APPLICATION FOR ACCREDITATION

Please type or write clearly in BLOCK LETTERS

This form must be returned with two (2) copies of a duly executed Accreditation Agreement (AG-01)

1 Contact Details

Organisation MISSION FOR ESSENTIAL DRUGS AND SUPPLIES (MEDS)

Address (Physical) MEDS CENTER ALONG MOMBASA ROAD OPPOSITE NATION PRESS, NAIROBI KENYA

Address (Postal) P.O. BOX 78040-00507 VIWANDANI, NAIROBI KENYA

Telephone +254-719-086000

Email Info@meds.or.ke

Website www.meds.or.ke

Contact person 1. DR. STEPHEN KIGERA

EMAIL: skigera@meds.or.ke

2. DR JOSEPH MURIU
EMAIL: jmuriu@meds.or.ke

Position within the organisation
Type and Nature of business.
3. MILDRED WANYAMA
EMAIL: mwanyama@meds.or.ke
1. HEAD OF QUALITY SERVICES
2. QUALITY ASSURANCE MANAGER
3. LABORATORY MANAGER
MISSION FOR ESSENTIAL DRUGS AND SUPPLIES (MEDS) IS A FAITH-BASED HEALTH
SOLUTIONS PROVIDER FOUNDED BY AN ECUMENICAL PARTNERSHIP OF THE KENYA
CONFERENCE OF CATHOLIC BISHOPS (KCCB) AND THE CHRISTIAN HEALTH
ASSOCIATION OF KENYA (CHAK) CONTRIBUTING TO THE HEALING MINISTRY OF
CHRIST. MEDS IS A REGISTERED TRUST.

SINCE INCEPTION IN 1986, MEDS HAS PLAYED AN INTEGRAL ROLE IN PROVIDING

QUALITY AND AFFORDABLE HEALTH PRODUCTS AND TECHNOLOGIES, HEALTH
SYSTEMS STRENGTHENING AND QUALITY ASSURANCE SERVICES. MEDS SERVES
CLIENTS ACROSS DIFFERENT MARKET SEGMENTS SUCH AS FAITH BASED
ORGANIZATIONS, REGULATORY AUTHORITIES, COUNTIES AND COUNTY FACILITIES,
NON-GOVERNMENTAL ORGANIZATIONS, COMMUNITY BASED ORGANIZATIONS AND
LEARNING AND RESEARCH INSTITUTIONS AMONG OTHERS.

IN THE PROVISION OF QUALITY ASSURANCE SERVICES, MEDS HAS AN IN-HOUSE

QUALITY CONTROL LABORATORY WHICH HAS BEEN PREQUALIFIED BY THE WORLD
HEALTH ORGANIZATION. THE LABORATORY TESTS PRODUCTS FROM MEDS SUPPLY
CHAIN AS WELL AS PROVIDING TESTING SERVICES TO EXTERNAL CLIENTS SUCH AS
REGULATORY AUTHORITIES, NON- GOVERNMENTAL ORGANIZATIONS, RESEARCH
AND LEARNING INSTITUTIONS AMONG OTHERS.

Does your organisation operate on Yes: ✘

No:

Identifier: ACC-FM-06
Version: 01
Issue Date: 10/10/2022 1 of 11
 APPLICATION FOR ACCREDITATION

mobile/satellite, other facilities?

If yes, please provide of details MEDS HAS A BRANCH IN KISUMU, KENYA WHICH ACTS AS A DISTRIBUTION CENTRE
mobile/satellite, other facilities? FOR HEALTH PRODUCTS AND TECHNOLOGIES. THE LABORATORY IS LOCATED AT
THE HEAD QUARTERS IN NAIROBI.

2 Organization Details

a) Indicate the Legal Status of your MEDS IS A REGISTERED TRUST FOUNDED BY AN ECUMENICAL PARTNERSHIP
organisation OF THE KENYA CONFERENCE OF CATHOLIC BISHOPS (KCCB) AND THE
CHRISTIAN HEALTH ASSOCIATION OF KENYA (CHAK). MEDS HAS BEEN
(List and attach the Legal Instrument and other
APPROVED AS A WHOLESALER OF HEALTH PRODUCTS AND TECHNOLOGIES
regulatory requirements including licenses that
BY THE PHARMACY AND POISONS BOARD (PPB). THE FOLLOWING
apply to your organization: If electronic versions
ATTACHMENTS HAVE BEEN PROVIDED
are available, provide an open-able link)
1. CERTIFICATE OF INCORPORATION
2. WHOLESALE DEALERS LICENSE ISSUED BY PPB
3. CERTIFICATE OF REGISTRATION OF WORKPLACE ISSUED BY THE
DIRECTORATE OF OCCUPATIONAL SAFETY AND HEALTH SERVICES
(DOSHS)
b) Total Number of Staff Technical Staff 25 Non-Technical Staff 5

(Laboratory & Quality Assurance)

MEDS HAS 200 CONTRACTED STAFF. THE LABORATORY HAS 18 STAFF WHILE
QUALITY ASSURANCE SECTION HAS 8 STAFF. THE REST OF THE STAFF ARE IN
SUPPLY CHAIN AND HEALTH SYSTEM STRENGTHENING BUSINESS UNITS.
c) List the conformity Assessment Services MICROBIOLOGY, MEDICAL DEVICES AND PHYSICO-CHEMICAL QUALITY
offered CONTROL TESTING

d) Are your conformity Assessment activities Yes: ✘

No:
part of a larger organisation

e) If yes, specify other organisation activities MEDS HAS THREE MANDATES

1. SUPPLY CHAIN AND DISTRIBUTION OF HEALTH PRODUCTS AND

TECHNOLOGIES. THIS INCLUDES PROCUREMENT, RECEIPT, STORAGE
AND DISTRIBUTION OF PHARMACEUTICAL PRODUCTS, MEDICAL
DEVICES AND MEDICAL EQUIPMENT
2. PROVISION OF QUALITY ASSURANCE SERVICES WHICH INCLUDES
PREQUALIFICATION OF SUPPLIERS, PRODUCT INSPECTION,
MAINTENANCE OF QUALITY MANAGEMENT SYSTEM, QUALITY
CONTROL TESTING OF PHARMACUTICAL PRODUCTS, AND MEDICAL
DEVICES
3. PROVISION OF HEALTH SYSTEMS STREGTHENING SERVICES
f) Are key activities carried out at other NO. THE LABORATORY DOES NOT HAVE ANY OTHER BRANCH.
locations / sites other than at the physical
location stated above?

Identifier: ACC-FM-06
Version: 01
Issue Date: 10/10/2022 2 of 11
 APPLICATION FOR ACCREDITATION

(Please note for Labs, if there are sample

collection sites away from the Lab, these need to
be stated)

g) List all the tests, calibrations or inspections REFER TO THE SCOPE OF ACCREDITATION IN PART (3) BELOW
fields / ranges or certifications (including
codes) that your CAB engages in whether
subject for accreditation or not

h) Previous Accreditation held SCOPE YEAR BODY

WHO PREQUALIFICATION OF THE 2009 WORLD HEALTH
(State the scope of accreditation, year accredited
QC LABORATORY ORGANIZATION (WHO)
and the Accrediting body)
ISO 9001:2015 (PREVIOUSLY ISO 2012 KEBS
9001:2008) CERTIFICATION OF
MEDS I.E. LABORATORY, SUPPLY
CHAIN AND LOGISTICS, HEALTH
SYSTEM STRENTHENING
DG-ECHO HUMANITARIAN 2016 DIRECTORATE-GENERAL FOR
PROCUREMENT CENTRE EUROPEAN CIVIL
PROTECTION AND
HUMANITARIAN AID
OPERATIONS
USAID-BHA PREQUALIFIED 2015 USAID'S BUREAU FOR
WHOLESALER HUMANITARIAN
ASSISTANCE
i) Current Accreditation held SEE CLAUSE (h) ABOVE

(State the scope of accreditation, year accredited

and the Accrediting body)

j) Indicate the Conformity assessment ISO/IEC 17025: 2017 GENERAL REQUIREMENTS FOR THE COMPETENCE OF
Standard to which you are seeking TESTING AND CALIBRATION LABORATORIES
accreditation.

k) Do you require pre assessment? YES

3 Scope of Accreditation

Please indicate below the scope/field to which you are seeking accreditation (Refer to ACC-PR-01) for guidance if required.

Identifier: ACC-FM-06
Version: 01
Issue Date: 10/10/2022 3 of 11
 APPLICATION FOR ACCREDITATION

Sample Method/
Scheme No. Component Test Techniques Test Location
e.g. Blood, Stool Equipment
NOT
APPLICABLE
Medical Testing (15189)

Percentage of applied scope against the list provided in 2(g)

Reference to
Examination Components Measurement Test
Scheme No. Vet. Field Equipment Specimen Standardise
Technique / Analytes Range Location
d Procedure
NOT
Veterinary Testing (17025

APPLICABLE
+ OIE)

Percentage of applied scope against the list provided in 2(g)

Calibration &
Calibration Calibration Calibration Measurement Calibration
Scheme No. Measurand Standard
Field Object Method Capability Site
(CMC)*
NOT
APPLICABLE
Calibration (17025)

Percentage of applied scope against the list provided in 2(g)

Identifier: ACC-FM-06
Version: 01
Issue Date: 10/10/2022 4 of 11
 APPLICATION FOR ACCREDITATION

*Calibration and Measurement Capability (CMC): (Measurement Point / Range + expanded uncertainty)
Note: Additional information on the CMC may be required in specialised areas like Electrical measurements one needs to indicate Frequency of
applied voltage.
Measurement
Scheme No. Testing Field Type of Test Test Method Test Object / Matrix Test Parameter Test Location
Range

1 SPECTROPHOTO IDENTITY, ASSAY, PHARMACOPOEIA PHARMACEUTICA ACTIVE AS PER PHYSICO-

METRY (FTIR, DISSOLUTION L (USP, IP, BP, LS, HERBAL AND INGREDIENT MONOGRAP CHEMICAL
NIR, UV) EUR.PH., INT.PH.) FOOD H LABORATORY
SUPPLEMENTS

2 CHROMATOGRAP IDENTITY, ASSAY, PHARMACOPOEIA PHARMACEUTICA ACTIVE AS PER PHYSICO-

HY (TLC, GC, DISSOLUTION, L (USP, IP, BP, LS, HERBAL AND INGREDIENT MONOGRAP CHEMICAL
HPLC) IMPURITIES, RELATED EUR.PH., INT.PH.) FOOD H LABORATORY
SUBSTANCES,CONTENT SUPPLEMENTS
UNIFORMITY

3 POLARIMETRY OPTICAL ROTATION, PHARMACOPOEIA PHARMACEUTICA ACTIVE AS PER PHYSICO-

ASSAY, IDENTIFICATION L (USP, IP, BP, LS, INGREDIENT MONOGRAP CHEMICAL
EUR.PH., INT.PH.) H LABORATORY

4 PHYSICAL LOD, PH, PHARMACOPOEIA PHARMACEUTICA ACTIVE AS PER PHYSICO-

CONDUCTIVITY, L (USP, IP, BP, LS, HERBAL AND INGREDIENT MONOGRAP CHEMICAL
UNIFORMITY OF EUR.PH., INT.PH.), FOOD H LABORATORY
DOSAGE UNITS (MASS/ SUPPLEMENTS
CONTENT), SULFATED
ASH, RESIDUE ON
IGNITION, FRIABILITY,
DISINTEGRATION,
DENSITY, MELTING
POINT

5 TITRATION ASSAY, WATER PHARMACOPOEIA PHARMACEUTICA ACTIVE AS PER PHYSICO-

(DIRECT CONTENT, L (USP, IP, BP, LS, HERBAL AND INGREDIENT MONOGRAP CHEMICAL
TITRATION AND IDENTITY, IMPURITIES, EUR.PH., INT.PH.) FOOD H LABORATORY
POTENTIOMETRI AND LIMIT TESTS SUPPLEMENTS
C TITRATION)

6 CHEMICAL IDENTITY, LIMIT TEST PHARMACOPOEIA PHARMACEUTICA ACTIVE AS PER PHYSICO-

REACTIONS L (USP, IP, BP, LS, HERBAL AND INGREDIENT MONOGRAP CHEMICAL
EUR.PH., INT.PH.) FOOD H LABORATORY
SUPPLEMENTS

7 MICROBIOLOGIC ANTIBIOTIC, BACTERIAL HARMONIZED ANTIBIOTICS, ACTIVE AS PER MICROBIOLOGY

AL ASSAY ENDOTOXINS, PHARMACOPOEIA BIOLOGICS INGREDIENT MONOGRAP LABORATORY
BIOLOGICAL ASSAYS TEXT (USP, IP, BP, H
EUR.PH., INT.PH.)
General Testing (17025)

8 MICROBIAL MICROBIAL LOAD, HARMONIZED PHARMACEUTICA BACTERIA, AS PER MICROBIOLOGY

ENUMERATION PROBIOTIC, CHALLENGE PHARMACOPOEIA LS, WATER, YEASTS, MONOGRAP LABORATORY
TEXT (USP, IP, BP, DISINFECTANTS, MOULD, H
EUR.PH., INT.PH.) HERBAL AND PRESERVATIVE
FOOD
SUPPLEMENTS,

Identifier: ACC-FM-06
Version: 01
Issue Date: 10/10/2022 5 of 11
 APPLICATION FOR ACCREDITATION

Measurement
Scheme No. Testing Field Type of Test Test Method Test Object / Matrix Test Parameter Test Location
Range

General 9 QUALITATIVE STERILITY, DIAGNOSTIC HARMONIZED PHARMACEUTICA FUNGI, PRESENT MICROBIOLOGY

Testing MICROBIAL TEST KIT, TEST FOR PHARMACOPOEIA LS, HERBALS, BACTERIA OR ABSENT LABORATORY
(17025) TESTS SPECIFIED ORGANISMS TEXT (USP, IP, BP, FOOD (AEROBIC &
EUR.PH., SUPPLEMENTS, ANAEROBIC),
INT.PH.),WHO DIAGNOSTIC KITS, ANTIGENS,
GUIDELINES WATER, MEDICAL ANTIBODIES,
DEVICES E.COLI, ST.
(INFUSION KITS, AUREUS, PS.
SYRINGES, AERUGINOSA,
NEEDLES, COLLIFORMS,
GLOVES, C. ALBICANS,
CLOSTRIDIUM,
SALMONELLA,
ENTEROBACTE
RIA

10 MEDICAL DIMENSION (LENGTH, KS 11193 SYRINGES, PHYSICAL AS PER PHYSICO-

DEVICES WIDTH AND ISO 7886 NEEDLES, GLOVES PROPERTIES STANDARD CHEMICAL
THICKNESS), ISO 10555 LABORATORY
LEAK TEST,
STRETCH AND
COMPRESSION,
BREAKING POINT,
VISUAL EXAMINATION

Percentage of applied scope against the list provided in 2(g)

Field Product / Type of Range of Codes/ Methods/ Inspection

Scheme No.
of Inspection Service inspection Inspection Regulations Location
NOT
APPLICABLE
Inspection (17020)

Percentage of applied scope against the list provided in 2(g)

Management Description of
Technical No. of No of
Scheme No. System Sub- IAF Code Economic Critical Code
Cluster Certifications Auditors
Scope Activity
NOT
Certification (MS)

APPLICABLE
(17021-1)

Identifier: ACC-FM-06
Version: 01
Issue Date: 10/10/2022 6 of 11
 APPLICATION FOR ACCREDITATION

Management Description of
Technical No. of No of
Scheme No. System Sub- IAF Code Economic Critical Code
Cluster Certifications Auditors
Scope Activity
(QMS,
EMS)

Percentage of applied scope against the list provided in 2(g)

Management
Technical No. of No of
Scheme No. System Sub- Category Description of Economic Activity
Cluster Certifications Auditors
Scope
NOT
APPLICABL
E
Inspection (17020)

Percentage of applied scope against the list provided in 2(g)

Scheme No. Scheme Product Code/ Regulations/Std.

NOT APPLICABLE
(product)
Certification
(17065)

Percentage of applied scope against the list provided in 2(g)

Scheme No. Scheme Code / Regulations/Std.

NOT APPLICABLE
Certification
(Persons)

Identifier: ACC-FM-06
Version: 01
Issue Date: 10/10/2022 7 of 11
 APPLICATION FOR ACCREDITATION

Scheme No. Scheme Code / Regulations/Std.

(17024
)

Percentage of applied scope against the list provided in 2(g)

Equipment / Measurement
Scheme No. Field Protocol Standard Parameter
Artefact Capability
NOT
APPLICABLE
Proficiency Testing (17043)

Percentage of applied scope against the list provided in 2(g)

4 Participation in PT Schemes / ILCs

Please indicate below the PT schemes / ILCs that you have participated in and provide results of participation.
Note: Participation in PT/ILC is a prerequisite to accreditation.

Remarks on The Adequacy and

Scheme Name Parameters Frequency of Participation
Acceptability of the PT

WHO-EQAAS 7 ASSAY- BY HPLC ANNUALLY SATISFACTORY

DISSOLUTION –BY UV

WHO-EQAAS 8 ASSAY –BY HPLC

R/S – BY HPLC

WHO-EQAAS 9 ASSAY – BY HPLC

ID- BY IR

WHO-EQAAS 10 ID- BY CHEMICAL TEST

DISINTEGRATION
ASSAY – BY TITRATION

PHARMACEUTICAL R&D LAB & ASSAY- BY HPLC ANNUALLY SATISFACTORY

PTB-1

PHARMACEUTICAL R&D LAB & ASSAY –BY HPLC

PTB-2

Identifier: ACC-FM-06
Version: 01
Issue Date: 10/10/2022 8 of 11
 APPLICATION FOR ACCREDITATION

Remarks on The Adequacy and

Scheme Name Parameters Frequency of Participation
Acceptability of the PT

PHARMACEUTICAL R&D LAB & ASSAY –BY HPLC

PTB-3

PHARMA R& D LABORATORY ASSAY-BY HPLC

EAC-QAAS FOR THE NETWORK DISSOLUTION-BY HPLC
OF PHARMACEUTICAL
LABORATORIES IN AFRICA- 4

FHI360 & USAID-1 ASSAY –BY HPLC ANNUALLY SATISFACTORY

DISSOLUTION- BY HPLC

FHI360 & USAID-2 ASSAY –BY HPLC

DISSOLUTION- BY HPLC

FHI360 & USAID-3 ASSAY –BY HPLC

DISSOLUTION- BY HPLC

FHI360 & USAID-4 ASSAY –BY HPLC

DISSOLUTION- BY HPLC

INDIAN PHARMACOPOEIA-1 ID-IR ANNUALLY SATISFACTORY

R/S- BY HPLC

INDIAN PHARMACOPOEIA-2 ID-BY IR

R/S- BY HPLC

INDIAN PHARMACOPOEIA-3 ASSAY -BY UV

INDIAN PHARMACOPOEIA-4 R/S- BY HPLC

INDIAN PHARMACOPOEIA-5 ID-BY IR

LOD

PHARMACEUTICAL R&D LAB ASSAY –BY HPLC ANNUALLY ONGOING

DISINTEGRATION

INDIAN PHARMACOPOEIA-6 ASSAY - BY HPLC ANNUALLY SATISFACTORY

ID- BY IR

INTERLABORATORY TESTING ID-BY IR ANNUALLY SATISFACTORY

FRIABILIT
WEIGHT PER ML
PH
ASSAY – BY UV
ASSAY – BY HPLC
DISSOLUTION – UV

5 Submission of Documents

Cross-reference matrix of internal documents against the

Yes: ✘
No:
Normative standard.

Identifier: ACC-FM-06
Version: 01
Issue Date: 10/10/2022 9 of 11
 APPLICATION FOR ACCREDITATION

Quality Manual (Where applicable) Yes: ✘

No:

Management System Policies and Procedures Yes: ✘

No:

Test/Inspection/Certification Methods/Procedures Yes: ✘

No:

CV’s of proposed Technical Signatories, certificates &

Yes: ✘
No:
competence profiles
Copies of current licences of practice for regulated professions
Yes: ✘
No:
(Medical, Engineers, etc.)

Evidence of PT / ILC Yes: ✘

No: N/A:

Status of legal entity (Certificate of incorporation / Act of

Yes: ✘
No:
Parliament / Legal Notice/ Trust deed, etc.)

Legal Requirements (Current Licenses / certificates) Yes: ✘

No: N/A:

Regulatory Requirements (Current Licenses / certificates) Yes: ✘

No: N/A:

Statutory Requirements (Current Licenses / certificates) Yes: ✘

No: N/A:

Industry Requirements (Current Licenses / certificates) Yes: ✘

No: N/A:

Assessment Fee paid Yes: ✘

No:

6 Declaration

I/We hereby declare that the above information is correct. I/We agree to abide with the terms and conditions of accreditation as stated in
the accreditation agreement and any other amendments as well as regulations that KENAS may determine from time to time.

Name JOSEPH MURIU

Organization MISSION FOR ESSENTIAL DRUGS AND SUPPLIES (MEDS)

Designation QUALITY ASSURANCE MANAGER

Signature

Date

7 Review by KENAS

Application form complete? Yes: No:

Assessment fee payment confirmed? Yes: No:

Applicable documents seen? Yes: No:

Applied Scope confirmed? Yes: No:

Adequacy of resources confirmed? Yes: No:

Explain any No response and Action

Identifier: ACC-FM-06
Version: 01
Issue Date: 10/10/2022 10 of 11
 APPLICATION FOR ACCREDITATION

Reviewed by;

Designation

Signature

Date

Revision History

Date Ver Revised By Reason for Revision

10/10/2022 01 RSQ Newly developed/formatted document

Identifier: ACC-FM-06
Version: 01
Issue Date: 10/10/2022 11 of 11