National quality control laboratory

National quality control laboratory

National Quality Control Laboratory


Quality control, or QC for short, is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as “A part of quality management focused on fulfilling quality requirements”

Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate.

Access to quality, safe and effective medicines is the cornerstone of any public health program and it requires an effective management system to ensure their quality. Thus, a big part of tackling Kenya’s problem involves increasing the capacity of its Ministry of Health’s National Quality Control Laboratory (NQCL) to ensure that the medicines available to the public are safe and of good quality.

National Quality Control Laboratory


National Quality Control Laboratory

It was first set up as Drug Analysis & Research Unit (DARU) at the University of Nairobi, Department of Pharmacy through facilitation of the Ministry of Health in 1978.
In 1992 the Government of Kenya through an Act of Parliament; CAP 244 Section 35D (Pharmacy & Poisons (Amendment) Act, 1992); established the Laboratory as a legal entity.
In 1999 it became fully operational and handed over to the Kenyan government by Germany Government

Mandate of National Quality Control Laboratory


The examination and testing of drugs and any material or substance from or with which and the manner in which drugs may be manufactured, processed or treated and ensuring the quality control of drugs and medicinal substances;

Performing chemical, biological, biochemical, physiological and pharmacological analysis and other pharmaceutical evaluation; and

Testing, at the request of the Board and on behalf of the Government, of locally manufactured and imported drugs or medicinal substances with a view to determining whether such drugs or medicinal substances comply with this Act or rules made there under.

Services offered by National Quality control laboratory


Below are some of the tests conducted by National quality Control Laboratory on Pharmaceuticals and Non Pharmaceuticals:

Wet Chemistry

  • Physical Characteristics,
  • Uniformity of weight,
  • Uniformity of content,
  • Disintegration,
  • Friability,
  • Identification,
  • Assay (UV, Titration & HPLC),
  • Dissolution,
  • PH determination,
  • Polarimetry

Biological Analysis Unit

  • Sterility testing,
  • Microbial limit testing,
  • Preservative efficacy testing,
  • Bacterial Endotoxin testing

Medical Devices

  • Condoms*
  • Gloves*

Current Board of Management for National Quality Control Laboratory


Chairperson:
1. William Mwatu (Dr.)

Members:
2. John Ronoh Sitienei (Dr.),
3. Irene Thiguki Kamanja (Dr.),
4. Georgina Muchai,
5. Lilian Balusi (Dr.),
6. Hellen Bosibori Okioma,
7. Paul Munyao Mutua,
8. Simon Njoroge Muigai (Dr.),
9. Edith Wakori (Dr.),

The above members were appointed by the Chairman of the Pharmacy and Poisons Board, Dr. Jackson Kioko.
The members were appointed for a period of three (3) years from 12th February, 2018.

Contacts / Location of National Quality Control Laboratory


National Quality Control Laboratory

 

National Quality Control Laboratory
Located at:
Hospital Road, KNH Complex,
University of Nairobi School of Pharmacy Building, 2nd Floor, Nairobi, Kenya.

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