General Information

Type of service provider
Testing laboratory
Physical postal address

NO. 17 INDIAN OCEAN STREET
NELSON MANDELA AVENUE SOUTH LEGON COMMERCIAL AREA,
Accra
Ghana

Phone number
+233 302235100/ 233 302233200
E-mail
fda [at] fdaghana.gov.gh
Has the laboratory been accredited in any scopes?
Yes
Scopes of Accreditation
SCOPES: CHEMICAL, MICROBIOLOGY AND MEDICAL DEVICES
Accreditation body
ANAB (ANSI-ASQ NATIONAL ACCREDITATION BOARD)
CERTIFICATE NUMBER- AT-1870
Does the laboratory have other sites?
Yes

Personnel

Chief Executive Officer (CEO) / Head of Organization

CEO Name
MRS. DELESE DARKO
CEO Phone
CEO E-mail
mimidarko66 [at] yahoo.co.uk

Total laboratory personnel

Total laboratory personnel
64
Male laboratory personnel
28
Female laboratory personnel
36

Technical personnel

Technical personnel total
61
Male technical personnel
26
Female technical personnel
35

Technical Information

Testing

Laboratory services offered
Biological
Medical
Chemical
Water / food
Environmental
Scope of services offered
Test object or product tested or matrices
Pharmaceutical and related products
Test parameter/ properties measured
Identification and Assay
Identification and Assay
pH
Dissolution
Loss on drying
Moisture Determination by Karl Fischer
Uniformity of Dosage
Identification
Assay
Optical Rotation
Identification
Total aerobic microbial count
Total yeast and mold count
Sterility
Test for specific organisms
• E. coli
• Salmonella
• S. aureus
• P. aeruginosa
Aerobic microbial count
Type of test/ instrumentation used
HPLC
UV/VIS Spectrophotometer
Potentiometric pH
Meter
Spectrophotometer
HPLC

Gravimetric ovens
Karl Fischer Titrators
Spectrophotometer
HPLC
FTIR
Automatic titrator
Polarimetry
Thin Layer Chromatography
(TCL)
Colony count
Colony count
Direct inoculation
Detection
Colony count
Methods
Current USP-NF<621>and Pharmacopeia Monographs, Current European and British Pharmacopeia
Current USP-NF<857>and Pharmacopeia Monographs, Current European and British Pharmacopeia
Current USP-NF<791> and pharmacopeia Monographs, Current European and British Pharmacopeia
Current USP<711> and pharmacopeia Monographs, Current European and British Pharmacopeia
Current USP<731> and Pharmacopeia Monographs, Current European and British Pharmacopeia
Current USP<921> and Pharmacopeia Monographs, Current European and British Pharmacopeia
Current USP<905> and Pharmacopeia Monographs, Current European and British Pharmacopeia
Current USP<197> and Pharmacopeia Monographs, Current European and British Pharmacopeia
Current USP<541> and Pharmacopeia Monographs, Current European and British Pharmacopeia
Current USP<781> and Pharmacopeia Monographs, Current European and British Pharmacopeia
Current USP<621> and Pharmacopeia Monographs, Current European and British Pharmacopeia
Current USP<61> and Pharmacopeia Monographs, Current European and British Pharmacopeia
Current USP<61> and Pharmacopeia Monographs, Current European and British Pharmacopeia
Current USP<71>and Pharmacopeia Monographs, Current European and British Pharmacopeia
Current USP<62> and Pharmacopeia Monographs, Current European and British Pharmacopeia
ISO 4833-1 AND 2:2013
Accreditation status
Yes
Test object or product tested or matrices
Food and Animal feeding stuffs
Test parameter/ properties measured
Coliform count
Yeast and mold count
Coagulase-positive Staphylococcus aureus count
ᵝ-glucuronidase positive E. Coli count
Clostridium perfringens count
Enterobacteriacease enumeration and detection
Detection of salmonella spp.
Type of test/ instrumentation used
Colony count
culture
Methods
ISO 4832:2006
ISO 21527-1 and 2:2008
ISO 6888-2:1999
ISO 16649-2:2001
ISO 7937:2004
ISO 21528:2:2004
ISO 6579: 2002
Accreditation status
Yes
Test object or product tested or matrices
Water
Test parameter/ properties measured
Pseudomonas aeruginosa enumeration and detection
Type of test/ instrumentation used
Membrane filtration
Methods
ISO16266:2006
Accreditation status
Yes
Test object or product tested or matrices
Environmental
Samples
Test parameter/ properties measured
Pathogenic indicator
Utility microbes
Type of test/ instrumentation used
Environmental monitoring testing
Methods
18593(ISO)
Accreditation status
No
Test object or product tested or matrices
Canned Products
Test parameter/ properties measured
Sterility
Type of test/ instrumentation used
Commercial Sterility testing
Methods
Compendium of methods for the microbiological examination of foods 5th Edition,2015
Accreditation status
No
Test object or product tested or matrices
Food and animal feeding
Test parameter/ properties measured
Bacillus cereus
Type of test/ instrumentation used
Enumeration of bacillus cereus-colony count technique
Methods
ISO 7932
2005
Accreditation status
No
Test object or product tested or matrices
Medical devices-Latex Male condom
Test parameter/ properties measured
Determination of length
Determination of width
Determination of thickness
Determination of burst volume and pressure
Testing for holes
Visible defects
Testing for package seal integrity
Determination of total lubricant for condoms in individual container
Condom sampling
Type of test/ instrumentation used
Dimensional
(Mandrel)
Dimensional
(Ruler)
Dimensional
Digital Thickness Gauge
Accurate Inflation System (AIS)
(Accurate Inflation Tester)
Water Leakage Test)
(Water Leakage Tester/Electric hole Tester)
Visual inspection
Package Seal Integrity
(Water Vacuum Bowl)
Gravimetric
(Balance, Sonicator Bath, Desiccator)
Sampling technique
(Themohygrometer and Camera)
Methods
ISO 4074:2015
Annex D
ISO 4074:2015
Annex E
ISO 4074:2015
Annex F
ISO 4074:2015
Annex H
ISO 4074:2015
Annex M
ISO 4074:2015
ISO 4074:2015
Annex N
ISO 4074:2015
Annex C
ISO 4074:2015
ISO 2859-1
WHO- Male Latex Condom Guidelines, 2010
Accreditation status
Yes
Test object or product tested or matrices
Medical Devices-Sterile Hypodermic Syringes
Test parameter/ properties measured
1. Limits for Acidity or Alkalinity
2. Lubricant


3. Tolerance on Graduated Capacity
4. Nozzle Lumen

5. Dead Space
6. Sterility Test
Type of test/ instrumentation used
1. pH meter, Oven

2. Observation under corrected-to-normal vision
3. Vernier Caliper

4. Vernier Caliper

5. Balance
6. Microbiology Lab
Methods
ISO 7886-1:1993
Accreditation status
No
Test object or product tested or matrices
Medical Devices- Sterile Hypodermic Needles
Test parameter/ properties measured
1. Cleanliness


2. Limits for Acidity or Alkalinity
3. Size Designation

4. Colour Coding
5. Needle Point

6. Sterility
Type of test/ instrumentation used
1. Observation under corrected-to-normal vision
2. pH meter, Oven

3. Vernier Caliper

4.
5. Accordance with ISO 6009
6. Microbiology
Methods
ISO 7864:1993
Accreditation status
No
Test object or product tested or matrices
Medical Devices-Sterile single-use Syringes, with or without needle, for Insulin
Test parameter/ properties measured
1. Freedom from extraneous matter

2. Limits for Acidity or Alkalinity
3. Range of Sizes, Dimensions, Graduation and Numbering of scale
4. Piston/Plunger assembly
5. Force required to operate plunger

6. Dead Space
7. Sterility
Type of test/ instrumentation used
1. Observation under corrected-to-normal vision
2. pH meter, Oven

3. pH meter, Oven

4. Vernier Caliper


5. Balance


6. Microbiology
Methods
ISO 8537
Accreditation status
No
Test object or product tested or matrices
Medical Devices- Sterile Injection Needles for single use
Test parameter/ properties measured
1. Dimensions: But end, Length
2. Needle point


3. Patency of Lumen

4. Colour Coding

5. Sterility
Type of test/ instrumentation used
1. Profile Projector

2. Stereo Microscope with illuminance of 300 lx to 700 lx
3. Needle Lumen Tester
4. Accordance with ISO 6009
5. Microbiology
Methods
ISO 7885:2000
Accreditation status
No
Test object or product tested or matrices
Medical Devices-
Pen-injectors for medical use
Test parameter/ properties measured
1. Colour Coding

2. Dimensions: Length
3. Needle point


4. Lubrication

5. Sterility
Type of test/ instrumentation used
1. Accordance with ISO 6009
2. Vernier Caliper
3. Needle Lumen Tester
4. Observation under corrected-to-normal vision
5. Microbiology
Methods
ISO 11608-2: 2000
Accreditation status
No
Test object or product tested or matrices
Medical Devices- Female Condoms
Test parameter/ properties measured
1. Dimension: Length
2. Dimension: Width
3. Dimension: Thickness
4. Determination of Bursting Volume and Pressure

5. Freedom from Holes
6. Visible Defects
7. Package Integrity

8. Total Lubricant Quantity
Type of test/ instrumentation used
1. Female Mandrel
2. Ruler
3. Digital Thickness Gauge
4. Accurate Inflation System (Female adopter)
5. Water Leakage Testier (Female adopter)
6. Visual Inspection
7. Water Vacuum Bowl
8. Gravimetric, (Sonicator Bath and Desiccator)
Methods
ISO 25841: 2014
Accreditation status
No
Test object or product tested or matrices
Medical Devices-Single-use Sterile Rubber Surgical Gloves
Test parameter/ properties measured
1. Dimensions: Length
2. Dimensions: Width
3. Dimensions: Thickness
4. Water tightness

5. Tensile Properties: (Force at Break and Elongation)
6. Sterility
Type of test/ instrumentation used
1. Ruler
2. Ruler
3. Digital Thickness Gauge
4. Water Leakage Tester
5. Tensile Testing Machine

6. Microbiology
Methods
ISO 10282:2002
Accreditation status
No
Test object or product tested or matrices
Medical Devices-
Sing-use Medical Examination Gloves
Test parameter/ properties measured
1. Dimensions: Length
2. Dimensions: Width
3. Dimensions: Thickness
4. Water tightness

5. Tensile Properties: (Force at Break and Elongation)
Type of test/ instrumentation used
1. Ruler
2. Ruler
3. Digital Thickness Gauge
4. Water Leakage Tester
5. Tensile Testing Machine
Methods
ISO 11193-1:2002
Accreditation status
No
Test object or product tested or matrices
Medical Devices-
Long Lasting Insecticide Nets (Deltamethrin, Alpha-cypermethrin and Permethrin coated)
Test parameter/ properties measured
1. Determination of Deltamethrin content



2. Determination of Alpha-cypermethrin






3. Determination of Permethrin content
Type of test/ instrumentation used
1. HPLC Column: 250x4mm, LiChrosorb Si60 5µm, or equivalent

2. GC Column: fused silica, 30x2.5mm, 0.25µm film thickness, coated with cross-linked dimethyl polysiloxane, DB-1 column, or equivalent
3. GC-FID and Reflux apparatus
Methods
CIPAC (Collaborative International Pesticides Analytical Council)
Accreditation status
No
Test object or product tested or matrices
Medical Devices- Single-use Disposable Baby Diapers
Test parameter/ properties measured
1. Absorption and Retention Capacity
2. Liquid Strike Through Test
3. Rewet Under Load


4. Shear Test
Type of test/ instrumentation used
1. Absorption and Retention Tester
2. Liquid Strike Through Plate
3. Liquid Strike Through Plate, 3.0 Kg wt and Filter paper
4. 1 Kg wt
Methods
GS 1166: 2017
Accreditation status
No
Test object or product tested or matrices
Medical Devices- Zinc Oxide Plaster
Test parameter/ properties measured
1. Content of Zinc Oxide in Adhesive Mass
2. Adhesiveness

3. Weight of Adhesive Mass
Type of test/ instrumentation used
1. Titrimetric

2. Chemistry
Methods
BPC 1973:
Pg. 633
Accreditation status
No
Test object or product tested or matrices
Medical Devices- Plasters (Strips)
Test parameter/ properties measured
1. Weight of Fabric
2. Weight of Adhesive Mass
Type of test/ instrumentation used
1. Chemistry
2. Chemistry
Methods
BPC 1973
Pg. 631
Accreditation status
No
Test object or product tested or matrices
Medical Devices- Giving Set/Infusion Set
Test parameter/ properties measured
1. Cleanliness


2. Dimensions
3. Limit for Acidity and Alkalinity
4. Flow Control
5. Luer Connectors
6. Tube Connectors
7. Sterility
Type of test/ instrumentation used
1. Vernier Caliper
2. pH meter
3. Timer, Beaker and Retort Stand

4. Microbiology
Methods
IFU
Accreditation status
No
Test object or product tested or matrices
Medical Devices- Transfusion equipment for medical use
Test parameter/ properties measured
1. Sterility
2. Leakage
3. Flow Regulator
4. Flow rate of blood and blood components
Type of test/ instrumentation used
1. Microbiology
2. Tensile Tester


3. Timer
Methods
ISO 1135-4: 2004
Accreditation status
No
Test object or product tested or matrices
Medical Devices- Sutures
Test parameter/ properties measured
1. Dimensions

2. Needle attachment

3. Soluble Chromium Compounds
4. Packaging Seal Integrity
Type of test/ instrumentation used
1. Vernier Caliper, Ruler, Thickness Gauge
2. Tensile Testing Machine
3. Chemistry
4. Dry Vacuum Bowl/Water Vacuum Bowl
Methods
US Pharmacopeia/
British Pharmacopeia
Accreditation status
No
Test object or product tested or matrices
Skin care cosmetic products
Test parameter/ properties measured
Corticosteroids
Hydroquinone
Metallic residues
Stability
pH
Type of test/ instrumentation used
HPLC
UV/VIS, HPLC, TITRIMETRY
AAS, Qualitative
Stability chambers, laboratory oven
pH meter
Methods
BP Current, USP Current, ISO
Accreditation status
No
Test object or product tested or matrices
Food and food products
Test parameter/ properties measured
Moisture

pH

Ash

Titrations

Methanol

Metal Analysis

Pesticides Residue Analysis

Sudan Dye Analysis

Fats and Oils

Food Additives

Mycotoxins
Type of test/ instrumentation used
Hot air oven

pH meter

Electrical Furnace

Autotitrator

Gas Chromatograph

Atomic Absorption Spectrophotometer

GC/MISD

HPLC-UV

GC-FID

HPLC-DAD

HPLC-FLD
Methods
AOAC

Validated In-house method

Food Chemical Codex / AOAC
Accreditation status
No
Test object or product tested or matrices
Talc-based product
Test parameter/ properties measured
Presence of asbestos
Type of test/ instrumentation used
FTIR
Methods
BP
Accreditation status
No
Test object or product tested or matrices
Hair care products
Test parameter/ properties measured
pH
Lye content
Type of test/ instrumentation used
pH meter
Titrimetry
Methods
USP, BP, ISO, GS
Accreditation status
No
Test object or product tested or matrices
Insect repellents
Test parameter/ properties measured
Pyrethrin’s / Pyrethroids content
Type of test/ instrumentation used
GC-FID
Methods
ISO, GS
Accreditation status
No
Test object or product tested or matrices
Colognes & perfumes
Test parameter/ properties measured
Alcohol content
pH
Type of test/ instrumentation used
Distillation
pH meter
Methods
USP, BP, ISO, GS
Accreditation status
No
Test object or product tested or matrices
Tobacco products
Test parameter/ properties measured
Tar, nicotine, carbon monoxide
Type of test/ instrumentation used
Smoking machine
GC-FID
GC-TCD
NDIR Analyzer
Methods
ISO, WHO
Accreditation status
No
Test object or product tested or matrices
Soaps and detergents
Test parameter/ properties measured
Free caustic alkali
Total fatty matter
Type of test/ instrumentation used
Reflux and titrimetry
Extraction and titrimetry
Methods
ISO 456, GS
ISO 685, GS
Accreditation status
No
Test object or product tested or matrices
Hypochlorite solutions
Test parameter/ properties measured
Available Chlorine
Type of test/ instrumentation used
Titrimetry
Methods
USP, BP, GS
Accreditation status
No
Test object or product tested or matrices
Oral care products
Test parameter/ properties measured
pH
Fluoride content
Type of test/ instrumentation used
pH meter
Ion-selective electrode
Methods
USP, BP, ISO, GS
ISO 11609, GS
Accreditation status
No
Does the laboratory conduct sampling, upon request of the client, of products to be tested?
Yes

Proficiency Testing

Does the lab participate in proficiency testing for accredited scopes
Yes
Does the lab participate in proficiency testing for non-accredited scopes
No
PT Scheme details
EDQM
WHO
USP
FAPAS
FHI360
LGC PHARMASSURE
Does the laboratory sub-contract testing work to other laboratories?
No

Quality Control / Quality Management

Does the lab operate an internal quality control (QC) system to ensure quality of test results?
Yes
Does the lab operate a management system (or Quality Management System) for assuring the quality of results?
Yes
Is the system documented in a Quality Manual?
Yes