How to write a pharmacy drug self-examination report, 3 pharmacy drug self-examination reports

Pharmacy drug self-inspection report 1

In accordance with the requirements of the "Drug Administration Law" and its implementation regulations and the "Good Manufacturing Practice for Drug Operations", in order to use XXX Pharmacy passed the GSP certification as soon as possible. Under the guidance of the xx Food and Drug Administration Department, our pharmacy conducted a self-examination in strict accordance with the "Guiding Principles for GSP On-site Inspection of Drug Retail Enterprises". The relevant situation is now reported as follows:

1. Basic situation

XXX Pharmacy is an independent pharmacy. There are no pollution sources and no high-risk facilities around the business address. The business premises are spacious and bright, hygienic and clean, and the layout is reasonable. The approved business scope of the pharmacy is: Chinese herbal medicines, Chinese patent medicines, chemical pharmaceutical preparations, antibiotic preparations, and biochemical drugs. In accordance with GSP requirements, our pharmacy has improved the corresponding equipment, revised the responsibilities of each position and related regulations, and carried out GSP transformation from both hardware and software aspects, and has achieved good results. This pharmacy insists on operating in accordance with the law, being honest and trustworthy, and does not commit any deception in GSP certification and daily operations.

2. Enterprise’s implementation of GSP self-examination

(1) Quality management and responsibilities

Our pharmacy operates in accordance with relevant laws and regulations and the "Good Manufacturing Practice for Pharmaceutical Operations" According to the requirements, we have formulated quality management documents and carried out quality management activities to ensure the quality of medicines. Established operating conditions suitable for the business scope and scale of the pharmacy, including organizational structure, personnel, facilities and equipment, quality management documents, and set up computer systems in accordance with regulations.

XXX is the main person responsible for drug quality. He is responsible for the daily management of the pharmacy, ensuring that quality management personnel effectively perform their duties, and supervising post personnel to implement the laws, regulations and "Specifications" on drug management. There is a quality manager XXX who is responsible for the quality of drugs and has formulated quality management documents. The quality manager carefully reviews the qualifications of the supplier and its sales staff, and is responsible for reviewing the legality of purchased drugs.

Guide and supervise the quality management of drug procurement, storage, display, sales and other aspects, and carefully Do a good job in drug quality inquiry and quality information management, confirm and deal with unqualified drugs, be responsible for reporting adverse reactions of fake and substandard drugs, and conscientiously carry out drug quality management education and training, review, control and quality management of computer system operation authority Maintain basic data and calibrate and verify measuring instruments, guide and supervise pharmaceutical services. Responsible for other duties that should be performed by the Quality Manager.

(2) Personnel management

The personnel engaged in drug operation and quality management in our pharmacy comply with relevant laws, regulations and the requirements of the "Specifications", and there is no industry ban. The person in charge of the company, XXX, has XXX pharmacist qualification and provides guidance on the rational use of medicines. The quality manager is XXX, who has the technical title of XXX pharmacist. The salesperson XXX has XX academic qualifications, and the Chinese medicine preparation staff XXX has XXX education (delete the sentence without Chinese medicine preparations).

XXX and XXX have received pre-job training and continuing education training on relevant laws and regulations and pharmaceutical professional knowledge and skills. The company develops annual training plans and conducts training. Annual health examinations are conducted every year, health certificates are obtained, and health files are established to meet job requirements. Our pharmacy does not store items or personal items that are not related to business activities and does not affect the quality and safety of medicines.

(3) Documents

This pharmacy has formulated practical quality management documents in accordance with relevant laws and regulations, including quality management systems, job responsibilities, operating procedures, files, records and vouchers, etc. . And review it regularly and revise it in a timely manner. Through training, personnel in each position can correctly understand the content of quality management documents and ensure the effective implementation of quality management documents. And formulated a drug quality management system: a management system for drug procurement, acceptance, display, sales, storage, maintenance and other links, a supplier unit and procurement variety review system, and a prescription drug sales management system.

Drug dismantling management system, specially managed drugs and drugs with special management requirements by the state, record and voucher management system, quality information collection and query management, quality accident and quality complaint management system, traditional Chinese medicine preparation review, deployment and verification management system, drug validity period management system, substandard drugs and drug destruction management

management; environmental sanitation and personnel health systems, pharmaceutical service management systems such as medication consultation and guidance on rational drug use, personnel training and assessment systems, defective drugs Response reporting system, computer system management system, implementation of electronic drug supervision system, formulating the responsibilities of enterprise leaders, quality management, procurement, acceptance, sales staff, prescription review, deployment and other positions. More than a dozen operating procedures have been established for drug procurement, acceptance, sales, prescription review, deployment, and verification.

Established records related to drug procurement, acceptance, sales, display inspection, temperature and humidity monitoring, and disposal of unqualified drugs to ensure authenticity, completeness, accuracy, effectiveness, and traceability. Records and related vouchers should be kept for at least 5 years.

When recording data through the computer system, relevant personnel should log in to the computer system through authorization and password in accordance with the operating procedures to enter the data to ensure that the data is original, authentic, accurate, safe and traceable.

(4) Facilities and equipment

The business premises of this enterprise are suitable for its pharmaceutical business scope and business scale. The business area of ??the enterprise is XX square meters, with a clean environment, reasonable layout, good ventilation, no pollutants, and separate business premises and living areas. There are XX sets of shelves for business use, XX sets of counters, and sales cabinets with eye-catching signs. Since we have legal and reliable drug supply channels, the drugs sold can be replenished in time and put on the shelves in time after passing the inspection. Therefore, our store does not have a warehouse. Medicine shelves and medicine cabinets can keep the distance between medicines and the ground at least 10cm. The pharmacy is equipped with dust-proof, moisture-proof, insect-proof, rodent-proof and other equipment. 1 thermometer and hygrometer, 1 dehumidifier, 1 ventilation fan, 1 sticky mouse board, equipped with dispensing tools and packaging supplies required for dismantling and selling of pharmaceuticals that meet the requirements. And there is a special counter containing ephedrine.

(5) Procurement and acceptance of drugs

1. Drug procurement

Drug procurement management is a key link in ensuring the quality of drug operations. Implement effective supervision and control over the drug procurement process. In order to strengthen the management of drug procurement, we first formulated a strict procurement management system during the procurement process. For specific matters in the procurement process, the first operation Enterprises and purchase and sale contracts have been effectively controlled and stipulated.

(1) Legality of purchasing enterprises

Conduct legality assessments on qualified suppliers and first-run enterprises. The purchaser is responsible for obtaining relevant information from the supplier, such as stamped The pharmaceutical production or operation license with the original seal of the enterprise, a copy of the business license and its annual inspection certificate, a copy of the "Good Manufacturing Practice for Pharmaceutical Manufacturing Practice" certification or the "Good Manufacturing Practice for Pharmaceutical Distribution" certification, relevant seals, and accompanying goods slips ( (ticket) format, account opening name, opening bank and account number, copies of "Tax Registration Certificate" and "Organization Code Certificate", fill in the approval form for first-run enterprises through investigation and understanding, and be reviewed and qualified by the quality manager, and have the person in charge of the pharmacy After approval, a qualified supplier file will be established.

(2) Legality of drug procurement

When purchasing drugs, buyers should obtain invoices from the supplier. The invoice should list the generic name, specification, unit, quantity, unit price, amount, etc. of the drug;

Procurement records should be established for purchasing drugs. Procurement records should include the generic name, dosage form, specification, manufacturer, supplier, quantity, price, purchase date, etc. of the drug.

(3) The legality of the supplier’s salesperson and the signing of the quality assurance agreement.

Check whether the business behavior of the supplier's salesperson is consistent with the business method and business scope approved by the company's "certificate and license". Obtain a copy of the salesperson's ID card with the original seal of the supplier's salesperson; check the original seal of the supplier's official seal and the authorization letter with the seal or signature of the legal representative. The authorization letter should state the name and ID card of the authorized person. number, as well as the variety, region, and period of authorized sales; information on the supplier unit and supply variety.

The signing of the quality assurance agreement should clarify the quality responsibilities of both parties; the supplier should provide information that meets the regulations and be responsible for its authenticity and validity; the supplier should issue invoices in accordance with national regulations; pharmaceutical packaging , labels and instructions comply with relevant regulations; quality assurance and responsibility for drug transportation; and the validity period of the quality assurance agreement.

The quality manager is responsible for verifying and auditing the above work, and the qualified materials will be entered into the qualified supplier's file together with the quality assurance agreement.

2. Drug acceptance

In order to ensure the quality of purchased drugs and prevent counterfeit and substandard drugs from entering our store, we have formulated management regulations for drug acceptance.

When the medicine arrives, the acceptance personnel should verify the actual medicine according to the purchase record and the supplier's accompanying receipt (invoice) to ensure that the invoice and the goods are consistent.

The enterprise shall inspect the incoming drugs batch by batch in accordance with the prescribed procedures and requirements.

The samples taken for acceptance shall be representative. The acceptance personnel shall inspect and verify the appearance, packaging, labels, instructions and relevant supporting documents of the sampled drugs one by one.

According to the actual quality inspection situation, the acceptance inspector will record the quality of the accepted drugs and make acceptance conclusions, and keep the acceptance records. Reject unqualified drugs and report to the quality manager.

(6) Display and storage

Our store strictly follows the requirements of the "Pharmaceutical Goods Management Practice" for the drugs it sells, and adheres to the principle of four separations, that is, drugs and non-drugs. Drugs are stored separately for internal and external use. Prescription drugs and non-prescription drugs are placed in separate cabinets. Drugs that are prone to odor are stored separately from general drugs and are stored according to the characteristics of the drugs. Disassembled drugs are stored centrally in the dismantling counters, and the original packaging labels and instructions are retained.

The quality and packaging of the displayed drugs are in compliance with regulations. The quality of the displayed drugs is inspected monthly and records are kept. If any problematic drugs are found, they are immediately removed from the shelves and counters, and relevant records are filled in. Keep the places and shelves where medicines are displayed clean and hygienic. There are fire-proof, moisture-proof, insect-proof, rodent-proof, and light-proof facilities and equipment.

In order to ensure the quality of drug storage, drug maintenance staff conduct regular monthly inspections of the drugs on display, and conduct weekly quality inspections of drugs that are perishable, near the expiration date, and easy to deliquesce. Any problems found are promptly taken Effective treatment measures. At the same time, maintenance inspection records are kept, and drug maintenance quality information is regularly summarized, analyzed and reported.

Pharmacy Drug Self-Inspection Report 2

Our store has conscientiously studied and implemented the "Good Manufacturing Practice for Pharmaceutical Products" (GSP) since its opening. Establish and implement various rules and regulations in the store in strict accordance with GSP standards. Adhere to GSP requirements to manage the enterprise. A self-examination is now conducted against the "Good Manufacturing Practices for Pharmaceutical Products" and the "GSP Certification Inspection and Assessment Standards for Drug Retail Enterprises". The self-examination results are as follows:

1. Overview of the pharmacy

Our pharmacy was established in xxx and is located in xxx. The legal representative is xxx, the person in charge of the company, and the quality manager is xxx. ***There are 2 employees, including 1 licensed pharmacist. Business nature: private, business mode: retail, business scope: (prescription drugs, over-the-counter drugs) chemical preparations, antibiotic preparations, biochemical drugs, Chinese patent medicines, family planning supplies, and retail of packaged foods.

2. Self-examination of GSP quality system

Our store has established a quality leadership group with the legal representative as the team leader and the quality manager (licensed pharmacist) as the deputy team leader, with division of responsibilities clear. Strictly implement national laws, regulations and GSP regulations. Strictly carry out pharmaceutical business activities in accordance with the business methods and business scope stipulated in the "Pharmaceutical Business License", and hang "Two Certificates and One Photo" and the "Original Licensed Pharmacist Registration" that conforms to the requirements of professional personnel in a prominent position in the store. The person in charge of quality carefully inspects and accepts the drugs sold in the store, first in, first out, keeps inspection records, and reports problems to the manager in a timely manner. Since the opening, the acceptance rate of incoming goods has been 100%, and the pass rate has been 100%. Individual damaged varieties will be replaced with pharmaceutical companies in a timely manner to ensure drug quality. Strengthen drug maintenance and ensure drug quality.

The drugs displayed in the store are placed in separate shelves in strict accordance with the "Measures for the Management of Drug Classification". Temperature and humidity records are recorded every day. Inventory drugs are inspected and maintained once a month, and key drugs are inspected and maintained on the 15th. Once, and register the drugs with the near-validity period, check whether there are any changes in the appearance quality of key drugs, and report and deal with any quality problems found in a timely manner. There is also a counter for dismantled medicines. The employees in the store have always adhered to standardized operations, conducted two-person quality reviews, and strictly controlled the quality, so that the quality of the medicines is well guaranteed and customers are reassured and satisfied.

Since the establishment of our store, we have received a large amount of drug information from higher-level departments such as the Municipal Food and Drug Administration. In addition, we have strengthened our contact with supplying pharmaceutical companies and first-line product manufacturers, and collected drug information in a timely manner through various channels. Various relevant medical information, and proactively communicate information with peer units. Orders are usually made as planned, keeping a ledger and keeping records at all times, and all work is standardized and institutionalized.

3. Ensure the safety and effectiveness of medication

Strictly control the purchase of goods. Our store must purchase products from pharmaceutical companies with certain qualifications and GSP certification. We regard quality as the primary condition for selecting drugs and suppliers, and strictly implement the principle of "purchasing on demand and purchasing on the best" when purchasing drugs. All purchased drugs must comply with legal standards and relevant quality requirements, and we must never purchase from “unlicensed drug dealers.” Due to strict controls since its opening, there have never been any cases of counterfeit and substandard drugs entering the store and no quality complaints.

Strictly control acceptance. Warehousing acceptance is the second step in ensuring the quality of drugs. The acceptance of drugs in our store is checked by the quality manager. The quality manager has the title of licensed pharmacist and has been engaged in drug management for many years. He adheres to principles and has rich experience in drug operation and management. Strictly follow the relevant regulations of GSP to conduct inspection and acceptance of purchased drugs, and register them into the warehouse through the drug supervision network.

Strictly control sales. We insist on keeping pharmacists on-the-job, and establish service standards for employees and what they need to know about their respective positions in the retail process. Prescription drugs are sold based on doctors’ prescriptions, and are prepared according to prescription review, formula, verification, and drug distribution. Strive to improve service levels and continuously improve the comprehensive business quality of employees. Organize regular training and learning. Employees are uniformly dressed and have their badges on duty. They are dignified in appearance and full of energy. They insist on asking questions and selling medicines, and guide customers to use medicines safely and rationally. Convenience measures such as free blood pressure measurement, free boiled water provision, free body temperature measurement, and free consultation on medication were carried out.

In the early days of opening, some systems were not implemented well and there were irregularities in work. After several rectifications, the system has now been fully implemented and fully complies with GSP requirements. Our store is determined to conscientiously implement the "Pharmaceutical Goods Management Practices" under the guidance and help of leaders at all levels, learn from time to time, continuously improve, increase internal management efforts, adhere to standards, use GSP to standardize our business behavior, and strengthen the quality of employees Education, improve the management level and market competitiveness of enterprises, and become a pharmacy that reassures leaders and satisfies the people.

Pharmacy Drug Self-examination Report 3

1. Company Profile

This company was established in March 2013 and is an individual drug retail company. Based on GSP, our company compiles and improves its quality management system.

At present, the company has 4 employees, including 2 pharmacists and 1 pharmacist. Pharmacy professional and technical personnel account for 100% of the total number. The allocation of pharmaceutical technicians can meet the requirements of drug operation quality management.

2. GSP organization and personnel structure

The company sets up the company responsible person, purchasing, maintenance personnel, and warehouse managers as XX; the quality manager is XXX; the quality manager and the acceptance officer are XXX; the auditors are XXXX, XXX; the salespersons are XXX, XXX. Clearly define the quality responsibilities of full-time quality personnel.

3. Personnel and Training

In order to continuously improve the professional and technical quality of all employees, we have formulated a learning and training plan and regularly organize all employees to learn drug management laws and regulations and professional and technical knowledge. Conduct assessments every six months and establish training files.

4. Facilities and Equipment

According to the requirements of the new version of GSP, our company is equipped with computers and drug purchase, sale and inventory management software that meets relevant management requirements, and is equipped with temperature and humidity detection equipment in the business premises. Equipment, now equipped with thermohygrometer and air conditioner. It is also equipped with rodent-proof, insect-proof, and fire-proof equipment.

The business premises is clean and bright, with complete business shelves and counters.

5. Drug purchase and acceptance management

In accordance with the requirements of relevant laws and regulations such as the "Drug Administration Law" and "Pharmaceutical Goods Management Practices", the quality and legal qualifications of purchased drugs are Review, and request copies of the drug GSP certification, drug business license (wholesale) and business license stamped with the company's official seal. The power of attorney should clearly specify the scope and period of authorization; a copy of the ID card of the drug salesperson; purchase For imported drugs, obtain copies of the "Imported Drug Registration Certificate" and "Imported Drug Inspection Report" from the supplier, and stamp them with the original seal of the supplier's quality management agency; imported drugs should have Chinese-labeled instructions. Implement an audit system for first-run enterprises and first-run drugs. The enterprise has established a drug purchase ledger. The ledger records the purchase of medicines truly and completely, ensuring that the invoices, accounts, and items are consistent. It is then entered into the computer according to relevant procedures to complete all basic work.

Acceptance management: Acceptance personnel inspect and record the purchased drugs batch by batch in strict accordance with the relevant regulations based on the original vouchers and tax stamps. It mainly checks whether the accepted drugs meet the corresponding appearance quality standards. (1) Whether the outer packaging is firm and dry; whether the seals and seals are damaged; whether the outer packaging is marked with the common name, specifications, manufacturer, approval number, registered trademark, batch number, and validity period. Whether specific storage and transportation markings comply with pharmaceutical packaging requirements. (2) Whether each piece of inner packaging has a product certificate, whether the container is reasonable, whether it is damaged, whether the sealing is tight and qualified, the packaging writing should be clear, and the product name, specification, batch number, etc. must not be missing; the bottle label must be firmly affixed. (3) The generic name, ingredients, specifications, manufacturer name, approval number, production batch number, production date, validity period, etc. of the drug are clearly printed on the drug label and instructions. The label or instructions should also include indications or main functions, usage and dosage, contraindications, adverse reactions, precautions, and storage conditions. (4) The labels on the packages of the imported drugs that are accepted shall indicate the name, main ingredients and registration number in Chinese, with instructions in Chinese, and be accompanied by the "Imported Drug Registration Certificate", "Imported Medicinal Material Approval Document" and "Imported Drug Inspection Report". And stamped with a copy of the red seal of the supplier's quality management organization. Collect adverse drug reactions in a timely manner and report to the drug regulatory department immediately if any adverse reactions occur.

6. Drug storage, maintenance and display (retail) management.

When our company was first established, we strictly followed GSP requirements, created a storage and display environment to high standards, and decorated the business area in accordance with the latest municipal bureau standards, making the business premises spacious and bright. Shopping is convenient, the signs are eye-catching, and medicines are classified according to business conditions and GSP requirements. According to the performance and nature of the drugs, the warehouse is divided into areas to be inspected (yellow), combined drugs (green), unqualified drugs (red) and returns (yellow). Drugs and non-drugs, external medicines and internal medicines are stored in separate areas to facilitate operation and prevent errors and contamination incidents. Shelves, greenhouse thermometer, light-shielding facilities (curtains), and rodent-proof facilities (door seam sealing) have been added to meet the requirements of the "seven preventions" (dust-proof, insect-proof, bird-proof, rodent-proof, moisture-proof, mildew-proof, and pollution-proof) . Lighting equipment that meets lighting requirements is installed. All business areas are equipped with air conditioners to ensure appropriate air humidity and temperature. At work, management is carried out in accordance with the store's "drug storage, maintenance and display management system", such as the "four separation principles" of displaying drugs and non-drugs separately, non-prescription drugs and prescription drugs, internal medicines and external medicines, etc. Special counters for special preparations containing ephedra are displayed and marked with warning slogans. The counters in the dismantling area are equipped with relevant dismantling tools. In addition, the temperature and humidity of the business area and warehouse are measured every morning and afternoon, and timely measures are taken to control if the requirements are not met; maintenance and inspection of the inventory and display of medicines are carried out regularly every month, and records are recorded as required. These measures can ensure the storage quality of medicines.

7. Sales and after-sales service

In order to provide consumers with reliable medicines and high-quality services, companies conduct business training and assessments for salespeople engaged in pharmaceutical retail work. When selling medicines, according to the customer's requirements for the medicines purchased, the medicines will be handed over to the customers after verification, and a sales voucher will be issued. At the same time, the instructions for taking the medicines and contraindications will be explained to the customers in detail; the service agreement will be clearly stated in the business premises, the supervision telephone number will be announced, and the customer will be set up. Opinion Book.

Customer evaluations and complaints will be resolved in a timely manner, and drug quality issues reported by customers will be taken seriously, recorded in detail, and dealt with in a timely manner.

8. Computer software system

Computer system is a well-known large company in China. Relevant modules comply with the application requirements of the new version of GSP. It can automatically remind the inventory amount every day, and can provide monthly sales reminders for products with a near-expiry date. Expired companies and expired drugs can automatically limit related procurement, acceptance, sales and other activities. Cannabis-containing preparations can be Automatically conduct limited sales and register name and ID card sales, etc.

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The first is to scientifically summarize and organize relevant files and records; the second is to fill in the sales labels on the shelves in a standardized way; the third is to re-clean the store; the fourth is to further inspect and standardize the classified management. . Through self-examination and self-correction activities, GSP management level has been further improved.

Through GSP self-inspection, we believe that we have initially met the standard requirements. We are now submitting an application for certification. We welcome all leaders to come for inspection and guidance.