Regulations of Manufacturing Sites Accreditation, Re-evaluation and
Cancellation for the Year 2013
Article (1):

These Regulations are called (Regulations of the Manufacturing Sites Accreditation, Reevaluation and Cancellation for the Year 2013) and they will be effective upon the date
of their publication in the official Gazette.
Article (2):

Words and terms defined in these regulations shall have the meanings ascribed to them
in Drug and Pharmacy law no (80) and its amendments, interpretations specified in the
regulations of drug registration and in the Arabic Good Manufacturing Practice
Guidelines, or as follows, unless the context indicates otherwise.
The Law: Drug and Pharmacy law no (80) with its amendments.
Administration: Jordan Food and Drug Administration
Committee: Accreditation of manufacturing sites committee mentioned in the law.
Good Manufacturing Practice (GMP): A valid certificate of good drug manufacturing
practice issued by the relevant authority in the country of origin specifying the name of the
manufacturing site, its address and accredited production lines and stating that the company
adheres to the good manufacturing practice guidelines of World Health Organization (WHO) as a
minimum requirement.
Manufacturing License (ML): the manufacturing license issued by the relevant authority in
the country of origin specifying the name of the manufacturing site and its address, the date and
number of factory license and accredited production lines.
Free Sale Certificate: A legalized certificate released from the relevant authority for a specified
pharmaceutical product including the following:
1- Trade name of the drug and its pharmaceutical form.
2- Registration or Trade permit number and date
3- Names and concentrations of Active and Inactive Ingredient/s.
4- A Statement mentions that the Product is permitted for sale, and another statement
mentioning that it's actively being sold, and stating the reasons if not.
5- Name and address of Marketing authorization holder, and names and addresses of the
manufacturing sites with their roles in the manufacturing process.
6- A statement mentions that the manufacturing site is compliant with the Good
Manufacturing Practice Guidelines.
7- Issuance date of the Certificate.
Registration of trade Agency: A registration by the relevant Jordanian authority specifying
the agent and the grantor of agency.
Letter of Appointment: Appointing a specific agent by the marketing authorization holder to
follow up registration, importation and distribution procedures.
Site Master File: A profile that defines the manufacturing site and includes information
provided in Appendix (5).
Manufacturing site: that part of the drug factory in which drugs are manufactured or prepared
or processed leading to the finished product. This includes any step of production except the
manufacturing of raw materials of non-biological products.
Technical contract: It is that part of the contract which states the following:
1. Agreement of the contractor given to the grantor of contract that proves the ability to conduct
an audit on production areas, control, storage, manufacturing methods, analysis, batch records
and all technical abilities.
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2. Responsibilities of the grantor of contract and the contractor concerning the manufacturing
steps.
3. The Party responsible for batch release.
4. Validity of the contract.
Grantor of contract: the party that benefits from the services provided by the contractor.
Contractor: the party / ies that has/have the qualified technical abilities to provide services to
the Grantor of contract.
Technical Abilities: experience and facilities that qualify the manufacturing company to work
in accordance with Good Manufacturing Practices (GMP).
Technical Manager in the local manufacturer: is the responsible pharmacist of Batch
release to the market and withhold both technical and legal responsibilities in front of the Health
Authorities, and allowed to delegate Quality Assurance Manager to review and release batch file,
and the Technical manager should be qualified and has a minimum of 5 years experience in the
pharmaceutical manufacturing field.
Marketing Authorization Holder Company: is the company responsible on the quality,
safety and efficacy of the product and making sure its manufactured under the requirements of
Good Manufacturing Practice, and releasing batches of finished products to the market, and
following up post marketing, procedures of selling, withdrawal and destructions, and it should be
a manufacturing company (accredited by the administration) or an office owner or owned by a
manufacturing company accredited by the administration.
Intermediate Product: partially processed material containing an active pharmaceutical
ingredient or more, which must undergo further processing steps before it becomes a bulk
product.
Soft Gelatin Capsules: a pharmaceutical dosage form consisting of a soft gelatin shell of a
single part made of gelatin or similar materials, containing an active ingredient or more, and
comes in various shapes and could be in bulk or packaged form.
Article (3):
 By implementing these regulations, the Food and Drug Administration aims to accredit
manufacturing sites, and for the purpose of under license manufacturing or transference
of a manufacturing site, re-evaluation of the manufacturing sites and cancellation of the
accreditation.
Article (4):
a) The manufacturing site accreditation request for a specific production line/s (according
to the product lines mentioned in appendix (6) ) or for a specific biological product
(starting from the manufacturing site of the active raw material/s of the biological
product till the finished product manufacturing site), should be submitted by the
responsible pharmacist in the drug store or the responsible technical manager in the
local pharmaceutical company, attached with it the fully documented file according to
appendix no (1), and submitted along with a product file manufactured on the
production line submitted for accreditation or with a handout of transferring the
manufacturing site, and the committee decides regarding the manufacturing site
accreditation request within a period of (180) days from the day of completing the file
including the inspection report.
b)
The manufacturing site accreditation request for the intermediate product (excluding
vitamins, enzymes and any active pharmaceutical ingredient added to it another
ingredients for the purpose of synergism or to enhance stability on which the
requirements of the active ingredients manufacturing sites are applied and excluding the
biological products) should be submitted by the responsible pharmacist in the drug store
or the responsible technical manager in the local pharmaceutical company, attached with
it the fully documented file according to appendix no (7) and the committee decides
regarding the manufacturing site accreditation request within a period of (180) days
from the day of completing the file including the inspection report.
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c) The manufacturing site accreditation request for a Soft Gelatin Capsule production line/s
(excluding biological products) should be submitted by the responsible pharmacist in the
drug store or the responsible technical manager in the local pharmaceutical company,
attached with it the fully documented file according to appendix no (8), along with a
product file manufactured by the production line submitted for accreditation or with a
handout of transferring the manufacturing site, and the committee decides regarding the
manufacturing site accreditation request within a period of (180) days from the day of
completing the file including the inspection report.
d) The request of accreditation of an additional production line should be submitted by the
responsible pharmacist in the drug store or the responsible technical manager in the
local pharmaceutical company, according to the requirements listed in appendix no (3),
along with a product file manufactured by the production line requested to be added or
with a handout for transferring the manufacturing site.
Article (5):
The requirements of the manufacturing sites that are subjected to re-evaluation (based on
article 17-a of the law in the cases mentioned in appendix (4)) should be submitted by the
responsible pharmacist of the drug store or the technical manager of the local manufacturing
company, attached with all the documents prepared in accordance with the requirements
mentioned in appendix (2).
Article (6):
a. For the
purpose of accrediting manufacturing sites for specific production line/s, an inspection is
conducted following a decision made by the committee after studying the requirements
mentioned in appendix no (1) or appendix no (3), taking into consideration what is
mentioned in paragraph (b) of this article, and as for the biological products, an inspection is
conducted starting from the active raw material’s manufacturing site till the manufacturing
site of the finished product after studying and evaluating the registration file of the product.
B. 1- As recommended by the committee, JFDA Director can replace the inspection in case of
providing any of the following documents:
- Free Sale Certificate from the relevant authority in the United States of America or from the
European Medicines Agency (EMA) or Japan or Canada or two Free Sale Certificates from the
responsible authorities in two accredited countries from the following list: (United Kingdom,
Germany, France, Belgium, Switzerland, the Netherlands, Sweden, Austria, Australia, Finland
and Spain). The Free Sale Certificate must meet the following criteria:
- For a product representing the production line/s requested for accreditation, and in case of
biological products, these Certificates must be for the same product.
- Valid Certificate and in case no expiry date for it, it will be considered valid for 5 years from
its issuance date.
2- If the manufacturing site is responsible for an intermediate step of a biological product
manufacturing and the required Free Sale Certificate/s needed for accreditation according to
article (6-B-1) could not be made available for reasons accepted by the committee, then it
can be replaced by GMP Certificate according to the countries mentioned in the same article.
c. Inspection of the manufacturing sites is conducted by a decision of the committee in the
following cases:
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1- Accreditation of a new manufacturing site or additional production line, taking into
consideration what is mentioned in paragraph (b) of this article.
2- The presence of adjustments or deficiencies in the manufacturing site.
3- Failure of the products of a manufacturing site to pass laboratory testing due to major
reasons affecting the safety and efficacy of the product.
4- Following up the accreditation of a manufacturing site that has done corrective actions,
according to a previous inspection report.
d. For the purposes of re-evaluating manufacturing sites that are subjected to re-evaluation
according to article (17-A) of the Law and appendix (4), inspection is carried out by a
decision from the General Director according to the committee’s recommendation after
reviewing the requirements mentioned in appendix (2) taking into account what is mentioned
in paragraph (b) of this article.
Article (7):
a) If the Marketing Authorization Holder Company was not accredited by the administration
and has no role in any of the manufacturing steps, then it is accredited by the committee
according to the evaluation of the requirements and documents mentioned in appendix
(1) unless it has an accredited manufacturing company by the same name.
b) In case of contract manufacturing, if the grantor of contract does not have any role in
the manufacturing steps and it is not accredited by the administration, it should be
accredited by the manufacturing sites accreditation committee according to the
evaluation of the requirements and documents mentioned in appendix (1) unless it is an
office which owns or is owned by a manufacturing company accredited by the
administration by the same name.
Article (8):
a. Taking into consideration what is mentioned in article (6-B), when studying the request of
accreditation or re-evaluation of the manufacturing sites, or the request of additional
production line accreditation, the committee depends on the requirements mentioned in
appendix (1), (2) and (3) respectively, and on a valid inspection report (not more than 2
years since the inspection date).
As for the manufacturing sites of intermediate products and Soft Gelatin Capsules, the
committee depends on the requirements mentioned in appendix (7) or appendix (8)
respectively in addition to a valid inspection report, if inspection on the site is required.
b. The committee issues the approval of the accreditation of the manufacturing site for the
requested production line, or the rejection of the accreditation request, with a clarification of
the reasons.
c. For biological products, the committee issues its decision for the accreditation of the
manufacturing site/s starting with the manufacturing site of the active raw material till the
manufacturing site of the finished product, or the rejection of the accreditation request, with
a clarification of the reasons.
Article (9):
The responsible Pharmacist in the Drug Store or the Technical Manager in the local
manufacturing company has the right to object on the committee's decision within thirty
days of receiving the decision. The committee raises its decision concerning the objection
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within thirty days from the date of the submission, and that decision is final. Then, an
appropriate action is to be taken regarding the related products by the relevant committee.
Article 10:
a. As recommended by the committee, after the re-evaluation of the manufacturing sites,
JFDA General Director has the authority to issue a decision of approving, suspending, or
cancelling the accreditation of manufacturing sites with a justified decision.
b. The responsible Pharmacist in the Drug Store or the Technical Director in the local
manufacturing company has the right to object on the suspension or the cancellation
decision within thirty days of receiving the decision. The committee raises its
recommendation concerning the objection within thirty days of the date of its
submission, after which, the decision of General Director is final. Then, an appropriate
action is to be taken regarding the related products by the relevant committee, either by
suspending them, or cancelling their registration, or any other appropriate action
according to Article (17-B) of the law.
Dr. Hayel Mohammad Obaidat
Director General of Jordan Food and Drug Administration
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Appendix 1
Requirements of Accreditation of the Manufacturing Site
An application form of accreditation filled in accordance to the required instructions. The
documents specified below are submitted by the pharmacist in charge of the drugstore or the
local factory in a cardboard file or a similar box file with the name of the company and the
manufacturing site on its outer face side and on the side. The name must be typed in Arabic or
English according to the following order:
Part (1): Administrative and Organizational Information:
1- Index of contents
2- Accredited administrative forms filled in accordance to the required instructions:
a) Application form of manufacturing site accreditation.
b) A form of documents required for the accreditation of the manufacturing site.
c) The computer form including the manufacturing site’s information.
Part (2): Site Master File: including the information mentioned in appendix (5) in
Arabic or English and to be stamped by the manufacturing company.
Part (3): Certificates:
1.
Good Manufacturing Practice certificate (GMP) issued by the country of the
manufacturing site and officially certified by the relevant authority. The (GMP)
certificate date of issue must not exceed 2 years and if it is confirmed that the
country of origin doesn’t issue (GMP) certificates, then it can be replaced by
Free Sale Certificate/s from the country of origin for product/s that represents
the production line/s requested for accreditation whilst containing its
commitment with Good Manufacturing Practice instructions.
2.
A valid legalized manufacturing license (ML) for the manufacturing site officially
certified by the relevant authority (requested in case the GMP certificate does
not mention the production lines submitted for accreditation or the
pharmaceutical forms of the products authorized to be manufactured or does
not include the required information) specifying the name and address of the
manufacturing site and the production lines submitted for accreditation or the
pharmaceutical forms of the products authorized to be manufactured.
3.
A mirror image of the certificate of a trade agency registration issued by the
relevant Jordanian authority in addition to the Letter of Appointment from the
Marketing Authorization Holder.
4.
For contract manufacturing purposes, a copy of the technical contract is
required (unless the manufacturing site of the contract acceptor is owned by
the contract grantor provided by submission of a document that proves that
and to be legalized by the relevant authority).
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Appendix (2)
Requirements for the Re-evaluation of the -Manufacturing Site
The re-evaluation application form filled in accordance with the required instructions. The
documents specified below are submitted by the pharmacist in charge of the drugstore or the
local factory in a cardboard file or a similar box file with the name of the company and the
manufacturing site on its outer face side and on the side.
The name must be typed in Arabic or English according to the following order:
Part (1): Administrative and organizational information:
1- Index of contents
2- Administrative forms filled in accordance to the required instructions:
a) Application form of the manufacturing site re-evaluation.
b) A form of documents required for the re-evaluation of the manufacturing site.
c) Computerized form to submit re-evaluation data of the manufacturing site.
Part (2): Site Master File: Including the information mentioned in appendix (5) in
Arabic or English and to be stamped by the manufacturing company.
Part (3): Certificates:
1) A valid Good Manufacturing Practice Certificate (GMP) issued by the country of
manufacturing site and officially certified by the relevant authority. The (GMP)
certificate date of issue must not exceed 2 years and if it is confirmed that the Country
of Origin doesn’t release (GMP) certificate, it can be replaced by Free Sale Certificate/s
from the Country of Origin of product/s that represents the product line/s requested for
re-evaluation whilst containing its commitment with Good Manufacturing Practice
instructions.
2) A valid officially certified manufacturing license (ML) for the manufacturing site issued
by the relevant authority (requested in case the GMP certificate does not mention the
production lines submitted for accreditation or the pharmaceutical forms of the
products authorized to be manufactured or does not include the required information) ,
specifying the name and address of the manufacturing site and the production lines
submitted for accreditation or the pharmaceutical forms of the products authorized to
be manufactured.
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Appendix (3)
Requirements for the Accreditation of an Additional Production Line
1) A form for the accreditation of an additional production line filled according to the
required instructions
2) An up-to-date Site Master File covering the additional production line or a letter from
the manufacturing company stating that no changes have occurred on the previously
reported SMF (if it was new and specifying its date) , in addition to personnel and
material flow charts for the additional line.
3) Valid GMP Certificate covering the additional production line.
4) Letter of Appointment and Trade Agency Record covering the additional production
line, wherever required.
5) Technical Contract that covers the additional production line in case of contract
manufacturing.
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Appendix (4)
Conditions Requiring Re-evaluation of a Manufacturing Site According to Article (17A) of the Law
1) Manufacturing Sites that were accredited before the year (2000).
2) Manufacturing Sites accredited by office address.
3) Manufacturing Sites accredited by name without specifying the address of the accredited
manufacturing site.
4) Manufacturing Sites accredited without specifying the production lines.
5) a- Manufacturing Sites/ Production Lines that have been accredited for more than 5
years without registering any related product(s).
b- Accredited Manufacturing Sites/ Production Lines with more than 5 years passing on
their related products’ cancellation.
6) The presence of Critical Notes related to the company's Products including:
a- Failure of passing the laboratory test for major reasons that affect the product's safety
and efficacy
b- Presence of justified and documented complaints or problems related to the
manufacturing of the product and its quality.
6) Any other condition the committee adds.
While applying the points from (1-5) when submitting a registration form for a product for
that site/ changing company's name/ agency transfer/ or any other adjustments related to
the company from the agent or from the committee.
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Appendix (5)
Contents of the Site Master File
1. General information about the manufacturer
1.1 Contact information of the manufacturer:
- Name and official address of the manufacturer.
- Name and street address of the manufacturing site, buildings and production units
located on the site, written in a detailed manner.
- Contact information of the manufacturer including telephone numbers of the responsible
persons for receiving calls 24 hours a day in case of product defects or recalls.
- Identification number of the manufacturing site e.g. GPS details, D-U-N-S (Data Universal
Numbering System) or any other geographical location system.
1.2 Licensed pharmaceuticals manufacturing activities of the site:
- A copy of valid manufacturing license issued by the relevant competent authority
(Attachment no. 1). It should be stated if the competent authority does not issue
manufacturing licenses.
- Brief description of manufacturing, import, export, distribution and any other activities
licensed by the relevant competent authorities, including pharmaceutical dosage forms,
and activities licensed by foreign authorities which are not covered by a manufacturing
license.
- Type of products currently manufactured on-site (Attachment no. 2).
- List of GMP inspections of the site within the last 5 years; including dates and names of
the country and/or official authority which conducted the inspection.
- A copy of current GMP certificate (Attachment no. 3).
1.3 Any other manufacturing activities carried out on the site
- Description of non-pharmaceutical activities being carried out on-site, if any.
2. Quality Management System of the Manufacturer
2.1 The quality management system of the manufacturer
- Brief description of the quality management systems in the company and the reference
standards being based on;
- Responsibilities related to following up and maintaining the quality system including
senior management;
- Information about the activities of the accredited and licensed sites, including dates of
accreditations and names of accrediting bodies.
2.2 Release procedures of finished products
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Detailed description of qualification requirements (education and work experience) of
qualified person(s) / technical director responsible for issuing batch certificates and batch
release.
- General description of issuing batch certificates and batch release procedures;
Role of qualified person / technical director in quarantine and release of finished products
and in assessment of compliance with the registration and marketing permissions;
- The arrangements between qualified persons when several ones involved;
- A statement whether the quality assurance system includes Process Analytical
Technology (PAT) and/or the Real time release /Parametric release.
2.3 Management of suppliers and contractors
- A brief summary of the supply chain and the external auditing program.
- A brief description of the accreditation system of contractors and manufacturers of active
pharmaceutical ingredients (API) and other suppliers of critical materials;
- Measures taken to ensure that manufactured products are compliant with TSE
(Transmitting animal spongiform encephalopathy) guidelines.
- Measures adopted where counterfeit products, finished products or bulk products, active
pharmaceutical ingredients or inactive are suspected or identified;
- Use of outsource scientific, analytical or any other technical assistance in relation to
analysis and manufacturing;
- A list of contract manufacturing and laboratories (contract analysis), including the
addresses, contact information and flow charts of supply-chains for outsourced
manufacturing and quality control activities; e.g. sterilization of primary packaging
material for aseptic processes and testing of raw materials, (to be presented in
attachment 4);
- A brief overview of the shared responsibilities between the grantor of contract and
contractor with respect to compliance with registration and marketing permissions.
2.4 Quality Risk Management (QRM)
- Brief description of QRM methodologies used by the manufacturer;
- Scope and focus of QRM including brief description of any activities which are performed
at corporate top-level policy, and those which are performed locally, including the
application of QRM system to assess the continuity of supply.
2.5 Product Quality Reviews
- Brief description of methodologies used.
-
3. Personnel
-
-
Organization chart showing the arrangements and job titles for quality management,
production and quality control, including senior management and qualified Person(s)
(Appendix 5).
Number of employees working in the quality management, production, quality control,
storage and distribution.
Qualification, experience & responsibilities of key personnel.
Personnel training plan, and a system for maintaining employees training records and
related documents.
Health checking system for personnel working in production.
Personnel hygiene requirements including clothing.
4. Premises and equipment
4.1 Premises
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Short description of the manufacturing site; including the area of the site and list of
buildings & description of surrounding environment. If the production for different
markets takes place in different buildings on the site, the buildings should be listed with
the destination markets identified (if not identified under 1.1);
- Simple layout or description of manufacturing areas with defined drawing scale
(architectural or engineering drawings are not required);
- Layouts and flow charts of the production areas (in Appendix 6) showing room
classification and pressure differentials between adjacent areas and indicating the
production activities carried out in the rooms i.e. mixing, filling, storage, packaging …
etc.
- Layouts of warehouses and storage areas including special areas for the storage and
handling of highly toxic, hazardous, and sensitizing materials, if applicable;
- A description of construction quality and finishing like floors, ceilings, walls... etc.
- A description of periodic and preventive maintenance programs and documentation
system.
- A brief description of special storage conditions -if applicable – which haven’t mentioned
in the lay outs of the manufacturing site.
4.1.1 Brief description of heating, ventilation and air conditioning (HVAC) ,including the
regulations of specifying air sources, temperature, humidity, pressure differentials and air
change rates, and air circulation policy (%), indicating the reference.
4.1.1 Brief description of water systems
- Quality references of produced water;
- Schematic drawings of the systems (attachment no. 7).
4.1.2 Brief description of other relevant utilities, such as steam, compressed air, nitrogen
… etc.
-
4.2
4.2.1
Equipments
List of main production and control laboratory equipments, mentioning the critical
parts of equipments. (provided in Attachment no. 8)
4.2.2 Cleaning and sterilization
- Brief description of procedures used to clean and sanitize surfaces of direct contact with
the products (manual cleaning, automatic cleaning Clean-In-Place (CIP), etc)
4.2.3 Critical computerized systems in good manufacturing practice (GMP)
4.2.4 Description of Periodic maintenance programs of equipments and devices, and
related documentation system.
5.
Documentation
-
6.
Description of documentation system (electronic - manual);
When documents and records, including Pharmacovigilance data are stored or archived
off-site, a list of types of documents/records should be kept in the site. It should include
the name and the address of storage site and an estimate of time required retrieving
archived documents.
Production
6.1
Types of manufactured products
(Reference to Appendix 1 or 2 can be made)
- Type of manufactured products including:
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List of dosage forms of both human and veterinary products which are
manufactured on the site
 List of dosage forms of investigational medicinal products (IMP) manufactured for
any clinical trials on the site, and when different from the commercial
manufacturing, information of related production areas and personnel should be
mentioned.
Toxic or hazardous substances handled in the manufacturing site, like materials of high
pharmacological activity and/or those with sensitizing properties);
Products types manufactured in a dedicated facility or on campaign basis, if applicable;
Process Analytical Technology (PAT) applications, if applicable, with general clarification
of the associated computerized systems.
6.2
Process validation
Brief description of general policy concerning process validation;
Policy for reprocessing or reworking.
6.3
Materials and warehouses management
Description of the arrangements for handling starting material, filling and packaging
materials, bulk and finished products, including sampling, quarantine, release and
storage procedures;
Description of the procedures for handling rejected materials and products.

-
-
-
7.
Quality Control (QC)
-
8.
Description of the quality control activities carried out on the site in terms of physical,
chemical, and microbiological and biological testing.
Distribution,
recalls
-
9.
complaints,
products
defects
and
8.1
Distribution (of the part under the responsibility of the manufacturer)
Types of companies (wholesale license holders, manufacturing license holders, etc.) and
locations to which the products are shipped from the manufacturing site;
Description of the system used to verify that each customer / recipient is legally licensed
to receive pharmaceutical products from the manufacturing company;
Brief description of the system that ensures appropriate environmental conditions during
transit, e.g. temperature monitoring and controlling ;
Required arrangements for product distribution and methods by which product
traceability is maintained;
Measures taken to prevent manufacturers’ products to fall in the illegal supply chain.
8.2
Complaints, products defects and recalls
Brief description of the system for handling complaints, product defects and recalls.
Self inspections
-
Brief description of the self-inspection system with focus on criteria used for selection of
the areas to be covered during planned inspections, practical arrangements and followup activities.
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SMF attached with:
 Attachment 1: Copy of valid manufacturing license (ML).
 Attachment 2: List of dosage forms manufactured in the site, including the scientific
names (INN) or common name (as available) of active pharmaceutical ingredients (API)
used.
 Attachment 3: Copy of valid good manufacturing process (GMP) certificate.
 Attachment 4: List of manufacturing sites and laboratories including the addresses and
contact information, and flow-charts of the supply chains for these contract activities.
 Attachment 5: Organizational charts
 Attachment 6: Lay outs of production areas including material and personnel flows,
general flow charts of manufacturing processes for each product (dosage form).
 Attachment 7: Schematic drawings of water systems.
 Attachment 8: List of main production and laboratory equipments.
Appendix (6)
Production Lines



Production lines are submitted for accreditation according to the table below with a list of
products produced from each production line required for accreditation.
If the production line is used for production of the following, then this should be
mentioned:
- Penicillins, Cephalosporins, and other allergy-causing substances (other BetaLactams).
- Hormones.
- Potentially hazardous products.
- Products containing highly potent substances.
If some of the production lines specified below are on the same production line in the
manufacturing site this should be specified.
No.
Production line
List
of
products
produced on line
( INN/common name)attached
1
1.1
Sterile Products
Aseptically Prepared
1.1.1 Large volume Parenterals (conventional)
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)*
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1.2
2
1.1.6 Eye drops ( blow-fill-seal technology)*
1.1.7 Solids & Implants
1.1.8 Other 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 Powder 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 capsules, dry
suspension, powder, granules, pellets**)
2.2 Soft gelatin capsules***
* taking into consideration that same machine may produce the 3 stated forms produced by
the blow-fill-seal technology.
** Requirements mentioned in Appendix (7) are applied on it.
*** Requirements mentioned in Appendix (8) are applied on it.
3
4
5
6
7
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 Radiopharmaceuticals ( per line)
2.11 Other non-sterile products ( specify)
Biological medicinal products ( per-product-specify the product & the activity towards it)
Primary packaging
Secondary packaging
Batch release
6.1 with quality control testing
6.2 without quality control testing
Others ( specify)
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Appendix (7)
Requirements of Manufacturing Sites’ Accreditation for Intermediate Products
The file of the Manufacturing site of intermediate products should be submitted according to
the following requirements:
1. Required Administrative Information:
- A filled form for the accreditation of intermediate products’ manufacturing site.
- A form of documents required for the accreditation of manufacturing site for
intermediate products.
- Computer form for the submission of the manufacturing site data.
2. Site Master File containing information according to the requirements listed in Appendix
(5), in Arabic or English and to be stamped by the manufacturing company.
3. Duly legalized Good Manufacturing Practice (GMP) certificate issued from the relevant
authority in the manufacturing site's country, containing the name and address of the
manufacturing site and the production line submitted for accreditation or the
pharmaceutical dosage forms of the products authorized for production. The certificate
must be valid and not issued for more than two years stating that the company is
following the instructions of Good Manufacturing Practice guidelines of World Health
Organization (WHO) as a minimum requirement. If it was proved that the country of
origin does not release GMP certificate, this can be substituted by Free Sale Certificate
from the country of origin for the product that represents the production line required for
accreditation, stating that it follows the Good Manufacturing Practice instructions.
4. A valid Manufacturing license (ML) issued and legalized in the country of the
manufacturing site from the relevant authorities (requested in case the GMP certificate
does not specify the production line required for accreditation or the pharmaceutical
dosage forms authorized for production), specifying the name and address of the
manufacturing site and the production line submitted for accreditation or the
pharmaceutical dosage forms of the authorized products while making sure it is valid.
5. Inspection is carried out on the manufacturing site for the accreditation of the
intermediate product and the inspection can be replaced by submission of Free sale
certificate ( showing the manufacturing site for the intermediate product) or a GMP
certificate from the relevant authorities in one of the following countries: United States of
America (USA), European Medicines Agency (EMA), Japan, Canada, United Kingdom
(UK), France, Germany, Belgium, Switzerland, Netherland, Sweden, Austria, Australia,
Finland, Spain, Denmark, Ireland, Finland, Norway and Portugal.
16
6. Letter issued from the manufacturing site of the intermediate product signed by the
Technical Director/Director General /the responsible qualified person including the
following:
a) Permission for the marketing authorization holder to audit the production areas, control,
storage, manufacturing methods and analysis, batch records and all technical facilities.
b) Commitment to inform the marketing authorization holder in case of updating the Site
Master File due to modifications or main additions on the manufacturing site.
Appendix (8)
Requirements for the accreditation of Soft Gelatin Capsules manufacturing sites
The file of the Manufacturing Site of Soft Gelatin Capsules is submitted according to the
following requirements:
1) Required administrative documents:
- A form for accreditation request of Soft Gelatin Capsules manufacturing site.
- Form of required documents for the accreditation of manufacturing site for Soft Gelatin
Capsules.
-Computer form for the submission of the manufacturing site data.
2) Site Master File containing information listed in Appendix (5), in Arabic or English and it
should be stamped by the manufacturing company.
3) Good Manufacturing Practice (GMP) certificate issued from the relevant authority in the
manufacturing site's country that is duly legalized, containing the name and address of the
manufacturing site and the production line submitted for accreditation or the pharmaceutical
dosage forms of the products authorized for production . The certificate must be valid and
not issued for more than two years stating that the company is following the instructions of
Good Manufacturing Practice guidelines of World Health Organization (WHO) as a minimum
requirement. If it was proved that the country of origin doesn’t release GMP certificate, this
can be substituted by Free Sale Certificate from the country of origin for the product that
represents the requested the production line required for accreditation, while stating that it
follows the Good Manufacturing Practice instructions.
4) A valid Manufacturing license (ML) released issued and legalized from the relevant
authorities in the country of the manufacturing site (requested in case the GMP certificate
doesn’t specify the production line required for accreditation or the pharmaceutical dosage of
the products authorized for production), specifying the name and address of the
manufacturing site and the production line submitted for accreditation or the pharmaceutical
dosage forms of the products authorized for production, while making sure it is valid.
5)Inspection is carried out on the manufacturing site for the accreditation of Soft Gelatin
Capsules and the inspection can be replaced if presenting Free sale certificate ( showing the
manufacturing site for the Soft Gelatin Capsules) or GMP certificate from the relevant
authorities in one of the following countries: United States of America (USA), European
Medicines Agency (EMA), Japan, Canada, United Kingdom (UK), France, Germany, Belgium,
Switzerland, Netherland, Sweden, Austria, Australia, Finland, Spain.
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6) Letter issued from the manufacturing site of Soft Gelatin Capsules signed by the Technical
Director/ Director General / the qualified authorized person in charge
including the following:
a) Permission for the marketing authorization holder to audit the production areas, control,
storage, manufacturing methods and analysis, batch records and all technical facilities.
b) Commitment to inform the marketing authorization holder in case of updating the Site
Master File due to modifications or main additions on the manufacturing site.
Appendix (9)
Manufacturing Sites Inspection
1. Inspections for the purpose of production line/s accreditation:
The Qualified Inspection Team conducts a pre-arranged visit between JFDA and the marketing
authorization holder for that product in Jordan, to the manufacturing site for the intended
product, to ensure that the product line/s adhere with GMP guidelines.
2. Inspection Team:
A team consisting of three qualified and authorized inspectors is delegated by JFDA to conduct
inspection missions as per a decision of JFDA General Director and according to the drug
director's recommendation. Expert from outside JFDA can join the team instead of the second
member (mentioned in Appendix 11) of the inspection team, if necessary.
3. Inspection Preparation:
1- After specifying the inspection time, the inspection team must follow these procedures:
Reviewing the site master file of the manufacturing site and request any necessary information.
a) Setting the inspection Plan
b) Conducting inspection in accordance to the plan set.
c) Holding the final wrap up meeting to provide the company with remarks about the site.
d) Submitting a comprehensive report about the result of the inspection visit within a period of
not more than three weeks starting from the date of their return. The report must indicate the
appropriate recommendation and include the elements mentioned in Appendix (10).
2- For the purpose of manufacturing site accreditation and in case the company could not meet the
inspection team after the inspection time was specified, a new inspection appointment will be set at
the last of the inspection schedule.
3- For the purpose of re-evaluation of the manufacturing site, inspection is planned within six months
from making the decision under the penalty of cancelling the manufacturing site accreditation.
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Appendix (10)
Inspection Report Form
Introduction:
The Inspection report provides a summary of the activities that have been done, the
remarks that have been taken during the inspection, the deficiencies that have been noticed, the
samples that have been followed, and the evaluations of the Site Master File (SMF). It includes
the summary and the recommendations of the inspection team.
Contents of Inspection Report:
-
Name and address of the company
-
Name and address of the manufacturing site
-
A summary of the main manufacturing operations carried out by the company
-
Inspection Date
-
Name of head and members of Inspection team
-
Scope of inspection on production line/s required for inspection.
-
Names of responsible persons met during the Inspection visit.
-
Date of previous inspection visit (if present).
-
Areas and systems audited. (Appendix 12)
-
Specifying the samples followed up
-
Remarks and deficiencies
-
Summary of inspection
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-
Recommendation
-
Attachments (Inspection plan, any other attachments………)
Appendix (11)
Inspections Team Qualifications
The inspection team is formed of qualified inspectors who are capable of taking decisions
and who are fully aware of the regulations and laws related to their field and tasks, in addition of
being aware of the fundamentals of English, and having the following qualifications:
1. Head of Inspection Team:
 Must be an inspector pharmacist who is currently working in Drug Control and Inspection
Department with an experience of not less than five years in the field of inspecting
pharmaceutical manufacturing companies.

Must have participated in workshops or training courses in the field of Good
Manufacturing Practice.

Must deliver at least two lectures yearly at JFDA, or presenting at least two papers
tackling technical and legal information on industry and inspection, or supervising two
courses annually, or attending two workshops annually.

Must be actively inspecting local pharmaceutical manufacturing companies in accordance
with the Good Manufacturing Practice Guidelines.
2. First Member:
 An Inspector Pharmacist working in the Control and Inspection Department with an
experience of not less than three years in the field of inspecting pharmaceutical
manufacturing companies.

Must have participated in workshops and training courses in the field of Good
Manufacturing Practice.
20

Must have conducted not less than five inspections yearly on local pharmaceutical
manufacturing companies, in accordance with Good Manufacturing Practice Guidelines.
3. Second Member:
 An inspector pharmacist working in the Control and Inspection Department with an
experience of not less than one year in the field of inspecting pharmaceutical
manufacturing companies

Must have participated in workshops or training courses in the field of Good
Manufacturing Practice.

Must have conducted not less than ten inspections yearly on local pharmaceutical
manufacturing companies, in accordance with Good Manufacturing Practice Guidelines.
Appendix (12)
Areas and systems to be inspected
1) Warehouse:
-
Receiving area
-
Sampling area
-
Quarantine area
-
Stock control
-
Storage conditions
-
Rejected materials
-
Printed materials
-
Dispatch/Distribution
-
Standard Operating Procedures (SOPs) and records
-
IT inspection
2) Production:
-
Clothing/sanitation and hygiene
21
-
Personnel flow
-
Raw material flow…Process flow
-
Finished product flow
-
Dispensary
-
Manufacturing operations
-
In process control ( IPC)
-
Production lines (liquid, solid… Etc)
-
Processing and processing area:
a) batch records
b) time limitation
c) SOPs & log book
-
Equipment:
a) construction Equipment
b) cleaning and maintenance equipment
-
Facilities design
-
Packaging operations
-
Change parts storage and control
-
Hygiene and cleanliness
-
Standard Operating Procedures ( SOPs) and records
-
Environmental control and monitoring
3) Quality Assurance:
-
Layout of the plant
-
Organization and responsibilities
-
Documentation system ( document control and issuance)
-
Change controls
-
Training
-
Internal quality audits
-
Product recalls
-
Product complaints
-
Batch record review and release
-
Annual product review
22
-
Signature records
-
Risk management system
-
Contract manufacturing / analysis
-
Pest control
-
Job description and qualification
-
Returned products
-
Health checking system
-
Vendor qualification
4) QC Labs:
-
Organization and responsibilities
-
Specifications ( Raw material, Packaging material, Finished product)
-
Test method
-
Analytical reports
-
Sampling plans
-
Out of specifications reports, investigations
-
Microbiology lab and testing
-
Stability rooms and reports
-
Reference/ working standards
-
Retained samples
-
QC identification system
-
Standard Operating Procedures ( SOPs) and records
-
Analytical instrument, qualification and calibration
-
Release and reject decision
-
Procedure available for:
a) Contamination prevention
b) Detergent selection and sanitizer
c) Raw material retesting system
-
Starting material and finished product approval
-
Sampling instruments
5) Utilities and engineering:
-
Layout of water treatment system
23
-
Layout of HVAC system
-
Pure steam
-
HVAC and Dust Extraction
-
Compressed air system
-
Preventative maintenance program
-
Calibration
-
Standard Operating Procedures ( SOPs) and records
-
Waste water treatment
6) validation:
-
Validation master plan
-
Equipment qualifications
-
Water treatment qualifications
-
Cleaning validation
-
Process validation
-
Validation of analytical method
-
HVAC qualification
-
Cross- contamination- control
-
Sensitizing and potent product
-
Campaign Production
7) Calibration:
-
Equipment calibration
-
Balance calibration
8) Others
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