What is EDQM 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 does EDQM stand for?

Quality of Medicines & HealthCare. Home. EDQM.

What is TSE CEP?

TSE compliance certificates are a type of CEP (Certificate of Suitability to the European Pharmacopoeia). They are used to maximize safety when working with materials that could potentially be contaminated with TSE.

What is OMCL Network?

Official Medicines Control Laboratory (OMCL) is the term coined in Europe for a public institute in charge of controlling the quality of medicines and, depending on the country, other similar products (for example, medical devices). They are part of or report to national competent authorities (NCAs).

What is the difference between Asmf and CEP?

Unlike ASMFs, CEP is a stand-alone document reviewed by EDQM, whereas ASMFs can go through several assessments by different Member States. Additional question related to API are rarely raised when CEP is used. When using a CEP, it is possible that you will have less variations during your product’s lifecycle.

What is the purpose of reference standard?

Reference standards are used to determine quantitative data (such as assay and impurity), qualitative data (such as identification test), and calibration (such as melting point standard). Therefore, the quality and purity of the reference standards are crucial to achieve scientifically valid results.

What is reference standard and working standard?

“A reference standard (i.e., primary standard) may be obtained from the USP/NF or other official sources (e.g., CBER, 21 CFR 610.0). A working standard (i.e., in-house or secondary standard) is a standard that is qualified against and used instead of the reference standard.”

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 EDQM traces its origins and statutes to a European treaty promoting the elaboration of a common pharmacopoeia in Europe.

What is meant by reference standard?

Reference standards means the physical standards of the state that serve as the legal reference from which all other standards and weights and measures are derived.

What are reference standards?

How do you search the CEP in EDQM?

Answer: A public list of CEPs is available on the EDQM Certification Database. You can search this database to find CEPs using the CEP number if you know it, or using other criteria such as substance name, etc. Instructions on how to search are provided on the search pages of the database.

What does EU GMP certified mean?

According to EU-GMP Chapter 1, “a Pharmaceutical Quality System appropriate for the manufacture of medicinal products should ensure that (…) a state of control is established and maintained by developing and using effective monitoring and control systems for process performance and product quality.” It is important to …

What is basic reference standard?

A reference standard for a unit of measurement is an artifact that embodies the quantity of interest in a way that ties its value to the reference base. At the highest level, a primary reference standard is assigned a value by direct comparison with the reference base.

What is USP reference standard?

A USP Reference Standard (also known as a physical standard) is a known quantity of a drug substance or ingredient, developed in alignment with the specifications outlined in the USP–NF.

What is the purpose of standard reference material?

Note: An SRM is prepared and used for three main purposes: (1) to help develop accurate methods of analysis; (2) to calibrate measurement systems used to facilitate exchange of goods, institute quality control, determine performance characteristics, or measure a property at the state-of-the-art limit; and (3) to ensure …

What are the differences between EU and FDA GMP?

Tracking & Trending and Key Process Indicators (KPIs) So the EU will have an eye on quality metrics data mainly in the course of GMP inspections whereas the FDA has a different approach: The draft “Submission of Quality Metrics Data Guidance for Industry” was issued in November 2016.

What is the difference between EU and FDA?

The FDA historically developed as a consumer protection agency, whereas the regulations from the European Commission arose out of a need to harmonize inter-state commercial interests while preserving national “autonomy.” Thus, whereas the FDA has the advantages of centralization and common rules, the European Union …

What is the difference between primary standard and reference standard?

Primary reference standards are obtained from EP, USP, BP, JP, FP and they are quite expensive. Secondary reference standards are substances which are prepared by comparison with a primary reference substance. They can be provided from manufacturers and they are also named as working standards.

What are standard reference sources?

This page contains definitions of and examples of different types of reference sources including almanacs, atlases, bibliographies, biographies, chronologies, dictionaries, directories, encyclopedias, handbooks, and indexes.

What are EU GMP standards?

How do I submit an order to EDQM?

using the WebStore. by e-mail to [email protected]. Please ensure that your order is on your company letterhead and states both the catalogue code and substance name, and is attached to your e-mail. Please submit each order or request only once, either via the WebStore or by e-mail.

What is the standard terms database?

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.

What is the catalogue of reference standards?

The catalogue lists all the reference standards officially valid for the uses prescribed in the European Pharmacopoeia monographs. It is updated daily. Download the PDF format of our catalogue here.