Company Profile for Toll Pharmaceutical Manufacturer

Company Profile For Toll Pharmaceutical Manufacturer

SECTION – A: general information

A.1: Company Information.

company 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:
Membership in the chamber of the medicinal industry / Date of issue
Invalidation date

a.2: Personnel.

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

Position / Name / Qualification / Experience / Tel/Fax / E-mail
Chair man
Managing Director
Registration Manager
Authorized Person
Company Consultant

·  Number of personnel in total:

Section – B: Manufacturing.

B.1: manufacturing SITE.

Please complete the following for each manufacturing site.

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

B.2. Quality Control

Nominate different QC labs you have.

1. / 2.
3. / 4.

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

Yes / No

Explain?

SECTION – c: Relationships.

c.1: Information about other branches located in the Arab republic of Egypt

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:

c.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

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

Company Name / Country / Relationship

c.4. 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.

c.5. Research and development activities

Please indicate the type of activities and annual investment

c.6. 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

c.7. Stock

*  Do you maintain a permanent stock?

Yes / Contract storage

If yes Please fill the following table for each one:

Postal address:
Physical address:
Telephone:
Fax:
E - mail address:
P.O.Box:
The MOH Register / Date of Issue:
Type of activity:
Responsible person: / Name:
Qualifications:

If contract stocks, Please fill the following table for each contract stock:

Name:
Postal address:
Physical address:
Telephone:
Fax:
E - mail address:
P.O.Box:
The MOH Register / Date of Issue:
Type of activity:
Responsible person: / Name:
Qualifications:
Products :

Section – d: Products

d.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 / Manufacturer
1.
2.
3.
4.

Products under Registration:

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

d.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.

d.3. 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?

D.4. 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

D.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 – e: Whole sale distribution information

Please specify the whole sale distributers for your products:

Whole sale distributer name / Products

SECTION – f: 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 بالشركات Toll

Å  معلومات خاصة بالشركة : (مع الإطلاع على الأصل)

1.  صورة من السجل التجارى.

2.  صورة من البطاقة الضريبية.

3.  صورة من ترخيص المصنع الذي يتم التعامل معه.

4.  صورة من ترخيص مكتب علمي للشركة.(إن وجد)

5.  صورة من عقد الشركة.

6.  صورة من شهادة عضوية غرفة صناعة الدواء.

7.  صحيفة الشركات ( يتم تقديمها كل 6 أشهر).

8.  عقود التصنيع مع جميع المصانع و المخازن التي يتم التعامل معها.

Å  معلومات عامة عن الشركة :

·  تفاصيل المستحضرات الخاصة بالشركة من حيث الآتي:

1.  (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).

2.  صور من الإخطارات النهائية لدى الشركة و صور من الموافقات التي حصلت عليها.

Å  معلومات عن قسم التصدير:

1.  يتم إرفاق تفاصيل موقف المستحضرات المقدمة في كل بلد (سواء مسجلة أو مقدمة للتسجيل).

2.  في حالة وجود فرع للشركة خارج جمهورية مصر العربية، يتم إرفاق تفاصيل المعلومات الخاصة بالمستحضرات التي يتم إنتاجها هناك.

Å  بالإضافة إلى الآتي:

1.  أسماء الشركات والبلاد التي تزود الشركة بالمواد الخام المستخدمة في التصنيع.

2.  اعتماد الشركات المصنعة للمواد الخام من بلد المنشأ

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

Email: Website: http://eda.mohp.gov.eg