HAB PHARMACEUTICAL & RESEARCH LIMITED
SELAQUI, DEHRADUN (For restricted circulation only)
SUBJECT STANDARD OPERATING SOP NUMBER HAB/QA/086
PROCEDURE
DEPARTMENT QUALITY ASSURANCE EFFECTIVE DATE 14 SEP. 2023
TITLE SOP FOR HOLD TIME REVISION NUMBER 00
STUDY REVIEW DATE 13 SEP. 2025
APPROVAL LIST
DESIGNATION NAME SIGNATURE DATE
PREPARED BY Officer-QA Kamendra Kumar
REVIEWED BY Executive-QA Vipul Singhal
REVIEWED BY VP-Operation P.N.Sharma
APPROVED BY QA Head Mohd. Abbas
CIRCULATION LIST
Department Copy No. No. of Copies Details of copies
Issued
Quality Assurance 1 1 Master Copy
Quality Assurance 2 1 Control copy for department
Quality Control 3 1 Control copy for department
Quality Microbiology 4 1 Control copy for department
Production (Tablets & Capsule) 5 1 Control copy for department
Production External Preparation 6 1 Control copy for department
Production Ophthalmic 7 1 Control copy for department
APPROVED BY
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HAB PHARMACEUTICAL & RESEARCH LIMITED
SELAQUI, DEHRADUN (For restricted circulation only)
SUBJECT STANDARD OPERATING SOP NUMBER HAB/QA/086
PROCEDURE
DEPARTMENT QUALITY ASSURANCE EFFECTIVE DATE 14 SEP. 2023
TITLE SOP FOR HOLD TIME REVISION NUMBER 00
STUDY REVIEW DATE 13 SEP. 2025
1.0 PURPOSE: To describe the procedure for deciding the hold time for storage conditions and period
within which products at various stages such as lubricated granules / blend, compressed tablets, coated
tablets, filled capsules, Ointment, Eye/Ear/Nasal Drops shall be stored before proceeding for the next
process.
2.0 SCOPE: This SOP is applicable to evaluate the impact of holding of products at various stages during
manufacturing process on the product quality for all products manufactured at HAB Pharmaceuticals &
Research Limited, Dehradun.
3.0 FREQUENCY: This SOP will be reviewed within two years from effective date or as and when
required.
4.0 RESPONSIBILITY:
4.1 Production Manager / Designee: Store the samples of hold time at various stages in simulated pack.
4.2 Assistant Manager QC/ Designee: To execute the study as per the study protocol.
4.3 Head QA / Designee: To review the data and conclude.
5.0 ACCOUNTABILITY: Head –QA
6.0 REFERENCE(S): In- house.
7.0 PRECAUTIONS: NA
8.0 PROCEDURE:
8.1 Lubricated granules, compressed tablets, coated tablet for Tablet Dosage form and Capsule Blend,
Filled Capsule for Capsule Dosage form, Mixing and Filling for Ointment Dosage form,
Blending and Manufacturing and storage tank for Eye /Ear/Nasal Drops Dosage form shall be
stored in simulated pack in production facility by production department for hold time study of
product.
8.2 Formulation Stages, Period of Storage, Storage Conditions and the Tests that shall be
performed are enumerated as below:
Formulation Stages Period of storage Storage condition Tests to be Performed
(s) (but not limited to)
Tablets Lubricated Initial, 7 days, 15 days, 30, Simulated Identification,
Granules 60 days OR as per contract Environmental as Appearance, Tapped
giver guideline from the per the product Density, Moisture
date of completion of Storage condition. content/ LOD
lubrication. Assay, Microbiological
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HAB PHARMACEUTICAL & RESEARCH LIMITED
SELAQUI, DEHRADUN (For restricted circulation only)
SUBJECT STANDARD OPERATING SOP NUMBER HAB/QA/086
PROCEDURE
DEPARTMENT QUALITY ASSURANCE EFFECTIVE DATE 14 SEP. 2023
TITLE SOP FOR HOLD TIME REVISION NUMBER 00
STUDY REVIEW DATE 13 SEP. 2025
Formulation Stages Period of storage Storage condition Tests to be Performed
(s) (but not limited to)
(if applicable) Limit Tests, Angle of
repose, Hausner ratio
Tablets Compressed Initial, 15 days, 30 days, Simulated Identification,
2nd and 3rd months Environmental as Appearance, Dissolution,
OR as per contract giver per the product Water content/ Moisture
guideline from the Storage condition. content/ LOD,
completion date of Assay, Microbiological
compression (if applicable). limit test, Angle of
repose, Hausner ratio
Tablets Coating Initial, 24, 48, 72 Hrs OR as Simulated pH, Viscosity,
Solution per contract giver guideline. Environmental as Microbiological limit test
(If applicable). per product Storage
condition.
Tablets Coated Initial, 15 days, 30 days, Simulated Identification,
2nd and 3rd months Environmental as Appearance, Related
OR as per contract giver per the product substance, Dissolution,
guideline from the Weight Variation, Water
Storage condition.
completion date of coating content, Assay,
(if applicable). Microbiological limit
Test
Capsules Blend Initial, 7 days, 15 days, 30 Simulated Identification,
days OR as per contract Environmental as Appearance, Water
giver guideline from the per the product Content/ LOD,
date of completion of Assay, Tapped Density
Storage condition.
lubrication. (if applicable) Microbiological limit
Tests.
Capsules Filled Initial, 15 days, 30 days, Simulated Identification,
2nd and 3rd months Environmental as Appearance, Related
OR as per contract giver per the product substance, Dissolution,
guideline from the
Storage condition. Weight Variation, Water
completion date of capsule
filling. (if applicable). content, Assay,
Microbiological limit
Test
Ointment Mixing Initial, 24, 48, 72 Hrs OR Simulated Rheological property,
as per contract giver Environmental as pH, Microbiological limit
guideline. (If applicable). per the product Test.
Storage condition.
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HAB PHARMACEUTICAL & RESEARCH LIMITED
SELAQUI, DEHRADUN (For restricted circulation only)
SUBJECT STANDARD OPERATING SOP NUMBER HAB/QA/086
PROCEDURE
DEPARTMENT QUALITY ASSURANCE EFFECTIVE DATE 14 SEP. 2023
TITLE SOP FOR HOLD TIME REVISION NUMBER 00
STUDY REVIEW DATE 13 SEP. 2025
Formulation Stages Period of storage Storage condition Tests to be Performed
(s) (but not limited to)
Ointment Storage Initial, 24,48,72 Hrs & 7 Simulated Rheological property,
days as per contract giver Environmental as Content uniformity,
guideline from the per the product pH,
completion date of Storage condition. Microbiological limit
Ointment filling.(if Test
applicable).
Manufactur Simulated Description, pH, Sterility,
Eye/Ear/Nasal Initial, 24, 48, 72 Hrs OR
ing Environmental as BET
Drops as per contract giver
per the product
guideline. (If applicable).
Storage condition.
Simulated Description, pH, Sterility,
Eye/Ear/Nasal Initial, 24, 48, 72 Hrs OR
Storage Tank Environmental as BET
Drops as per contract giver
per the product
guideline. (If applicable).
Storage condition.
8.3 Test performed shall be as per the protocol and compile the results for review.
8.4 This is only a general guideline; the study shall be extended as per the guideline of the contract giver
or as per the approved protocol of the product by Head QA and contract giver.
8.5 The samples stored for hold time study shall be mentioned in the Annexure-I: HAB/QA/086/01/00
8.6 If results are out of limit at any Stage/ Period of Testing as per specification then decrease the hold
time as per the requirement and mentioned the same.
8.7 On completion of the study, Head QA shall review the data and conclude the result.
8.8 Conformance to acceptance criteria of the study shall be used to assign the hold time of the
manufacturing stage within which next process is to be taken.
8.8 Numbering System for Hold Time Study Protocol
8.8.1 Numbering of Hold Time Study Protocol shall be done as follows,
HTS/XX/00
Where,
HTS Stands for Hold Time Study
XX Stands for Product code
00 stands for version number of the protocol
8.8.2 Hold Time Study Protocol shall be prepared as per Annexure-II: HAB/QA/086/02/00
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HAB PHARMACEUTICAL & RESEARCH LIMITED
SELAQUI, DEHRADUN (For restricted circulation only)
SUBJECT STANDARD OPERATING SOP NUMBER HAB/QA/086
PROCEDURE
DEPARTMENT QUALITY ASSURANCE EFFECTIVE DATE 14 SEP. 2023
TITLE SOP FOR HOLD TIME REVISION NUMBER 00
STUDY REVIEW DATE 13 SEP. 2025
9.0 ENCLOSURE:
9.1 Annexure I: Hold Time Study Schedule: HAB/QA/086/01/00
9.2 Annexure II: Hold Time Study Protocol: HAB/QA/086/02/00
10.0 HISTORY OF REVIEW:
DATE SUPERSEDE No. CCF No. REASON FOR REVIEW
14 SEP. 2023 NA NA New SOP
11.0 ABBREVIATIONS: The abbreviations used in the SOP are:
11.1 SOP - Standard Operating Procedure
11.2 QA - Quality Assurance
11.3 QC - Quality Control
11.4 NA - Not Applicable
11.5 CCF No - Change Control Format Number
END OF SOP
APPROVED BY
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