by - Objective
To lay down a procedure for the status labeling system & its control.
2. Scope
This Standard Operating Procedure is applicable for identification labels and status labels.
3. Responsibility
All concerned department personnel & their HODs are responsible for implementation and execution of status labeling.
QA personnel shall responsible for checking, implementation & control of status labeling.
4. Accountability
Department Heads & QA Head shall be accountable for implementation of this SOP.
5. Procedure
Label shall be filled by respective person by following.
Adequate information shall be filled by respective personnel on labels.
At the time of use, label shall be filled manually by using blue ball pen, only QA personnel shall use black ball pen.
Any information should not be blank.
Information on label shall be filled as instructed on respective label.
Doer & checker of concerned activities and department shall signature the label or as directed on label.
5.1 Contents of Status Label
All labels shall have a unique format no. (As described in SOP on SOP) which shall be written on bottom left side of label in font size 10.
All status label shall be surrounded by a boarder of ½ pt.
Contents of status label shall differ for all. It shall be depend on activities performed.
Status label shall be colour specific as described under individual annexure.
Size of label shall be fixed as per suitability; it is described under individual annexure.
Labels shall be of sticker, card type or generated by computer. Details of the type shall be described in the respective specimen of the labels.
All label shall have company logo & company name (in font size 12).
Font size shall be fixed as per suitability for all labels, but font type times new roman shall use for all.
Spacing between contents shall be as per suitability
5.2 The detail of the in process status labels along with department responsible for handling the same are given below:-
a. Quarantine
After received the consignment from manufacturer/supplier Quarantine label shall be affixed.
Specimen copy is attached in Annexure.
b. Dispensed Label
The “Dispensed” Label shall be used to indicate that material has been dispensed in Dispensing Area.
c. Online Rejection
During manufacturing process if any material shall reject on line it shall be labeled as online rejection.
d. Status Label
All the Products lying in the area to be Identify with Status Label indicate the status of the product.
e. To be Cleaned Label
The “To be cleaned” Label shall be used to indicate that the Equipment is not cleaned .
Note: In an area, if any equipment is not in use although a product is running on other equipment, in that case after completion of the product/ batch, affix, To Be Cleaned label on both used and unused equipments, previous product will be the product which was last run on that particular equipment (as per log book). Clean the equipments as per next product/ batch, which is to take under process. After cleaning, replace “To be Cleaned label” with “Cleaned label”.
f. Cleaned Label
The “Cleaned” Label shall be used to indicate that the Equipment is in cleaned condition and ready for use for the next batch / product.
g. Container / Bin Status Label
All the material / product which shall be store in a container / bin to be identified with “Container / Bin Status” Label and indicate the details of the material.Additional space in bottom in this label is given for affixing label for detailing of the under test and approval status.
h. To Be Inspected Label
The “To Be Inspected” Label shall be used to indicate that the product is to be inspected on an Inspection Belt.
i. Inspected Label
The “inspected” Label shall be used to indicate that the product has been inspected and found as good after the inspection.
j. Recoverable Rejection Label
The “Recoverable Rejection” Label shall be used to indicate that the product rejects at any stage can be recovered as a product of intended standard after reprocessing.
k. Non Recoverable rejection Label
The “non-recoverable rejection” Label shall be used to indicate that the product is not to be added in the next product and subjected for the destruction.
l. Loose box Label
The “Loose box” Label shall be used for the packed corrugated box containing the packed finished product which does not contain the standard quantity for a complete corrugated box.
m. In Process Under Test Label
The “In process under test” Label shall be used to indicate that the In process Product has been sampled and send to quality control Department for analysis and the release is awaited.
n. Under Hold Label
The “Under Hold” Label shall be used when some non-conformation or out of specification finding and not to be taken for further process till proper documentation clearance for activity is not done.
o. In Process Rejected Label
The “In Process Rejected” Label shall be used to indicate that the product or material has been rejected during the operation of any process (such as online rejection for foils) or the product is rejected during in process (such as in process sample/ in process loss) and not to be taken for next process and subjected for destruction /return to the vendor/subjected for further analysis.
p. Under Installation Label
The “Under Installation” Label shall be used to indicate that the equipment is under installation.
q. Under Maintenance Label
The “Under Maintenance” Label shall be used to indicate that the equipment/ area is under maintenance.
r. Approved Label
The “Approved” Label shall be used to indicate that the product is released by quality control department after analysis. After approval product is ready for the release for the next process.
s. Sample For Analysis Label
The “Sample for analysis” Label shall be used to store and transfer the sampled specimen of drug product for analysis.
t. Calibration Status Label (For In house & External calibration)
The calibration status label shall be used on equipment/instrument which is calibrated in-house as per given schedule.If calibration shall be done by external party than label shall be of their standard, but label shall have following minimum information but not limited to:
Equipment/ instrument ID No.
Calibration date
Due date of calibration
Date & Sign. of doer
u. Scrap LabelThe
“Scrap” Label shall be used to store and transfer the non-recoverable material other than drug component of product.
v. Equipment Status Label
Equipment status label shall be used on equipment to indicate the status of equipment.
w. Sampled Slip (Bulk product sampling)
After sampling of bulk product sampled slip shall be affixed.
x. Passed Slip (Bulk Product)
After sampling of bulk product slip shall be affixed.
5.3 Inventory of Status label
Inventory of all status label shall be maintained as per annexure QA as these are the formats.
5.4 Issuance of Status label
Issuance of all status label shall be same as format issuance as per SOP
5.5 Archival of Status label
Archival of filled status label shall be the part of respective batch no. BPCR.When the batch activities shall be completed all the respective status label shall be attach with BPCR.Labels which shall not be the part of BPCR shall be send to QA by respective department after completion of their valid period.These labels shall be destroyed by QA as per SOP on destruction
Labels printing specification shall be as described in Annexures.
However, the list of labels along with format numbers (updated list) shall be maintained by QA. Furthermore the format number for a newly introduced label shall also be assigned after reviewing the format number list, in order to avoid repetition, and this case SOP will be revised.
6.0 TRAINING
Trainer : Head – Quality Assurance
Trainees : Staff of all the departments
7.0 Distribution
Master copy – Quality Assurance
Controlled Copy – Quality Assurance
8.0 ATTACHMENTS
| Sr. No. | Annexure No. | Title | Format No. |
| 1 | NA | NA | NA |
- 9.0 REFERENCES
In-house
10.0 ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
11.0 REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
| 1 | NA | New SOP | 00 |
