Assigning identification numbers to equipment
1.0 OBJECTIVE :
1.1 To lay down a procedure to identify the name and no of equipment/instrument
2.0 SCOPE :
2.1 This procedure is applicable to Assigning identification numbers to all the equipment/instrument installs at ABC Pharma Private limited
3.0 RESPONSIBILITY :
3.1 Officer/Executive/Head of user department:
3.2 QA officer/executive.
4.0 ACCOUNTABILITY :
4.1 QA Head/Respective department Head.
5.0 PROCEDURE :
5.1 Officer/Executive of QA department shall give the identification no. of each equipment/instrument that are to be installed at ABC Pharma Private Limited.
5.2 Whenever, Officer/Executive of QA shall give the identification number of equipment is as given below:
APPL/ DP/ EQP/ NNN
Where:
APPL = ABC PHARMA PVT.LTD.
DP = Department code (like QC,QA)
EQP = Equipment/Instrument
NNN = Serial Number 001, 002, 003……….etc. with respect to no. of equipments in the respective department e.g. FPPL/QA/EQP/001
5.3 Whenever, Officer/Executive of QA shall give the identification number of Instrument is as given below:
APPL/ EN/XX/ YYY
Where:
APPL = ABC PHARMA PVT.LTD.
EN = Engineering Department
XX = Instrument Code (Like, MG for Magnehelic gauge, PG for Pressure gauge…etc.)
YYY = Serial Number 001, 002, 003……….etc. with respect to no. of Instrument.
e.g. FPPL/EN/MG/001, APPL/EN/PG/001…etc.
5.4 Whenever, Officer/Executive of QA shall give the identification number of Hygrometer is as given below:
APPL/ HM/ YYY
Where:
APPL = ABC PHARMA PVT.LTD.
HM = Hygrometer
YYY = Serial Number 001, 002, 003……….etc. with respect to no. of Hygrometer.
e.g. FPPL/HM/001
5.5 Whenever, Officer/Executive of QA shall give the identification number of Air Handling unit is as given below:
APPL/ EN/ AHU/ NNN
Where:
APPL = ABC PHARMA PVT.LTD.
EN = Engineering Department
AHU = Air Handling Unit
NNN = Serial Number 001, 002, 003……….etc. with respect to no. of Air Handling unit.
e.g. APPL/EN/AHU/001
5.6 Whenever, Officer/Executive of QA shall give the identification number of Computer is as given below:
APPL/ COM/ YYY
Where:
APPL = ABC PHARMA PVT.LTD.
COM = Computer system
YYY = Serial Number 001, 002, 003……….etc. with respect to no. of Computer system.
e.g. APPL/COM/001
5.7 Whenever, Officer/Executive of QA shall give the identification number of Drain Point is as given below:
APPL/ DN/ YYY
Where:
APPL = ABC PHARMA PVT.LTD.
DN = Drain Point
YYY = Serial Number 001, 002, 003……….etc. with respect to no. of Drain Point.
e.g. APPL/DN/001
5.8 Whenever, Officer/Executive of QA shall give the identification number of Fire Extinguisher is as given below:
APPL/ FE/ YYY
Where:
APPL = ABC PHARMA PVT.LTD.
FE = Fire Extinguisher
YYY = Serial Number 001, 002, 003……….etc. with respect to no. of Fire Extinguisher.
e.g. APPL/FE/001
5.9 Whenever, Officer/Executive of QA shall give the identification number of Insect Killer is as given below:
APPL/ HR/INK/ YYY
Where:
APPL = ABC PHARMA PVT.LTD.
HR = Human Resources
INK = Insect Killer
YYY = Serial Number 001, 002, 003……….etc. with respect to no. of Insect Killer.
e.g. APPL/HR/INK/001
5.10 Whenever, Officer/Executive of QA shall give the identification number of Light is as given below:
APPL/ EN/LIT/ YYY
Where:
APPL = ABC PHARMA PVT.LTD.
EN = Engineering Department
LIT = Light
YYY = Serial Number 001, 002, 003……….etc. with respect to no. of Light.
e.g. APPL/EN/LIT/001
5.11 Whenever, Officer/Executive of QA shall give the identification number of Air Condition is as given below:
APPL/ EN/AC/ YYY
Where:
APPL = ABC PHARMA PVT.LTD.
EN = Engineering Department
AC = Air Condition
YYY = Serial Number 001, 002, 003……….etc. with respect to no. of Air Condition.
e.g. APPL/EN/AC/001
5.12 Whenever, Officer/Executive of QA shall give the identification number of Printer is as given below:
APPL/ DP/PRT/ YYY
Where:
APPL = ABC PHARMA PVT.LTD.
DP = Department code (like QA,QC…etc.)
PRT = Printer
YYY = Serial Number 001, 002, 003……….etc. with respect to no. of Printer.
e.g. APPL/QA/PRT/001
5.13 Officer/executive of Quality Assurance department shall maintain the list of equipment/instrument of as per Annex-I.
5.14 Whenever any new equipment/instrument is received respective department inform to QA. Existing equipment/instrument ID is not be used permanently, officer/executive of QA department shall amend this list.
5.15 If any equipment/instrument not be used permanently, ID no. of that equipment/instrument must not be given to any other equipment/instrument.
6.0 ABBREVIATION :
Sr. No. | Abbreviation used | Full form of abbreviation used |
1.0 | SOP | Standard Operating Procedure |
2.0 | QC | Quality Control |
3.0 | QA | Quality Assurance |
4.0 | EN | Engineering Department |
5.0 | HR | Human Resource |
6.0 | ID | Identification |
7.0 | No. | Number |
8.0 | DN | Drain Point |
9.0 | INK | Insect Killer |
7.0 ATTACHMENTS (ANNEXES) :
Annex-I : List of equipment and instruments
8.0 REFERENCE :
Sr. No. | Reference Title |
1.0 | In House |
Annex-I
List of equipment and instruments
DEPARTMENT: | ||||
SR.NO | DESCRIPTION | EQUIPMENT /INSTRUMENT ID | MAKE | CAPACITY |
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipment
concurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Assigning identification numbers to equipment