1.1 To lay down a standard procedure to be followed to assign a unique number to each preclinical study.
2.0 SCOPE
2.1 This SOP shall be applicable to the procedure for coding all preclinical studies in the Animal House Facility.
3.0 RESPONSIBILITY
3.1 Head- QA
3.2 QA Personnel (QAP)
3.3 Study Director
4.0 DEFINITIONS
4.1 Nil
5.0 PROCEDURE
5.1 Each study shall be assigned a unique identification number so that the traceability of all the records becomes convenient and it becomes easy to differentiate the different types of activities carried out in the test facility.
5.2 Each identification number shall consist of 20 characters.
5.3 COMPANY/ AHF/XXX/YY/01
5.4 The first characters denote the organization abbreviation i.e. COMPANY.
5.5 The eighth character is '/'
5.6 Ninth, tenth, and eleven characters denote department code i.e. AHF for Animal House Facility.
5.7 Twelfth character is '/'.
5.8 Thirteenth, fourteenth and fifteenth characters denote the type of study i.e. TOX for toxicity study. Abbreviations for the type of studies have been mentioned as annexure no. A………….
5.9 The sixteenth character is '/'
5.10 Seventeenth and eighteenth characters denote the current year, e.g., 21 for 2021.
5.11 The nineteenth character is '/'
5.12 Twentieth and Twenty first characters are numerical indicating the number of studies.
5.13 For example The First efficacy study carried out in the year 2015 will be numbered as COMPANY/AHF/TOX/21/01.
6.0 ENCLOSURES
6.1 Annexures
7.0 ABBREVIATIONS
7.1 SOP- Standard Operating Procedure
7.2 COMPANY- Related Organization name in short
7.3 QAD- Department of Quality Assurance
7.4 AHF- Animal House Facility
8.0 REFERENCES
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF DOCUMENT
2.1 This SOP shall be applicable to the procedure for coding all preclinical studies in the Animal House Facility.
3.0 RESPONSIBILITY
3.1 Head- QA
3.2 QA Personnel (QAP)
3.3 Study Director
4.0 DEFINITIONS
4.1 Nil
5.0 PROCEDURE
5.1 Each study shall be assigned a unique identification number so that the traceability of all the records becomes convenient and it becomes easy to differentiate the different types of activities carried out in the test facility.
5.2 Each identification number shall consist of 20 characters.
5.3 COMPANY/ AHF/XXX/YY/01
5.4 The first characters denote the organization abbreviation i.e. COMPANY.
5.5 The eighth character is '/'
5.6 Ninth, tenth, and eleven characters denote department code i.e. AHF for Animal House Facility.
5.7 Twelfth character is '/'.
5.8 Thirteenth, fourteenth and fifteenth characters denote the type of study i.e. TOX for toxicity study. Abbreviations for the type of studies have been mentioned as annexure no. A………….
5.9 The sixteenth character is '/'
5.10 Seventeenth and eighteenth characters denote the current year, e.g., 21 for 2021.
5.11 The nineteenth character is '/'
5.12 Twentieth and Twenty first characters are numerical indicating the number of studies.
5.13 For example The First efficacy study carried out in the year 2015 will be numbered as COMPANY/AHF/TOX/21/01.
6.0 ENCLOSURES
6.1 Annexures
|
Sr. No. |
Annexures Title |
Annexures No. |
No. of Pages |
|
1. |
Types of
preclinical studies in Animal House Facility |
A…………………… |
01 |
7.0 ABBREVIATIONS
7.1 SOP- Standard Operating Procedure
7.2 COMPANY- Related Organization name in short
7.3 QAD- Department of Quality Assurance
7.4 AHF- Animal House Facility
8.0 REFERENCES
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF DOCUMENT
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