Search results
Results From The WOW.Com Content Network
History. In the 1980s the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
product certifications (many nations) Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications (sometimes called "certification schemes" in the product certification industry).
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common ...
product and identification of the operation performed by each contract facility; and the results of any test performed on the components used in the manufacture of the drug product as required by 211.84(d) of this chapter and on the drug product as required by 211.165 of this chapter.
In the United States, a registration statement is a set of documents, including a prospectus, which a company must file with the U.S. Securities and Exchange Commission before it proceeds with a public offering. As of May 2022, the United States Supreme Court was considering the case of Slack Technologies, LLC v.
Advanced product quality planning. Advanced product quality planning ( APQP) is a framework of procedures and techniques used to develop products in industry, particularly in the automotive industry. It differs from Six Sigma in that the goal of Six Sigma is to reduce variation, but has similarities to Design for Six Sigma (DFSS).
A product requirements document ( PRD) is a document containing all the requirements for a certain product. It is written to allow people to understand what a product should do. A PRD should, however, generally avoid anticipating or defining how the product will do it in order to later allow interface designers and engineers to use their ...
The new iPad Pro’s price tag in the U.S. will begin at $999 for the 11-inch and $1,299 for the 13-inch. Customers looking at those devices will have silver and space black colors to choose from ...