Sop Qa 060

CELEBRITY BIOPHARMA LIMITED
Format No.: QAS001/F/01/00Reference SOP No.: SOP/QA/001/01

STANDARD OPERATING PROCEDURE
Location QUALITY ASSURANCE SOP Number SOP/QA/060/00
Version 00
Superseded SOP No. Nil
Title Hold Time Study Effective Date
Review Date
Page Number 1 of 4
1. OBJECTIVE
1.1 To establish a procedure to lay down the storage conditions and holding time for in-process
materials
2. SCOPE
2.1 This Standard Operating Procedure is applicable to tablet, Capsule, Liquid and Dry syrup
sections of Production Department of Celebrity Biopharma Limited.
3. RESPONSIBILITY
3.1 The Officer/Executive production/QA shall insure the storage conditions of in-process
materials are appropriate and it does not cross the holding time.
3.2 Chemist QC shall be responsible of testing the material as per specification.
3.3 The QA Head is responsible for the compliance of the SOP.
4. PROCEDURE
4.1 All the manufacturing stages where in-process materials are produced are clearly define the
storage conditions and holding time of the in-process materials.
4.2 Storage time and holding time need to be defined for in-process materials that are tested and
immediately taken up for further processing
4.3 For Tablets:
The different in-process materials which shall store are:
 Lubricated Granules
 Compressed tablets to be coated
 Coated and uncoated to be packed
4.3.1 The lubricated granules should be stored in a HDPE container. The container should
be closed properly and labeled adequately. The lubricated granules can be stored to a
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maximum period of 45 days at temperature NMT 27°C & RH NMT 60 % & will
sample at 15th, 30th& 45th day for testing.
4.3.2 The compressed tablets, which are awaiting coating, should be stored in HDPE
containers lined with double bag virgin poly bags, tied and labeled properly. The
tablets can be stored to a maximum period of 90 days at temperature NMT 27°C &
RH NMT 60 % & will sample at 30th, 45th, 60th& 90thday for testing.
4.3.3 The uncoated and coated tablets awaiting packing should be stored in HDPE
containers lined with double virgin poly bags, tied properly and labeled adequately.
4.3.4 The compressed or coated tablets can be stored to a maximum period of 90 days at
temperature NMT 27°C & RH NMT 60 % & will sample at 30 th, 60th& 90th day for
testing.
4.4 For Capsules:
The different in-process materials which shall store:
 Blend ready for filling
 Filled capsule ready for packing
4.4.1 Blend should be stored in a HDPE container. The container should be closed
properly and labeled adequately. Blend can be stored to a maximum period of 45
days at temperature NMT 15-25°C & RH NMT 60 % & will sample at 15 th,
30th&45th day for testing.
4.4.2 Filled capsules awaiting for packing should be stored in HDPE containers lined with
double virgin poly bags, tied properly and labeled adequately. Filled capsules can be
stored to a maximum period of 90 days at temperature NMT 15-25°C & RH NMT
60 % & will sample at 30th, 60th& 90th day for testing.
4.5 For Oral Liquid:
The different in-process materials shall be store are:

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 Bulk ready for filling

4.5.1 Starting materials should be stored in a HDPE container. The container should be
closed properly and labeled adequately. Starting materials can be stored to a
maximum period of 60 days at temperature NMT 27°C & RH NMT 60 % & will
sample at 30th, 45th& 60th day for testing.
4.6 In case any in process materials cross the stipulated holding time, then follow the SOP for
handling of deviations. In such cases in process material should be tested as per the
specification before it is released for further processing.
5. RELATED DOCUMENTS
5.1 Nil
6. REFERENCES
6.1 WHO TRS 992-Annex 4
7. RECORDS
7.1 Nil
8. ABBREVIATIONS
8.1 SOP : Standard Operating Procedure
8.2 QA : Quality assurance
8.3 % : Percentage
8.4 RH : Relative Humidity
8.5 °C : Degree Centigrade
8.6 NMT : Not More Than

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8.7 HDPE : High Density Poly Ethylene

9. REVISION RECORD
Version Reason for Revision Effective Date

00 New SOP -----
END OF DOCUMENT

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CELEBRITY BIOPHARMA LIMITED

Format No.: QAS001/F/01/00Reference SOP No.: SOP/QA/001/01

Name Designation Signature Date Stamp

 Bulk ready for filling

Name Designation Signature Date Stamp

8.7 HDPE : High Density Poly Ethylene

Version Reason for Revision Effective Date

Name Designation Signature Date Stamp

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