There is a characteristic of industrial production that almost all enterprises have to face, that is, the management of semi-finished products.
Semi-finished products include unfinished products produced during the production process of new feeding, and for various reasons, mainly non-conformity, products produced when rework is in progress, and in pharmaceutical production, these semi-finished products are usually stored in a separate area called an intermediate station for the next process.
Compared with finished products, the management and financial accounting of semi-finished products is complex. Therefore, it has become one of the mysteries that can be used to calculate the number of finished products.
In the early stage of the implementation of good manufacturing practices, many details have not yet had particularly clear requirements, and manufacturers have a relatively high degree of freedom. Because of this, the nonconforming products that we have found in the production process and have been sold and returned have the possibility of being reprocessed into new finished products.
Indeed, the failure rate of some products is relatively high. This has also accumulated a lot of experience in dealing with the rework of these varieties. I have to say that the rework of solid preparations is much more complicated than the injections I came into contact with in the early days, especially some solid preparations of Chinese patent medicines.
The reason why Chinese patent medicine preparations are more difficult to deal with is not entirely because the content conversion is not easy to control. In fact, in the years when the legal quality standards were not upgraded to the national standards, most of the proprietary Chinese medicine testing items only quantitatively measured the dissolution or disintegration time limit, and some items of microbial examination. However, the content of the main ingredient (in fact, there is a lack of research on the main ingredient) is not required to be determined. There is one specification in the standard, and many varieties are only specified by sheet weight. Therefore, there is no need to convert the content of the rework treatment at all, directly crush the unqualified products and mix them with new raw materials, add some auxiliary materials such as starch slurry, hydroxypropyl cellulose or talc, re-granulation, and then go through the follow-up process.
Later, after the local quality standards were upgraded to national standards, there were quantitative content determination indicators for Chinese patent medicines. At this time, the rework needs to be converted according to the quality standard requirements according to the test results before the new material is put in. Accurate conversion is required to ensure that the content of the new finished product meets the requirements. In fact, there is no difficulty in the conversion itself, the difficulty is that in order to avoid the taste and color, the solid preparations of Chinese patent medicine are usually coated with sugar coating on the outside. The controllability and stability of the production of sugar-coated tablets are technical difficulties, and the amount of sugar-coating, thickness and thickness of different batches and even different pots are different. This directly leads to a relatively large fluctuation in the conversion of reworked materials.
At the same time, the presence of the reworked product icing added to the new material will also affect the control of some other indicators of the new material finished product, so for such unqualified products, there is one more process to deal with ...... before rework and feeding
Good morning, February 9 Chinese New Year's Eve.