1.1 To lay down a procedure for Equipment/Instrument Codification
2.0 SCOPE
2.1 This procedure applies to the Pharmaceutical Manufacturing Facilities of ....................................................................................................
3.0 RESPONSIBILITY
3.1 Executive User Department shall be responsible for assigning the code number for Equipment / Instrument.
3.2 User Department shall be responsible for displaying the codes for Equipment / Instrument.
3.4 Head-Quality Assurance is responsible for the Implementation and compliance.
4.0 ACCOUNTABILITY
4.1 Head-Quality Assurance/his designee
5.0 PROCEDURE
5.1 Basic Guidelines for Formation of Codification System are as follows:
5.1.1 A - Denotes Alphabet
5.1.2 N - Denotes Numerical
5.1.3 Allocation of Code Number for Equipment/Instrument
5.1.4 The coding format consists of Seven Digits, which can be broken down as “AAA– NNN”
5.1.5 AA: The first and second digit represents the department code as listed in Annexure: 2 of SOP No. …………… (Title: Preparation, Approval control and Review of Standard Operating Procedure.
5.1.6 A : The third digit represents the ‘Equipment/Instrument as ‘E’ or ‘I’
Note: For Quality Control, Quality Assurance and Analytical Development Departments only the third digit shall represent as ‘I’. For all other departments third digit shall represent as ‘’E’’
5.1.7 The fourth digit represents the ‘–’
5.1.8 NNN: The fifth, sixth and seventh digits represent the sequential number of the Equipment/Instrument starting from 001 onwards.
5.1.9 e.g.: The first Code for an Equipment/Instrument of Quality Control Department shall be numbered as ‘QCI-001’.
5.1.10 QC : Represents code for Quality Control Department
5.1.11 I : Represents Equipment/Instrument
5.1.12 001: Represents first sequential number
5.1.13 e.g.: Code for an instrument in Production Department shall be as PDE-001.
5.1.14 PD: Represents code for Production Department
5.1.15 E: Represents Equipment/Instrument
5.1.16 001: Represents first sequential number
5.1.17 Executive of the User department shall assign Equipment/Instrument numbers to respective department and record the same in ‘’ EQUIPMENT/INSTRUMENT NUMBERING REGISTER’’ (Annexure: 2), which shall be maintained department wise.
5.1.18 Executive of the User department shall maintain an updated MASTER LIST OF EQUIPMENT/INSTRUMENT CODES (Annexure: 1) and same shall be approved by HOD or his designee.
6.0 ABBREVIATIONS
6.1 SOP - Standard Operating Procedure
6.2 NA - Not Applicable
6.4 e.g. - Example
7.0 REFERENCES
7.1 SOP No. …………… - (Title: Preparation, approval, control and review of
8.0 ANNEXURES
8.1 Annexure: 1 - Format of Master List of Equipment/Instrument codes.
8.2 Annexure: 2 - Format of Equipment/ Instrument numbering Register.
ANNEXURE
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DEPARTMENT NAME: |
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S.NO |
EQUIPMENT/INSTRUMENT
NAME |
CODE No. |
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ANNEXURE –2
EQUIPMENT/INSTRUMENT
NUMBERING REGISTER
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S. No. |
Equipment/Instrument Name |
Code Number |
Allotted By |
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Sign |
date |
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END OF DOCUMENTS
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