API quality specification documents are closely related to traceability investigation

As a part of crisis management, the enterprise shall confirm and keep the tracking information of the raw materials used in the company's products in advance In case of any problem, it can smoothly respond to the questions from consumers, distributors and medical institutions, which is also related to the acquisition of public trust From the perspective of consumer protection and corporate crisis management, the importance of API traceability is one of the important contents emphasized, and API specification documents are closely related to this In the gqp provincial order, the quality contract and raw material specification of pharmaceutical APIs are mostly under the same management as preparations Article 7 of the gqp provincial order, "contract with manufacturers, etc." is also applicable to the quality contract of APIs Article 7 stipulates seven items that should be agreed between the manufacturer and the seller When signing the quality contract, a written document shall be made with the contents as the outline Although there is no law on the signing of cosmetic raw material quality contract, it is better to manage important raw materials like APIs Important process changes and mechanical equipment changes and other factors that can affect the quality of raw materials are equally important for cosmetic raw materials For the buyer, it is the basis of quality management to obtain and grasp these information in advance And the signing of quality contract has become an effective way to obtain these important information in time The raw material specification is the document that specifies the quality of the purchased raw materials, and it is also one of the most important documents attached to the quality contract According to different enterprises, they are also referred to as raw material summary, raw material specification, raw material specification, etc These documents not only specify the quality of relevant raw materials in detail, but also stipulate the preservation conditions, packaging forms and other conditions related to quality maintenance, which is the basis for smooth daily quality management In addition, when there is a quality problem, it also provides a basis for the judgment of the quality problem and the determination of the scope of the returned object, which plays a very important role in the quality assurance of the whole raw material Therefore, when making the raw material specification, it should be carefully considered With the frequent occurrence of food and drug safety incidents, consumers and distributors have become very sensitive to the safety issues of pharmaceuticals, cosmetics and food In this case, as a part of the crisis management, the enterprise shall confirm and keep the tracking information of the raw materials used by the company's products in advance In case of any problem, it can smoothly respond to the questions from consumers, distributors and medical institutions, which is also related to the acquisition of public trust The items recorded in the specification shall be set by each company However, on the basis of the property information of raw materials such as raw material name, official documents, chemical structure, physical properties, etc., add retest time (or validity period), storage conditions, batch composition, batch specification, etc., and specify the information of raw material quality, as well as packaging form, packaging during transportation, transportation conditions, etc The quality assurance information during transportation should be listed in the specification in advance In addition, for the raw materials such as animal and plant extracts that need to be traceable for investigation, on the basis of confirming the relevant information, it is hoped to write down the necessary matters in the specification In particular, pesticide residues in cattle derived raw materials and plant extracts must be managed in accordance with the law From various perspectives, the retrospective investigation of pharmaceutical and cosmetic raw materials will become more and more important in the future When enterprises carry out the specific work of traceability, they should first classify the raw materials from the perspective of safety At this time, according to the provisions of relevant laws and regulations, pharmaceutical APIs, pharmaceutical additives, cosmetics raw materials, food raw materials, etc are classified as the first ring; according to the origin and production methods of relevant raw materials, chemical synthetic raw materials, biological raw materials, extracts, etc are classified as the second ring After finishing, they are sorted according to the level of safety, so it is easier to finish them How to deal with it Animal extracts, allergies, allergic reactions, pesticide residues, residual solvents and so on can be said to be the representative keywords of raw material safety evaluation and investigation perspective In addition, when considering the response method of retrospective investigation, in addition to simply confirming the production, preservation, circulation and other professional information of the raw materials of the investigated object, it is also necessary to confirm the safety evaluation index items, and whether there is cross pollution is also very important It is particularly important to evaluate the safety of raw materials that cause allergies and allergic reactions During the audit and inspection of the raw material factory, in addition to confirming the raw materials of the object, it is also necessary to confirm which kind of products are produced with the same equipment and production line To ensure the traceability of raw materials, the representative regulations are: the notice related to bovine spongiform encephalopathy (BSE) and the regulations of Japan drug administration related to pesticide residues of extracts In the BSE related notice, there are detailed provisions on the country of origin, use position and other relevant service life of bovine raw materials Therefore, when making the raw material specification, if the relevant raw material is not bovine extract, or bovine extract, but its country of origin and place of use are not among the restricted objects (not available) in the above notice, follow-up investigation shall be carried out for confirmation, which should be specified in the specification in advance In addition, the relevant biological origin raw material standard (hhlw Notice No 210) is also the legal basis to be observed With regard to plant extracts, the Japanese pharmaceutical Bureau adopted purity test on some Chinese herbal medicines to define the allowable range of pesticide residues (total BHC and total DDT) However, the Chinese herbal preparation Association of Japan adopts the self-made management standard for pesticide residues On the other hand, in foreign countries, who's "quality management standards for cultivation and collection of medicinal plants" (GaCp), the cultivation, picking and post harvest treatment of medicinal plants used in Chinese formula and extract preparation, a series of thinking methods and specific measures for management of microorganisms and residual pesticides in professional production are described In addition, in PIC / s-gmp, the same thinking method is marked for annex7 "production of plant medicine" In addition, it is very important to abide by the production management and quality management standard of Han Fang preparation and extract preparation issued by the Ministry of health, labor and welfare By the way, in the report on the results of the questionnaire survey (September 1, 2010) conducted by the Quality Committee of Japan OTC pharmaceutical association with its subordinate enterprises as the object, the thinking methods for ensuring the traceability survey of pharmaceutical raw materials are outlined Next article will study "quality contract and specification of raw materials" Please look forward to it.