How do I get a certificate of suitability?
How do I get a certificate of suitability?
To obtain a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP), applicants must send in electronic format the following documentation to the Certification of Substances Department (DCEP) of the EDQM: a completed application form which includes your invoicing details.
What is the certificate of suitability?
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).
What is CEP for API?
An API’s (active pharmaceutical ingredient) Certificate of Suitability (CEP) proves that its quality complies with the quality described in the relevant monograph of the European Pharmacopoeia; it therefore creates a direct link to the Ph.
What is CEP and DMF?
Being a European certificate, the CEP is granted by the EDQM but is recognized by other countries or institutes such as the FDA in the US. Furthermore, just like the DMF, the data as submitted in the CEP is handled strictly confidential and provides a centralized system recognized by many countries.
What is the difference between EMA and Edqm?
The European Medicines Agency (EMA) works with the European Directorate for the Quality of Medicines and HealthCare (EDQM), a directorate of the Council of Europe. The EMA and the EDQM cooperate on matters aimed at ensuring the quality of medicines and protection of public health.
What is a certificate of suitability CEP?
CEPs certify that the chemical purity and microbiological quality of a manufacturer’s drug substance is suitably controlled by the monographs of the European Pharmacopoeia.
What is certificate of suitability to European Pharmacopoeia?
The Certificate of Suitability (CEP) Certifies that the quality of a given substance can be suitably controlled by the Ph. Eur. monograph – with additional tests, if necessary (stated on the CEP). • It DOES NOT certify that a batch or batches of the substance complies with the Pharmacopoeia monograph.
What are the types of DMF?
Types of Drug Master Files (DMFs)
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product.
- Type III Packaging Material.
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation.
- Type V FDA-Accepted Reference Information.
What is the full form of MHRA?
the Medicines and Healthcare products Regulatory Agency ( MHRA ), the UK’s regulator of medicines, medical devices and blood components for transfusion, responsible for ensuring their safety, quality and effectiveness.
What is the certification of suitability?
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). CEP should consist of an explicit description of the chemical composition of the substances.
Where can I find information on certificates of suitability (CEPS)?
Search our Certification database for information on Certificates of Suitability (CEPs) granted by the EDQM. The Standard Terms database contains terms and definitions to describe pharmaceutical dose forms, routes and methods of administration, containers, closures and administration devices and patient-friendly terms.
How do I obtain a certificate of suitability to the monographs?
To obtain a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP), applicants must send in electronic format the following documentation to the Certification of Substances Department (DCEP) of the EDQM: a single copy of the Quality Overall Summary (QOS).
What is a certificate of rental suitability?
Property owners that rent out residential property must give tenants a Certificate of Rental Suitability before they move in. Property owners and their authorized agents can get this certificate.
