FOOD AND DRUGS AUTHORITY LABORATORY SERVICES

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

Website

https://www.fdaghana.gov.gh

Legal Status

Public

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

00233 244632523

CEO E-mail

mimidarko66 [at] yahoo.co.uk

Total laboratory personnel

Male laboratory personnel

Female laboratory personnel

Technical personnel

Technical personnel total

Male technical personnel

Female technical personnel

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Test object or product tested or matrices

Talc-based product

Test parameter/ properties measured

Presence of asbestos

Type of test/ instrumentation used

FTIR

Methods

Accreditation status

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

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

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

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

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

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

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

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

PT Scheme details

EDQM
WHO
USP
FAPAS
FHI360
LGC PHARMASSURE

Does the laboratory sub-contract testing work to other laboratories?

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