OBJECTIVE
To provide the procedure for allocating "Analytical report number" (AR No.) for each Raw Material, Packing Material, Formulation, Water sample, Vendor evaluation sample (prepurchase sample), and Market sample.
This system helps in identifying the samples analyzed by the Quality Control Laboratory.
SCOPE
This procedure is applicable to PharmaInfo Limited.
RESPONSIBILITY
Quality Control Chemist, whoever analyses a sample to allocate the AR No. for each sample.
Quality Control Manager to ensure compliance.
PROCEDURE
- Quality control Chemist after receiving the sample(s) along with the request shall cross-check the details of the label, if any of the sample pack, against the analysis request. After ensuring the details, if matching, the Chemist shall enter the details of the sample(s) in the respective AR register and allocate the AR No. If any discrepancy immediately refer to Manager-QC.
- The numbering of analytical reports for Raw materials, water analysis samples, Formulation samples, packaging material, and Miscellaneous shall be in the form of X/YYYY/ZZ
Where,
X is
RM (For raw materials)
PM (For Packaging Materials)
WS (For water analysis sample)
FS (For formulation samples)
XS (For Miscellaneous samples)
YYYY: Serial No starting from 0001
ZZ: Year (e.g. 2009 as 09)
- Numbering of analytical reports for Raw materials Retest samples shall be in the form of RM/YYYY/ZZ-R1
Where,
RM: Raw materials
YYYY: Serial No starting from 0001
ZZ: Year (e.g. 2009 as 09)
R1 : re-test first time (e.g. R1, R2…)
REFERENCE
Nil.
ABBREVIATION
No.: Number
SOP: Standard operating procedure
Q.C: Quality Control
Q.A: Quality assurance
A.R.No.: Analytical report number
ANNEXURE:
Annexure No. – 1 - Specimen format of “AR Register – Raw material”
Annexure No. – 2 - Specimen format of “AR Register- Packing material
Annexure No. – 3 - Specimen format of “AR Register – Formulations
Annexure No. – 4 - Specimen format of “AR Register – Water
Annexure No. – 5 - Specimen format of “AR Register – Raw material retest
Annexure No. – 6 - Specimen format of “AR Register – Miscellaneous
REVISION HISTORY
Nil
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