European Pharmacopoeia First Identification Requirements

#1
Hi

In the general chapter of the Ph. Eur. it states that

Identification: Certain monographs give two or more sets of tests for the purpose of the first identification, which are equivalent and may be used independently.

We interpret this to be that if there are two or more tests then you only need to perform one of them for compliance.

For example if the first identification states tests A and C then we need only perform either test A or C and not both.

However the EDQM has indicated that both need to be performed and I am struggling to understand why if the tests are deemed equivalent would you need to perform both, especially as they state that the tests may be used independently.

Has anyone else got any further clarification on this subject please?

Thank you in advance.
 
Elsmar Forum Sponsor

v9991

Trusted Information Resource
#2
Hi

In the general chapter of the Ph. Eur. it states that

Identification: Certain monographs give two or more sets of tests for the purpose of the first identification, which are equivalent and may be used independently.

We interpret this to be that if there are two or more tests then you only need to perform one of them for compliance.

For example if the first identification states tests A and C then we need only perform either test A or C and not both.

However the EDQM has indicated that both need to be performed and I am struggling to understand why if the tests are deemed equivalent would you need to perform both, especially as they state that the tests may be used independently.

Has anyone else got any further clarification on this subject please?
The understanding is NOT-that they are equivalent, it is that they are "complimenting / supplementing" each other.
so the way to interpret them are that they are specific/primary and secondary identification tests.
viz., FTIR, Melting range, is different than UV / HPLC test is different than the chemical/color tests for specific comounds.

DESPITE the fact that the "certificate of analysis and certificate of conformance" are issued by the respective manufacturer,
AND DESPITE the above clarification,
various regulatory agencies insist and issue an deficiency insisting to include secondary identification test in the specification .
and hence industry practice is to include primary and secondary identification tests.[/quote]

EDQM Helpdesk

No, the test or tests that constitute the ‘First identification’ may be used in all circumstances. The second identification series is not intended for use in any other context than pharmacies. It may be used only if it can be demonstrated that the substance or preparation is fully traceable to a batch certified to comply with all the other requirements of the monograph.
Identification • For pharmaceutical industry (excipients, API, medicinal products), tests as described under First identification section shall be performed. • Community and hospital pharmacies may only perform the tests as described under 2nd identification if all other tests (under Assay and Tests section) have been performed by the manufacturer of the excipient/API (and a respective CoA is available).
 

Attachments

Thread starter Similar threads Forum Replies Date
J European Pharmacopoeia Properties Testing ISO 13485:2016 - Medical Device Quality Management Systems 2
A European UDI-DI CE Marking (Conformité Européene) / CB Scheme 2
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
dgrainger Medical Device News MDR postponed - link to Official Journal of the European Union (24-4-2020) EU Medical Device Regulations 2
P European versions of standards - ISO 10993-1 and ISO 11607-1 EU Medical Device Regulations 6
shimonv Recall - Is there a European regulation for recalls of products EU Medical Device Regulations 3
atitheya Need of conducting medical trials in European Union EU Medical Device Regulations 2
P ISO 10993-1:2018 - When will the European equivalent become a Harmonized Standard? Other Medical Device Related Standards 13
M Informational TGA – European implementation of Medical Device and IVD Regulations – Implications for Australia Medical Device and FDA Regulations and Standards News 0
M Informational EU – Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council o Medical Device and FDA Regulations and Standards News 2
M Informational European Commission expert panels on medical devices and in vitro diagnostic devices Medical Device and FDA Regulations and Standards News 0
Marc European universities dismal at reporting results of clinical trials - 2019 Other Medical Device Regulations World-Wide 0
M Informational Medtech Europe – Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR) Medical Device and FDA Regulations and Standards News 0
M Informational Technology and innovation of human implants | Panel for the Future of Science and Technology (STOA) | European Parliament Medical Device and FDA Regulations and Standards News 0
M Informational EU – Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited Medical Device and FDA Regulations and Standards News 0
moounir Medical Device Nomenclature - Free of Charge? (European Union MDR MDR 2017/745) EU Medical Device Regulations 7
M Informational EU – Questions And Answers Related To The United Kingdom’s Withdrawal From The European Union With Regard To Industrial Products Medical Device and FDA Regulations and Standards News 0
N European Authorised Representative (also called Authorized Representative) - Cost competitive recommendation EU Medical Device Regulations 1
Marc Regulation (EU) 2017/745 of the European Parliament EU Medical Device Regulations 12
J Medical Device Registration in Argentina - Client asks us to provide “European FSC” Other Medical Device Regulations World-Wide 4
S CE ETA (A2) Audit - CE mark for the european construction market CE Marking (Conformité Européene) / CB Scheme 0
N Will an FDA UDI be compatible with a European MDR UDI? EU Medical Device Regulations 7
M Medical Device News MedTech Europe - European Parliament further clarifies Commission proposal on HTA for medical technologies EU Medical Device Regulations 0
W Sale medical device to European Hospitals Hospitals, Clinics & other Health Care Providers 1
R Brexit - European Commission - The impact of the Brexit per March 29, 2019 EU Medical Device Regulations 3
E European Weld Callouts - Confused with the "/C" and the "a2" portions Various Other Specifications, Standards, and related Requirements 7
Q IVD vs EMC OJ (Official Journal of the European Union) Harmonised Standard Conflicts EU Medical Device Regulations 1
S Medical Device Registration & Technical Format/Template - European Union CE Marking (Conformité Européene) / CB Scheme 8
L ISO 13485 and European GMP ISO 13485:2016 - Medical Device Quality Management Systems 3
E European Regulations defining the terms Repair and Refurbish EU Medical Device Regulations 5
Marc Definition PEPPOL - Pan-European Public Procurement Online Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
J Label translation requirements for EU (European Union) EU Medical Device Regulations 3
U What if UK leaves EU? What will happen to European Authorized representative in UK? EU Medical Device Regulations 22
rob73 New MDD (European Medical Device Regulations) next steps - 2016 EU Medical Device Regulations 1
E I'm looking for old publications of European Quality in pdf Book, Video, Blog and Web Site Reviews and Recommendations 2
F What is the European UDI implementation timeline? EU Medical Device Regulations 3
K May 16 2014 Official Journal of the European Union Publication - 60601-2-33 EU Medical Device Regulations 3
M Overview of European Regulations of Medical Device Other ISO and International Standards and European Regulations 12
Ajit Basrur Is there an European equivalent of FDA Debarment List? EU Medical Device Regulations 2
P Is the European directive, 2011/65/EU applicable for Engineering Samples? RoHS, REACH, ELV, IMDS and Restricted Substances 5
Stijloor The European Union Explained Coffee Break and Water Cooler Discussions 4
E Current MRI Labeling requirement for European Union CE Marking (Conformité Européene) / CB Scheme 2
J0anne US Working Permit Requirements for European Consultants Career and Occupation Discussions 2
N Confusion within CE Mark and European Regulations CE Marking (Conformité Européene) / CB Scheme 5
J European Laboratories which can do IEC/EN 60601-2-50 Testing? (Close to Turkey) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J EC Certificate and European Market Introduction CE Marking (Conformité Européene) / CB Scheme 8
W East European NB for MD - How are they when compared with Western NB's? EU Medical Device Regulations 6
D Auditing Abroad - Internal Audits of our European Sister Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
J Responsibilities of a distributor in European market EU Medical Device Regulations 10
D Translation Procedure (to other European languages) for Class IIa in Technical File CE Marking (Conformité Européene) / CB Scheme 16

Similar threads

Top Bottom