GMP Certificate Form

Certificate No:

CERTIFICATE OF GMP (GOOD MANUFACTURING PRACTICE)

COMPLIANCE OF A MANUFACTURER

Part 1

Issued following an inspection in accordance with Jordan Good Manufacturing Practice Guidelines dated
01/2020, which is in line with requirements of pharmaceutical inspection cooperation scheme (PIC/S) and
Criteria of Manufacturing Sites Accreditation, Re-evaluation and Cancellation for the Year 2016, based
on article (5) of the Drug and Pharmacy Law no. (12) For the year 2013 and its amendments, and article
(7) of Jordan Food and Drug Administration Law no. (41)

Jordan Food & Drug Administration confirms the following:

Manufacturer’s Name: RAM Pharmaceutical Industries Co.Ltd

Head Office : P.O.Box:211- King Abdulla II Industrial Estate sahab 11512 Jordan
Site Address:P.O.Box:211- King Abdulla II Industrial Estate sahab 11512 Jordan
Manufacturing Authorization Date: 01/08/2021
Manufacturing Authorization Number: 2/16/9/31982

Has been inspected in accordance with Good Manufacturing Practice Guidelines dated 01/2020 which is
in line with requirements of pharmaceutical inspection cooperation scheme (PIC/S) and Criteria of
Manufacturing Sites Accreditation, Re-evaluation and Cancellation for the Year 2016, based on article (5)
of the Drug and Pharmacy Law no. (12) For the year 2013 and its amendments, and article (7) of Jordan
Food and Drug Administration Law no. (41)

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on

29/04/2021, it is considered that it complies with the principles of good manufacturing practices laid
down in JFDA & PIC/S guidelines. This certificate reflects the status of the manufacturing site at the time
of the inspection, and Jordan Food & Drug Administration should be consulted to verify compliance of
the manufacturing site with GMP requirements if more than 3 years have elapsed since the date of
inspection.

The authenticity of this certificate may be verified with Jordan Food & Drug Administration upon
request.

This Certificate is valid only when presented with all pages and both parts 1 & 2.

JFDA Page 1 of 4 FR03/FAC/02/Rev02

 GMP Certificate Form
The validity of this certificate can be shortened or extended under special circumstance.

JFDA Page 2 of 4 FR03/FAC/02/Rev02

 GMP Certificate Form

Part 2

Manufacturing Operations of Human Medicinal Products*

If the company is engaged in manufacture of products with special requirements, e.g. radiopharmaceuticals or
products containing penicillin, sulphanomides, cytotoxics, cephalosporins, substances with hormonal activity or
Other potentially hazardous active ingredients, this should be stated under the relevant product type and dosage
form.
1 Sterile Products
1.1 Aseptically Prepared
1.l.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 Powder 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-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 & Implants
1.1.8 Other Aseptically Prepared Products (specify)
1.2 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 Powder vials
1.2.2.5 Eye Drop
1.2.3 Semi-solids
1.2.4 Solids & Implants
1.2.5 Other terminally sterilized prepared products (specify)

JFDA Page 3 of 4 FR03/FAC/02/Rev02

 GMP Certificate Form

2 Non sterile Products

2.1 Solid dosage forms ( tablets, hard shell capsules, dry suspension, powder, granules, pellets)
2.2 Soft gelatin capsules
2.3 Chewing gums
2.4 Liquids for external use
2.5 Liquids for internal use
2.6 Medicinal gases
2.7 Aerosols ( pressurized inhalations)
2.8 Semi-solids ( creams/ointments/gels/sup./ovules)
2.9 Patches
2.10 Other non-sterile products ( specify)
3 Biological medicinal products ( per-product-specify the product & the activity towards it)
4 Primary packaging
5 Secondary packaging
6 Batch release
6.1 with quality control testing
6.2 without quality control testing
7 Others ( specify): Non Cytotoxic Antineoplastic

Any restrictions or clarifying remarks related to the scope of this certificate *:

…solid dosage form (Non Cytotoxic Antineoplastic)

…../...…/.....… [date].............[number]

Drug Directorate's Director

Pharmacist Amal Ahmad

* Delete that which does not apply

JFDA Page 4 of 4 FR03/FAC/02/Rev02