SOP FOR ALLOTMENT OF BATCH NUMBERS | STANDARD OPERATING PROCEDURE FOR ALLOTMENT OF BATCH NUMBERS

1.0 OBJECTIVE

1.1 To lay down a procedure for the allotment of batch numbers for drug products.

2.0 SCOPE

2.1 This procedure is applicable COMPANY NAME……………………...

3.0 RESPONSIBILITY

3.1 The Executive production shall be responsible for allotment of the batch numbers.

3.2 Head of Quality Assurance is responsible for the implementation and compliance of this SOP.

4.0 ACCOUNTABILITY

4.1 Head Quality/designee

5.0 PROCEDURE

5.1 Batch

A defined quantity of starting material, packaging material or bulk, intermediate or finished product that is intended or purported to be homogenous in character and quality, and which has been produced during a defined cycle of manufacture.

5.2 Batch Number

A distinctive combination of numbers and/ or letters, which specifically identifies a batch or lot and permits its history to be traced.

5.3 A unique batch number shall be assigned to each batch of the drug product.

5.4 Batch numbering for the first batch of the product shall start at the beginning of the each calendar year (1st Jan to 31st Dec).

5.4.1 Numbering system for batches:

5.4.1.1 Batch numbering system shall consist of six alphanumerical characters:

AAA 001

5.4.1.2 The first alpha characters ‘A’ shall indicate company name second and third alpha characters ‘AA’ shall indicate section.

5.4.1.3 The Forth fifth & sixth numerical characters shall indicate the serial number of the respective batch, which shall start from 001 and continue serially till 31st march of the same calendar year.

5.4.2 Production-Executive shall allot the batch number as per the details described in Annexure 1.

5.4.3 A batch number once allotted shall not be reused again even if the batch is cancelled.

5.4.4 Batch number shall be unique for each Batch.

5.4.5 For any reprocessing / reworking activity performed on a batch, suffix ‘R’ shall be included with parent batch number. e.g. Batch number AAA001 after reworking or reprocessing, shall be AAA001R.

5.4.6 Assignment of batch numbers in different scenarios shall be as described in Annexure 2.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure

6.2 No. - Number

6.3 QA - Quality Assurance

7.0 REFERENCES

7.1 Nil

8.0 ANNEXURES

8.1 Annexure: 1 - Format for Allotment of Batch No.

8.2 Annexure: 2 - Format for Assignment of Batch numbers in different scenarios.

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