The questions below address some key concerns that may arise in relation EudraGMDP application. Simply click the question to expand and view the answer.
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A: No. In addition, an NCA cannot create a record for a site in a different EU/EEA MS.
A: No and it is also applicable vice versa. The Community legislation to be used in the GMDP certificates should be compatible with the responsibilities of the NCA (e.g. a human NCA should only include reference to legislation for human products).
A: No. Only NCAs responsible for human medicinal products may create new GMDP certificates for human IMP.
A: It is possible to include manufacturing/importing operations in Part 2 of the GMDP certificates for both human products and human IMP. However, the format of the GMDP certificate cannot distinguish between operations for human or human IMP. Therefore, it is recommended to create 2 new GMDP certificates; one for the human operations and the second one for the human IMP.
A: Primary packing of sterile products is considered part of the finished product manufacturing. Therefore, if a manufacturer is involved in the primary packaging of sterile products, the inspectors should choose the relevant option(s) under the section 1.1 “Sterile Products”. For other products (i.e. non-sterile) they inspectors should choose the relevant option(s) under the section 1.5 “Primary packing”.
If the company is engaged “only” in the primary packaging of sterile products, the inspectors should choose the relevant option(s) under section 1.1. but it is advisable to clarify the limitation of the activity (i.e. primary packaging “only”) under the section “Restriction and clarifying remarks”.
A: In addition to the type of biological medicinal product (section 1.3), the inspector should also select the type of dosage forms (sections 1.1 “sterile products” and/or 1.2. “non-sterile products”).
A: The explanation note in the upper part of the page 7 of the Manufacturing authorisation format states: “authorised importation activities without manufacturing activity”. This means that if a site is authorised, for example, to manufacture and import tablets, then there is then no need to repeat both sections (i.e. 1.2.1.13 in Part 1 and 2.2.2 in Part 2). It should be only included in the manufacturing operations (section 1.2.1.13 - tablets).
In addition, the explanation note of the Part 1 - manufacturing operations (page 4) states “authorised manufacturing operations include total and partial manufacturing, batch release and certification, IMPORTATION, storage and distribution...”. Therefore, the section 1.2.1.13 would imply the importation, storage, distribution, etc., unless indicated to the contrary.
GMP Certificates for Active Substance Manufacturers
A: The activities at an active substance manufacturing site may include a broad scope from importation only to full manufacture of the active. Therefore it is necessary to clearly identify those activities which come within the scope of a GMDP certificate.
A: Where a site is carrying out any of manufacturing steps listed under parts A,B, C or D (see Answer 1) in relation to active substances which are the subject of the inspection then these active substances should be listed on any GMP Certificate issued to the manufacturer.
The activities under the parts E, F or G could be performed in relation to a large number of active substances. Where these are the only types of activities carried out in relation to these active substances, it is not considered necessary to add the individual names of the active substances to the GMP Certificate.
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