Laboratory for Quality Control of Medical Immunobiological Products

 

                             
                                   
                                     
                                   
                                     
                                   
                                     
                               



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Address: 

9, Mykola Amosov St., Kyiv, 03680, Ukraine

Head of Structural Department - Natalia Zubkova, Candidate of Biological Sciences

Tel.:(+380-44) 275-2466

Deputy Head of Structural Department - Oleksandr Makushenko, Candidate of Medical Sciences

Tel.: (+380-44) 275-3788

Inquiries (otherissues) Tel./Fax: (+380-44) 393-7583

The Laboratory MIP includes the following units:

-         Viral and Immunological Studies;

-         MicrobiologicalControl;

-         Physical and Chemical Control Methods;

-         Vivarium;

-         Quality Assurance.

Main areas of Laboratory’s activity:

-  Qualitycontrol (in established order) ofmedical immunobiological products (hereinafter – MIP) and other domestic-andforeign-made  medicinal products, which are used, manufactured or proposed for use in medical practice in Ukraine, which undergo registration (re-registration) or already registered in Ukraine;

- Testing methods of quality control of MIP and other medicinal products.

Functions of the Laboratory:

  1. Quality control (in established order) of MIP and other medicinal products, which undergo registration (re-registration) procedure in Ukraine, and issue a study protocol on compliance with draft regulation.
  2. According to MoH Ukraine’s referral, state quality control of MIP, being at the market of Ukraine, and issue of Statement on MIP compliance with quality parameters.
  3. Laboratory has been authorized to perform quality control of medicinal products and health products according to Order of State Administration of Ukraine on Medicinal Products № 794 as of 14.06.2013.
  4. Quality control of MIP and other medicinal products on request of other organizations.

 Certification/accreditation of the Laboratory:

  • Certificate №178 as of 04.06.2013 issued by State Administration of Ukraine on Medicinal Products (expiration date 15.05.2016) regarding organization of independent laboratory quality control of medicinal products according to the field of certification.
  • Certificate № ПТ-77/13 as of 04.03.2013 issued by Public Enterprise “All-Ukrainian State Scientific and Production Center of Standardization, Metrology, Certification and Customer Protection” (expiration date 03.03.2016 р.). Certificate indicates that Laboratory for Quality Control of MIP has been certified to measure object parameters according to the field.
Procedure of analysis of medicinal products submitted to the Laboratory for state registration (re-registration)
  1. The Applicant is to submit to Laboratory:
    - Draft quality control methods (hereinafter – QCM) which contains information about composition of medicinal product, specifications and control methods specified in registration materials (3 copies).
    - Referral to analysis from Public Enterprise “The State Expert Center of the Ministry of Health of Ukraine (hereinafter – the Center), issued by Center’s expert, signed by Center’s General Director or authorized person and note of the Center’s Financial and Economic Department (FED) about availability of contract for analysis of medicinal product.
  2. Laboratory draws up a letter of inquiry to the Applicant, which contains information about:
    - Number of product samples to be submitted to the Laboratory for total quality control according to the draft regulation to be repeated twice;
    - List and number of reference standards and reagents needed for laboratory control if there are none in Laboratory.
  3. The Applicant is to submit to Laboratory:
    - Samples of product batch in quantity specified in letter of inquiry;
    - Manufacturer’s quality certificate with product name, batch number, date of production, expiration date, regulations according to which the certificate has been issued;
    - Reference standards and reagents (if necessary), specified in letter of inquiry, with manufacturer’s quality certificate.

State quality control of MIP

The Laboratory performs state quality control of medical immunobiological products based on MoH Ukraine referral.
If referral for quality control has been received:
  1. The Laboratory draws up a letter of inquiry to the Applicant, which contains information about:
    - Number of product samples to be submitted to the Laboratory for two total analyses according to the analytical regulation based on parameters specified in MoH Ukraine referral;
    - List and number of reference standards and reagents needed for product quality control if there are none in the Laboratory.
  2. The Applicant is to submit to the Laboratory:
    - Manufacturer’s quality certificate with product name, batch number, date of production, expiration date, regulations according to which the certificate has been issued;
    - Copies of quality control regulation;
    - Samples of MIP batch in quantity specified in letter of inquiry;
    - Reference standards and reagents (if necessary), specified in letter of inquiry, with manufacturer’s quality certificate.

The Laboratory shall accept product samples if quality control has been paid in full and if they have been delivered with observance of “cold chain” requirements.
Quality control shall start if the Applicant has submitted the required number of product samples, reference standards/reagents and paid cost of works in full.