HOLD TIME STUDY OF PRODUCT

Product Name TELMISARTAN TABLETS

Strength Telmisartan IP 40 mg
Product Code Protocol No.
Batch Size 1000000 Nos. Version No. 00
Market Domestic Page 1 of 9

HOLD TIME PROTOCOL

FOR
TELMISARTAN TABLETS

PROTOCOL EFFECTIVE DATE :

TOTAL PAGE No. : 09
 HOLD TIME STUDY OF PRODUCT

Product Name TELMISARTAN TABLETS

Strength Telmisartan IP 40 mg
Product Code Protocol No.
Batch Size 1000000 Nos. Version No. 00
Market Domestic Page 2 of 9

CONTENTS
S.No. Title of sections Page No.
1.0 Protocol Approval page 3
2.0 Objective 4
3.0 Scope 4
4.0 Responsibility 4
5.0 Introduction 4
6.0 Procedure 5
6.1 Study plan 5-6
6.2 Environment conditions 6
6.3 Sampling method, Sample quantities and Sampling frequency 6-7
6.4 Method of analysis 7
7.0 Acceptance criteria 7
8.0 Deviation/ OOS (if any) 7
9.0 Result and evaluation 7
10.0 Conclusion 8
11.0 Abbreviation 8
12.0 Revision history 8
13.0 Attachment if any 9
 HOLD TIME STUDY OF PRODUCT

Product Name TELMISARTAN TABLETS

Strength Telmisartan IP 40 mg
Product Code Protocol No.
Batch Size 1000000 Nos. Version No. 00
Market Domestic Page 3 of 9

1.0 Pre-approval Protocol:

Signing of this approval page of hold time study for protocol indicates agreement with
the approach described in this document. If modifications to the approach become
necessary; an addendum will be prepared and approved.

Prepared By Signature Date

(Quality Assurance)

Checked By Signature Date

(Head/ Designee - Production)

(Head/ Designee - Quality control)

Approved By Signature Date

(Head/ Designee - Quality Assurance

 HOLD TIME STUDY OF PRODUCT

Product Name TELMISARTAN TABLETS

Strength Telmisartan IP 40 mg
Product Code Protocol No.
Batch Size 1000000 Nos. Version No. 00
Market Domestic Page 4 of 9

2.0 OBJECTIVE:
Objective of hold time study is to establish the storage time of the respective bulk
finished/ in-process material/ product with documented evidence.

3.0 SCOPE:
This protocol is applicable for hold time study of Binder solution, blend, uncoated tablets
manufactured at ..........................

4.0 RESPONSIBILITY:
QUALITY ASSURANCE:
- Preparation, Execution & reviewing the protocol.
- Initiation of hold time sample request cum report.
- Collection of hold time samples as per hold time study protocol.
- Reviewing the QC result and draw conclusion.
- Preparation of hold time study summary report.

QUALITY CONTROL:
- Analysis of hold time samples.
- Review of hold time study protocol and summary report.

PRODUCTION:
- Review of hold time study protocol and summary report.
- Destruction of remaining hold time sample stored at manufacturing area.

5.0 Introduction:
Hold time Study of Product Telmisartan-40 shall be conducted to establish the time
limits for holding the materials at different stages of production to ensure that the quality
of the product does not get impacted during the hold time.
 HOLD TIME STUDY OF PRODUCT

Product Name TELMISARTAN TABLETS

Strength Telmisartan IP 40 mg
Product Code Protocol No.
Batch Size 1000000 Nos. Version No. 00
Market Domestic Page 5 of 9

6.0 Procedure:
6.1 Study plan:
6.1.1 Product Details under Hold Time Study:

S.No. Product Name Batch No. Batch Size MFG. Date EXP. Date

6.1.2 Frequency/Reason of study:

Frequency/Reason Tick mark the No. of Justification for
applicable Batches to No. of batches
option be kept selected if less
under study than 3 batches
New product (New/ Transferred)
Change in Manufacturing Formula
components and composition
Change in Manufacturing Procedure
Change in batch size (More than 10 times)
Change of Critical Manufacturing
Equipment in Manufacturing Procedure
Change in Active Source Supplier
Change in In-process container/In-process
storage conditions
Change in critical specifications of the in-
process stage
Significant change in the existing
manufacturing process
Change in Storage condition
Change in source of Key Raw material
 HOLD TIME STUDY OF PRODUCT

Product Name TELMISARTAN TABLETS

Strength Telmisartan IP 40 mg
Product Code Protocol No.
Batch Size 1000000 Nos. Version No. 00
Market Domestic Page 6 of 9

6.2 Environment conditions:

6.2.1 Storage area/condition:
6.2.1.1 Store the sample of hold time study at a temperature NMT 250C and Relative
humidity NMT 60%.

6.2.2 Sample pack configuration:

6.2.2.1 For Sample of binder solution - Stainless steel (SS) container.
6.2.2.2 For sample of lubricated blend - Stainless steel (SS) container or in poly bag kept in
High density polyethylene (HDPE) container as applicable.
6.2.2.3 For sample of compressed tablet - Poly bag kept in HDPE container.

6.3 Sampling method, Sample quantities and Sampling frequency (if any):
6.3.1 Sampling method:

6.3.1.1 Hold time sample shall be collected by IPQA person.

6.3.1.2 Store the hold-time samples in the same pack as is used in production unless the pack is
exceptionally large, in which case one that is equivalent (constructed of the same material and
using the same closure system as the production packaging system) may be used.
6.3.1.3 Sampling shall be carried out in respective hold area by IPQA person as per Hold time
sample collection request shall be initiated by QA as per specified scheduled time interval.
6.3.1.4 QA shall ensure availability, cleanliness of sampling bag, sampling tools, and
sampling label before sampling activity.
6.3.1.5 Affix “HOLD TIME SAMPLE” label by on the sample poly bag or container in which
the sample is to be collected.
6.3.1.6 Wear hand gloves, open the container and sample the required quantity as mentioned in
the hold time study protocol. Container shall be closed and tagged back at respective place after
completion of sampling.
6.3.1.7 Send the hold time sample along with the Hold time sample collection request to QC.
6.3.1.8 Hold time study sample of binder solution shall be collected in a sterile container and
shall be sent to microbiology laboratory and sampling at defined intervals shall be done by the
microbiologist and shall be recorded.

6.3.2 Sample quantities and Sampling frequency:

6.3.2.1 Sample shall be collected as per defined quantity mentioned in the protocol.
6.3.2.2 Sampling frequency shall be as per the defined frequency in the annexure for “HOLD TIME
STUDY SAMPLING AND SCHEDULE”.

6.3.2.3 Sampling Plan for Hold Time Study:

 HOLD TIME STUDY OF PRODUCT

Product Name TELMISARTAN TABLETS

Strength Telmisartan IP 40 mg
Product Code Protocol No.
Batch Size 1000000 Nos. Version No. 00
Market Domestic Page 7 of 9

S.No. Storage Time Sampling Test Parameters Quantity of Sample Total

intervals quantity of
sample
BINDER SOLUTION FOR GRANULATION
1. Refer Annexure for Total Interval: a) Appearance *20 gm for every 120 gm
“HOLD TIME 05 b) Microbial Test testing interval
STUDY (Initial, After 2
SAMPLING AND Hrs, 4Hrs, 12
SCHEDULE” Hrs. & 24 Hrs.)
LUBRICATED BLEND
2. Refer Annexure for Total Interval:a) Particle size *120 gm for every 720 gm
“HOLD TIME 05 distribution testing interval
STUDY Initial, 15th day,
b) Bulk density (80 gm for
SAMPLING AND 30th day, 45th day c) Tap density chemical/Physical test
SCHEDULE” & 60th day d) Assay and 40 gm for
e) Microbial Test microbial test)
COMPRESSED TABLETS
3. Refer Annexure for Total Interval: a) Description *425 Nos. for every 2550 Nos.
“HOLD TIME 06 b) Hardness testing interval
STUDY c) Thickness (225 Nos. For
SAMPLING AND Initial, 15th day, d) Friability Chemical/ Physical
SCHEDULE” 30th day, 45th e) Disintegration test and 200 Nos. for
day, 60th day & time microbial test
90th day f) Dissolution
g) Assay
h) Microbial test
* Contains additional sample quantity to repeat the test in case of failure as per QC specification.

6.4 Method of analysis:

6.4.1 As per QC STP No.: _________________________.

_________________________.

_________________________.

7.0 Acceptance criteria:

As per QC specification No.: _________________________.

_________________________.
 HOLD TIME STUDY OF PRODUCT

Product Name TELMISARTAN TABLETS

Strength Telmisartan IP 40 mg
Product Code Protocol No.
Batch Size 1000000 Nos. Version No. 00
Market Domestic Page 8 of 9

8.0 Deviation/OOS/Change Control (if any):

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9.0 Result and Evaluation:

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10.0 Conclusion:

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11.0 Abbreviation:

Mfg.: Manufacturing
Exp.: Expiry
0
C: Degree Celsius
%: Percentage
SS: Stainless steel

HDPE: High density polyethylene

gm: Gram
STP: Standard test procedure
OOS: Out of specification
 HOLD TIME STUDY OF PRODUCT

Product Name TELMISARTAN TABLETS

Strength Telmisartan IP 40 mg
Product Code Protocol No.
Batch Size 1000000 Nos. Version No. 00
Market Domestic Page 9 of 9

12.0 Revision History:

Version No. Details of Revision

00 New

13.0 Attachment if any:

Attachment No. Attachment Details