Microsoft word - report on lab activities.doc

QUALITY CONTROL LABORATORY
Monrovia, Liberia
Report on Activities Covering March-April, 2013
INTRODUCTION
The Quality Control Laboratory of the Liberia Medicines and Health Products Regulatory Authority is concerned with the qualitative and quantitative analyses of medicines and medicinal products, with as much accuracy as possible, to ensure the quality, safety and efficacy of medicines in line with the vision of the authority. Therefore, the laboratory continually tests all products submitted to it from the other departments within the authority. Such testing is done within the scope of its available resources which are limited. Currently, the department has six (6) staff employed on probation. They include three (3) pharmacists, two (2) chemists, and a laboratory technologist. A. WORK PLAN: Please see attachment.
B. ACHIEVEMENTS:
Sample Analyses: During the period under review, the laboratory analyzed fifty (50)
samples. These include samples from both Registration and Inspectorate Departments, twelve
(12) samples from the National Aids and Sexually Transmitted Infections Control Program
(NACP & STIs).
Additionally, the laboratory successfully participated in the first NOMCOL-Africa
Proficiency Testing. For this Proficiency Testing, the laboratory received ciprofloxacin
tablets from PQM/USP.
Results: The results of these analyses are herein tabulated.
Source of Medicines # of Samples
Received
Proficiency
Test
PERCENTAGE
The laboratory has completed a preliminary investigation of forty three (43) herbal products and /or concoctions received from the Ministry of Health & Social Welfare, Liberia. Our findings show the following faults about these herbals: i) No labels to establish the identity of the herbs (i.e., active ingredients & therapeutic ii) Foul odor was noticed, suggesting that some of the ingredients may have decayed and iii) Random pH sampling showed that some of the drugs were unfit for human consumption because the pH determined did not conform to the acceptable pH range for human consumption ( Two persons from the Laboratory Department successfully participated in the evaluation of some 200 dossiers from the Registration Department (April 15—19, 2013). Trainings
The laboratory held a one week training seminar on Laboratory Quality Manual writing (March 20-27, 2013). The result of this training was the drafting of the Laboratory Quality Manual for onward presentation to LMHRA management. Also, thirty-three (33) Standard Operating Procedures (SOPs) are being re-written. The laboratory Quality Control Manager participated in a 3-day training program on ECOWAS Medicines Registration Harmonization-Common Technical Document, held in Accra, Ghana from April 17-19, 2013 under the auspices of West African Health Organization (WAHO). C. ITEMS RECEIVED FROM PQM/USP (JANUARY 2013 – PRESENT)
REFERENCE STANDARDS
Name of Standard
Quantity
Ciprofloxacin Ethylenediamine Analog (25 mg) CHEMICALS/REAGENTS & OTHERS

D. CHALLENGES/CONSTRAINTS
1. UV-Vis spectrophotometer developed additional fault which cannot be repaired by the local technician. 2. Water purification unit is faulty and no local technician is available to repair it. Consequently, the lab depends on HPLC-grade water which is usually supplied by PQM/USP. 3. The low capacity of the stand-by generator which hinders the progress of the lab, and often renders the lab environment unsuitable for analysis. E. RECOMMENDATIONS
1. A new UV-Vis spectrophotometer needs to be procured. 2. A new water purification system needs to be procured or the existing one be repaired. QUALITY CONTROL LABORATORY
Monrovia, Liberia
Report on Activities Covering March-April, 2013
INTRODUCTION
The Quality Control Laboratory of the Liberia Medicines and Health Products Regulatory Authority is concerned with the qualitative and quantitative analyses of medicines and medicinal products, with as much accuracy as possible, to ensure the quality, safety and efficacy of medicines in line with the vision of the authority. Therefore, the laboratory continually tests all products submitted to it from the other departments within the authority. Such testing is done within the scope of its available resources which are limited. Currently, the department has six (6) staff employed on probation. They include three (3) pharmacists, two (2) chemists, and a laboratory technologist. A. WORK PLAN: Please see attachment.
B. ACHIEVEMENTS:
Sample Analyses: During the period under review, the laboratory analyzed fifty (50)
samples. These include samples from both Registration and Inspectorate Departments, twelve
(12) samples from the National Aids and Sexually Transmitted Infections Control Program
(NACP & STIs).
Additionally, the laboratory successfully participated in the first NOMCOL-Africa Proficiency Testing. For this Proficiency Testing, the laboratory received ciprofloxacin tablets from PQM/USP. Results: The results of these analyses are herein tabulated.
Source of
Medicines
Received
Proficiency Test
PERCENTAGE
The laboratory has completed a preliminary investigation of forty three (43) herbal products and /or concoctions received from the Ministry of Health & Social Welfare, Liberia. Our findings show the following faults about these herbals: No labels to establish the identity of the herbs (i.e., active ingredients & therapeutic indications) Foul odor was noticed, suggesting that some of the ingredients may have decayed and accumulated microbial growth. Random pH sampling showed that some of the drugs were unfit for human consumption because the pH determined did not conform to the acceptable pH range for human consumption ( Two persons from the Laboratory Department successfully participated in the evaluation of some 200 dossiers from the Registration Department (April 15—19, 2013). Trainings
The laboratory held a one week training seminar on Laboratory Quality Manual writing (March 20-27, 2013). The result of this training was the drafting of the Laboratory Quality Manual for onward presentation to LMHRA management. Also, thirty-three (33) Standard Operating Procedures (SOPs) are being re-written. The laboratory Quality Control Manager participated in a 3-day training program on ECOWAS Medicines Registration Harmonization-Common Technical Document, held in Accra, Ghana from April 17-19, 2013 under the auspices of West African Health Organization (WAHO). C. ITEMS RECEIVED FROM PQM/USP (JANUARY 2013 – PRESENT)
REFERENCE STANDARDS
Name of Standard
Quantity
10. Ciprofloxacin Ethylenediamine Analog (25 mg) 12. Zidovudine Related Compound B (25 mg) 13. Zidovudine Related Compound C (100 mg) CHEMICALS/REAGENTS & OTHERS
D. CHALLENGES/CONSTRAINTS
1. UV-Vis spectrophotometer developed additional fault which cannot be repaired by the local technician. 2. Water purification unit is faulty and no local technician is available to repair it. Consequently, the lab depends on HPLC-grade water which is usually supplied by PQM/USP. 3. The low capacity of the stand-by generator which hinders the progress of the lab, and often renders the lab environment unsuitable for analysis. E. RECOMMENDATIONS
1. A new UV-Vis spectrophotometer needs to be procured. 2. A new water purification system needs to be procured or the existing one be repaired.

Source: http://www.libmhra.org/downloads/Report%20on%20Lab%20Activities.pdf