Qualtrus Polyglactin 910 - For - Stability - Study - Protocol-24 May

Non-PPE Form XXXXXXX
Quality System Revision Y

Form for Stability Study Protocol CO:XXXXXX
FORMAL STABILITY STUDY PROTOCOL FOR THE EVALUATION OF

QUALTRUS POLYGLACTIN 910 SUTURE PACKAGED IN AMCOR LOW
TEMPERATURE PEELABLE LAMINATE FOIL IN SUPPORT OF SHELF
LIFE CONFIRMATION OF MULTIPLE BATCHES MANUFACTURED AT
AURANGABAD PLANT IN INDIA
STABILITY STUDY # (CLICK HERE TO ADD ADAPTIV NUMBER) Commented [MA[N1]: Adaptiv number to be provided
ETHICON CONFIDENTIAL use pursuant to Company Procedures Page 1 of 15

Form number 100091194/Revision 3
TABLE OF CONTENTS
1 OBJECTIVE ..................................................................................................................................................3
2 BACKGROUND............................................................................................................................................3
3 ROLES AND RESPONSIBILITIES ............................................................................................................7
4 COMPONENT AND STERILIZATION INFORMATION ......................................................................8
5 STUDY CONDITIONS AND QUANTITIES ..............................................................................................9
6 SAMPLING AND TESTING PLAN ..........................................................................................................11
7 ACCEPTANCE CRITERIA ......................................................................................................................15
8 REPORTING ...............................................................................................................................................15
9 REFERENCE ..............................................................................................................................................15
10 PROTOCOL REVISION HISTORY ........................................................................................................ 15
LIST OF TABLES
Table 2- 1: Family regulatory details .............................................................................................................3

Table 2- 2: Preconditioning steps for excursion simulation samples ..............................................................5
Table 3- 1: Study responsibilities ....................................................................................................................7
Table 4- 1: Device and sub-component traceability........................................................................................8
Table 4- 2: Primary and secondary package component traceability .............................................................8
Table 4- 3: Tertiary package component traceability .....................................................................................9
Table 4-4: Sterilization traceability ................................................................................................................9
Table 5-1: Total sample quantities* per study condition for this(ese) stability study lot(s) for real time study
.........................................................................................................................................................................9
Table 5-2: Total sample quantities* per study condition for this(ese) stability study lot(s) for accelerated
study ..............................................................................................................................................................10
Table 6- 1: Sampling and testing plan for QUALTRUS Polyglactin 910 Suture in real time conditions ...... 11
Table 6- 2: Sampling and testing plan for QUALTRUS Polyglactin 910 Suture in accelerated study .........13
Table 7- 1: Acceptance Criteria for [enter product information] ................................................................. 15
Table 10- 1: Protocol revision history ..........................................................................................................15

1 OBJECTIVE
The objective of this protocol is to describe the plan for confirming the shelf life (60 months; expiry date
period) of QUALTRUS Polyglactin 910 Sutures, manufactured, packaged and sterilized at Aurangabad
plant, India. This protocol outlines the formal stability study that will confirm the shelf life label claim of
QUALTRUS Polyglactin 910 Suture.
The real time study will be conducted in 300 C +/- 20 C, 70% RH +/- 5% RH conditions through 60 months Commented [MA[N2]: 60 months or 72 months as a few
protocols suggest 72 months of real time testing
of testing. The accelerated study will be conducted in 500 C+/- 20 C, 45% RH +/- 5% RH conditions for 15
months.
2 BACKGROUND
QUALTRUS Polyglactin 910 Suture elicits a minimal acute inflammatory reaction in tissue and ingrowth
of fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of QUALTRUS
Polyglactin 910 Suture occurs by means of hydrolysis, where the copolymer degrades to glycolic and lactic
acids which are subsequently absorbed and metabolized in the body. Absorption begins as a loss of tensile
strength followed by a loss of mass. Implantation studies in rats indicate that QUALTRUS Polyglactin 910
Suture retains approximately 75% of the original tensile strength at two weeks post-implantation. At three
weeks, approximately 50% of the original strength is retained for sized 6-0 and larger and approximately
40% of its original strength is retained for sized 7-0 and smaller. Approximately 25% of its original strength
is lost between four weeks post-implantation. Absorption of QUALTRUS Polyglactin 910 Suture is
essentially complete between 56 and 70 days.
QUALTRUS Polyglactin 910 Suture is indicated for use in general soft tissue approximation and/or
ligation, including use in ophthalmic procedures, but not indicated for use in cardiovascular or neurological
tissues.
The stability studies planned under this protocol are being initiated to address corrective actions established
under EtQ CAPA-002192 (formerly known as CAPA110348). The batch selection is based upon the study
design outlined in stability strategy [enter strategy number and title]. Commented [MA[N3]: Stability Strategy number needs to be
mentioned
2.1 PRODUCT INFORMATION

Table 2- 1: Family regulatory details
Device Regulatory
CE Manufacturing
Family Name Device Indications Classification
Marked? Sites
(FDA & ISO)
QUALTRUS Polyglactin 910
Suture is indicated for use in
general soft tissue
QUALTRUS
approximation and/or Class C as per
Polyglactin 910 Not Aurangabad,
Suture
ligation, including use in Medical Device
Applicable India
ophthalmic procedures, but Rule, India
not indicated for use in
cardiovascular or
neurological tissues.

QUALTRUS Polyglactin 910 sutures manufactured at Aurangabad plant, India are sterilized by Ethylene
Oxide. All samples will be worst case sterilized, using three ethylene oxide (EO) X cycles followed by two
EO J cycles. Worst case sterilization conditions may be achieved by multiple exposures to nominal cycles
in excess of routine expected production including cycle disruption/restart or by exposing product to a
single worst case sterilization cycle. To achieve worst case sterilization for the samples in this study,
samples will be exposed to a minimum of five cycles, preferably three X cycles and two J cycles Worst-
case sterilization information applied to the products in this study can be found in Table 4-4. Commented [MA[N4]: Leveraged from existing Franchise
protocol 100306664. Need to check whether same worst case logic
applies to Vicryl* sutures manufacture at Aurangabad plant or not
For the studies planned within this family, samples will be evaluated for moisture in package, Knot Tensile
strength, Packaging Seal strength, Vacuum Leak decay, needle pull along with length and diameter, suture
appearance, In vitro Breaking strength testing for the device and package. Refer to subsequent sections for Commented [MA[N5]: These are the testing attributes
details pertaining to product and package component information, storage conditions, and test and interval
selection. Lot information traceable to the batch and sterilization records will be provided in the interim
and completion report(s) for this protocol.
Forced degradation (FD) study(ies) were initiated under FD study # [study number] to evaluate the Commented [MA[N6]: Need to mention study number related
to Forced Degradation
temperature and humidity sensitivities of QUALTRUS Polyglactin 910 Sutures and the primary package
when exposed to extreme cycles simulating short term distribution excursion conditions. FD samples were
exposed to -200 C +/- 50 C, Ambient RH for 72 hours and then to 600 C+/- 20 C, Ambient RH for 72 hours.
The data was used to identify this protocols excursion upper and lower limits as well as the number of
cycles that the product and package can be expected to tolerate over the duration of the label claim. Refer
to Table 2-2 for distribution excursion simulation parameters used in this protocol.

Table 2- 2: Preconditioning steps for excursion simulation samples

Step Preconditioning Stability Testing
All samples will be worst case sterilized, using Ethylene Oxide. All samples
will be worst case sterilized, using three ethylene oxide (EO) X cycles followed
1 Sterilization
by two EO J cycles. Sterilization will occur prior to temperature conditioning Commented [MA[N7]: Need to check whether same worst case
(exposure to distribution excursion simulation). scenario is applicable to Vicryl* sutures manufactured at
Aurangabad
Prior to preconditioning (Step 3), one set of baseline samples (59 packages/ lot)
Commented [MA[N8]: For pre-conditioning, number of
Stability will be tested according to the test schedule in Table 6.1. The remaining samples will be same as baseline samples as identified below
2
Testing samples in the protocol (1101 packages/ lot) will be subjected to Steps 3 and 4
Commented [MA[N9]: Total number of samples for real time
that follow. study
Temperature Temperature conditioning will be conducted according to the following
Conditioning schedule:
Duration
Controlled at each
Step Time/Activity Condition/Activity
Temperature Step
(hours)
Starting from Room
Temperature, decrease
Approx.
3a Initial ramp n/a temperature 3.33C/hour
13.5
for approximately 13.5
hours to reach -20C
st -200 C+/- 50 C
3b 1 72 hours Dwell at Extreme Cold 72
Ambient RH
Beginning at -200 C C,
increase temperature
3c 24 hour ramp n/a 24
3.33C/hour for 24 hours
to reach 60C +/- 20 C
3 60C +/- 20 C
3d 2nd 72 hours Dwell at Extreme Heat 72
Ambient RH
Beginning at 60C,
decrease temperature
3.33C/hour for 24 hours
to reach -20C and go to
Step 3b for next dwelling
cycle until a total of four
(4) Extreme Cold and
Extreme Hot cycles are 10.5 to
3e Final ramp n/a
complete. 24
THEN
Starting from 60C,
decrease temperature
3.33C/hour for 10.5
hours to reach
25C. Excursion profile Commented [MA[N10]: It was mentioned in the template itself
is complete. as 25 degree C. But, as per requirements of India, the real time
stability is being carried out at 30 degree C. So, it should be 30
degree instead of 25 degree.

Quality Systems Revision Y
Table 2- 2: Preconditioning steps for excursion simulation samples

Step Preconditioning Stability Testing
Samples will be tested at the end of temperature conditioning and
Stability then samples will be placed in the stability chamber for
4 n/a
Testing aging. Samples will be allowed to equilibrate to 25C for a Commented [MA[N11]: The real time testing will be performed
minimum of 24 hours prior to conducting any testing. at 30 degree C
Repeat the above cycle a total of four times (12 days Extreme Cold plus 12 days Extreme Heat,
Notes
and up to 10.4 days of temperature ramping = ~35 days of cycling, 24 total days of excursion).
Prior to aging, all formal study test samples will be exposed to distribution excursion simulation after
sterilization - at atmospheric conditions appropriate to the transport and storage of the device as described
in Table 2-2 above.
Samples will be analyzed at the end of the simulation cycle as time zero prior to loading study samples into
real-time aging conditions.
Sample size chosen for this study are designed to satisfy the requirements of 100248164 Global Product
Stability Shelf Life Determination Procedure, which recommends sample sizes to meet 95% confidence
level with 95% probability. Commented [MA[N12]: Some of the sample size rationale has
been mentioned below
The following considerations were taken into account for sample size selection:
Per the USP U.S. Pharmacopeia (USP 21, 2003) page 1751: [Knot] Tensile- Determine the tensile
strength on not fewer than 10 strands of suture as directed for Surgical Sutures Under Tensile
Strength (881).
Sample size for In-Vivo Breaking Strength will be n=8 to align with the test method sample
preparation requirements identified in NAMSA SOP-00578.
With the aforementioned criteria, the sampling plan for the remaining tests (Moisture in Package,
In-Vitro Breaking Strength, Seal Strength) will be aligned with the USP tensile strength
requirements of n = 10.

QUALTRUS Polyglactin 910 sutures are bracketed as shown below to identify the worst case product
codes: Commented [MA[N13]: Bracketing Logic:
1) Go to EPID final list (after excluding SAP lock codes)
2) Identify folders used from column FL and filter for each folder
type
3) After folder, classify based on number of strands (select 1 for
single, more than 1 for multi)
Aurangabad 4) Then identify lowest diameter lowest length suture and highest
diameter highest length suture
Note: In most of the cases, Ethicon India do not manufacture the

Undyed Dyed worst case product codes identified. So, next size available suture is
marked as an alternative.
FT Box FT Box
Single Single
Strand Strand
PG143 (4-0) PG149 (5-0)
PG 131 (3-
PG112 (2)
0)
3 ROLES AND RESPONSIBILITIES

The Study Director and Stability Administration or designee has the following responsibilities as described
in 100248169: Global Product Stability Roles and Responsibilities.
The following laboratories and/or departments will be responsible for the various aspects of the stability
study.
Table 3- 1: Study responsibilities Commented [MA[N14]: Need to assign responsibilities to
Type of Activity Responsible Site respective department
Manufacturing Name of the department, site, state, country
Packaging Name of the department, site, state, country
Sterilization Name of the department, site, state, country
Baseline Testing Name of the department, site, state, country
Storage, Sampling, and Distribution of Samples Name of the department, site, state, country
Analytical Testing Name of the department, site, state, country
Physical Testing Name of the department, site, state, country
Microbiological Testing Name of the department, site, state, country
Protocol Issuance Study Director
Interim /Final Reports Issuance Study Director

4 COMPONENT AND STERILIZATION INFORMATION
The following device components were manufactured from commercial material used for this(ese) stability study lot(s).
Table 4- 1: Device and sub-component traceability
Device Sub-Component
Study Number Product Code Device Description Sub-
Description Component
Product Code Commented [MA[N15]: Mention Needle and Suture only from
QUALTRUS POLYGLACTIN 910 DDCS 28 19 56 B S INR3247 BOM
XXXXXXXXX-1 PG143
SUTURE VICRYL* UNDYED SIZE 4-0 SPOOL 1242408
QUALTRUS POLYGLACTIN 910 DDCS 33 19 61 A S INR3246
XXXXXXXXX-2 PG131
SUTURE VICRYL* UNDYED SIZE 3-0 SPOOL 1242308
QUALTRUS POLYGLACTIN 910 DHR 22 17 46 B S INR3244
XXXXXXXXX-3 PG149 SUTURE VICRYL VIOLET 5/0 SPOOL 1232508
QUALTRUS POLYGLACTIN 910 DZ 40 57 100 INS2547
XXXXXXXXX-4 PG112 SUTURE VICRYL* VIOLET SIZE 1 SPOOL 1232018
HR180 57 40 100 ARS INR3395
The following primary and secondary packaging components were used for this(ese) stability study lot(s).
Table 4- 2: Primary and secondary package component traceability
Study Number Primary and Secondary Packaging Components
Description RMC# Commented [MA[N16]: Mention Foil and Folder from BOM.
AMCOR PEELABLE FOIL TOP INP5538P Filter Category 2 with Bulk PM and Packaging Material. Under that,
select Foil and Folder from Category 1
XXXXXXXXX-1 FT BOX TYPE FOLDER FOR PG143 INP5960
AMCOR PEELABLE FOIL BOT INP5539
AMCOR PEELABLE FOIL TOP INP5538P
FT BOX TYPE FOLDER FOR PG112 INP5954
XXXXXXXXX-4

Table 4- 2: Primary and secondary package component traceability

Study Number Primary and Secondary Packaging Components
Description RMC# Commented [MA[N16]: Mention Foil and Folder from BOM.
AMCOR PEELABLE FOIL BOT INP5539 Filter Category 2 with Bulk PM and Packaging Material. Under that,
select Foil and Folder from Category 1
The following tertiary packaging components were used for this(ese) stability study lot(s).
Table 4- 3: Tertiary package component traceability
Study Number Tertiary Packaging Components
Description RMC#
XXXXXXXXX-1
XXXXXXXXX-2
Not Applicable Not Applicable
XXXXXXXXX-3
XXXXXXXXX-4
The following sterilization campaign(s) were used to sterilize the material used for this(ese) stability study lot(s).
Table 4-4: Sterilization traceability
Study Number Sterilization Method Cycle/Dose Range (worst-case) Commented [MA[N17]: How to define worst case for EO
XXXXXXXXX-1 sterilization?
All samples will be worst case sterilized, using
XXXXXXXXX-2
Ethylene Oxide three ethylene oxide (EO) X cycles followed by
XXXXXXXXX-3
two EO J cycles. Commented [MA[N18]: Need to check whether same worst
XXXXXXXXX-4 case scenario is applicable to Vicryl* sutures manufactured at
Aurangabad
5 STUDY CONDITIONS AND QUANTITIES
Quantity of Samples Stored for Each Study Lot Commented [MA[N19]: Study number (XXXXX-1) wise
Quantity samples are not mentioned as there are total 9 study numbers and
Study Condition hence representation wise, it creates problems. The study lot, for
Required Reserve Per Condition which, sample requirement is maximum, that is mentioned here,
(row total) because that will be the worst case requirements
Initial (Baseline) 69 21 90
Commented [MA[N20]: Reserve is considered as 30% except
5C 3 C / Ambient for control samples, where reserve is 100%
12 12 24
RH
30C 2 C / 70%RH
5% RH (Real time 759 228 987
study)
Subtotal 840 261
TOTAL 1101

Quantity of Samples Stored for Each Study Lot Commented [MA[N19]: Study number (XXXXX-1) wise
Quantity samples are not mentioned as there are total 9 study numbers and
Study Condition hence representation wise, it creates problems. The study lot, for
Required Reserve Per Condition which, sample requirement is maximum, that is mentioned here,
(row total) because that will be the worst case requirements
*NOTE: Preconditioned sample quantities are not accounted for in this table; they are quantified in the conditions identified above.
Commented [MA[N20]: Reserve is considered as 30% except
for control samples, where reserve is 100%
Table 5-2: Total sample quantities* per study condition for this(ese) stability study lot(s) for accelerated study
Quantity of Samples Stored for Each Study Lot
Quantity
Study Condition
Required Reserve Per Condition
(row total)
Initial (Baseline) 69 21 90 Commented [MA[N21]: Need to discuss if Initial Baseline
5C 3 C / Ambient testing and control study is performed during accelerated study also
7 7 14 or not
RH
50C 2 C / 45%RH
5% RH (Accelerated 414 125 539
study)
Subtotal 490 153
TOTAL 643
*NOTE: Preconditioned sample quantities are not accounted for in this table; they are quantified in the conditions identified above.

6 SAMPLING AND TESTING PLAN

The required number of devices will be taken from the following storage conditions at each time interval.
Table 6- 1: Sampling and testing plan for QUALTRUS Polyglactin 910 Suture in real time conditions
Init-
Storage Condition pT 1m 3m 6m 9m 12 m 18 m 24 m 36 m 48 m Expiry 60 m 72 m
ial
Prior to Distribution
A-H - - - - - - - - - - - -
Simulation Excursion
Distribution Simulation
- A-H - - - - - - - - - - -
Excursion
5C 3 C / Ambient RH A-H A A A A A A A A A A A A
30C 2 C / 70%RH 5%
A-H A-H A-H A-H A-H A-H A-H A-H A-H A-H A-H A-H
RH (Real time study)
Acceptance
Source Numbe Numbe Number of
Test Criteria
Test Document and Test Method Test Department, Location r of r of Reported
ID (lower and/or
Revision Devices Tests Results
upper limit) Commented [MA[N22]: Acceptance criteria limits consists of
FGQA, long list as per suture sizes. So, document reference has been
Control mentioned
A NA NA NA Aurangabad, 1 NA NA
(for appearance only)
India
SOP-12843 and Quality Laboratory,
B Moisture in package SPEC-04508 SOP-12843 10 10 10
SOP-12661 Aurangabad, India
10 111
10 (for
Needle pull FGQA, 10
length)
C (along with length and SPEC-04508 SPEC-04508 SOP-12843 Aurangabad, 10
diameter) India 10 (for
diamet 10
er)
Quality Laboratory,
D Knot tensile SPEC-04508 SPEC-04508 SOP-12843 10 10 112
Aurangabad, India
In Vitro
E Breaking SPEC-04508 SPEC-04508 SOP-12659 10 10 113 Commented [MA[N23]: Need to check whether this hold good
Strength or not
In Vivo
NAMSA TM-
Breaking
F SPEC-04508 SPEC-04508 00153, current NAMSA, Northwood, OH 8 8 94
Strength
revision
Evaluation (21

days)
Package Design COE
G Seal strength TM-0000177 10 30 305 Commented [MA[N24]: We can use the stability strategy as
Somerville source
100158723
Package Design COE
H Vacuum leak decay or 10 10 10 Commented [MA[N25]: We can use the stability strategy
Somerville
100353542
- = No testing required at this interval.
NA = Not Applicable
Quantities described in Table 6.1 do not include reserve samples.
Test samples will be stored in random orientation.
Texp = Expiry Interval. This interval is based upon the date on the package and not necessarily the study initiation date.
In-vivo testing is required only when stability failures are seen in In-vitro testing
Notes: 1=
Report 10 individual needle pull results along with one average needle pull result
2
= 10 individual results and one average result are reported for Knot Tensile and for In-Vitro testing for a total of 11 reported results per interval.
3
= Report 10 individual in vitro breaking test result and one average result, total 11 reported results per interval
4
= In vivo test is required only when stability failures are seen in in-vitro testing. The straight pull is measured before implantation and after implantation
for 21 days
5
= Report 10 individual results each from both sides and bottom seal for a total of 30 individual peak maximum values per interval only for the baseline
samples. Report 10 individual results from one side seal for a total of 10 individual peak maximum values for each interval thereafter .

Table 6- 2: Sampling and testing plan for QUALTRUS Polyglactin 910 Suture in accelerated study
Init-
Storage Condition pT 1m 3m 6m 9m 12 m 15 m
ial
A-H - - - - - - -
- A-H - - - - - -
Excursion
5C 3 C / Ambient RH A-H A A A A A A Commented [MA[N26]: Need to check whether Control study,
30C 2 C / 70%RH 5% initial baseline testing as performed in real time study is performed
A-H A-H A-H A-H A-H A-H in accelerated study or not
Acceptance
Test Criteria
ID (lower and/or
FGQA, long list as per suture sizes. So, document reference has been
Control mentioned
A NA NA NA Aurangabad, 1 NA NA
(for appearance only)
India
SOP-12843 and Quality Laboratory,
B Moisture in package SPEC-04508 SOP-12843 10 10 10
SOP-12661 Aurangabad, India
10 111
10 (for
Needle pull FGQA, 10
length)
C (along with length and SPEC-04508 SPEC-04508 SOP-12843 Aurangabad, 10
diameter) India 10 (for
diamet 10
er)
Quality Laboratory,
D Knot tensile SPEC-04508 SPEC-04508 SOP-12843 10 10 112
Aurangabad, India
In Vitro
E Breaking SPEC-04508 SPEC-04508 SOP-12659 10 10 113 Commented [MA[N28]: Need to check if this holds good or not
Strength
In Vivo
Breaking NAMSA TM-
F Strength SPEC-04508 SPEC-04508 00153, current NAMSA, Northwood, OH 8 8 94
Evaluation (21 revision
days)
Package Design COE
G Seal strength TM-0000177 10 30 305 Commented [MA[N29]: Stability Strategy can a source
Somerville

Table 6- 2: Sampling and testing plan for QUALTRUS Polyglactin 910 Suture in accelerated study
Init-
Storage Condition pT 1m 3m 6m 9m 12 m 15 m
ial
A-H - - - - - - -
- A-H - - - - - -
Excursion
5C 3 C / Ambient RH A-H A A A A A A Commented [MA[N26]: Need to check whether Control study,
30C 2 C / 70%RH 5% initial baseline testing as performed in real time study is performed
A-H A-H A-H A-H A-H A-H in accelerated study or not
Acceptance
Test Criteria
ID (lower and/or
100158723 long list as per suture sizes. So, document reference has been
Package Design COE mentioned
H Vacuum leak decay or 10 10 10
Somerville
100353542 Commented [MA[N30]: Same query as G
- = No testing required at this interval.
NA = Not Applicable
Quantities described in Table 6.1 do not include reserve samples.
Test samples will be stored in random orientation.
Texp = Expiry Interval. This interval is based upon the date on the package and not necessarily the study initiation date.
In-vivo testing is required only when stability failures are seen in In-vitro testing
Notes: 1=
Report 10 individual needle pull results along with one average needle pull result
2
= 10 individual results and one average result are reported for Knot Tensile and for In-Vitro testing for a total of 11 reported results per interval.
3
= Report 10 individual in vitro breaking test result and one average result, total 11 reported results per interval
4
= In vivo test is required only when stability failures are seen in in-vitro testing. The straight pull is measured before implantation and after implantation
for 21 days
5
= Report 10 individual results each from both sides and bottom seal for a total of 30 individual peak maximum values per interval only for the baseline
samples. Report 10 individual results from one side seal for a total of 10 individual peak maximum values for each interval thereafter.

7 ACCEPTANCE CRITERIA Commented [MA[N31]: Acceptance criteria for all attributes

needs to be mentioned
STABILITY PROTOCOL GUIDE
Enter the acceptance criteria in the space provided below. This can include acceptance criteria that
will not reasonably fit in Table 6-1 above. Use the table provided below. Commented [MA[N32]: As discussed, we will perform testing
as per SOP or TM. So, acceptance criteria will also be judged by
---DELETE THIS BOX--- those documents.
So, is there any other acceptance criteria that will not reasonably fit
with Table 6.1 and Table 6.2?
7.1 All variable and attribute data will meet acceptance criteria through the [proposed/established] shelf
life of the device.
Table 7- 1: Acceptance Criteria for [enter product information]
8 REPORTING
STABILITY PROTOCOL GUIDE
The Study Director will document the frequency of report writing in this section of the protocol.
For example, Interim reports will be written at 6, 12, 24, 36, 48, expiry, and 60 months.
--DELETE THIS BOX--
8.1 A final report will be issued by the Study Director or designee at the completion or cancellation of
the study with cumulative stability study results.
8.2 Interim reports will be issued by the Study Director or designee. Interim reports will be written at
"click to insert the reporting schedule" months. The report will be provided as required for regulatory
submission. Each interim report will include cumulative stability study results.
9 REFERENCE
9.1 [enter strategy number and title]
10 PROTOCOL REVISION HISTORY

Table 10- 1: Protocol revision history
Revision Author Reason for Change
1 Name of Study Director New issue.
---END OF DOCUMENT---


Qualtrus Polyglactin 910 - For - Stability - Study - Protocol-24 May

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Qualtrus Polyglactin 910 - For - Stability - Study - Protocol-24 May

Uploaded by

Copyright:

Available Formats

Non-PPE Form XXXXXXX

Quality System Revision Y

FORMAL STABILITY STUDY PROTOCOL FOR THE EVALUATION OF

ETHICON CONFIDENTIAL use pursuant to Company Procedures Page 1 of 15

3 ROLES AND RESPONSIBILITIES ............................................................................................................7

4 COMPONENT AND STERILIZATION INFORMATION ......................................................................8

5 STUDY CONDITIONS AND QUANTITIES ..............................................................................................9

6 SAMPLING AND TESTING PLAN ..........................................................................................................11

7 ACCEPTANCE CRITERIA ......................................................................................................................15

10 PROTOCOL REVISION HISTORY ........................................................................................................ 15

Table 2- 1: Family regulatory details .............................................................................................................3

ETHICON CONFIDENTIAL use pursuant to Company Procedures Page 2 of 15

2.1 PRODUCT INFORMATION

ETHICON CONFIDENTIAL use pursuant to Company Procedures Page 3 of 15

ETHICON CONFIDENTIAL use pursuant to Company Procedures Page 4 of 15

Table 2- 2: Preconditioning steps for excursion simulation samples

ETHICON CONFIDENTIAL use pursuant to Company Procedures Page 5 of 15

Table 2- 2: Preconditioning steps for excursion simulation samples

ETHICON CONFIDENTIAL use pursuant to Company Procedures Page 6 of 15

Note: In most of the cases, Ethicon India do not manufacture the

PG143 (4-0) PG149 (5-0)

3 ROLES AND RESPONSIBILITIES

ETHICON CONFIDENTIAL use pursuant to Company Procedures Page 7 of 15

4 COMPONENT AND STERILIZATION INFORMATION

ETHICON CONFIDENTIAL use pursuant to Company Procedures Page 8 of 15

Table 4- 2: Primary and secondary package component traceability

ETHICON CONFIDENTIAL use pursuant to Company Procedures Page 9 of 15

ETHICON CONFIDENTIAL use pursuant to Company Procedures Page 10 of 15

6 SAMPLING AND TESTING PLAN

ETHICON CONFIDENTIAL use pursuant to Company Procedures Page 11 of 15

ETHICON CONFIDENTIAL use pursuant to Company Procedures Page 12 of 15

ETHICON CONFIDENTIAL use pursuant to Company Procedures Page 13 of 15

ETHICON CONFIDENTIAL use pursuant to Company Procedures Page 14 of 15

7 ACCEPTANCE CRITERIA Commented [MA[N31]: Acceptance criteria for all attributes

Table 7- 1: Acceptance Criteria for [enter product information]

10 PROTOCOL REVISION HISTORY

ETHICON CONFIDENTIAL use pursuant to Company Procedures Page 15 of 15

You might also like