When will the pain of standard dislocation of the

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Hollow capsules: when will the pain of standard dislocation stop?

"hollow capsules can't go without standards all day. The current chaos should be over!" On December 17, at the 2005 annual meeting of the hollow capsule Professional Committee of China Pharmaceutical Packaging Association, xuzhenying, deputy general manager of Shandong Qingdao Yiqing pharmaceutical capsule Co., Ltd., spoke the heart of the participating hollow capsule manufacturers

indeed, all hollow capsule manufacturers have suffered from disordered management and misplaced standards for a long time, and the development of the industry has also been greatly affected. Now, with the gradual standardization of the management of the industry by the State Food and drug administration, the process of formulating the national standard for hollow capsules by the State Pharmacopoeia Committee has also been greatly accelerated, and the enterprise has finally seen the dawn

■ multi head management causes enterprises to be at a loss

the development history of domestic hollow capsule industry is not too long. It is only half a century since the appearance of manual hollow capsules, which have been gradually eliminated. The mechanism hollow capsule appeared in the mid-1980s, and it has been only 20 years. However, the national management of the hollow capsule industry is not plain sailing. According to an insider, "the Ministry of health first issued the drug manufacturing enterprise license and drug approval number according to the drug administration, while the production was managed by the then drug administration." Since 1992, experiments on the ring stiffness, ring flexibility, flattening, zigzag, weld stretch, etc. of pipes have been completed. The former State Pharmaceutical Administration has issued the drug packaging material manufacturing enterprise license to enterprises, and the Pharmacopoeia Committee has drafted and issued the national standard (GB) for hollow capsules, but this standard is not perfect. During this period, the Ministry of health is still responsible for issuing the drug manufacturing enterprise license and drug approval number to the enterprise. "At that time, an enterprise had three certificates from the two departments at the same time. The hollow capsule enterprise had to implement the GB standard, while the pharmaceutical factory continued the Ministry of health standard, which made the hollow capsule enterprise at a loss." This situation continued until 1995, when the Ministry of health no longer managed the industry. Enterprises only need to apply for the production license of drug packaging materials. After the establishment of the former State Drug Administration, hollow capsules were included in the administration of the administration. The 2000 edition of the national pharmacopoeia was implemented. Although there are great disputes in the industry about whether the hollow capsule should be managed according to drugs or drug packaging materials or pharmaceutical excipients, the manufacturer of the hollow capsule has changed to the drug production license. Since then, the 2000 edition of national pharmacopoeia standard has been recognized both inside and outside the industry

however, the ownership of hollow capsules has been debated, which is helpful to improve the mileage per gallon of gasoline. Although it is a kind of container used for drug packaging, it is different from the general packaging container. It should be taken orally into the human body with the drug. Because it has no curative effect, it is different from the drug. In 2004, the State Food and Drug Administration decided to manage the hollow capsules as special and important pharmaceutical excipients. A person in charge of an enterprise said: "so far, no official document has been announced, and the management department also needs some time to straighten out, so now the management procedures have been accepted according to the auxiliary materials, but the management mode, personnel and department are still on the side of the drug packaging materials for the time being." Due to the long-standing dispute over ownership and the previous management based on drug packaging materials, the standards for hollow capsules and enteric coated hollow capsules were not included in the revision of the national pharmacopoeia in 2005. At present, the enterprise still implements the pharmacopoeia standard of 2000 edition. Yuhui, deputy director of the drug packaging materials office of Zhejiang Institute for drug control, the drafting unit of the standard, said: "since the standard for hollow capsules was not included in the 2005 edition of the Pharmacopoeia, and the indicators in the 2000 edition of the pharmacopoeia standard are relatively old, they can no longer meet the requirements of industry development in terms of quality controllability, so the national pharmacopoeia commission is preparing to formulate a new national standard."

■ ensuring safety has become the core of the new standard

in recent years, with the development of food industry and pharmaceutical industry, the market demand for gelatin is growing. However, food and drugs have high requirements on the quality, process and production environment of gelatin in hollow capsules. However, for their own economic interests, some people, regardless of public health and life safety, use tanned leather leftovers to produce gelatin. In order to pursue profits, some hollow capsule enterprises use inferior gelatin as raw materials to produce hollow capsules in extremely poor conditions. CCTV's report on this issue in 2004 has attracted the attention of government departments and the industry. Yu Hui stressed: "in the context of the continuous strengthening of food and drug safety management by the state, it is urgent to introduce or revise the national standards for gelatin and hollow capsules as soon as possible to ensure the safety of people's diet and medication." Liangzujiang, vice president of China Pharmaceutical Packaging Association, also said that since the quality of hollow capsule products directly affects people's health, it is very important for its raw and auxiliary materials, including water, to meet the safety requirements. Safety has become a core issue of common concern for the government and the industry when formulating standards

in the three standard exposure drafts of gelatin, hollow capsules and enteric coated hollow capsules, the focus of attention first focused on the limit detection of chromium. Chromium is extremely toxic to human skeletal system, especially to children's skeletal development. Yaolongkun, Secretary General of gelatin branch of China Daily Chemical Association, pointed out that chromium generally exists in a large amount in blue alum leather (tanned leather) and cannot be cleaned and removed; As long as the content of chromium in gelatin or hollow capsules exceeds 5ppm (fiveparts per million) or 10ppm, it generally indicates that blue alum skin is mixed in the process of gelatin production. However, there is no limit test item for chromium in the 2000 edition of the Pharmacopoeia, and this index is not included in the test item in the draft for comment of the standard drafted in 2002. In 2002, the hollow capsule Professional Committee of China Pharmaceutical Packaging Association made a proposal to the Pharmacopoeia Committee: increase the detection of chromium. However, in the draft for comments this time, the test method -- Atomic Absorption Spectrophotometry proposed by the Pharmacopoeia Committee has made it difficult for enterprises: an atomic absorption meter is very valuable, and most enterprises are unable to purchase it. Yuhui said that relevant experts of the Pharmacopoeia Commission also considered this problem and proposed that enterprises could entrust testing institutions to carry out testing. At the same time, they may not be too strict in terms of testing frequency and batch. However, a person in charge of Jiaozuo Jinyu capsule Pharmaceutical Co., Ltd. expressed concern about this: "what if the enterprise is required to have such equipment when it issues a new production license, carries out ISO9000 or future GMP certification, or even signs a contract with the customer?" Lizhengda, deputy general manager of Suzhou capsule Co., Ltd., believes that the high cost of testing will affect the operability of the standard. Can we consider not using batch testing or using another rapid testing method instead. According to yaolongkun, the Chinese Academy of Sciences has developed a simple and rapid method for gelatin Association, which can quickly detect the content of chromium. It was suggested that in practice, technical personnel can also determine the content of chromium according to the method in pharmaceutical gelatin (QB)

another safety related issue is ethylene oxide. According to liangzujiang, although the literature shows that ethylene oxide is harmful to human body, as a traditional and effective sterilization process, ethylene oxide is still widely used. Zhangshide, chairman of Qingdao Yiqing capsule Co., Ltd., chairman of hollow capsule Professional Committee of China Pharmaceutical Packaging Association, believes that enterprises that organize production according to GMP specifications do not need to use this process. If individual enterprises use this process for sterilization, they must control the residue, which is what enterprises should do. However, its detection repeatability is poor and easy to remain, so it is better to use other detection methods. Lizhengda said that the sterilization method is not the only and the best method should not appear in the national standards

■ improving standards is beneficial to the development of the industry.

it can be seen that in a report on suggestions for modification of the three standards (Exposure Draft) provided by the hollow capsule Professional Committee of China Pharmaceutical Packaging Association, the special committee put forward 28 suggestions for the three standards, including names, properties and various detection indicators. However, the participating enterprises believe that many of these standards are too loose and should be made more difficult. For example, in terms of brittleness, the exposure draft stipulates that "no more than 15 grains" and the enterprise suggests that it should be changed to "no more than 5 grains"; As for the disintegration time limit, the original provision that "all dissolve or disintegrate within 15 minutes" is proposed to be changed to "dissolve or disintegrate within 10 minutes" (since it is easy to be misunderstood in actual operation, the word "all" is removed from the proposal); In the item of transmissivity, the transmissivity is measured at the wavelengths of 450nm and 620nm. It is suggested that the original "not less than 50% and 70% respectively" be changed to "70% and 90%"; In the item of ignition residue, it is suggested to change the original "not more than 2%" to "not more than 1.5%". In addition, it is also recommended to add the provisions on the shelf life, add two indicators of "viscosity" and "viscosity drop" of gelatin, and add detection indicators such as hydrogen peroxide and arsenic from the perspective of safety. The practice that enterprises require to improve standards shows the development level of the industry on the one hand, and also reflects the strict requirements of enterprises for their own and national standards on the other hand. Of course, it also includes the strict requirements for gelatin raw materials, which is also a guarantee for the drug safety of the industry in terms of product quality and safety. The relevant person of the hollow capsule Professional Committee stressed: "the national standard is a threshold in a certain sense, but this threshold is not for the scale or technical level of the card enterprise, but a safety threshold. Safety is the only premise, and unsafe factors should be stuck outside the national standard." Some insiders also believe that if the national standard is too low, some non-standard enterprises will take advantage of the standard

many enterprises say that the release of new national standards can no longer be delayed! The 2000 edition of the Pharmacopoeia can no longer meet the requirements of the development of the industry. Improving the national standards is of great benefit to the development of the industry. We saw the draft for comment in 2002 and happily organized enterprises to make suggestions, but the national standard has not been released yet. The industry cannot live without standards. We hope this standard can be released as soon as possible. According to Yu Hui, the national pharmacopoeia commission will finalize and publish the standard in the first half of 2006. Does this mean that the pain of lifting standards in the hollow capsule industry is just around the corner? However, enterprises are not confident about this. Someone said: "the opinions put forward by the professional committee three years ago and the additional testing items in terms of safety by the Pharmacopoeia Committee have not been reflected in the new draft for comments. It is worrying whether the national standard can be released in the first half of next year."

while discussing the draft of the national standard for comments, the hollow capsule special committee also put forward suggestions to enterprises on formulating the association standard. The proposal was approved by Caihong, vice president and Secretary General of China Pharmaceutical Packaging Association. She believes that the national standard mainly focuses on safety and is a mandatory standard with legal effect, while the association standard can be a useful supplement to the national standard and make some provisions in terms of practicality and operability. As a recommendatory standard, the association standard should be fair, reflect the interests of both supply and demand sides, and play a role in the market activities of enterprises. Another important topic related to the development of standards and industries is the calibration and zeroing of the extension of GMP: suggestions on measuring the standard length

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