Can API intermediate products not be labeled as to be inspected and qualified?

[technical article of China Pharmaceutical network] in 2018, due to the impact of environmental protection and high-pressure policies, the upgrading and adjustment of API industry is accelerated, and its production standards are more stringent Recently, netizen @ xiaoxueer001 posted a question on the public post: "do you need to paste the label of pending inspection and qualification on the intermediate products of APIs? Post every piece after release? Or can I leave it untagged? " This netizen said, "at present, we encounter a puzzle in the actual operation We need to paste a label to be inspected and qualified for each of the intermediate products of API I think this operation is too cumbersome, and costs manpower, material resources and time I would like to ask you great Xia and experts if you can simplify the process and implement it according to the following plan." The scheme pointed out by the netizen is: cancel the intermediate label to be inspected and qualified label, and separate according to different areas or different temporary warehouses Intermediate products are produced and transferred to temporary storage or waiting area A yellow label to be inspected shall be pasted on the storage space card After QC inspection and QA release, the technologist will issue a process instruction to collect materials QA will paste a green qualified label on the report? It is no longer necessary to paste the label of to be inspected and qualified on each intermediate product Is this against GMP and feasible? Insiders put forward different opinions and answers to this plan @ EVA wallI: every piece needs to have a material label The materials to be inspected and released can be managed according to the batch, just hang a signboard Mr Crazy: it's not necessary to put the products to be tested in a special test area Every qualified label should be pasted @ guiguigui1957: the intermediate products can only enter the next process after they are produced and tested to be qualified The intermediate products produced shall be put in the temporary storage room or the waiting area, and the identification, qualification identification or waiting identification shall be made If every container is pasted, it will be very troublesome I used to put them on one or more pallets as a whole, and leave a mark on them together with the location card .. it is understood that intermediate products refer to the in-process products in each step after the raw materials are put in Such as extract, ultrafiltration, potted, sterilized and lamp tested products Intermediates used in the chemical synthesis of APIs are the substances obtained in the first few steps of reaction to get the finished product China is the second largest producer and exporter of APIs The export of APIs is close to 20% of the world API market share However, with the implementation of new GMP standards and environmental protection policies, such as this year's environmental protection tax law, API manufacturers belonging to heavy pollution industries are also in trouble Up to now, there have been many API companies in China that have been shut down, closed down or forced to move In this context, the survival of APIs is difficult It is not only necessary to pay attention to environmental protection, but also to strictly follow GMP standards for production, and check every link The new GMP standard requires that the API quality standard should include the control of impurities (such as organic impurities, inorganic impurities, residual solvents) If the API has the requirements for microbial or bacterial endotoxin control, corresponding limit standards shall also be formulated As a product in the synthesis of APIs, intermediate products must also be produced and inspected in strict accordance with the standards It is worth noting that according to Article 35 of Chapter VIII of GMP standard, unqualified intermediate products and APIs can be reworked or reprocessed according to the requirements of Article 36 and Article 37 To ensure that the quality of the intermediate product or API is not adversely affected by the possible generation of by-products and overreactors The final treatment of unqualified materials shall be recorded.