Learn how to write a SOP for batch numbering system for raw and packaging materials in Pharmaceuticals.
Table of Contents
1. PURPOSE
To describe the batch number system used in the factory to identify all Raw and packaging materials.
2. SCOPE
This SOP outlines the key concepts, specifies roles, and provides the process for batch numbers for Raw and Packaging materials.
3. RESPONSIBILITY
The executive of the warehouse is responsible for issuing the batch number of Raw and Packaging materials.
ACCOUNTABILITY
Head of the Quality Control Department
5. REFERENCES/ASSOCIATED DOCUMENTS
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6. PRECAUTIONS
6.1 Ensure that the number is identical for each consignment.
7. PROCEDURE
7.1 Use 8 (eight) numeric digits to indicate the batch number of Raw and packaging materials.
7.2 For Raw Materials
7.2.1 Use the first digits “A” to identify the active materials and “E” to identify the excipient materials.
7.2.2 Use the second four digits to identify the code number and serial number of that particular raw material.
7.2.3 The last three digits to identify the serial number of the same raw material but a different consignment.
7.2.4 For example, the batch number of Atenolol BP (active material) in the first consignment is
A0002001 & second consignment is A0002002.
7.2.5 For example, the batch number of Crospovidone BP (excipient material) in the first consignment is
E0015001 & second consignment is E0015002.
7.3 For Packaging Materials
7.3.1 Use the first two alphabetical digits of the code number.
7.3.2 Use the third three digits to identify the code number and serial number of that particular packaging material.
7.3.3 Last three digits to identify the serial number of the same material but a different consignment.
7.3.4 For example, the batch number of Leaflet for the Aceclofenac tablet’s first consignment is LF001001
& second consignment is LF001002.
8. ABBREVIATIONS
8.1 QA : Quality Assurance
8.2 QC : Quality Control
8.3 PD : Product Development
9. APPENDICES
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Read Also: SOP of SOP in Pharmaceutical
SOP in the Pharmaceutical industry
Abdus Sobhan Salim is professional experienced pharmacist in pharmaceuticals, author and founder of pharmabossbd.com, the first Bangladeshi pharmaceutical blogger since 2019.
