Writing questions about the verification procedures for in vitro diagnostic reagents
The specific content of the manufacturing verification procedure is derived from the conclusion of the diagnostic reagent research work, that is, according to the relevant conclusions in the research report, the contents of the procedures regarding the “raw materials and auxiliary materialsâ€, the “manufacturing proceduresâ€, and the verification items and indicators are written. According to the conclusion of the product stability test study, write the contents of the procedure regarding the preservation and validity period.
1. Definition, composition and use
Explain the test principle and method such as ELISA method, colloidal gold method and the like. Describe the biological sources and other characteristics of the main components, such as antigen (or antibody) for coating, antigen (or antibody) for labeling, and the like. Explain the use of qualitative or quantitative determination, screening, household, confirmation, etc.
2. Raw materials and accessories
(1) In vitro biological diagnostic reagents based on the principle of antigen-antibody reaction: source and quality standards of antigens, antibodies, solid phase carriers such as microplates, solid phase membranes, and the like.
(2) In vitro biodiagnostic reagents based on the principle of molecular biological reaction: source and quality standards of primers and probes.
(3) Source and quality standards of the color development system.
(4) Source and quality standards for calibration standards (calibrators).
(5) Source and quality standards for quality control materials used for quality control.
(6) Source and quality standards for enterprise reference products used for semi-finished and finished product verification.
(7) Sources and quality standards for other raw materials.
3. Manufacturing procedures
(1) Manufacturing procedures for antigens, antibodies, standards (calibrators), quality control materials, and enterprise reference products.
(2) The coating of the solid phase membrane, such as the coating process of the enzyme-labeled plate in the enzyme-linked immunoassay kit, the coating of the test strip of the colloidal gold product, and the masking process.
(3) Marking procedures.
(4) Other important processes. For important processes, not only the exact process, but also a clear quality control method is required.
4. Semi-finished and finished product verification
For products with national reference products, the R&D unit can refer to the national reference products as the standard for semi-finished products and finished products, refer to the items and indicators set by the national standards, and set the semi-finished and finished product verification items of the products according to the conclusions of the research work. For indicators, it is also possible to use the enterprise reference products calibrated by national reference products as the standard for semi-finished and finished product verification.
5. Saving and expiration date
According to the requirements of the pharmacopoeia, the storage conditions such as temperature, dryness, wetness, lightness and darkness are indicated. The expiration date of this product is in months.
Problems that should be noted
From the writing of the manufacturing verification procedures to the final draft, the main body of responsibility is the applicant. The applicant has an unshirkable responsibility for the “manufacturing verification proceduresâ€. While the applicant attaches great importance to the writing and proofreading of the inspection procedures, the following aspects should also be noted:
1. For the manufacturing verification procedures that have been revised by the reviewers, the applicant may not arbitrarily modify them when confirming and proofreading. If there are different opinions on the revised inspection and inspection procedures, the “modification instructions†should be attached, and the modification of the technical indicators must be revised.
2. When confirming and proofreading the manufacturing verification procedures, if the applicant does not understand, please contact the reviewer to avoid the inspection rules being returned to the center and still not meeting the requirements, and returning to the enterprise for modification and delay. Overall review time.
3. Avoid non-technical problems as much as possible, such as wrong lines, loss of entire paragraphs, incorrect expressions, and incorrect company names. Due to the large differences in methods and processes involved in in vitro biodiagnostic reagent products, and the variety and variety of development, the framework for manufacturing verification procedures is not the same. The format and content of the inspection procedures shall be further determined by the Biological Products Standardization Committee when the procedures are corrected.
The format and content sections of the inspection procedures in this article are provided as examples only to facilitate communication and discussion, rather than uniform requirements. The purpose is to propose how to write and revise the verification procedures for in vitro reagent manufacturing, and I hope to hear many opinions. It is hoped that this work will be done through the joint cooperation of the reviewers of the enterprise and the drug review center and the positive interaction between them to shorten the modification time and improve the overall quality of the manufacturing verification procedures.
Shanghai Chuangsai Technology Co., Ltd. provides excellent performance, CANSPEC performance, spot promotion, biochemical reagents, chemical and chemical, scientific instruments, laboratory supplies, Shanghai Chuangsai, mass products special promotions, welcome to inquire!
This product is fit for MD size ball jointed dolls.The product including MSD Size Wig.They are made of high temperature material.And this product have all kinds of colors you can choose.
Except this product,we also have many types of Ball Jointed Doll,nude Doll Body , Doll Parts , BJD Wig ,BJD Clothing, BJD Shoes , BJD Eyes ,Other Accessories,Stock Items,if you want buy someone of these,please contact us.
Msd Size Wig,Male Ball Jointed Dolls,Boy Bjd Doll,Fashion Bjd Dolls Boy
Changchun Huadu Network Service Co., Ltd , https://www.legenddollbjd.com