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| REVIEW DATE EXTENDED
PRYMAX HEALTHC: :
PE_IMAX™ | catzndustoral area Faredeac2400} Haryana, NIA
STANDARD OPERATING PROCEDURE
TITLE: BATCH NUMBERING ~~
‘SOP NUMBER | DEPARTMENT [EFFECTIVE DATE |REVIEW DATE] SUPERSEDES | PAGE NO.
‘SOP/QAD/026 ‘QAD 04-07-2019 | 30-06-2021 | _—R-01 10f2
4.0 PURPOSE
To Lay down the procedure for assigning batch number of al the products,
2.0 SCOPE
‘This procedure is applicable for Batch Numbering system of all the products, manufactured in Prymax
Healthcare LLP., Faridabad,
3.0 RESPONABILITY
Production Process Owner
4.0 ACCOUNTABILITY
Production Head
5.0 PROCEDURE
5.1 Definitions
5.1.1 Batch (or Lot)
AA defined quantity of starting material, packaging material, or product processed in a
single process or series of processes so that it could be expected to be
homogeneous. In the case of continuous manufacture, the batch must correspond to
€ defined fraction of the production, characterized by its intended homogeneity. It may
sometimes be necessary to divide a batch into a number of sub-batches, which are
later brought together to form a final homogeneous batch.
5.1.2 Batch number (or Lot number)
A distinctive combination of numbers and/or letters which specifically identifies a batch
‘on the labels, the batch records, the certificates of analysis, etc,
5.2 Batch/Lot Number allotment:
Prymax Healthcare LLP. Faridabad, batch numbering system assigns a unique batch no. to
each batch of a product. The Batch no. represents a series of 8 numeric characters as
mentioned below which provide a unique batch identification through which the manufacturing
history of the batch can be traced
Explanation to series "XXYYZZ22" as given below:
PREPARED BY REVIEWED BY APPROVED BY
Wy 99-06-2019 “ee we
‘ALOK KUMAR PATEL YOGESH KUMAR ‘SHIVOM ‘SHARMA
EXECUTIVE OA INCHARGE QUALITY OPERATIONAL HEAD
Format PRLFIOADIOOTA
MASTER COPY: pr mad)
| REVIEW DATE EXTENDED |
PRYMAX HEALTHCARE-ELP-——- |
53/17,Industerial area,N.1.T Fariadabad,121001,Haryana, INDIA
STANDARD OPERATING PROCEDURE
(TITLE: BATCH NUMBERING
SOP NUMBER | DEPARTMENT [EFFECTIVE DATE [REVIEW DATE| SUPERSEDES | PAGE NO.
‘SOP/QAD/026 QAD 01-07-2019 | 30-06-2024 R01 20f2
XX: Denotes the current Year last two digits in numeric, Example- for year 2019 is 19
YY: Represents the respective month (i.e, "06" for the month of the June).
2222: Represents the batch serial number respective year starting from 0001, 0002 and so
fon. The Serial No. of Batch shall be increased to five digits if batch in a year reached
above four digits,
For Example: 19060001
”
oem | AG B
ALOK KUMAR PATEL YOGESH KUMAR ‘SHIVOM SHARMA
Format: PHUFIQAD/OOTA
MASTER COPY
