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Production Line
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1.1
Sterile products
Aseptically prepared
1.1.1 Large volume parenterals
(conventional)
1.1.2 Small volume parenterals
(conventional)
1.1.2.1 Liquid vials
1.1.2.2 Liquid PFS (Pre-filled syringe)
1.1.2.3 Liquid amp
1.1.2.4 Power vials
1.1.2.5 Lyophilisates
1.1.2.6 Eye drops
1.1.3 Semi-solids (eye ointments/gels)
1.1.4 Large volume parenterals (blow-fillseal technology)
1.1.5 Small volume parenterals (blow-fillseal technology)
1.1.6 Eye drops (blow-fill-seal technology)
1.1.7 Solids & implants
1.1.8 Other a aseptically prepared products
(specify)
Terminally Sterilized
1.2.1 Large volume parenterals
1.2.2 Small volume parenterals
1.2.2.1 Liquid vials
1.2.2.2 Liquid PFS (Pre-filled syringe)
1.2.2.3 Liquid amp
1.2.2.4 Power vials
1.2.3 Semi-solids
1.2.4 Solids & implants
1.2.5 Other Terminally Sterilized prepared
products (specify)
Non-sterile products
2.1 Solid dosage forms (tablets, hard shell
1.2
List of products
produced on line
(INN/common name)attached
NOTES:
9-1; The CPP certificate must be for product from the same production be
registered in Jordanalso the CPP certificate must be valid.
9-2; In case none of the above are not applying for you then you must
submit letter addressed to Jordan FDA that you agreed to Jordan
FDA to inspect your manufacturing site.
10-In case that you have manufacturing contract with other pharmaceutical
manufacturing sites for some or all of your products that you want to
register in Jordan, then you must prepare the documents requested in Items
no.(1 to 9) plus the following documents:
a) List of the products that will be manufactured according to the
manufacturing contract agreement
b) Original copy of the manufacturing contract agreement with clear
clarification for:
A manufacturer company or (contract executor) agreed to
marketing authorization holder company (contract giver) the
possibility to inspect or check the production area, quality control
area, ware houses, manufacturing process, analysis process,
batches records and other technical matters.
The responsibility of each part in the manufacturing contract
agreement about the manufacturing and quality control process.
The name of the part responsible for the product batch releases.
Duration of the agreement.
c) In case that you are manufacturing company according to the
manufacturing contract you must prepare two registration files:
I- One file for the manufacturer according to the documents
requested in items no.( 1 to 9)
II- The other file is for the marketing authorization holder company
according to the documents requested in items no. (1 to 10)...
IMPORTANT NOTES TO BE READ CAREFULLY;
1- Marketing authorization holder company (MHA) was defined by JFDA AS;
The company that responsible about the product quality, safety, efficacy &
to be guaranteed that the manufacturing process of the product are
according to the GMP roles that followed by WHO guidelines & must be
responsible about the finished product batch release for the market use,
follow up after the marketing (post marketing study)etc. The MHA
company according to JFDA regulations must be only one of the
following;
I- THE MANUFACTURING SITE .
II- OR OFFICE OWNED TO /OR BY THE MANUFACTURING
SITE.
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2- In case that the MHA company dont involve in any role in the
manufacturing process of the product that will be registered in Jordan, then
it will be registered with JFDA without inspectionalso in case the
manufacturing contract agreement if the contract giver is not involve in any
role in the manufacturing process of the product that will be registered in
Jordan then contract giver company will be registered with JFDA without
inspection.
3- In Jordan and according to JFDA regulations the contract manufacturing
agreement must between two working manufacturing sites this mean that
the product contract giver company and the product contract executor
company must have their own working manufacturing sites.
4-All the signs from the manufacturer company and from MAH
Company should be from the technical director and to be sealed by
company seal on each page.
5-When there are no Jordan embassy you can legalize from any Jordan
embassy in the nearest country to your country.
6-The name and the address of the manufacturer and of the MAH must
be same in the following documents:
a) Site master file.
b) Agency declaration.
c) GMP certificate
d) Manufacturing license certificate.
e) Pricing certificate and CPP certificate.
7-The file must be organized very will with indexing and separators.
8-We want from you to send us two copies of the whole file contents
as follows:
a) Hard copy (paper copy).
b) Electronic copy (CD copy).
9-All the documents must be in English.
10-The SOPs or the documents requested to be attached with the site
master file must be in English.