1.0 Purpose
1.1 To describe procedure for preparation and affixing label to Raw & Packing Materials.
2.0 Scope
2.1 This SOP shall be applicable for preparation and affixing label to Raw & Packing Materials of "NAME" Pharmaceuticals Ltd.
3.0 Responsibility
3.2 Sampler / QC Officer are responsible for preparing affixing SAMPLED LABEL and / UNDER TEST label.
3.3 QC Officer / Lab Analysis are responsible for preparing PASSED label and REJECTED label.
3.4 Store assistant is responsible for affixing PASSED label and REJECTED label in present of QC Officer.
4.0 Abbreviations and Definitions
4.1 Status label : Label that indicates the status of material/product like QUARANTINED, SAMPLED, UNDER TEST, PASSED, REJECTED etc.
5.0 Materials and Equipment
5.1 Not Appreciable
6.0 Precaution / Health and Safety Considerations
6.1 Never
use correction fluid for any mistake while preparing the label.
6.2 Never
affix any status label on the lid of the container.
7.0 Procedure
7.1 Fill up the contents for status labels legibly and correctly. In case of any mistake pen through
the wrong information, sign with date and write the correct information legibly or tear the label prepare a
new one. Do not overwrite any letter during writing labels.
7.2 Affix QUARANTINED label after checking and receiving the raw material containers. Affix them
beside the original label of each container so that those can easily be read.
7.3
Affix SAMPLED LABEL
on the sample container only.
7.4
Affix UNDER TEST label
on each and every container.
7.5
Affix PASSED /
REJECTED label after completion of analysis.
7.6 Ensure that all labels are affixed in cascading manner properly.
8.0 Reference Document
8.1 In-house
9.0 Annexure
9.1 Not Appreciable
10.0 Revision
History
|
Version No. |
Brief Reason for the Revision |
Effective Date |
Remarks |
|
01. |
New |
|
- |
|
02 |
|
|
|
11.0 Training
11.1 Training on this SOP is required for respective operators and Executives of Warehouse.
