Medicines Control Authority of Zimbabw e
QUALITY INFORMATION SUMMARY (QIS)
FOREWORD
The Quality Information Summary (QIS) template should be completed to provide a condensed summary
of the key quality information for product dossiers (PDs) containing APIs of synthetic or semi-synthetic
origin and their corresponding products that are. submitted to the MCAZ for registration.
The QIS constitutes part of the registration PD. The QIS provides an accurate record of technical data in
the PD at the time of registration and thereafter serves as an official reference document during the
course of GMP inspections, and variation (amendment) assessments performed by the MCAZ. The QIS is
a condensed version of the Quality Overall Summary – Product Dossier (QOS-PD) and represents the
final, agreed upon key information from the PD review (inter alia identification of the manufacturer(s),
API/FPP specifications, stability conclusions and relevant commitments).
The QIS template is structured to permit the rapid assembly of the QIS by copying requisite information
from the corresponding portions of the QOS-PD submitted with the original PD. It is acknowledged that
the numbering of the sections may not be entirely sequential. Those sections not considered necessary to
be included in the QIS have been removed (e.g., 2.3.S.5 Reference Standards or Materials) and the
remaining sections have retained their numbering to be consistent with the original PD.
For original PDs, the QIS should be provided in MS-Word format at the time of PD submission. The QIS
should be revised and submitted with the change history (see table at the end of the template) each time
additional data is provided during the assessment process. If no revision is necessary due to no change in
the information, a statement should be made to this effect in the covering letter. For amendments, the
QIS should be completed in its entirety (regardless of the proposed change), it should include
information on all strengths, with any changes highlighted and it should be provided at the time of
submission of such amendments.
When completing the QIS template, this covering Foreword should be deleted.
QUALITY INFORMATION SUMMARY (QIS)
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Medicines Control Authority of Zimbabw e
INTRODUCTION
(a)
Summary of product information:
Non-proprietary name of the finished
pharmaceutical product (FPP)
VetAg Wound Oil
Proprietary (Trade) name of the finished
pharmaceutical product (FPP)
N/A
International non-proprietary (generic)
name(s) of the active pharmaceutical
ingredient(s) (API(s)), including form (salt,
hydrate, polymorph)
1.
Applicant name and address
Aherechem (Pvt) Ltd, 356 Esap Way, Willowvale,
Harare, Zimbabwe
Dosage form
Oily liquid, light blue
Reference Number(s)
N/A
Strength(s)
Deltamethrin,
1mg/g;
Chlorfenvinpho
s, 1mg/g
Route of administration
Topical
LamaVet Wound Oil is a ready-to-use, combined
insecticidal and antimicrobial topical application
liquid for the following applications:
 Screw-worm remedy
 Active against bacteria and fungi for wound
treatment
 Control of ticks, fleas and lice
 Capabilities of repelling flies
 Preventing or eliminating maggot infestations due
to fly-strike
Name: Adherechem (Pvt) Ltd
Proposed indication(s)
Contact information
Deltamethrin Technical, 98% min.
2. Chlorfenvinphos Technical, 92% min.
Phone: +263 773 085 519, +263 771 332 880; +263
775 735 713; +263 773 404 166
Fax: N/A
Email: lamas@zol.co.zw; info@lamas.co.zw
(b)
Administrative Summary:
Reference number e.g. H999
N/A
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Applicant’s date of preparation or revision of
the QIS
30 April 2023
Internal version and/or date of acceptance
(MCAZ use only)
Related dossiers (e.g. FPP(s) with the same API(s) submitted to the Prequalification Programme
by the applicant):
Reference
number
(eg H999)
N/A
Prequalified
(Y/N)
API, strength, dosage form
(eg. Abacavir (as sulphate)
300 mg tablets)
Deltamethrin, 98% min.,
powder
Chlorfenvinphos, 92% min.,
liquid
API manufacturer
(including address)
2.3.S DRUG SUBSTANCE (or ACTIVE PHARMACEUTICAL INGREDIENT (API)) (NAME,
MANUFACTURER)
Indicate which option applies for the submission of API information:
1. Deltamethrin 2. Chlorfenvinphos
Name of API:
Name of API manufacturer:
□
Certificate of suitability to the European Pharmacopoeia (CEP)
□
□
Full details in the PD
2.3.S.2 Manufacture (name, manufacturer)
2.3.S.2.1 Manufacturer(s) (name, manufacturer)
(a)
Name, address and responsibility (e.g. fabrication, packaging, labelling, testing,
storage) of each manufacturer, including contractors and each proposed production
site or facility involved in these activities:
Name and address
(including
block(s)/unit(s))
Adherechem (Pvt) Ltd
Responsibility
APIMF/CEP
number (if
applicable)
Packaging, labelling, testing and
storage
2.3.S.4 Control of the API (name, manufacturer)
2.3.S.4.1 Specification (name, manufacturer)
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Letter of access
provided?
Medicines Control Authority of Zimbabw e
(a)
API specifications of the FPP manufacturer:
Standard (e.g. Ph.Int., Ph.Eur., BP, USP, House)
Specification reference number and version
Test
Acceptance criteria
Analytical procedure
(Type/Source/Version)
Description
Identification
Impurities
Assay
etc.
2.3.S.6 Container Closure System (name, manufacturer)
(a)
Description of the container closure system(s) for the storage and shipment of the
API:
2.3.S.7 Stability (name, manufacturer)
2.3.S.7.1 Stability Summary and Conclusions (name, manufacturer)
(c)
Proposed storage conditions and re-test period:
Container closure system
Storage statement
Re-test period*
* indicate if a shelf-life is proposed in lieu of a re-test period (e.g. in the case of labile APIs)
2.3.P DRUG PRODUCT (or FINISHED PHARMACEUTICAL PRODUCT (FPP))
2.3.P.1 Description and Composition of the FPP
(a) Description of the FPP:
LamaVet Wound Oil is a ready-to-use, combined insecticidal and antimicrobial topical
application liquid for the following applications:
 Screw-worm remedy.
 Active against bacteria and fungi for wound treatment.
 Control of ticks, fleas and lice.
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 Capabilities of repelling flies.
 Preventing or eliminating maggot infestations due to fly-strike.
It is a light blue oily liquid free from visible impurities packed in 500ml HDPE bottles with a
tamper-proof lid.
(b)
Composition of the FPP:
(i)
Composition, i.e. list of all components of the FPP and their amounts on a
per unit basis and percentage basis (including individual components of
mixtures prepared in-house (e.g. coatings) and overages, if any):
Component and
quality standard
(and grade, if
applicable)
Function
Strength (label claim)
Deltamethrin, 0.1% (m/v)
Chlorfenvinphos, 0.1% (m/v)
Quant. per
Unit
%
200ml Wound Oil
Deltamethrin
Insecticide API
0.2041 0.10
Chlorfenvinphos
Insecticide API
0.2128 0.10
Tar Acid
Antiseptic
1.0000 0.50
Linseed oil
Diluent
Gum rosin
Processing Aid &
Binder
Turpentine
Solvent
73.2000 36.60
White oil
Diluent
20.0000 10.00
Blue dye
Colour
0.0200 0.01
Total
97.7632 48.89
7.6000
3.80
200.0000 100.0000
(ii)
(c)
Composition of all components purchased as mixtures (e.g. colourants,
coatings, capsule shells, imprinting inks): N/A
Description of accompanying reconstitution diluent(s), if applicable: N/A
2.3.P.2.2.1 Formulation Development
(b)
Information on primary (submission, registration, exhibit) batches including
comparative bioavailability or biowaiver, stability, commercial:
(i)
Summary of batch numbers:
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Batch number(s) of the FPPs used in
Bioequivalence or biowaiver
Dissolution profile studies
Stability studies (primary batches)
Batches
Packaging
N/A
N/A
PS-20-100-025
PS-20-100-026
PS-20-100-027
500ml HDPE
500ml HDPE Bottle 500ml HDPE
Bottle
Bottle
Stability studies (production batches)
PS-20-100-028
500ml HDPE
Bottle
Validation studies (primary batches) if available
PS-20-100-025
Batches
500ml HDPE
Packaging
Bottle
PS-20-100-031
Validation studies (at least the first three
consecutive production batches)
or code(s)/version(s) for process validation
protocol(s)
Batches
Packaging
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PS-20-100-029
500ml HDPE Bottle
PS-20-100-030
500ml HDPE
Bottle
PS-20-100-026
500ml HDPE Bottle
PS-20-100-027
500ml HDPE
Bottle
PS-20-100-033
PS-20-100-032
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Medicines Control Authority of Zimbabw e
(ii)
Summary of formulations and discussion of any differences:
Relevant batches
Component
and quality
standard
(e.g. NF,
BP, Ph.Eur,
in-house)
Compa
rative
bioavail
ability
or
biowaiv
er
Pilot/Process
Validation
Production/Commercial
(2.3.P.1)
<Batch nos. and sizes>
PS-20-100-028-100kg
PS-20-100-029-100kg
PS-20-100-030-100kg
Theor.
%
quantity
per batch
(kg)
<Batch nos. and sizes>
a) PS-20-100-031-200kg
b) PS-20-100-032-200kg
c) PS-20-100-033-200kg
Theor.
%
quantity
per batch
(kg)
Stability/Primary
Theor.
quantit
y per
batch
(kg)
<Batch nos. and sizes>
a) PS-20-100-025-5kg
b) PS-20-100-026-5kg
c) PS-20-100-027-5kg
%
Theor.
%
quantity
per
batch
(kg)
Deltamethrin
Tech., 98%
min.
Chlorfenvinp
hos Tech.,
92% min.
High Boiling
Tar Acid
N/A
N/A
0.0051
0.1
0.1020
0.1
0.2041
0.1
N/A
N/A
0.0054
0.1
0.1087
0.1
0.2174
0.1
N/A
N/A
0.0250
0.5
0.5000
0.5
1.0000
0.5
Linseed Oil
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
2.4440
0.1900
1.8300
0.5000
0.0005
48.89
48.8793
3.8000
36.6000
10.0000
0.0100
48.89
101.5585
3.8000
73.2000
20.0000
0.0200
48.89
Gum Rosin
Turpentine
White Oil
Blue Dye
<Batch
nos.
and
sizes>
Total
5.0000
3.8
36.6
10
0.01
100
3.8
36.6
10
0.01
100.0000
100.0000
3.8
36.6
10
0.01
200.0000
2.3.P.3 Manufacture
2.3.P.3.1 Manufacturer(s)
(a)
Name, address and responsibility (e.g. fabrication, packaging, labelling, testing,
holder of the national manufacturing authorization of the FPP) of each
manufacturer, including contractors and each proposed production site or facility
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involved in manufacturing and testing:
Name and address
(include block(s)/unit(s))
Adherechem (Pvt) Ltd
Responsibility
Packaging, labelling and testing
2.3.P.3.2 Batch Formula
(a)
List of all components of the FPP to be used in the manufacturing process and their
amounts on a per batch basis (including components of mixtures prepared in-house
(e.g. coatings) and overages, if any):
Strength (label claim)
Master production document
reference number and/or version
Proposed commercial batch size(s) (e.g.
number of dosage units)
Component and quality standard (and
grade, if applicable)
Deltamethrin
Chlorfenvinphos
Tar Acid
Linseed oil
Gum rosin
Turpentine
White oil
Blue dye
TOTAL
LamaVet Wound Oil
Deltamethrin, 0.10% m/v
Chlorfenvinphos, 0.10% m/v
MPD-VET-22003, Version: 01
200kg
% Mass/Mass
Quantity per batch (kg/batch)
0.1000
0.1000
0.5000
48.8900
3.8000
36.6000
10.0000
0.0100
0.2041
0.2128
1.0000
97.7632
7.6000
73.2000
20.0000
0.0200
100.0000
200.0000
2.3.P.3.3 Description of Manufacturing Process and Process Controls
(a)
Flow diagram of the manufacturing process:
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Flow Diagram of the LamaVet Wound Oil Manufacturing Process
(b)
Narrative description of the manufacturing process, including equipment type and
working capacity, process parameters:
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
Measure linseed oil into mixing tank.
Heat to 70 OC.
Slowly mix in gum rosin until dissolved.
Mix in Deltamethrin and Chlorfenvinphos.
Stop heating and allow the solution to cool to about 45 oC.
Mix in turpentine followed by HBTA & White oil.
Add blue dye and mix until homogeneous.
Let cool and take 500ml sample for analysis
2.3.P.3.4 Controls of Critical Steps and Intermediates
(a)
Summary of controls performed at the critical steps of the manufacturing process
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and on isolated intermediates:
Step
(e.g. granulation, compression, coating)
Heating and Melting
Mixing
Controls
a)
b)
c)
d)
a)
b)
c)
d)
e)
f)
g)
Drug substance particle size
Equipment
Scale
Temperature
Blending time
Blending speed
Blending homogeneity of the drug substance
Assay
Content uniformity
Appearance
Specific gravity
2.3.P.3.5 Process Validation and/or Evaluation
(a)
Summary of the process validation and/or evaluation studies conducted and/or a
summary of the proposed validation protocol for the critical steps or critical assays
used in the manufacturing process (e.g. protocol number, parameters, results):
Document code(s) for the process validation protocol(s) and/or report(s) (including
reference number/version/date):
Refer to Process Validation Protocol, Document Number PRPV-221021and the Process
Validation Report, Document Number PV-221003in Module 3
2.3.P.5 Control of FPP
2.3.P.5.1 Specification(s)
(a)
Specification(s) for the FPP:
Standard (e.g. Ph.Int., BP, USP, House)
In-HouseAdherechem
Specification reference number and version
PS-20-22403
Test
Description
Acceptance criteria
(release)
Oily liquid, free from invisible
impurities
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Acceptance criteria
(shelf-life)
Oily liquid, free from
invisible impurities
(QIS) (2012-02-20)
Analytical
procedure
(type/source/versio
n)
Visual
Medicines Control Authority of Zimbabw e
Standard (e.g. Ph.Int., BP, USP, House)
In-HouseAdherechem
Specification reference number and version
PS-20-22403
Test
Acceptance criteria
(release)
Assay
Deltamethrin
0.095 – 0.12%
(m/v)
Acceptance criteria
(shelf-life)
Analytical
procedure
(type/source/versio
n)
94.0-106% of labelled
amount of Deltamethrin
333/WP/M/3,
CIPAC Handbook L,
p.45, 2006
Chlorfenvinphos 0.095 – 0.12%
(m/v)
94.0-106% of labelled
CIPAC Method
amount of Chlorfenvinphos 88/1/M/1.3; 1A p.
1131)
Colour
Light blue
Light blue
Visual
Odour
Characteristic
Characteristic
Visual
Specific Gravity
0.923 – 0.933
0.923 – 0.933
CIPAC Method F
MT 3
2.3.P.7 Container Closure System
(a)
Description of the container closure systems, including unit count or fill size,
container size or volume:
Description
(including materials
of construction)
Container: Round,
opaque, high density
polyethylene (HDPE)
jars
Closure: Round,
opaque, polypropylene
(PP) lid
Strength
Unit count or fill size
Deltamethrin,
Bottles of 10's
1mg/g;
Chlorfenvinphos,
1mg/g
Container size
500ml bottles
2.3.P.8 Stability
2.3.P.8.1 Stability Summary and Conclusions
(c)
Proposed storage statement and shelf-life (and in-use storage conditions and in-use
period, if applicable):
Container closure system
HDPE Bottle with a PP lid
Storage statement
Store below 30°C (room
temperature) in closed, original
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Shelf-life
2 years from the date of
manufacture
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container in a dry well-ventilated
area, out of direct sunlight
2.3.P.8.2 Post-approval Stability Protocol and Stability Commitment
(a)
Stability protocol for Primary stability batches (e.g. storage conditions (including
tolerances), batch numbers and batch sizes, tests and acceptance criteria, testing
frequency, container closure system(s)):
Parameter
Storage condition(s) (◦C, % RH)
Batch number(s)
Batch size(s)
Tests and acceptance criteria
Testing frequency
Number of batches per strength and
batch sizes
Container closure system(s)
Tests and acceptance criteria
(b)
Details
30ºC±2ºC / 75% ±5%RH
B/Nos: PS-20-100-013, PS-20-100-014 & PS-20-100-015
20kg
Appearance
Jelly, free from invisible
impurities
Assay
Deltamethrin: 0.020 +0.001%
(m/m)
Chlorfenvinphos: 0.20 +0.01%
(m/m)
Odour
Characteristic
Colour
Pale Blue
Odour
Characteristic
Drop Point
35-45 oC
0, 3, 6, 9, 12, 18, 24, 36 months
First three production batches (200kg) each of the same
strengths will be added to the stability programme
HDPE Dixie Jar
Stability tests described in 2.3.P.5.1
Stability protocol for Commitment batches (e.g. storage conditions (including
tolerances), batch numbers (if known) and batch sizes, tests and acceptance
criteria, testing frequency, container closure system(s)):
Parameter
Storage condition(s) (◦C, % RH)
Batch number(s)
Batch size(s)
Tests and acceptance criteria
Details
30ºC±2ºC / 75% ±5%RH
B/Nos: PS-20-100-013, PS-20-100-014 & PS-20-100-015
20kg
Appearance
Jelly, free from invisible
impurities
Assay
Deltamethrin: 0.020 +0.001%
(m/m)
Chlorfenvinphos: 0.20 +0.01%
(m/m)
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Testing frequency
Number of batches per strength and
batch sizes
Container closure system(s)
Tests and acceptance criteria
(c)
Odour
Characteristic
Colour
Pale Blue
Odour
Characteristic
Drop Point
35-45 oC
0, 3, 6, 9, 12, 18, 24, 36 months
First three production batches (200kg) each of the same
strengths will be added to the stability programme
HDPE Dixie Jar
Stability tests described in 2.3.P.5.1
Stability protocol for Ongoing Batches (e.g. storage conditions (including
tolerances), number of batches per strength and batch sizes, tests and acceptance
criteria, testing frequency, container closure system(s)):
Parameter
Storage condition(s) (◦C, % RH)
Batch number(s)
Batch size(s)
Tests and acceptance criteria
Testing frequency
Number of batches per strength and
batch sizes
Container closure system(s)
Tests and acceptance criteria
Details
30ºC±2ºC / 75% ±5%RH
B/Nos: PS-20-100-013, PS-20-100-014 & PS-20-100-015
20kg
Appearance
Jelly, free from invisible
impurities
Assay
Deltamethrin: 0.020 +0.001%
(m/m)
Chlorfenvinphos: 0.20 +0.01%
(m/m)
Odour
Characteristic
Colour
Pale Blue
Odour
Characteristic
Drop Point
35-45 oC
0, 3, 6, 9, 12, 18, 24, 36 months
First three production batches (200kg) each of the same
strengths will be added to the stability programme
HDPE Dixie Jar
Stability tests described in 2.3.P.5.1
i) Expiration dates may be extended based upon room temperature stability data
from a minimum of three production batches.
ii) If, in these post-approval stability studies, any lots are found to fall outside the
approved specifications, these lots may be withdrawn from the market.
iii) Deviations that do not affect the safety and efficacy of the product will be promptly
discussed between the applicant and the reviewing division at MCAZ and must be
reported to the MCAZ.
2.3.P.8.3 Stability Data
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(c)
Bracketing and matrixing design for commitment and/or continuing (i.e. ongoing)
batches, if applicable:
The actual stability results (i.e., raw data) can be found in Module 3.2.P.8.3.
WRITTEN COMMITMENTS OF THE MANUFACTURER
API
If applicable (primary stability study commitment):
The Applicant (or API manufacturer) undertook in writing (date of letter of commitment) to continue
long-term testing of <INN of API> for a period of time sufficient to cover the whole provisional re-test
period (period ending month/year) and to report any significant changes or out-of-specification results
immediately to MCAZ for the following batches :
<Batch numbers, manufacturing dates, batch size, primary packing materials>
If applicable (commitment stability studies):
Since stability data on three production scale batches were not provided with the application, the
remaining number of production scale batches should be put on long-term stability testing and the data
should be provided as soon as available. Any significant changes or out-of-specification results should be
reported immediately to MCAZ. The approved stability protocol should be used for commitment batches.
API option 2 - CEP
The Applicant provided a commitment in writing (date of letter of commitment) to inform MCAZ in the
event that the CEP is withdrawn. Note that withdrawal will require additional consideration of the API
data requirements to support the dossier.
API option 3 - full details in the PD (ongoing stability study commitment)
The Applicant undertook in writing (date of letter of commitment) a commitment regarding ongoing
stability studies. Unless otherwise justified, at least one batch per year of the product will be included in
the stability programme (unless none is produced during that year). The stability protocol will be that
which was approved for primary batches (or the protocol was submitted for assessment). Out-ofspecification results or significant atypical trends should be investigated. Any confirmed significant
change, out-of-specification result, or significant atypical trend should be reported immediately to
MCAZ. The possible impact on batches on the market should be considered in consultation with MCAZ
inspectors.
FPP
If applicable (primary stability study commitment):
The Applicant undertook in writing (date of letter of commitment) to continue long-term testing of < FPP
reference number, trade name (INN of API), strength, pharmaceutical form> for a period of time
sufficient to cover the whole provisional shelf-life (period ending month/year) and to report any out-ofspecification results or significant changes immediately to WHO for the following batches :
<Batch numbers, manufacturing dates, batch size, primary packing materials >
If applicable (commitment stability studies):
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Since stability data on three production scale batches was not provided with the application, the
Applicant undertook in writing, (date of letter of commitment) to put the remaining number <e.g.
additional two (2)> production scale batches of < FPP reference number, trade name (INN of API),
strength, pharmaceutical form, primary packing material> on long-term stability testing. Any out-ofspecification results or significant changes during the study should immediately be reported to MCAZ.
The approved stability protocol should be used for commitment batches.
If applicable (the proposed commercial batch size is 200 000 units (x units) or less)
The Applicant undertook in writing (date of letter of commitment) to place the first three batches of any
production size larger than x units on stability. The stability protocol will be that which was approved
for primary batches (or the protocol was submitted for assessment). Out-of-specification results or
significant atypical trends will be investigated. Any confirmed significant change, out-of-specification
result, or significant atypical trend will be reported immediately to MCAZ.
Ongoing stability study commitment
The Applicant undertook in writing (date of letter of commitment) a commitment regarding ongoing
stability studies. Unless otherwise justified, at least one batch per year of the product manufactured in
every primary packaging type will be included in the stability programme (unless none is produced
during that year). The stability protocol will be that which was approved for primary batches (or the
protocol was submitted for assessment). Out-of-specification results or significant atypical trends should
be investigated. Any confirmed significant change, out-of-specification result, or significant atypical
trend should be reported immediately to MCAZ. The possible impact on batches on the market should be
considered in consultation with MCAZ inspectors.
If applicable (validation of production batches)
Since validation data on production scale batches of not less than three (3) consecutive batches of <FPP
reference number, trade name (INN of API), strength, pharmaceutical form, primary packing material>
were not provided with the application, the Applicant submitted a written commitment (date of letter of
commitment) that a validation report —in accordance with the details of the validation protocol provided
in the dossier— would be made available as soon as possible for evaluation by assessors or for
verification by the MCAZ inspection team. The approved validation protocol should be used for
commitment batches.
<Dossier Reference Number(s) e.g. H999> Page 15 of 16
(QIS) (2012-02-20)
Medicines Control Authority of Zimbabw e
Change History
Date of preparation of original QIS:
Date of revised
version
Section (e.g.
S.2.1)
<Dossier Reference Number(s) e.g. H999> Page 16 of 16
Revision
(QIS) (2012-02-20)