xx, the company has made reactive power compensation for transformers in various production outlets, and the power factor has improved a lot, from about 0.8 to more than 0.9 now. Reward the company's electricity fee adjustment every month, which reduces the cost and increases the company's benefit. At the same time, the company forcibly eliminated the split compressor with high power consumption, high noise and backward technology, and equipped a series of large-scale equipment such as new frequency conversion screw energy-saving intelligent air compressor and pump. In the past, a mining equipment cost more than 90,000 yuan in electricity every month. After updating the intelligent energy-saving equipment, the electricity bill is about 60 thousand yuan, which is greatly reduced. It not only reduces the power supply pressure of Sanjun Line, but also improves the efficiency of electricity consumption, and at the same time reduces the waste of manpower and material resources, achieving a win-win situation with the labor construction team.
Third, strengthen process operation management and strictly control key links.
According to the actual situation of the company, grasp the key links of energy saving and emission reduction, mainly including the following aspects:
1. Strictly save electricity and strengthen the management of electrical equipment. Each workshop arranges professional patrol personnel to maintain and manage the equipment, which reduces the mechanical loss of the equipment and plays an important role in prolonging the service life of the equipment and reducing the power consumption of the equipment.
2. Strictly control the index of consumables, strengthen the energy-saving knowledge of workshop operators, improve process parameters, promote the full use of chemicals, improve efficiency, reduce the emission of harmful substances and improve environmental pollution.
Four, strengthen the statistical analysis of energy, timely feedback.
Adopt scientific statistical methods to ensure the accuracy of energy data, make a monthly energy consumption cumulative table, and pass the? Monthly indicators? Comparison, make an analysis report on the energy consumption of the company's main products and feed it back to all energy-using units, and arrange special personnel to fill in the energy utilization report on time.
Problems existing in verb (abbreviation of verb) energy-saving work and energy-saving measures to be taken
The energy-saving management system is not perfect, and the energy-saving incentive and restraint mechanism is not refined. The company's energy-saving management can't meet the development needs of energy-saving work in terms of organization setting, staffing and funding guarantee, and it is difficult to mobilize the enthusiasm and creativity of all aspects of energy-saving work, and the overall energy-saving work is still in a passive state. Energy conservation has a long way to go. In the future, we will continue to strengthen energy-saving publicity, organize relevant personnel to do energy-saving skills training according to work characteristics, establish and improve the company's energy management system and management mechanism, and make new contributions to promoting the company's all-round development.
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