Global SUPP OTH 000047390 Implementation Assessment Global SOP QC 0000003582 2.0 1.0 副本111111

Implementation Assessment for Instructive Global QM Documents
For any published global QM Document which was assessed as “applicable” and GxP relevant by the local organization (documented in local
document library) the implementation mode must be documented in Table 2 and the detailed gap assessment in Table 3.
See as well Global-SOP-QM-000002376 for further explanation (decision tree in Figure 1).
For organizations or global QM Documents in scope for the Pharmaceutical Quality System please refer to Global-SOP-QM-000002714
“Pharmaceutical Quality System” for further rules concerning the implementation modes.
Table 1 General Information

Local organization:
Document ID: Global-SOP-QC-000003582
Document Version: version 2.0
Document Title: Growth Promotion of Microbiological Media
Application note:
This implementation assessment takes into account the adjustments that were incorporated in version 2 of the Global-SOP-QC-000003582
(see yellow background). The impact of the changes made must be reassessed. Requirements that have not changed with regard to version
2 do not have to be reassessed if an initial implementation assessment has already been carried out. If an implementation assessment for
this instruction/guiding document is carried out for the first time, all requirements must be taken into account (please remove the diagonal
strikethrough).
Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 1 of 19

Table 2 Implementation Approach: What is the approach for implementing the Instructive Global QM Document?
# Implementation Mode Action Selection Justification

1 Instructive global QM Document will Complete Implementation Assessment Form for Yes No
be implemented „as-is” in English. traceability and maintain within local QMS.
be implemented „as-is” after traceability and maintain within local QMS.
translation into local language. No Create an exact translation and implement the
content modifications allowed. global translated document into the local QMS
(use Global-FORM-QM-000002796 for
translation)
be implemented „as-is” (in English or traceability and maintain within local QMS.
after translation into local language) Reference to local Annex or WI to be included;
adding local supplementary content to (title, number and version)
the document in form of a local Annex
or supplementary Working
Instruction. No content change or
deletion of the global QM Document
allowed.
4 Instructive global QM Document will Complete Implementation Assessment form for Yes No
be used to create/modify a local QM traceability and maintain within local QMS.
Document; additional requirements Assessment must include reference to local QM
can be included or not all Document (title, number and version).
requirements will be included.
Additional local requirements to be
implemented must be described in justification.
Any global requirements which will not be
implemented must be described in justification.

Table 3 Gap Assessment for Implementation: Which process steps are implemented? Where are gaps identified and how is the plan to close the gaps?
Process(step) Applicable Already Describe the gap and the details for implementation:
Implemented  For already existing process steps, list local QM Document(s)
which will be replaced by the global QM Document
 For not yet existing process steps describe the actions
planned to implement
Refer to a KabiTrack Record# for the process change(s)
Scope of testing Yes No Yes No
If a supplier for Ready-to-Use (RTU) media is fully certified and
the transport of media can be verified to be within proper storage
conditions (e.g., via temperature loggers), no additional growth
promotion test with ATCC organisms may be performed as long
as the manufacturer has demonstrated the growth-promoting
properties of the medium using the ATCC strains (i.e.,
compendial strains).
However, the growth promoting properties of the individual, site-

specific in-house microorganisms must be regularly verified (see
Global-SOP-QC-000002969 “Best Practices in the Microbiology
Laboratory", Special considerations for RTU media), meaning in-
house isolates must be tested per batch and delivery and reliance
on the supplier verification for the compendial strains per batch
(provided that the temperature record of the delivery was
acceptable).
A complete test of media, including in-house isolates (exceptions

see footnote Error: Reference source not found in section Error:
Reference source not found) and compendial strains, must be
performed annually in order to maintain the supplier’s
certification status.

Check of pH value /Check of supplier COA Yes No Yes No No content-related changes compared to version 1. If
The pH value of the media from each lot prepared in-house Implementation Assessment version 1 has already been filled
should be measured after cooling down to room temperature. out, there is no need to re-evaluate this requirement. If this IA is
being filled out for the first time, this should be mentioned in
Table 2 and the requirement on the left shall be answered in
terms of applicability and implementation status (see columns 2
and 3).
If individual units (e.g., small bottles, vials, ampoules) of liquid Implementation Assessment version 1 has already been filled
media are available, one unit is tested with an immersion pH out, there is no need to re-evaluate this requirement. If this IA is
probe, and the remainder of the unit should be discarded. being filled out for the first time, this should be mentioned in
and 3).
For large volume units (e.g., large bottles, bags), an aliquot may Implementation Assessment version 1 has already been filled
be taken aseptically, where the remainder of that aliquot can be out, there is no need to re-evaluate this requirement. If this IA is
used. being filled out for the first time, this should be mentioned in
and 3).
Even if no physical pH test is required for purchased media, the Implementation Assessment version 1 has already been filled
pH value specified by the manufacturer (COA) must be checked out, there is no need to re-evaluate this requirement. If this IA is
for acceptance. being filled out for the first time, this should be mentioned in
and 3).

A lot of media not conforming to the pH limit cannot be released Implementation Assessment version 1 has already been filled
for use and must be investigated per Global-SOP-QM-000002473 out, there is no need to re-evaluate this requirement. If this IA is
“Event Handling & CAPA Process”. being filled out for the first time, this should be mentioned in
and 3).
Sterility check Yes No Yes No No content-related changes compared to version 1. If
A lot of media not conforming to the sterility cannot be released Implementation Assessment version 1 has already been filled
for use and must be investigated per Global-SOP-QM-000002473 out, there is no need to re-evaluate this requirement. If this IA is
“Event Handling & CAPA Process”. being filled out for the first time, this should be mentioned in
and 3).
Frequency of the testing Yes No Yes No No content-related changes compared to version 1. If
GPT must be performed for each lot and each delivery of media Implementation Assessment version 1 has already been filled
to be used in microbiological testing or used in the Environmental out, there is no need to re-evaluate this requirement. If this IA is
Monitoring program, whether manufactured in-house or being filled out for the first time, this should be mentioned in
purchased from an external supplier. Table 2 and the requirement on the left shall be answered in
and 3).
Frequency of the testing Yes No Yes No
For purchased ready-to-use media, each shipment received from
the supplier must undergo independent GPT (for exception see
Error: Reference source not found)
For in-house prepared media, GPT shall be performed for each Implementation Assessment version 1 has already been filled
sterilization lot (i.e. autoclave load). out, there is no need to re-evaluate this requirement. If this IA is
and 3).


Microbiological media used in the laboratory support activities not
directly influencing test results (e.g., stock culture maintenance)
are exempt from GPT.
GPT is always required when establishing a shelf life for the
media. For media manufactured in-house, determination of shelf
life is mandatory to verify the growth suitability, while for RTU
media, the shelf life specified by the manufacturer can be used
without the need for additional shelf-life establishment (provided
that the storage conditions specified by the supplier are used –
otherwise validation shall be performed).
Shelf life is validated using GPT to confirm that the performance Implementation Assessment version 1 has already been filled
of the media still meets acceptance criteria up to and including out, there is no need to re-evaluate this requirement. If this IA is
the expiration date. being filled out for the first time, this should be mentioned in
and 3).
If a validated shelf life has not been determined, the GPT should Implementation Assessment version 1 has already been filled
be repeated as follows: out, there is no need to re-evaluate this requirement. If this IA is
 every two weeks for media stored in unsealed
containers (e.g. plates, tubes)
 every three months for media stored in sealed and 3).
containers (e.g. flasks)
After shelf life has been established, a periodic stability check to Implementation Assessment version 1 has already been filled
confirm the shelf life should be performed once every two years. out, there is no need to re-evaluate this requirement. If this IA is
and 3).


In order to prove that medium shows growth-promoting
properties even after the intended shelf life has been exceeded
by the incubation period (i.e., if using the medium for incubation
on the last day of expiry), GPT should be carried out with
medium that has also exceeded the shelf life by the
corresponding incubation time. This study shall be carried out
according to Global-SOP-QC-000003495 “Incubation, Reading
and Subculturing of Microbial Samples and Potentially
Contaminated Units”.
For RTU media, there may be a declaration from the
manufacturer that the medium has growth-promoting properties
beyond its shelf life; if such information is not available,
validation is required as for in-house prepared medium.
Selection of microorganisms Yes No Yes No No content-related changes compared to version 1. If
The growth-promoting properties of media are demonstrated by Implementation Assessment version 1 has already been filled
the use of suitable microbiological cultures. Generally accepted out, there is no need to re-evaluate this requirement. If this IA is
cultures for GPT can be found in the relevant chapters of the being filled out for the first time, this should be mentioned in
USP, Ph. Eur. or JP and can be obtained as stocks from culture Table 2 and the requirement on the left shall be answered in
collections (such as ATCC) or secondary qualified suppliers. terms of applicability and implementation status (see columns 2
and 3).
Selection of microorganisms Yes No Yes No
In addition to standard stock cultures sourced from a national
culture collection, selected in-house isolates (at least one strain,
and typically not more than two different strains) isolated from
the EM program (isolated from grade A & B), positives of sterility
test or aseptic process simulation (media fill) failures should be
included in GPT of relevant media1.

Footnote 1: The production facilities of non-sterile APIs are Yes No Yes No

exempt from the requirement to include in-house isolates in the
test. For those sites, use of compendial strains is sufficient. If
there is an obligation to use in-house isolates as part of the GPT,
but there are no isolates available from the corresponding
locations/analyzes, strains isolated from the next lower
cleanroom area could also be used (e.g., Grade C). In any case,
the choice of inhouse isolates used in the GPT must be justified in
the annual microbiological assessment and, if necessary,
adjusted.
The recommended number and types of in-house isolates to be Implementation Assessment version 1 has already been filled
included within the GPT should reflect the generally present, out, there is no need to re-evaluate this requirement. If this IA is
predominant microorganisms. being filled out for the first time, this should be mentioned in
and 3).
The rationale for the selection of the in-house isolates shall be Implementation Assessment version 1 has already been filled
documented and reviewed annually as part of annual review of out, there is no need to re-evaluate this requirement. If this IA is
microbial flora as per gGD-PH-OT-002 “Determination, being filled out for the first time, this should be mentioned in
Preservation and Use of Microbial In-house Flora”. Table 2 and the requirement on the left shall be answered in
and 3).
Selection of microorganisms Yes No Yes No
In the case of a customer complaint with a fatal or severe
outcome resulting from potential microbial contamination,
relevant medium should be tested in regard to its growth-
promoting properties for the microbial strain originating from the
complaint (if available). This should be done as part of the
investigation program and does not need to be included in the
routine testing for media release.


While the treatment (e.g. storage, rehydration) of purchased Implementation Assessment version 1 has already been filled
stock cultures should be carried out according to the out, there is no need to re-evaluate this requirement. If this IA is
manufacturer’s instructions, in-house cultures must be cultivated being filled out for the first time, this should be mentioned in
and conserved as described in the internal SOPs. Table 2 and the requirement on the left shall be answered in
and 3).
Challenge microorganisms for each media type are selected Implementation Assessment version 1 has already been filled
according to the usage of the media: out, there is no need to re-evaluate this requirement. If this IA is
• General standard purpose media (e.g., TSA, TSB) are
challenged with a wide range of microorganisms
representing gram-positive, gram-negative, Bacillus
and 3).
spp. and fungi.
• Selective or differential media (e.g., MacConkey) are
challenged with individual strains designed to show
growth promoting, inhibitory or indicative properties of
the media. Selection of these microorganisms may be
based on compendial test chapters or manufacturer’s
recommendation for a particular medium.
Table 1: New requirements/conditions in Table 1. Yes No Yes No
Selection of incubation temperatures Yes No Yes No
Where the incubation temperatures described in Table 1
correspond to specific compendial chapters that include fixed
pre-defined incubation temperatures (as i.e., the Pharmacopeial
chapter for sterility testing), those conditions must be chosen.


Where the incubation temperatures as described in Table 1
correspond to specific compendial chapters or other GMP
standards that do not include fixed pre-defined incubation
temperatures, but give a range for incubation (as i.e., for EM,
bioburden testing), the plant specific incubation conditions should
be used instead (for all microorganisms).
For the GPT of media that is to be used for aseptic process
simulation, it is appropriate to incubate the different compendial
strains according to the separate temperature ranges preferred
for their detection.
GPT procedure Yes No Yes No No content-related changes compared to version 1. If
Method 1: Media inoculated through in-house cultures are usually Implementation Assessment version 1 has already been filled
reactivated from a stock solution and adjusted to the level of use out, there is no need to re-evaluate this requirement. If this IA is
by serial dilution. Therefore, the actual colony-forming value being filled out for the first time, this should be mentioned in
must be tested and verified on control plates (usually the already Table 2 and the requirement on the left shall be answered in
approved batch of media). terms of applicability and implementation status (see columns 2
and 3).
GPT procedure Yes No Yes No No content-related changes compared to version 1. If
Method 2: The standardized inocula refer to the value of the Implementation Assessment version 1 has already been filled
colony-forming units in the final volume specified by the out, there is no need to re-evaluate this requirement. If this IA is
manufacturer and can be used for the GPT without further being filled out for the first time, this should be mentioned in
dilution series (including verification approaches). Table 2 and the requirement on the left shall be answered in
and 3).
GPT procedure Yes No Yes No
When testing inhouse-prepared cultures it is recommended to
perform the test on the new and previously approved (control)
medium by the same technician in parallel in order to exclude
additional influential variables such as temperature, technique,
incubation time or inoculum. If RTU cultures are used, cell
comparison on old media is not required since the manufacturer
provides a standardized inoculum with an appropriate cell count.

Method 1 - Use of in-house prepared inoculum Yes No Yes No No content-related changes compared to version 1. If
suspensions of challenge microorganisms Implementation Assessment version 1 has already been filled
Prepare suspensions of each required challenge microorganism out, there is no need to re-evaluate this requirement. If this IA is
from a freshly revived culture not more than five passages being filled out for the first time, this should be mentioned in
removed from the reference seed lot. Table 2 and the requirement on the left shall be answered in
and 3).
Use buffered Sodium Chloride Peptone solution (pH 7.0) or out, there is no need to re-evaluate this requirement. If this IA is
Phosphate buffer solution (pH 7.2) to make serial dilutions of the being filled out for the first time, this should be mentioned in
challenge microorganism to obtain a final inoculum suspension Table 2 and the requirement on the left shall be answered in
yielding in 10 - 100 CFU/ml. terms of applicability and implementation status (see columns 2
and 3).
Use the suspensions within 2 hours, or within 24 hours if stored out, there is no need to re-evaluate this requirement. If this IA is
between 2 – 8 °C. being filled out for the first time, this should be mentioned in
and 3).
Method 1 - Use of in-house prepared inoculum Yes No Yes No
suspensions of challenge microorganisms
Inoculate each medium (test at least in duplicates per strain)
with an appropriate volume (e.g., 100 to 250 µL for agar plates)
corresponding to NMT 100 CFU of a relevant challenge
microorganism according to Error: Reference source not found.
When testing liquid medium, the volume of the inoculum should
not exceed 1% of the volume of the media to be tested. Where
quantitative determinations are to be carried out (i.e., non-
selective agar plates), testing must be carried out at least in
duplicate per strain. Repeat on additional sets of media units for
each of the remaining challenge microorganisms required.


In parallel, inoculate as above each challenge microorganism on
a previously approved media lot that is within expiry. These units
will represent the inoculum control. For non-selective media
(e.g., TSA), the plating must be performed in duplicates due to
quantitative measurement (for each microbial strain use two
plates from the new medium and two from the already approved
medium, i.e., a total of 4 plates).
If the media being tested is a liquid (broth), inoculate TSA plates
as an additional inoculum control (as described above). The
inoculum must also be controlled when using selective liquid
media (such as MacConkey broth). For that purpose, also the
usage of non-selective media such as TSA is accepted.
Incubate tests according to the conditions as described in Table out, there is no need to re-evaluate this requirement. If this IA is
1. being filled out for the first time, this should be mentioned in
and 3).
For solid media where colonies can be counted, calculate the out, there is no need to re-evaluate this requirement. If this IA is
average of the colony forming units of the new media and of the being filled out for the first time, this should be mentioned in
inoculum control media. Table 2 and the requirement on the left shall be answered in
and 3).

For liquid media, check turbidity/growth for each challenge out, there is no need to re-evaluate this requirement. If this IA is
microorganism on the test media and on the inoculum control being filled out for the first time, this should be mentioned in
media. Table 2 and the requirement on the left shall be answered in
and 3).
Method 1 - Use of in-house prepared inoculum
Old medium that has expired for not more than 4 weeks may be
used as a control in exceptional cases. If this case occurs
regularly or if it cannot be guaranteed that the medium does not
expire, the establishment of method 2 should be considered as
the test can be carried with the newly delivered medium only.
Method 2 – Use of RTU cultures (such as Quanticult, Yes No Yes No No content-related changes compared to version 1. If
BioBall™ or BEC growth kits) Implementation Assessment version 1 has already been filled
Each culture lot must be accompanied by a COA demonstrating a out, there is no need to re-evaluate this requirement. If this IA is
min-max count (e.g. 10-100 CFU/volume) and may include a being filled out for the first time, this should be mentioned in
mean CFU count on general culture media. Table 2 and the requirement on the left shall be answered in
and 3).
Suppliers of RTU cultures must be qualified prior to use and out, there is no need to re-evaluate this requirement. If this IA is
applicable steps for supplier qualification must be considered being filled out for the first time, this should be mentioned in
(information can be found in Global-SOP-MM-000002564 Table 2 and the requirement on the left shall be answered in
“Supplier Selection & Qualification”). terms of applicability and implementation status (see columns 2
and 3).

Each supplier Lot must be released by verifying the COA claim out, there is no need to re-evaluate this requirement. If this IA is
and results be within min-max count unless the supplier is being filled out for the first time, this should be mentioned in
certified. Table 2 and the requirement on the left shall be answered in
and 3).
In case the supplier has been certified, one lot of each out, there is no need to re-evaluate this requirement. If this IA is
representative challenge microorganism (1 gram-positive and 1 being filled out for the first time, this should be mentioned in
gram-negative strain) must be tested annually as part of Table 2 and the requirement on the left shall be answered in
maintaining the certified status of the supplier. terms of applicability and implementation status (see columns 2
and 3).
RTU cultures are used in an undiluted volume which corresponds out, there is no need to re-evaluate this requirement. If this IA is
to a count NMT 100 microorganisms per test. being filled out for the first time, this should be mentioned in
and 3).
Method 2 – Use of RTU cultures (such as Quanticult, Yes No Yes No
BioBall™ or BEC growth kits)
Inoculate each medium with the corresponding volume (typically
between 100 to 250 µL for agar plates) of a relevant challenge
microorganism according to Error: Reference source not found.
When testing liquid medium, the volume of the inoculum should
not exceed 1% of the volume of the media to be tested.

Acceptance criteria of method 1 Yes No Yes No No content-related changes compared to version 1. If

Solid media acceptance criteria are as follows: Implementation Assessment version 1 has already been filled
out, there is no need to re-evaluate this requirement. If this IA is
 There must be NMT 100 CFU on each agar plate.
and 3).
Acceptance criteria of method 1 Yes No Yes No
Solid media acceptance criteria are as follows:
 The average number of colonies from the new lot of
medium must be within a factor of 2 (corresponds to the
same as 50 to 200%) of the average number of colonies
from the previously approved lot of medium (represents
the positive control)5.
Footnote 5: Count comparison according to the factor 2 concept Yes No Yes No
is not required for selective media. However, it shall be verified
that the challenge microorganisms actually grow on the media
and, if defined, show characteristic morphology as described in
the Pharmacopoeia. For some selective media it must also be
shown that other microorganisms do not grow (e.g.,
MacConkey).

Liquid media acceptance criteria are as follows: Implementation Assessment version 1 has already been filled
 There must be growth/turbidity in the test tubes from
both the new lot of media and the previously approved
lot of media, as well as on the control agar plates.
and 3).


 The non-selective control plate should have NMT 100
CFU.
and 3).
 The turbidity/growth in the tubes from the tested
medium should be visually comparable to the turbidity
in the tubes from the previously approved lot of
medium. A quantitative definition of “comparable” is not
and 3).
established by USP, Ph. Eur. or JP; visual comparability
is sufficient and accepted.
 There must be NMT 100 CFU on each agar plate.
and 3).
 The average number of colonies from the tested
medium must be within the min – max values given on
the supplier COA.
and 3).


 There must be growth/turbidity in the test tubes from
the new lot of media.
and 3).
Acceptance criteria of method 2 Yes No Yes No
Liquid media acceptance criteria are as follows:
 The control must show NMT 100 CFU.
Handling of failing results Yes No Yes No No content-related changes compared to version 1. If
An invalid GPT is defined if more than 100 CFU are countable on Implementation Assessment version 1 has already been filled
inoculum control plates. Results must be recorded, and test is out, there is no need to re-evaluate this requirement. If this IA is
repeated only with the microorganisms and medium that did not being filled out for the first time, this should be mentioned in
meet the acceptance criteria. Table 2 and the requirement on the left shall be answered in
 If the repeat test also fails, the failure should be
and 3).
addressed per Global-SOP-QM-000002473 “Event
Handling & CAPA Process”.
Handling of failing results Yes No Yes No
In case the acceptance criteria are not met by growth of less
than a factor of 2, or growth not comparable to previous
approved batch:
 If the inoculum control plate showed an average of NMT
10 CFU, then the inoculum is considered to be too low
and the test can be invalidated and repeated. Results
shall be recorded, and test is repeated only with the
challenge microorganisms and medium that did not
meet the acceptance criteria.
 If the repeat test also fails, the failure should be
addressed per Global-SOP-QM-000002473 “Event
Handling & CAPA Process”.

Handling of failing results Yes No Yes No

Note: When using Method 1, on the new media cell counts above
100 CFU may be accepted as long as the control plates show
NMT 100 CFU and the factor of 2 is met. Counts between 5 and
10 CFU are acceptable as long as the factor of 2 is met.
Responsibilities Yes No Yes No
The responsibilities and duties of key personnel as defined by
Global-SOP-QM-000002830 “Authority, Responsibilities and
Duties of Local Key Personnel and Organizations” apply. The
department conducting the GPT is responsible for implementing
and maintaining the described process on site level and that
personnel involved in these activities are qualified and trained
(see also Global-SOP-HR-000002835 “Personnel Qualification and
Training”).
[fill in single process steps described in global QM Document] Yes No Yes No
Yes No Yes No
Yes No Yes No

Reviewed and
Generated by:
Approved by:
[Name] [Name]
[Function] [Function – QA Head local organization]
[Organization] [Organization]
[Signature] [Date] [Signature] [Date]

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Implementation Assessment for Instructive Global QM Documents

Table 1 General Information

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 1 of 19

# Implementation Mode Action Selection Justification

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 2 of 19

However, the growth promoting properties of the individual, site-

A complete test of media, including in-house isolates (exceptions

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 3 of 19

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 4 of 19

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 5 of 19

Frequency of the testing Yes No Yes No

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 6 of 19

Frequency of the testing Yes No Yes No

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 7 of 19

Footnote 1: The production facilities of non-sterile APIs are Yes No Yes No

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 8 of 19

Selection of microorganisms Yes No Yes No No content-related changes compared to version 1. If

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 9 of 19

Selection of incubation temperatures Yes No Yes No

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 10 of 19

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 11 of 19

Method 1 - Use of in-house prepared inoculum Yes No Yes No

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 12 of 19

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 13 of 19

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 14 of 19

Acceptance criteria of method 1 Yes No Yes No No content-related changes compared to version 1. If

Acceptance criteria of method 1 Yes No Yes No No content-related changes compared to version 1. If

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 15 of 19

Acceptance criteria of method 1 Yes No Yes No No content-related changes compared to version 1. If

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 16 of 19

Acceptance criteria of method 2 Yes No Yes No No content-related changes compared to version 1. If

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 17 of 19

Handling of failing results Yes No Yes No

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 18 of 19

[Function] [Function – QA Head local organization]

[Signature] [Date] [Signature] [Date]

Source of Form: Global-FORM-QM-000002753 Version: 3.0 Page: 19 of 19

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