China's Drug Administration Law does not make it mandatory to set up a drug quality inspection organization as a market access condition for drug wholesalers. The reason is that the Drug Administration Law stipulates that drug manufacturers must carry out quality inspection of the drugs they produce, and those that do not comply with the national drug standards shall not be shipped out of the factory.
Considering the large wholesale volume of pharmaceutical wholesale links, the complexity of the operating environment, so the "Drug Business Quality Management Code" for pharmaceutical wholesale enterprises and to make the following provisions: Chapter II, Article 6, "Enterprises should be set up a special quality management organization, the exercise of quality management functions, the quality of the drugs within the enterprise has the right to adjudication ". Article 7 "Enterprises shall set up drug inspection departments and organizations for acceptance and maintenance that are appropriate to the scale of their operations. The drug inspection department and acceptance organization shall be subordinate to the quality management agency". Chapter II, Article 37 provides that "the drug inspection department of an enterprise shall undertake the task of inspecting the quality of the enterprise's drugs and provide accurate and reliable inspection information". Article 38 stipulates that "the number of batches sampled by the drug inspection department shall reach the prescribed proportion of the total number of batches of goods." Note: The "drug testing department" should be "drug wholesalers within the inspection department".
At the same time, "Drug Certification Practice Rules" more detailed provisions: Chapter II, Article 19 "drug wholesale and retail chain enterprises set up a drug testing room should be used for instrumental analysis, chemical analysis, titrant calibration of special places, and for flammable, explosive, toxic and other environments such as operation of the safety facilities and temperature, humidity control devices. The area of the drug testing room, large enterprises not less than 150 square meters; medium-sized enterprises not less than 100 square meters; small enterprises not less than 50 square meters". Article 20 "drug testing room should be carried out chemical determination, instrumental analysis (large and medium-sized enterprises should also increase the hygiene inspection, potency determination) and other testing projects, and is equipped with the size of the enterprise and business varieties of instruments and devices appropriate to.
(a) small enterprises: the configuration of one-ten-thousandth analytical balance, acidity meter, electric thermostatic drying oven, thermostatic water bath, tablet disintegration meter, clarity detector. Business Chinese herbal medicine and Chinese medicine tablets, should also be configured with moisture meter, ultraviolet fluorescent lamps and microscopes.
(B) medium-sized enterprises: in small enterprises on the basis of the configuration, increase the automatic spinning meter, ultraviolet spectrophotometer, biochemical incubator, autoclave, high temperature furnace, ultra-clean bench, high-frequency microscope. Management of Chinese herbal medicines, Chinese medicinal herbs should also be configured biomicroscope.
(C) large enterprises: in small and medium-sized enterprises on the basis of configuration, increase the tablet dissolution meter, vacuum drying oven, constant temperature and humidity incubator.
It can be seen that the pharmaceutical wholesale enterprises also need to set up inspection laboratories to carry out the inspection of drug quality.
With the manufacturer's qualified inspection report, I still need to test?
"Drug business quality management specification" is very clear, the drug wholesale enterprises should be into the inventory of drugs for acceptance and inspection. Please note that the "acceptance and inspection" here are two concepts. "Acceptance" means checking the packaging, labeling, instructions, and the relevant requirements of the certificate or file of the drugs one by one. However, Article 35, paragraph 5 states: "acceptance of the first camp varieties, should also be carried out to test the intrinsic quality of the drug".
Article 37 " The enterprise's drug testing department to undertake the task of testing the quality of the enterprise's medicines, to provide accurate and reliable test information". Article 38 " The number of batches sampled and tested by the drug inspection department shall reach the prescribed proportion of the total number of batches imported".
These provisions are clear: drugs are a special commodity, due to storage and transportation temperature, humidity and storage time of different, may affect the intrinsic quality of drugs, so there are manufacturers of qualified inspection report, or to test.
What are the main contents of the pharmaceutical company acceptance inspector acceptance of drugsengaged in the acceptance of work, should have a pharmacy or medicine, biology, chemistry and other related professions with secondary education or more than a junior professional and technical title of pharmacy;
engaged in the acceptance of Chinese herbal medicines, traditional Chinese medicine tablets, should have a secondary education in traditional Chinese medicine or more than a professional and technical title of secondary education or more than a professional and technical title of traditional Chinese medicine. Technical title; direct acquisition of real estate Chinese herbal medicines, the acceptance of personnel should have intermediate or higher professional and technical title in Chinese medicine.
Personnel engaged in acceptance work should be on duty, not *** other business work.
Can the device be returned after acceptance?To see whether you and the other side of the contract inside the provisions of the acceptance of the acceptance of the same can not be returned, otherwise it is possible to return, and if the quality of the other side of the problem, no matter when, can be returned.
Shanghai recycling drugs , find Shanghai door-to-door recycling drug ...
Shanghai recycling drugs , provide Shanghai area door-to-door recycling drugs
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2865) Recycling of drug types:
Western medicine: sugar is flat, Lodging new, Xibirin, BaoLiZhi, ShuXueZhi, BaiYuXie, Martingale, FenPiDe, SisMin, BaysinTong, BayguanPing, Dameikang, Shiprui, Hexinshuang, Futalin, Baxpin, Prokofo, Saisepin, Neosandimin, Kaito, Yinmulan, Nemeton, Visteon, Tanco, Hikarao, Lipinzai, Ducohexil, Pollivet, Xincang, Medopa, Siroda, Kepoton, Hepatidine, Yandex, Liguenza, Loxicidin, and so on. ...... (Shanghai Recycling) (Drugs) injection class: Shanning, gold sodium more, Farmacin, Bonin, Kang Lait, Jian blame, Shupu Shen, Goshuda, Snapdragon, Merowind, Li Zhiwei, albumin, Hao Saidin, Kangquan, Taisu, Tainen, Rochefen, Fudaxin, Cilixin, stable credible, Ridaxian, Huier blood, Fotilon, Mepin, Tessodi, Fudaxia, Gelivi, and so on....
My friend in Guangzhou to help me buy, good for the body of the medicine, Binhai hospitals are more garbage, the county hospital doctors pushed to the Chinese hospital, Chinese hospitals pushed to the county hospital. Review the original post >>
Hopefully adopted
There are recycled medicines?
There are no recalls of medicines because pharmacies can only return them after they have been sold unless there is a problem with the medicine.
Acceptance of medicines should be obvious what color sign of substandard products
The production or operation of products should be in accordance with the provisions of GMP or GSP: the product of the storage and storage area to implement the color-coded management: the establishment of the ability to
Prevent errors and cross-pollution measures, the establishment of the product to be inspected area, the qualified product area, substandard products, return processing area, etc., with the internationally recognized
Red, yellow, green Color to distinguish.
Wuhan who recycle drugs ahThe local Drug Administration, there is the establishment of drug recycling points, generally in pharmacies, hospitals will have, the country is the same, you can go to the nearby hospital to consult, do not go to the clinic! To go to the public hospital
Drug acceptance flow chart1. Purpose: To standardize the drug acceptance process, to ensure that the quality of drugs into the store qualified, accurate quantity.
2. Scope: the purchase of drugs and sold back to acceptance work
3. Responsible for: acceptance
4. Content
4.1 All drugs must be accepted before storage, pharmacy display and sales, the purchase of drugs acceptance of the work of the pharmacy acceptance officer is responsible for.
4.2 Acceptance of purchased drugs:
4.2.1 Acceptance should be based on the contents of the "accompanying list" and purchase records, the arrival of drugs for acceptance of each batch.
4.2.2 Acceptance of drugs should be in the inspection area, within the specified time limit for timely acceptance. General drugs should be half a working day after the arrival of acceptance, the need for refrigeration drugs should be accepted within 2 hours after the arrival of acceptance.
4.2.3 Acceptance inspection should be in accordance with relevant laws and regulations, the packaging of drugs, labels, instructions, and relevant certificates and files for one-by-one inspection;
① The label of the package of drugs and the accompanying instructions should be the name and address of the manufacturer, the generic name of the drug, specifications, approval number, batch number, date of production, expiry date and so on. Label or instructions should also be the composition of drugs, indications or functions, usage, dosage, contraindications, adverse reactions, precautions and storage conditions, etc.;
② acceptance of the whole package of drugs should be product certification;
③ acceptance of the external use of drugs, the label of the package or instructions to be provided with the required warning instructions. Prescription drugs and non-prescription drugs in accordance with the requirements of classification management, labeling, instructions have the appropriate warning or advice; non-prescription drug packaging has the state's proprietary logo "OTC" words;
④ acceptance of traditional Chinese medicine tablets should be packaged with the mark of quality. Each package, Chinese medicine tablets should be marked with the name, manufacturer, date of production, etc., the implementation of the approval number management of Chinese medicine tablets should also indicate the approval number of the drug;
⑤ acceptance of imported medicines, the labeling of its inner and outer packaging should be in Chinese to indicate the name of the drug, the main ingredients and the registration number, and the smallest unit of sale should be in Chinese instructions. Imported drugs should be "imported drugs registration certificate" and "imported drugs inspection report" or "imported drugs customs clearance" acceptance; imported preventive biological products, blood products should be "biological products import approval" photocopy; imported medicinal herbs should be "imported medicinal herbs batch" photocopy;
⑥ acceptance of the first varieties of camps should be the same batch with the first batch of arriving medicines with the drug factory inspection report.
4.2.4 Acceptance of drugs should be sampling in accordance with the provisions of the acceptance of samples taken should be representative. Acceptance of the whole piece of medicine taken, acceptance should be labeled after the completion of the obvious acceptance of the sampling mark, recovery and sealing.
4.2.5 Acceptance of drugs should check the expiration date, generally less than 6 months of the expiration date of the drugs shall not be stored.
4.2.6 Acceptance of drugs found to have quality problems, the acceptance should be filled out in a timely manner, "Drug Rejection Report Form", reported to the quality manager, and returned to the supplier.
4.2.7 The name of the drug, specifications, batch number, manufacturer or quantity and "accompanying the same list" does not match, the pharmacy inspector should be "accompanying the same list" on the note and record, and notify the supplier. Verified by the supplier to confirm, be corrected.
4.2.8 Acceptance of the drugs, to the warehouse manager into the warehouse or to the cabinet sales staff according to the requirements of the drug display and storage of categorized placement.
4.2.9 The inspector should do a good job of "Drug Purchase Quality Acceptance Record" and signed, stamped acceptance seal, indicating the date of acceptance. Records include the supply unit, quantity, date of arrival, product name, dosage form, specifications, approval number, batch number, manufacturer, expiration date, quality status, acceptance conclusions and acceptance of personnel and other special cases. Monthly filing, centralized storage, according to the provisions of the storage to more than 1 year beyond the expiration date of drugs, but not less than 2 years.
4.3 Acceptance of the sale of returned medicines
4.3.1 The sale of returned medicines must be identified by the sales clerk to find out whether the returned medicines are sold by the pharmacy, including checking invoices or computerized tickets, purchase time, product name, specifications, manufacturer, quantity, batch number and so on. After confirming that the medicine is sold by the pharmacy, it will be inspected and accepted by the inspector. If not, it will not be returned.
4.3.1 The sale of returned medicines must be in accordance with the acceptance criteria for the purchase of drugs by the acceptance of quality inspection. Acceptance of quality qualified to continue to display sales, unqualified will not be returned.
4.3.2 Receiving and inspection staff in accordance with the provisions of the fill in the "after-sales return processing record", and will be stored until the record exceeds the expiration date of the drug 1 year, but shall not be less than 2 years
devices on the account of the device must have a corresponding acceptance formThat is, of course.
Anything that doesn't have an acceptance may not work properly, and subsequent processing may include returning it, which means not buying it.
That way, the device won't be in the device ledger.