1.0 OBJECTIVE
1.1 To lay down a standard procedure for procurement, coding, labeling, storage, and distribution of Test items.
2.0 SCOPE
2.1This SOP shall be applicable for procurement, coding, labeling, storage, and distribution of Test items in the Department of Quality Assurance (QAD) and Animal House Facility (AHF).
3.0 RESPONSIBILITY
3.1 Head- QA
3.2 QA Personnel (QAP)
3.3 Head- AHF
4.0 DEFINITIONS
4.1 Nil
5.0 PROCEDURE
5.1 Procurement of Test Item
5.1.1 TICO upon receipt of the requisition from Head- AHF / Study director (SD) will generate indent of the test item required.
5.1.2 In case the test item is to be provided by the sponsor, TICO will communicate with the sponsor (through e-mail or telephonically) informing him about the quantity of sample, characterization, and all relevant documents required.
5.1.3 For items not provided by the sponsor, which need to be procured from the approved vendors, TICO will indent the material to the commercial department, with all necessary information.
5.1.4 TICO will timely intimate SD / Head-AHF and QA if there is any reasonable delay in procurement of the test item.
5.1.5 The Test Item Controller will document the details of the Test Item received along with the documents (if any), source, and quantity as per Format no. F……………… entitled “Test Item Receipt, Distribution, and Storage record”.
5.2 Coding, Labeling, and Storage of Test Item
5.2.1 TICO will allot a code number to all the test items received and shall apply the label as per Format no. F……………….
5.2.2 Test Items shall be numbered as per a unique numbering system of 13 characters as below:
TI-XXX-YY-ZZZ
5.2.3 Where the First two characters signify denote abbreviation for test item i.e. TI.
5.2.4 Third character is ‘-‘.
5.2.5 4th, 5th, and 6th characters “XXX” signify the department code i.e. AHF for Animal House Facility.
5.2.6 The seventh character is ‘-‘.
5.2.7 8th and 9th characters are ‘YY’ which signifies the year in which the test item is received.
5.2.8 Tenth character is ‘-‘.
5.2.9 11th, 12th, and 13th characters are numerical indicating the sample number for that year.
5.2.10 For example, The identification number for the first sample received in the year 2015 in AHF Department shall be numbered as TI-AHF-15-001.
5.2.11 After coding test item shall be labeled properly as per format no. F……………. entitled “Test Item (TI) Label”.
5.2.12 After coding and labeling of test item/s TICO will shift all the items to the respective storage conditions, depending upon the test-specific details.
5.3 Distribution of Test Item/s
5.3.1 TICO shall inform QA personnel and HOD-AHF / SD about the arrival of the test item.
5.3.2 The Study Director / HOD-AHF shall generate a requirement of the Test Items to the Test Item Controller as per Format No. F……………. entitled “Requisition for Test Item to TICO”.
5.3.3 The Test Item Controller after receiving the requisition form from HOD-AHF / SD will issue the Test Item to the concerned person along with the original of all the related documents (COA / MOA / Test request etc.) received from the supplier/sponsor.
5.3.4 TICO shall issue the entire quantity of Test items received to the Head AHF / SD. Once issued, Head AHF / SD shall be responsible for proper handling, storage, and archive of the test items.
6.0 ENCLOSURES
6.1 Formats
2.1This SOP shall be applicable for procurement, coding, labeling, storage, and distribution of Test items in the Department of Quality Assurance (QAD) and Animal House Facility (AHF).
3.0 RESPONSIBILITY
3.1 Head- QA
3.2 QA Personnel (QAP)
3.3 Head- AHF
4.0 DEFINITIONS
4.1 Nil
5.0 PROCEDURE
5.1 Procurement of Test Item
5.1.1 TICO upon receipt of the requisition from Head- AHF / Study director (SD) will generate indent of the test item required.
5.1.2 In case the test item is to be provided by the sponsor, TICO will communicate with the sponsor (through e-mail or telephonically) informing him about the quantity of sample, characterization, and all relevant documents required.
5.1.3 For items not provided by the sponsor, which need to be procured from the approved vendors, TICO will indent the material to the commercial department, with all necessary information.
5.1.4 TICO will timely intimate SD / Head-AHF and QA if there is any reasonable delay in procurement of the test item.
5.1.5 The Test Item Controller will document the details of the Test Item received along with the documents (if any), source, and quantity as per Format no. F……………… entitled “Test Item Receipt, Distribution, and Storage record”.
5.2 Coding, Labeling, and Storage of Test Item
5.2.1 TICO will allot a code number to all the test items received and shall apply the label as per Format no. F……………….
5.2.2 Test Items shall be numbered as per a unique numbering system of 13 characters as below:
TI-XXX-YY-ZZZ
5.2.3 Where the First two characters signify denote abbreviation for test item i.e. TI.
5.2.4 Third character is ‘-‘.
5.2.5 4th, 5th, and 6th characters “XXX” signify the department code i.e. AHF for Animal House Facility.
5.2.6 The seventh character is ‘-‘.
5.2.7 8th and 9th characters are ‘YY’ which signifies the year in which the test item is received.
5.2.8 Tenth character is ‘-‘.
5.2.9 11th, 12th, and 13th characters are numerical indicating the sample number for that year.
5.2.10 For example, The identification number for the first sample received in the year 2015 in AHF Department shall be numbered as TI-AHF-15-001.
5.2.11 After coding test item shall be labeled properly as per format no. F……………. entitled “Test Item (TI) Label”.
5.2.12 After coding and labeling of test item/s TICO will shift all the items to the respective storage conditions, depending upon the test-specific details.
5.3 Distribution of Test Item/s
5.3.1 TICO shall inform QA personnel and HOD-AHF / SD about the arrival of the test item.
5.3.2 The Study Director / HOD-AHF shall generate a requirement of the Test Items to the Test Item Controller as per Format No. F……………. entitled “Requisition for Test Item to TICO”.
5.3.3 The Test Item Controller after receiving the requisition form from HOD-AHF / SD will issue the Test Item to the concerned person along with the original of all the related documents (COA / MOA / Test request etc.) received from the supplier/sponsor.
5.3.4 TICO shall issue the entire quantity of Test items received to the Head AHF / SD. Once issued, Head AHF / SD shall be responsible for proper handling, storage, and archive of the test items.
6.0 ENCLOSURES
6.1 Formats
|
Sr.
No. |
Format Title |
Format No. |
No. of pages |
|
1. |
Test
Item Receipt, Distribution, and Storage Record |
F.................................. |
01 |
|
2. |
Specimen Label for Test Item |
F.................................. |
01 |
|
3. |
Requisition for Test Item to TICO |
F.................................. |
01 |
7.0 ABBREVIATIONS
7.1 SOP- Standard Operating Procedure
7.2 QAD- Department of Quality Assurance
7.3 TICO- Test Item Controller
7.4 SD- Study Director
7.5 AHF- Animal House Facility
8.0 REFERENCES
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF DOCUMENT
8.0 REFERENCES
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF DOCUMENT
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