Material management on September 15 is one of the key factors in drug production quality management. The new edition of GMP involves almost a third of the terms of material management. Although the relevant provisions of the provisions have been more specific and more operable, in practice, there will still be some problems that are not clear enough for the concept of the concept. The author raises several specific questions for discussion.
The understanding of "one thing and one yard"
Article 112 of GMP stipulates that the original auxiliary materials in the enterprise storage area shall have proper identification, indicating the material name and the material code within the enterprise. Article 182 of GMP stipulates that the material of the enterprise shall be numbered (or code), and the operation procedures shall be formulated to ensure the uniqueness of the number (or code).
According to the above regulations, all materials used in drug production must be assigned by the enterprise and ensure the uniqueness of the code. In order to ensure the "uniqueness" of the code, a material can only be assigned to one code, and it is not allowed to have a multi-code phenomenon.
What is "a thing"? The product name, specification and quality standard are all consistent with the original auxiliary materials from different manufacturers. Can it be regarded as "one thing"? The author believes that the purpose of the preparation of material coding system is to prevent confusion and mistakes, and facilitate tracing, and if from multiple manufacturers of the same material use the same code, will be detrimental to the quality of the product traceability.
For this reason, different material codes are still recommended for the same materials from different manufacturers, names and specifications. You can also distinguish codes by the basic code suffix. For example, A company produces A drug called tritrizole, and its API is purchased from A, B, and C3 manufacturers. The enterprise gives the basic code of the raw materials of the drug, Y001, and according to the different manufacturers, the assignment of Y001-1, y001-2, y001-3, respectively refers to the products of 3 enterprises.
In addition, products of the same enterprise, packaging specifications are different, also need the suffix identification code to differentiate. The understanding of "one thing" in a yard is clearly not the same as the material of the same item. Although the name is different from the manufacturer, it cannot be regarded as "one thing".
The error of the reinspection period
At present, in many drug production enterprises, there is still the understanding deviation of the reinspection period, so that the label signs are labeled as false. One is the non-product regulation, all marked the reinspection period. As a matter of fact, the original auxiliary materials that have been marked "validity period" can no longer be marked with the reinspection period except for individual special varieties. Second, the implementation of a unified reinspection period. The reinspection of various materials shall be two or three years. The preparation of the material reinspection period also requires the continuous accumulation of stability investigation data. Different reinspection periods shall be made according to the characteristics of different materials. Third, frequent reinspection. Some enterprises will reinspect materials for more than two years or three years. This, too, is clearly lacking in scientific evidence. The correct method should be the stability investigation accumulation data, plus the relevant scientific literature support, reasonable determination of the interval.
In addition, some enterprises determine "miscalculation" of the reinspection period. For example, some enterprises stipulate that the period of material reinspection is two years, but it is calculated from the entry into the warehouse. Some materials have been in circulation for more than a year before buying into the warehouse. The reinspection time must be calculated from the date of production, or the determination of the reinspection period will be meaningless.
Some enterprises strictly implement the "reinspection period". Some enterprises stipulate that the material reinspection is only limited once, after the re-examination is qualified, after a year of continued use, may not continue to use. In fact, some materials (including some chemical raw materials, packaging materials) have relatively stable quality, and the length of storage time has little impact on product quality.
Can I mix the ingredients?
Then, from different manufacturers of the same variety of raw materials, can you mix the ingredients?
According to the existing regulations on drug regulation, raw materials from different manufacturers can be used in the production process, but the relevant verification and supplementary application or filing must be done in accordance with the requirements. GMP has specific provisions on the change control and product quality review of the original auxiliary materials. The relevant regulations do not exclude the original auxiliary supplier of the newly added preparation products according to the need.
The same raw material used for the same preparation can be purchased from different suppliers. Then, does it mean that the same batch of products can be used for the same kinds of raw materials produced by different manufacturers? There is no specific provision in the GMP clause for this issue.
The author believes that the basic principle of GMP is to minimize the risk of contamination, cross contamination, confusion and error in the production of drugs. Different manufacturer production with varieties of raw materials, all the purchases the acceptance inspection qualified, in theory there is no confusion and mistakes, but there is also one of the biggest risks, traceability is not conducive to the product quality problem.
In the production process, the control of various technological parameters, the execution of various operating procedures and the role of various risk factors may have an impact on the final product quality. If there is a problem of mixed feeding, the investigation will be more difficult if quality problems occur. At the same time, from the perspective of product quality review, it is not advisable to mix the raw materials of different manufacturers. Even if the original auxiliary materials of the same manufacturer, if their batches are different, they should avoid mixing.
The relationship between head office and branch office
With the increasing number of mergers and restructurings of drug manufacturers, the subsidiaries of large pharmaceutical groups have become more and more. Many of the original independent legal persons, have been bought and merged by big companies, no longer single.
After the reorganization of the company, some new problems arose in the management of materials. For example, the materials of some enterprises are procured by the group headquarters. Some enterprises have unified integration, some materials are purchased from headquarters, and some of them are purchased by the branch. In warehousing management, there are also many accounts that are difficult to "synchronize". If strictly based on GMP requirements, these issues are "flawed", but companies have their own justifications.
How to solve such problems properly? The author puts forward the following thinking: first, both the headquarters and the branch should establish strict management procedures and operating procedures. Material management is one of the core of GMP management, and all links must be seamless, and there must be no two or both of them. Second, identify the main body of responsibility. Although some branches are not independent legal persons, the GMP certification inspection must comply with the GMP requirement. From this point of view, the branch is the responsibility subject. Third, the branch must ensure that all kinds of data reliability inspection can be accepted at any time. During the inspection, the branch cannot provide the data (including all kinds of documents) from the headquarters control. Fourth, the branch should have a relatively independent and GMP quality management system. (author: food and drug administration, nantong city, jiangsu province)
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