شنبه ٠٣ آبان ١٣٩٣
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Biologic

Organization Chart:

-Head of department

-Vaccine section: -Bacterial , Viral and Recombinant Vaccines and therapeutic Serums

-Plasma derivatives Section: Immunoglobulin’s, Albumin , Anti-coagulant factors

-Recombinant products & Monoclonal antibodies Section

-Cell and Tissue derivatives Section

-Secretary

Services:

Generally biological department activity is supervision on production and control of biological products as follows:

ØA- Registration procedure

•There is a registration system for review of internal or imported products document and Compliance study between them and International or internal requirement or standards befor being in the market.

•There is no difference between internal or imported products in registration requirements.

•Biological departments activity is according to Drug production and importing guideline and rules.

•All Kind of variation must be informed to biological department

  ØB- GMP Inspection

 •Compliance of production site with GMP requirements for approving consistency of manufacturing efficient, qualified and safe products, must be evaluated.

•Inspection team, Visit production site (in Iran or foreign country) according to Iranian GMP requirements in following time table:

1- registration time

2-periodic

3- major variations

4- complaints from market (if it related to production conditions).

5-Action plan follow-up in appropriate intervals

ØC –Lot Release

 •Control of biological products is most important because of variability and contamination possibility of this products. Based on drug rules each final lot of a licensed biological product must be assess before it is released onto the market.

NRA experts review the document according to registration file. Sampling carry is carriedon guidelines and SOP by NCL, in appropriate intervals.

•Lot release certificate is issued after document review.

ØD _ Clinical Trial Study

•Clinical trials study is one of the registration steps and has been done according to international guidelines and standard protocols by respective comity.

•If necessary biological department apply clinical trial based on regulations from pharmaceutical company.

•Review of protocols and clinical trials data id duty of clinical trial expert committee.

• Every pharmaceutical company should have passive ADR collection system and send data to ADR department refer to SOP No 7350 Date 84/7/19

Ø E _ Consultative Committees:

•For each type of biological products there are some consultative committees in order to give suggestion and reply to any unknown question

•The member of these committees should complete the conflict of interest and confidentiality forms.

List of personnel

-          Head of biological department:

Dr.Mohammad gheisar zadeh

-          Responsible Expert of Vaccines and therapeutic serums:

Dr. Saeedeh Fakhrzadeh

Experts of Vaccines and therapeutic serums:

Dr. Mahbubeh Valadkhani

Dr. Maryam Abousaber

Mrs. Mahtab Hajheydari

-          Responsible Expert of plasma derivatives:

Dr. Aida Zarbakhsh

Experts of plasma derivatives:

Dr. Mahin Jouharian

Dr. Mitra Gheraati

Dr.Marzieh Shahabi

Dr.Ali Vasheghani Farahani

-          Responsible Expert for Recombinants:

Dr.Abbas Tahzibi

Expert of Recombinants:

Dr.Shahrokh Veisi

Dr.Nazila Hassan Nia

Dr.Sepideh Safari

-          Expert of cell and tissue derivatives section

Dr.Behnush Zare

 

Secretaries:                                                                                                                          

Mrs. Mokaram mejdar khalkhali

       Hanieh Jafari

 

Application Forms

Application form for shippment certificate of  biological products

•Application form for sample delivery to NCL

•Application form for lot release

•Application form for recall

Application form for SPC

• Application form for renewal of manufacturing or importing license of biological products.

• Application form for registration of biological products.

• Applicatorm for Sample sending to NCL

 

check list of registration file for recombinants and monoclonal antibodies

check list of registration file for plasma derivatives

•check list of registration file for vaccine

check list for preview of registration file by authorized person

•Summary of product characterization of biological products.

Flow chart

  registration flow chart  .

lot release flow chart  .

Regulations:                

Regulations for registration of  locally produced and imported products .

• Regulations for establishment license (either for local manufacture or imports).

• Regulations for good distribution practice.

• Regulations on adverse drug  reaction reporting .

• Regulations for establishment of private plasmapheresis center.

Regulations for license renewal of biological products.

Regulations for contract manufacturing .

Regulation for Releasing Biological Products by the Authorized Person

• Regulations for biological shipments temperature monitoring.

Regulations for plasmapheresis center

• Regulations for lot release of biological products without summary protocol.

• Regulations for bilingual lable and packaging of biological products .

• Regulations for manufacturing in investigation and research centers.

• Regulations for Recall

 Regulation for Pharmacovigilance

Guidelines:

Guideline for biological products definition and characterization.

• Guideline for registration of biological products.

• Guideline for quality evaluation of biological products.

• Guideline for viral safety evaluation of biotechnological products derived from mammalian cell.

• Guideline for Biosimilar products

• Guideline for analysis of cell expression for recombinant proteins.

• Guideline for stability study for recombinant products.

• Guideline for derivativing  and characterization of cell substrates for production of recombinant products.

• Guideline for comparability study of biological products in case of major variations.

• Guideline for characterization, analytical methods and specifications for biological products.

• Guideline for labeling of biological products.

• Guideline for variations in biological products.

• Guideline for preparation of registration dossier for biological products.

• Guideline for preparation of site master file for biological products.

• Guideline for lot release of biological products.

• Guideline for establishment license of biological products.

• Guideline for regulatory inspection of biological products manufacturers.

• Guideline for sampling.

• Guideline for classification of non conformities in inspection.

• Guideline for providing PSUR to Iran ADR center.

• Guideline for number of samples for NCL. 

Guideline for definition and specification of biologic products

  

Ø•Index

•list of recombinant products

ØSPC of registered products in biological department

•SPC of Agrippal

•SPC of Engerix

•SPC of Fluarix

•SPC of Hepavax – Gen

•SPC of Inflexal

•SPC of Influvac

•SPC of Mencevax

•SPC of Albumin from Grifos

•SPC of Avonex

•SPC of Betaferon

•SPC of Ig Vena

•SPC of Intratect

•SPC of Koate

•SPC of Plasbumin

•SPC of Tetagam

•SPC of Striptease

•SPC of MMR Vaccine

•SPC of Rabipur

•SPC of Euvax- B

•SPC of Hepatits – B (r DNA) from Pasteur Institute

•SPC of Polio Vaccine from Razi

•SPC of B.C.G Vaccine from Pasteur Institute

•SPC of Anti Scorpion Serum Razi

•SPC of Anti Snake serum from Razi

•SPC of DT Vaccine from Razi

•SPC of dT Vaccine for Adult from Razi

•SPC of DTP Vaccine from Razi

•SPC of DTP Vaccine for adult from serum Institute of India

•SPC of DTP Vaccine from serum Institute of India

•SPC of Botulinium Antitoxin Trivallent type A + B + E

•SPC of Botulinium antitoxin monovallent type A

•SPC of Botulinium antitoxin monovallent type B

•SPC of Botulinium antitoxin monovallent type E

Contact number: + 9821 66466057

Internal code: 721

Farsi Biologic home page

E . mail : Biologic@Fdo.ir

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