Company Profile for Factories

Company Profile For Factories

SECTION – A: general information

A.1: Sector.

Public Sector / Investment Sector / Multi National

A.2: TYPE of License.

Human / Veterinary / Cosmetics
Insect Pesticide

A.3: Manufacturer Information.

Factory Name:
Abbreviation:
Postal address:
Physical address:
Telephone:
Fax:
Website address:
Contact E - mail address:
P.O.Box:
The Register of Trade: / Date of Issue:
Type of activity:
The Tax Card: / Date of Issue:
Type of activity:

Section – B: Manufacturing.

B.1: manufacturing SITE.

Factory Name:
Abbreviation:
Physical address:
Year of built:
Activity (Nominate production lines):
Recent Upgrades:
Planned future upgrade or expansion:

B.2: Production Line.

The present working production lines:

Solid Dosage Form / Tablets / Hard Gelatin Capsule / Soft Gelatin Capsules
Powder / Effervescent Powder / Effervescent tablets
B- Lactam Tablets / Cephalosporin Tablets / Hormonal Capsules
B- Lactam powder for suspension / Cephalosporin Powder for suspension / Dry mix
Granules / Others
Semi Solid Dosage Form / Cream / Ointment / Gel
Suppositories / Paste / Others
Solution / Oral Drops / Syrup / Lotion
Paint / Topical Solution / Others
Sterile Area / ampoules / Solution in Vial / Powder in vial
Irrigation solution / B-Lactam vial / Cephalosporin vial
Eye drops

In case of others, maintain it :………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

B.3: Personnel.

Please indicate the name, qualification and years of experience of the following key staff:

Position / Name / Qualification / Experience
Managing Owner
Managing Director
Production Manager
Quality control Manager
Quality Assurance Manager

Number of personnel in total:
Number of personnel in production:
Number of personnel in quality assurance:
Number of personnel in quality control:
Number of personnel in Scientific office:

B.4.: Ventilation System

Please indicate whether the manufacturing areas are equipped with controlled ventilation systems

Yes / No

If yes, please give a brief description of the ventilation system.

Attach lay out showing the following:

Code of AHU supplying each area.
Classification of each manufacturing area.
Differential pressure between different rooms.

If No, explain why?

B.5. Quality Control

Nominate different QC labs you have.

1. / 2.
3. / 4.

Do you have facility and equipments to perform all analysis and testing for your products?

Yes / No

If No, explain why?

Do you subcontract any third party to perform any testing (if yes nominate the test name and where it is performed)?

Yes / No

If No, explain why?

SECTION – C: Regulatory Issues

C.1. Good manufacturing practice

Indicate the GMP standards with which the company complies. (Attach any documented evidence or certificates you have).

WHO Standard / PIC Standard
EU Standard / FDA Standard
Others

C.2.: Manufacturing license for medicinal products:

Please list the pharmaceutical dosage forms you are licensed to manufacture by the National Regulatory Authority and attach a copy of the Manufacturing license(s)

C.3 Inspection:

Date of last inspection by a National Drug Regulatory Authority:---/---/-----

SECTION – D: Relationships.

D.1: Information about scientific office / administrative headquarters of the plant

Postal address:
Physical address:
Telephone:
Fax:
E - mail address:
P.O.Box:
The Register of Trade: / Date of Issue:
Type of activity:
The Tax Card: / Date of Issue:
Type of activity:

D.2: Affiliates.

If the company is owned by another company, or belongs to a group of companies, please describe your position within the structure.

Name of company / Position within the structure

D.3: Name and address of foreign & Local companies to cooperate or participate in the effectiveness of this plant in the field of medicine and the nature of the relationship between them (Manufacturing or participation agreement)

Company Name / Country / Relationship

D.4. Contract manufacture

Kindly indicate if you undertake contract manufacture for other companies?

Yes / No

If yes, indicate the type of products (e.g. pesticides, antibiotics, hormones, cytotoxic, etc,).

Do you subcontract to other companies?

Yes / No

If yes, please list products and/ or services.

D.5. Complaints and Recalls

Do you have a recall procedure, which enables you to recall any product effectively and promptly within 24 hours from the distribution points or market?

Yes / No

If yes, please list products and the method of recall.

Do you have a procedure for complaints handling?

Yes / No
If yes, explain?
Does it cover analysis of trends? / Yes / No

If yes, explain?

-Please indicate significant product complaints and any recalls the last three years.

D.6. Research and development activities

Please indicate the type of activities and annual investment

D.7. Production capacity

Dosage form / No. of units per year / Last year’s production units
Tablets
Capsules
Ampoules
Vials, liquids
Vials, dry powder
Vials, lyophilized
creams
Liquids
Powder for oral suspensions
Suppositories
Penicillin, tablets / capsules
Penicillin, powder for oral suspension
Penicillin, powder for injection
Other, specify

Is production capacity figures based on one or more shifts?(Tick in appropriate box)

1 / 2 / 3

D.8. Stock

Do you maintain a permanent stock?

Yes / No

D.9. Quality Systems (Including Quality Management and Quality Assurance)

Give a brief description of the Quality Management system, with specific reference to aspects such as organization, documentation, infrastructure, validation, training, statistical analysis, and other related aspects).

Section – E: Products

E.1. Product licenses

Please enclose a list of all products manufactured by your company and authorized please complete the table below and categorize as follows:

Product name / Generic Name / Shelf life / Registration no. / price
1.
2.
3.
4.

Products under Registration:

Product name / Generic Name / Date of approval
1.
2.
3.
4.

E.2. Documentation

The following product documentation must, upon request, be available for each product offered:

1. / Product Composition / 5. / Starting materials specification
2. / Master Formula / 6. / Manufacturing and packaging specifications
3. / Finished product specification / 7. / In process test specifications and methods
4. / Packaging and labeling specifications / 8. / Analytical procedures

Please indicate if this documentation is NOT available for any of the products on the list, Point E.1.

Upon request, "the common product questionnaire" must be completed and returned.

E.3. Starting materials

List starting materials manufacturing by the company or by affiliates, fill in the table below:

Material name / category / Specification according to which pharmacopeia

Are all steps completed in your company? (If no explain?)

Yes / No

If No, explain?

E.4. Stability studies and shelf – life

Do you perform initial and on-going stability studies on your production?

Yes / No

Give a brief description of the stability procedure and program.

What type of studies do you carry out? Fill in the table below:

Type / Temperature / Relative Humidity
Accelerated studies
Real-time studies
Ongoing stability

How do you determine the shelf life of your product?

E.5. Bio – Equivalence

Have you conducted in vivo Bioequivalence studies for some of your products?

Yes / No

If yes, fill the table below:

Product / Reference product / Place contracted to do study

E.6. Retention samples

Do you keep retention samples?

Yes / No

If yes, fill the table below:

Samples / Yes / No / Retention period / Storage conditions
Each finished product
Active pharmaceutical Ingredients
Excipients

SECTION – F: Audit

Is a site Master File (PIC or WHO format) available upon request?

Yes / No

Will additional information be provided if we wish to perform an audit of the company?

Yes / No

SECTION – g: Other information

Contact person (commercial issues):

Name:
Telephone:
Fax:
E-Mail:

Contact person (quality issues):

Name:
Telephone:
Fax:
E-Mail:

Contact person (regulatory affairs):

Name:
Telephone:
Fax:
E-Mail:

Add any other information:

I hereby certify that the information given in this questionnaire and the attachments is correct and true.

Name Position Signature

Date:

المرفقات الخاصة بالمصانع

معلومات خاصة بالمصنع :

صورة من السجل التجاري (الإطلاع على الأصل).
صورة من البطاقة الضريبية (الإطلاع على الأصل).
صورة من رخصة المصنع.
صورة من ترخيص مكتب علمي (الإطلاع على الأصل).

أسماء وعناوين الشركات الأخرى التي تتعاون أو تشارك هذه الشركة في فعاليتها في حقل الدواء وما طبيعة العلاقة بينهما:

صور من العقود الخاصة بهذه الشركات و ملاحق العقود.

معلومات عامة عن الشركة :

تفاصيل المستحضرات الخاصة بالشركة من حيث الآتي:

(في أي مرحلة من مراحل التسجيل – نوع التسجيل – المادة الفعالة – التركيز – الشكل الصيدلي – العبوة – السعر الجبري) مقسمة إلى مجموعات دوائية، مع إرفاق إخطار التسجيل الخاص بكل مستحضر وإخطارا لتسعير(في حالة المستحضرات المسجلة والمسعرة فقط).
يتم إرفاق أسماء المستحضرات الخاصة بالشركة والتي يتم تصنيعها في أماكن أخرى وأين يتم التصنيع مع ذكر السبب.
صور من الإخطارات النهائية لدى الشركة و صور من الموافقات التي حصلت عليها.

معلومات عن قسم التصدير:

يتم إرفاق تفاصيل موقف المستحضرات المقدمة في كل بلد (سواء مسجلة أو مقدمة للتسجيل).
في حالة وجود فرع للمصنع خارج جمهورية مصر العربية، يتم إرفاق تفاصيل المعلومات الخاصة بالمستحضرات التي يتم إنتاجها هناك.

الشهادات المعتمدة التي حصلت عليها الشركة:

يتم إرفاق صورة هذه الشهادات من (GMP, ISO,…….. ,Others).

بالإضافة إلى الآتي:

أسماء الشركات والبلاد التي تزود الشركة بالمواد الخام المستخدمة في التصنيع.
اعتماد الشركات المصنعة للمواد الخام من بلد المنشأ

تليفون : 23684288 – 23648046 – 23640368 – 23648769 داخلي:211 فاكس : 23684194

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