a- manuf. site reg. requirements

8/9/2019 A- Manuf. Site Reg. Requirements

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Registration Requirements of thepharmaceutical manufacturing site with

Jordan - FDA

1-The foreign manufacturer should appoint Nobles Medical Supplies Co.LTD – Nobles Drug Store P.O Box 840102 Amman Zip Code 11184Jordan , as their agent representative through the attached agencydeclaration form requested by Jordan FDA (duly legalized).Duly legalized means that: this agency declaration should be legalized fromthe manufacturer , chamber of commerce, notary public, ministry of justice,foreign affairs ministry and Jordanian Embassy. In case there is noJordanian Embassy in your country then you can legalize from any JordanEmbassy available in the near country to your country.

2- The manufacturer should prepared the site master file according to theattached JFDA site master file content.. the site master file should besealed by the company seal and signed from the manufacturer (technicaldirector) on each page.

3- Good manufacturing practice certificate (GMP) must be valid ( at leastfor 60% of its validity date) and issued by the health or the competentauthority in the county of origin and must declare clearly the following

points;a) Name & address of the manufacturing site.

b) All the production lines.c) The manufacturing site must follow the W.H.O manufacturing

practice of the pharmaceutical products.

Notes; 3-1; In case that the country of origin don’t issue GMP certificate ( you must approve that by documents) then you can submit CPP certificate

from the country of origin for the product from the same production linethat you want to register in Jordan and the CPP certificate must indicatethat the manufacturer apply the good manufacturing practices accordingto the who roles.

3-2 ; The GMP certificate must be duly legalized...duly legalized meansthat: this certificate should be legalized from the health or the competentauthority, foreign affairs ministry and Jordan embassy.

4- Manufacturing license certificate must be valid and issued from the healthor the competent authority with number & new issued date and must

include all the productions lines that the manufacturer licensed to produce plus the name & address of the manufacturing site ( duly legalized ).Duly legalized means that: Same as item 3.

Form no. 11/1 (5pages)



5- Products list contain the following information; (product trade name,generic name, pharmacological group, unite pack, dosage form, shelf lifeand registration no & date in the country of origin. This should be sealedand signed by the manufacturer on each page only.

6-The manufacturer production lines must be arranged according to this table;

No. Production Line List of products produced on line(INN/common name)-attached

1 Sterile products1.1 Aseptically prepared

1.1.1 Large volume parenterals(conventional)

1.1.2 Small volume parenterals(conventional)1.1.2.1 Liquid vials1.1.2.2 Liquid PFS (Pre-filled syringe)1.1.2.3 Liquid amp1.1.2.4 Power vials1.1.2.5 Lyophilisates1.1.2.6 Eye drops1.1.3 Semi-solids (eye ointments/gels)

1.1.4 Large volume parenterals (blow-fill-seal technology)1.1.5 Small volume parenterals (blow-fill-seal technology)1.1.6 Eye drops (blow-fill-seal technology)1.1.7 Solids & implants1.1.8 Other a aseptically prepared products(specify)

1.2 Terminally Sterilized

1.2.1 Large volume parenterals1.2.2 Small volume parenterals1.2.2.1 Liquid vials1.2.2.2 Liquid PFS (Pre-filled syringe)1.2.2.3 Liquid amp1.2.2.4 Power vials1.2.3 Semi-solids1.2.4 Solids & implants1.2.5 Other Terminally Sterilized prepared

products (specify)2 Non-sterile products2.1 Solid dosage forms (tablets, hard shell



capsules, dry suspension, powder, granules, pellets)2.2 Soft gelatin capsules2.3 Chewing gums2.4 Liquids for external use2.5 Liquids for internal use2.6 Medicinal gases2.7 Aerosols (pressurized inhalations)2.8 semi-solids(creams/ointments/gels/sup./ovules)2.9 Patches2.10 Radiopharmaceuticals (per line)2.11 other non-sterile products (specify)

3 Biological medical products (per product-specify the product & the activity toward it)

4 Primary packaging (specify dosage form)5 Secondary packaging6 Batch release

6.1 with quality control testing6.1 without quality control testing

7 Others (specify)NOTES :6-1 ;If the production line is for the products with special requirements e.g.

products containing penicillin, cephalosporin, other Beta- lactamsubstances, or hormonal substances or potentially hazardous substances or

potent active products …This should be stated und er the relevant production line.6-2 ; If some of the production lines specified above are on the same

production line in the manufacturing site this should be specified.6-3 ; taking into consideration that the same machine may be produced the(3) stated forms produced by the blow-fill-seal technology.

7- Factory machineries List, to be sealed by company seal and signed from the

manufacturer on each page only.8-Colored Company layout (A3 paper size) for the manufacturing site and for

the personal, material flow ….etc.

9-In order to avoid Jordan FDA inspection to your manufacturing site youmust provide one of the following documents:

ONE CPP certificate from USA FDA or EMA or Japan or Canadaor two (CPPS) from two of the following countries: (Germany,

France, Belgium, Switzerland, Holland, Sweden, UK, Austria,Fenland, Australia and Spain).



NOTES:9-1 ; The CPP certificate must be for product from the same production be

registered in Jordan…also 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 JordanFDA to inspect your manufacturing site.

10-In case that you have manufacturing contract with other pharmaceuticalmanufacturing sites for some or all of your products that you want toregister in Jordan, then you must prepare the documents requested in Itemsno.(1 to 9) plus the following documents :

a) List of the products that will be manufactured according to themanufacturing contract agreement

b) Original copy of the manufacturing contract agreement with clear

clarification for: A manufacturer company or (contract executor) agreed tomarketing authorization holder company (contract giver) the

possibility to inspect or check the production area, quality controlarea, 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 themanufacturing 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 areaccording to the GMP roles that followed by WHO guidelines & must beresponsible about the finished product batch release for the market use,follow up after the marketing (post marketing study)… etc. The MHAcompany according to JFDA regulations must be only one of thefollowing;

I- THE MANUFACTURING SITE .II- OR OFFICE OWNED TO /OR BY THE MANUFACTURING

SITE.



2- In case that the MHA company don’t involve in any role in themanufacturing process of the product that will be registered in Jordan, thenit will be registered with JFDA without inspection… also in case themanufacturing contract agreement if the contract giver is not involve in anyrole in the manufacturing process of the product that will be registered inJordan then contract giver company will be registered with JFDA withoutinspection.

3- In Jordan and according to JFDA regulations the contract manufacturingagreement must between two working manufacturing sites …this mean thatthe product contract giver company and the product contract executorcompany must have their own working manufacturing sites.

4-All the signs from the manufacturer company and from MAHCompany should be from the technical director and to be sealed bycompany seal on each page.

5-When there are no Jordan embassy you can legalize from any Jordanembassy 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 certificated) 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 contentsas 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 sitemaster file must be in English.

Last updating 13/05/2014

a- manuf. site reg. requirements

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