sop for Batch number and Manufacturing and Expiry Date Coding System

1.0 PURPOSE

To describe the unique Batch Number and Manufacturing and Expiry date coding system to be followed for the products manufactured.

2.0 SCOPE

2.1 This procedure applies to all products and batches manufactured

3.0 REFERENCE(S)

3.1 In- House

4.0 DEFINITION & ABBREVIATION(S)

4.1.1 Batch
A defined quantity of starting material, packaging material or product processed in one process or series of processes so that it could be expected to be homogeneous.

4.1.2 Batch Number
A distinctive combination of numbers and/or letters which specifically identifies a batch.
4.1.3 Manufacturing Date
The date given on the individual pack/container of the product, which indicates the date, manufacturing activity is started.
4.1.4 Expiry Date
The date given on the individual container (usually on the label) of a drug product upto and including which the product is expected to remain within specifications, if stored correctly.

4.2 Abbreviations
4.2.1 BMR : Batch manufacturing record
4.2.2 BPR :Batch packing record.

4.2.3 QA : Quality Assurance
4.2.4 SOP : Standard operating procedure

5.0 RESPONSIBILITY

5.1 Quality Assurance
5.1.1 To allocate product code for new product.
5.1.2 To allocate manufacturing location code to any new location.
5.2 Production:
5.2.1 To verify the batch number, manufacturing date and expiry date while raising the request to QA for BMR & BPR.
5.3 Quality Assurance:
5.3.1 To keep a track & ensure that correct batch number, manufacturing date and expiry date is allotted at the time of issuance new BMR and BPR.
5.3.2 To maintain a record of BMR/BPR issuance register which has got entries for batch number, manufacturing date and expiry date and Product Serial Number of each product.
5.4 Quality Assurance Head
5.4.1 To ensure implementation of the defined procedure.
5.5 Plant Head
5.5.1 To ensure implementation of the defined procedure.

6.0 Distribution:
I. Quality Assurance
II. Quality Control
III. Production
IV. Ware house
V. Engineering

7.0 PROCEDURE:
7.1 Allotment of Batch Number for product:
7.1.1 Batch number runs in serial for each of the product manufactured at that location.

7.1.2 Batch numbering system shall be product specific.
7.1.3 A unique batch numbering system shall be as follows.
7.1.3.1 The batch number of a product shall consist of following digits:

PPIAYNNN
Where,
PP : First two digits shall be product code as per approved Product code list prepared as per Attachment-I (Product code shall be in alfa-numeric or Numeric-alfa).
IA : Second two characters stands for the manufacturing location code for Pharma
Scholars
Y : Third one digit code for year, it shall be an alphabet as per Attachment -II.
NNN : Last three digits is sequential serial number of batch manufactured during the year of that particular product.
Example:
First batch of product “A1” to be manufactured in …………in year 2016 shall be A1IAP001 Where,
A1 : Product code of (As per Attachment-I).
P : Year of 2016 (16th digit of alphabet and Q for 2017, 17th digit for alphabet & so on. Refer attachment-II)
001 : First batch of product “A1” manufacturing in year 2016.

For first batch product “A2” to be manufactured in n year 2016 shall be A2IAP001.
For first batch product “A3” to be manufactured in n year 2016 shall be A3IAP001.
7.1.3.2 A typical batch number for the first batch of product A1, A2, A3…n manufactured in the year 2016, 2017 at the location …………..shall be as per below table-1.

Table-1
Typical first three batch numbers of …………Product A1, A2, A3 for the year 2016-2017:

Year First Batch of product
“A1” Batch No. First Batch of product
“A2” Batch No. First Batch of product
“A3” Batch No.
2016 A1IAP001 A2IAP001 A3IAP001
2017 A1IAQ001 A2IAQ001 A3IAQ001

7.1.3.3 On receipt of Batch Record Requisition Slip, batch number shall be generated/auto batch number mentioned.
7.1.3.4 Once the batch number is allotted for any product it cannot be repeated/relocated in any case.

7.1.4 For product which have not sufficient space for batch coding, batch coding shall be as per below details.
7.1.4.1 The batch number of a product shall consist of following digits:
PPYNNN,

Where,
PP : First two digits shall be product code as per approved Product code list prepared as per Attachment-I.
Y : Third one digit code for year, it shall be an alphabet as per Attachment -II.
NNN : Last three digit sequential serial number of batch manufactured during the year of that particular product.

Example: First batch of product “A1” to be manufactured in year 2016 shall be A1P001 Where,
A1 : Product code of (As per approved Product code list prepared as per Attachment-I).
P : Year of 2016 (16th digit of alphabet and Q for 2017, 17th digit for alphabet & so on. Refer Attachment-I).
7.1.5 For generic name of product, separate product code shall be allotted.

7.1.6 Product code shall be allotted for Export registration sample and same code shall be

applicable for first country commercial product. If same product is commercial

supply for other country, then separate product code shall be issued.

7.2 Assigning of Manufacturing and Expiry date:
7.2.1 QA shall be responsible for assigning of manufacturing and expiry date on the BMR/ BPR at the time of issuance of BMR/ BPR.
7.2.2 Manufacturing and Expiry date shall be assigned in following format: MM/YYYY
First two alphabets of month followed slash and year of manufacturing
Example:
Batch manufactured in month of October 2016 the Manufacturing

date shall be mentioned as “12/2016”. Batch expiry date is November 2018 the Expiry date shall be mentioned as “11/2018”.
7.2.3 Manufacturing date shall be assigned on the basis of date of issuance of Batch Record from QA.

The month in which the BMR/ BPR are issued to production shall be the date of manufacturing.
7.2.4 Expiry date shall be assigned on the basis of shelf life mentioned on the BMR/BPR.

7.3 Allotment of Product code for manufacturing location:
7.3.1 CQA shall allocate product code for all the existing products of manufacturing plant separately as applicable.
7.3.2 In case of new product introduction, location shall get product code from CQA.
7.3.3 CQA shall allocate the product code and Quality Assurance of location shall prepare the list as per Attachment -I for that location and respective person shall sign in the columns provided for prepared by QA and checked by QA and same shall be approved by QA Head.
7.3.4 CQA shall provide the product code in case if any product is included.
7.3.5 Plant QA shall update the approved product code list as per Attachment-I.

7.4 Allotment of manufacturing location code:
7.4.1 CQA shall allocate location code along with the location address for any new manufacturing location.

Attachment-I

PRODUCT CODE