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Application Form REQUEST FOR REVISION OR RENEWAL CERTIFICATE OF SUITABILITY(to be filled in for each request for revision or renewal of a Certificate of Suitability to the monographs of the European.
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Holdership FAQ
Standard CEP Format substance name. name of the CEP Holder. CEP number. previous CEP number being superseded. statement of compliance with the specific Ph. Eur monograph. list of annexures. retest date, if applicable.
Certificate of Suitability to the monographs of the European Pharmacopoeia. A certificate that certifies compliance of the active pharmaceutical ingredients (API) or pharmaceutical ingredients with that of the rules laid down in the monograph of the European Pharmacopoeia (EP).
Certificate of suitability means a written document issued by the executive director that indicates an applicant has been chosen for licensure if the applicant meets the requirements set forth in section 5(e) of this rule.
The Certification of Suitability (CEP) is a certificate that certifies compliance of the active pharmaceutical ingredients (API) or pharmaceutical ingredients with that of the rules laid down in the monograph of the European Pharmacopoeia (EP).
The CEP applicant must declare if there are any materials of animal or human origin used in the substance manufacture. The applicant can obtain a chemical CEP only or a double CEP (chemical CEP and TSE statement). In the case of a sterile substance this information is combined with either a chemical or double CEP.
The European Pharmacopoeia and certificates of suitability (CEP)
By identifying and analyzing cause-and-effect relationships among events in real time, CEP allows personnel to take effective actions in response to specific opportunities or threats.
Código de Endereçamento Postal (Postal Addressing Code) is the Brazilian postal code system commonly known as CEP. Introduced in 1972 as a sequence of five digits, it was expanded to eight digits in 1992 to allow for more precise localization.
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