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A certificate of analysis (COA) is a formal laboratory-prepared document that details the results of (and sometimes the specifications and analytical methods for) one or more laboratory analyses, signed—manually or electronically—by an authorized representative of the entity conducting the analyses. This document gives assurances to the ...
The US Truth in Negotiations Act 1962 ("TINA") requires that contractors submitting bids should supply certified cost or pricing data before an agreement on price for most negotiated procurements for government contracts worth more than $750,000 for prime contracts awarded before July 1, 2018, and $2 million for prime contracts awarded on or ...
Type approval or certificate of conformity is granted to a product that meets a minimum set of regulatory, technical and safety requirements. Generally, type approval is required before a product is allowed to be sold in a particular country, so the requirements for a given product will vary around the world.
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 Technical Document (eCTD).
The ex-factory/manufacturer's price is considered more accurate and thus preferable for international price comparisons. [3]: 194 [6] The WHO recommends the use of the median supplier price [5]: 215 for the reference countries of the target medication in the International Medical Products Price Guide for all studies.
In addition, chemicals of higher concern or toxicity also have to meet the 2010 deadline. About 143,000 chemical substances marketed in the European Union were pre-registered by the 1 December 2008 deadline. Although pre-registering was not mandatory, it allows potential registrants much more time before they have to fully register.
The guide has been published annually since 1986 with the World Health Organization becoming involved in 2000, [2] [3] though has not been updated since 2015. [4] The prices in the guide are specifically for low and middle income countries (LMIC). [2] There are two sources of price data in the guide: Buyers and Suppliers.
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).