PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

1.0 PURPOSE
To define a procedure for Status labeling.

2.0 SCOPE
2.1 This procedure applies to labels used at ……………….
2.2 Specific departments under the scope of this SOP are “Quality Assurance, Quality Control, Production,
Warehouse, Engineering, Environment, Health and safety, Human Resource and Administration”.

3.0 REFERENCE(S) & ATTACHMENTS

3.1 References
3.1.1 In-House

3.2 Attachments
3.2.1 Attachment- I: Quarantine Status label (Raw/ Packing material)
3.2.2 Attachment-II: Sampled Label (Raw/packing/ In-process material)
3.2.3 Attachment-III: Under test label (Raw/packing/ In-process material/ Finished Product)
3.2.4 Attachment-IV: Sample for Analysis (Raw/packing/ In-process material/ Finished Product)
3.2.5 Attachment-V: Passed Label Analysis (Raw/packing/ In-process material/ Finished Product)
3.2.6 Attachment-VI: Rejected Label Analysis (Raw/packing/ In-process material/ Finished Product)
3.2.7 Attachment-VII: Dispensing Label (raw/packing material)
3.2.8 Attachment-VIII: Loose Pack Label (raw/packing material)
3.2.9 Attachment-IX: Repacking Label (raw/packing material)
3.2.10 Attachment-X: Control Sample (Raw Material)
3.2.11 Attachment-XI: Control Sample (Finished Product)
3.2.12 Attachment-XII: Under hold (In-process Material/ Finished Product)
3.2.13 Attachment-XIII: Scrap material label
3.2.14 Attachment-XIV: To be cleaned Label
3.2.15 Attachment-XV: Cleaned Label
3.2.16 Attachment-XVI: Material Return Label
3.2.17 Attachment-XVII: Under Breakdown Maintenance Label
3.2.18 Attachment-XVIII: Area Status Label
3.2.19 Attachment-XIX: Online Rejection Label
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

3.2.20 Attachment-XX: Preventive Maintenance Status Label

3.2.21 Attachment-XXI: Under Preventive Maintenance Status Label
3.2.22 Attachment-XXII: Calibration Status Label
3.2.23 Attachment-XXIII: Out of Calibration Status Label
3.2.24 Attachment-XXIV: For ETP label
3.2.25 Attachment-XXV: Loose Shipper Label
3.2.26 Attachment-XXVI: Market returned product under hold label
3.2.27 Attachment-XXVII: Specimen issuance label for log
3.2.28 Attachment-XXVIII: Validation sample label
3.2.29 Attachment-XXIX: Label for swab/ rinse sample
3.2.30 Attachment-XXX: Daily verification Status for Weighing Balance
3.2.31 Attachment-XXXI: Filter cleaning status label
3.2.32 Attachment-XXXII: Disinfectant/ Detergent/ Deactivating/ Sanitizing solution Label
3.2.33 Attachment-XXXIII: Label of Stock / Stability Solution
3.2.34 Attachment-XXXIV: Label of Reference / Impurity Standard
3.2.35 Attachment-XXXV: Label of Working Standard
3.2.36 Attachment-XXXVI: Label for Instrument/ Equipment (In-house Code)
3.2.37 Attachment-XXXVII: Label for Restricted entry (Quality Control Department)
3.2.38 Attachment-XXXVIII: Label for Glassware in Use
3.2.39 Attachment-XXXIX: Label for Column/Syringe/Plunger Flushing
3.2.40 Attachment-XL: Status Label for HPLC/GC Analysis
3.2.41 Attachment-XLI: Status Label for Dissolution Test
3.2.42 Attachment-XLII: Status Label for Analysis (Other than HPLC/GC & Dissolution)
3.2.43 Attachment-XLIII: Label for Karl Fisher Reagent
3.2.44 Attachment-XLIV: Label Methanol for Karl Fisher Reagent
3.2.45 Attachment-XLV: Status Label for Mobile Phase
3.2.46 Attachment-XLVI: Status Label for TLC Chamber
3.2.47 Attachment-XLVII: Specimen Label for Bulk Finished Placebo
3.2.48 Attachment-XLVIII: Specimen Label for Placebo for Analytical Purpose
3.2.49 Attachment-XLIX: Isopropyl alcohol (IPA) 70% (v/v) Solution Label
3.2.50 Attachment-XLX: Material for Destruction Label
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

4.0 DEFINITION & ABBREVIATION(S)

4.1 Definitions
4.1.1 Nil

4.2 Abbreviations
4.2.1 etc.: Etcetera
4.2.2 QA: Quality Assurance
4.2.3 A.R. No.: Analytical Reference Number
4.2.4 B. No.: Batch Number
4.2.5 No.: Number
4.2.6 Wt.: Weight
4.2.7 QC: Quality Control
4.2.8 IPA: Iso Propyl Alcohol
4.2.9 V/V: Volume by Volume
4.2.10 SOP: Standard operating procedure
4.2.11 Qty.: Quantity
4.2.12 GR No.: Goods receipt number
4.2.13 Avg.: Average

5.0 RESPONSIBILITY
5.1 Applicable Departments
5.1.1 To prepare and display proper labels at appropriate stages/activity/times.
5.2 Applicable Department Heads
5.2.1 To check whether the labels are properly affixed as per SOP.
5.3 Quality Assurance Head:
5.3.1 To ensure implementation of system as per defined procedure.
5.4 Plant Head:
5.4.1 To ensure implementation of system as per defined procedure.

6.0 Distribution:
I. Quality Assurance
II. Production
III. Ware house
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

IV. Engineering
V. Human resource and Administration
VI. Environment, Health and safety
VII. Quality Control

7.0 PROCEDURE:
7.1 Concern department will prepare the specimen for label by following the attachments of this standard
operating procedure.
7.2 Head of concern department will approve the label.
7.3 Approved format will send to QA department for approval. After QA approval specimen will be sent to
purchase department for printing of the label.
7.4 Purchase department will receive the approved specimen of label and proceed for final printing of labels
as per the requirement.
7.5 Any printed labels left after updation in label format shall be destroyed.
7.6 All equipments, in-process material, finished product, containers etc. shall be labeled appropriately and
at all times. No unlabeled equipment, in-process material, finished product etc., shall be taken / used for
processing:
7.7 All equipment containers, area, pack and in-process shall be labeled before the start of the activity to
clearly depict their status and identification.
7.8 Labels shall be attached in a manner that they are clearly visible.
7.9 Text of the label shall be in clear and legible language.
7.10 Concerned persons shall sign with date on labels properly.

7.11 Quarantine Status Label (Raw/ Packing Material): This label shall be affixed by warehouse person on
consignment of raw or packaging materials received from manufacturer /supplier as per Attachment-I.

7.12 Sampled: After sampling of raw material/ packing materialfrom the received consignment from
manufacturer /supplieror after sampling of in-process material, affix the sampled label as per Attachment-
II on the container/ bag/ unit from which the sampling is done.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

7.13 Under Test:This label is affixed after taking sample of raw /packing material from the received
consignment from manufacturer /supplier, on in-process material and finished product which is under
analysis. Affix the labels on each container/ bag/ unit as per Attachment-III near the Sampled Label.

7.14 Sample for Analysis (Raw/ Packing/ In-Process Material/ Finished Product):This label is affixed on
sample poly bag/ bottle/ poly bag containing raw material/ packing material/ in-process/ finished product
sample for analysis purpose as per Attachment-IV.

7.15 Passed Label (Raw/ Packing/ In-Process Material/ Finished Product): After Approval of batches
affix passed label on the container/bag/unit as per Attachment-V over under test label in such a way that
the passed label shall completely hide the “UNDER TEST” label.

7.16 Rejected Label (Raw/ Packing/ In-Process Material/ Finished Product): This label is affixed on Raw
/Packing/ In-process Material/ Finished Product as per Attachment-VI when material does not comply
the specifications of Pharmacopoeia or In-House specifications. It shall be affixed on the “UNDER
TEST” label by completely hiding the “UNDER TEST” label.

7.17 Dispensing label: This label is affixed on raw and packing material after dispensing from warehouse as
per Attachment-VII.

7.18 Loose Pack label (Raw/Packing Material): This label is affixed on loose container of raw/ packing
material as per Attachment-VIII.

7.19 Repacking label (Raw/Packing material): This label is affixed on repacking of Raw/ Packing material
as per Attachment-IX.

7.20 Control sample Label (Raw material): This label is affixed on the container/poly bag containing
control sample of raw materials as per Attachment-X. This label shall be prepared and affixed by Quality
Control person.

7.21 Control Sample label (Finished Product): This label is affixed on the container such as cartons/poly
bag containing finished product as per Attachment-XI.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

7.22 Under Hold Label (In-process material/ Finished Product):If at any stage during manufacturing /
packing operation, process is stopped or not continued due to reasons, which require investigation, etc.,
then “HOLD” label shall be pasted as per Attachment-XII.

7.23 Scrap Material label: This label is affixed on container/ polybag of Scrap as Attachment-XIII.

7.24 To be cleaned label: All equipment/accessory to be cleaned shall bear a status label “TO BE
CLEANED” as per Attachment-XIV. Details of previous product shall be given on the label per
Attachment-XIV.

7.25 Cleaned label: After cleaning, the equipment shall bear status label as “CLEANED” (as per Attachment-
XV). Cleaning shall be done by user department. If after cleaning, equipment is not used within 07 days,
re-cleaning shall be carried out (as per Attachment-XV).

7.26 Material return label: This label is affixed on those containers of excess material which are returned
from production to ware house, as per Attachment-XVI.

7.27 Under breakdown maintenance label: When Instrument/equipment under maintenance due to
breakdown of the equipment/instrument, then affix the label “UNDER BREAKDOWN
MAINTENANCE” as per Attachment-XVII.

7.28 Area status label: Area in which the dispensing/ manufacturing/ packing is being done shall bear the
“AREA STATUS” label that gives the details of product under process as per Attachment-XVIII.

7.29 On line rejection label: This label is affixed on containers/materials which are rejected at the time of
manufacturing / packing stage, as per Attachment-XIX.

7.30 Preventive maintenance status label: This label is affixed after preventive maintenance of equipments
is completed as per Attachment-XX.

7.31 Under Preventive Maintenance Status Label: This label is affixed during preventive maintenance of
equipments as per Attachment- XXI.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

7.32 Calibration Status label: When instrument /equipment is calibrated in-house then this label affixed on
the calibrated instrument/equipment as per Attachment-XXII.

7.33 Out of Calibration Status Label: If calibration of instrument has expired/or failed then user department
shall affix “OUT OF CALIBRATION” label as per Attachment-XXIII.

7.34 FOR ETP: This label is affixed on container containing material or product for disposition in ETP as per
Attachment- XXIV.

7.35 Loose Shipper Label: “LOOSE SHIPPER” label shall be affixed on the shipper having less than the
standard quantity bearing all the details related to product as per Attachment-XXV. The original stamped
/labeled quantity on the shipper shall be appropriately modified with sign and date by Production
personnel.

7.36 Market return product under hold label: When material is returned from market then affix the label
“UNDER HOLD (MARKET RETURNED) as per Attachment-XXVI.

7.37 Specimen Issuance Label for Log: This label is affixed on the log as per Attachment-XXVII at the time
of issuance to user department by QA person.

7.38 ValidationSample: This label is affixed on the validation samples which shall be sent to QC for analysis
purpose as per Attachment – XXVIII.

7.39 Label for Swab/ Rinse Sample: “SWAB/ RINSE SAMPLE” label shall be affixed on the test tube stand
or on the wrapper containing the swab samples and on the container of rinse sample as per Attachment-
XXIX.

7.40 Daily verification status for weighing balance: This label shall be affixed on the weighing balance for
daily verification status as per Attachment-XXX.
7.41 Filter cleaning Status Label: This label is used for filter cleaning status of AHU as per Attachment –
XXXI.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

7.42 Disinfectant/ Detergent/Deactivating/Sanitizing solution Label: This label shall be on the containers in
which Cleaning agents/ deactivating/ disinfectant/ sanitizing solutions shall be stored in the designated
areas as per Attachment- XXXII.

7.43 Label of Stock/Stability Solution: This label shall be affixed on Stock/ Stability solution as per
Attachment-XXXIII.

7.44 Label of Reference / Impurity Standard: This label shall be affixed on Reference / Impurity Standard
as per Attachment-XXXIV.

7.45 Label of Working Standard: This label shall be affixed on Reference / Impurity Standard as per
Attachment-XXXV.

7.46 Label for Instrument/ Equipment (In-House Code): This label shall be affixed on Instrument/
Equipment in Quality Control department as per Attachment-XXXVI.

7.47 Label for Restricted Entry (Quality Control Department): This label shall be used for Restricted
Entry in Quality Control department as per Attachment-XXXVII.

7.48 Label for Glassware in Use: This label shall be affixed on the glassware in use in Quality Control
department as per Attachment-XXXVIII.

7.49 Label for Column/Syringe/Plunger Flushing: This label shall be affixed on the solvent used for
Column/Syringe/Plunger Flushing in Quality Control department as per Attachment-XXXIX.

7.50 Status Label for HPLC/GC Analysis: This label shall be affixed on HPLC/ GC used for analysis in
Quality Control department as per Attachment-XL.

7.51 Status Label for Dissolution Test: This label shall be affixed on Dissolution Apparatus used for
analysis in Quality Control department as per Attachment-XLI.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

7.52 Status Label for Analysis (Other than HPLC/ GC& Dissolution): This label shall be affixed on
equipment/ instrument used for analysis other than HPLC/ GC and Dissolution Apparatus in Quality
Control department as per Attachment-XLII.

7.53 Label for Karl Fischer Reagent: This label shall be used for Karl Fischer Reagent in Quality Control
department as per Attachment-XLIII.

7.54 Label for Methanol for Karl Fischer Reagent: This label shall be used for methanol for Karl Fisher
Reagent in Quality Control department as per Attachment-XLIV.

7.55 Status Label for Mobile Phase: This label shall be used for mobile phase in Quality Control department
as per Attachment-XLV.

7.56 Status Label for TLC Chamber: This label shall be used for TLC Chamber in Quality Control
department as per Attachment-XLVI.

7.57 Specimen Label for Bulk Finished Placebo: This label shall be affixed on the bulk finished placebo
after completion of batch manufacturing and before start of packing activity as per Attachment-XLVII.

7.58 Specimen Label for Placebo for Analytical Purpose: This label shall be affixed on the bulk finished
placebo after completion of manufacturing of a placebo batch required for analytical purpose as per
Attachment-XLVIII.

7.59 Isopropyl Alcohol (IPA) 70% V/V Solution label: This label is affixed on the container of disinfectant
solution as per Attachment-XLIX.

7.60 Material for Destruction Label: This label is affixed on the container of material to be destroyed as per
Attachment-XLX.

NOTE: Put (-) mark or ‘NA’ in the provided space of label which is not required or not applicable.

8.0 REVISION HISTORY

Version No. 00 Effective Date
Details of revision: New SOP Prepared
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-I

QUARANTINE STATUS LABEL

(RAW/PACKING MATERIAL)

QUARANTINE

Material/ Item Name:

Item Code :
Vendor Batch/ Lot No.:
Mfg. Date : Exp. Date:
Total Quantity :
Total Packs/ Containers (Nos.): _____ Container/ Pack No.: ____ of ____
Signature : Date:
Format No……………..

Color of Shading: Yellow

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-II

SAMPLED LABEL
(RAW/ PACKING/ IN-PROCESS MATERIAL)

SAMPLED
Sampled By:
Sign/ Date
Format No……….
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-III

UNDER TEST LABEL

(RAW/PACKING/ IN-PROCESS MATERIAL/FINISHED PRODUCT)

UNDER TEST

Product/ Item Name :

Batch / Lot No. :
Item Code :
A.R. No. :
Mfg. Date : Exp. Date:
Stage :
GR No. : GR Date:
Total Quantity :
Total Packs/ Containers (Nos.): _____ Container/ Pack No.: ____ of ____
Quantity/ Pack or Container: _______________
Manufacturer/ Supplier Name:
Signature : Date:
Format No…………….

Color of Shading: Yellow

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-IV

SAMPLE FOR ANALYSIS

(RAW/ PACKING/IN-PROCESS MATERIAL/FINISHED PRODUCT)

SAMPLE FOR ANALYSIS

Type of Sample : Sampling Stage:
Name of Sample:
Batch No. : Lot No.:
Item Code : Qty. Sampled:
Mfg. date : Expiry date:
A.R. No. : GR No.:
Manufacturer/Supplier Name:

Sampled By
Sampled at Time
Sign / Date

Format No……………..
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-V

PASSED LABEL
(RAW/PACKING/ IN-PROCESS MATERIAL/ FINISHED PRODUCT)

PASSED

Product/ ItemName:
Batch/ Lot No. :
Item Code :
A.R. No. :
Mfg. Date : Exp. Date:
Stage :
GR No. :
Total Quantity :
Total Packs/ Containers (Nos.): _____ Container/ Pack No.: ____ of ____
Signature : Date:
Format No……………

Color of Shading: Light Green

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-VI

REJECTED LABEL
(RAW/PACKING/ IN-PROCESS MATERIAL/ FINISHED PRODUCT)

REJECTED

Product/ Item Name:

Batch/ Lot No. :
Item Code :
Mfg. Date : Exp. Date :
Stage :
Total Quantity :
Total Packs/ Containers (Nos.): _____ Container/ Pack No.: ____ of ____
Gross Wt.: Tare Wt.: Net Wt.:
GR No. : A.R. No.:
Supplier/ Manufacturer Name:
Reason for Rejection:

Prepared by (Sign/ Date) Checked by QA (Sign/ Date)

Format No…………..

Color of Shading: RED

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-VII

DISPENSING LABEL (RAW/PACKING MATERIAL)

DISPENSING LABEL
Item Name :
Item Code :
A.R. No. : Pack No.:
Product Name :
B. No. : Lot No.:
Gross Wt. :
Tare Wt. :
Net Wt./ Nos. :

Dispensed By Checked By Verified By

(Sign/ Date) (Sign/ Date) (Sign/ Date)
Format No……………..
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-VIII

LOOSE PACK LABEL (RAW/PACKING MATERIAL)

LOOSE PACK LABEL

(RAW / PACKING MATERIAL)

Item Name :
Item Code :
Batch No. :
A.R. No. :
Net Quantity :
Signature / Date :
Format No……………..
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-IX

REPACKING LABEL FOR RAW / PACKING MATERIAL

REPACKING LABEL
(RAW/PACKING MATERIAL)

Item Name :
Item Code :
Batch No. :
Mfg. Date : Exp. Date:
Manufacturer/ Supplier Name:
No. of Containers/ Packs: _____________ of ____________
Gross Wt.: Tare Wt.: Net Wt.:
Reason :

Prepared by Warehouse Checked By Quality Assurance

(Sign/ Date) (Sign/ Date)

Format No………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-X

CONTROL SAMPLE LABEL

(RAW MATERIAL)

CONTROL SAMPLE
(RAW MATERIAL)

Item Name :
Item Code :
Batch/ Lot No. :
A.R. No. :
Mfg. Date : Exp. Date:
Quantity of sample:

Prepared By Disposal due On

Sign / Date (one year after expiry)
Format No……………..
Color of Shading: ORANGE

Format No……………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XI

CONTROL SAMPLE LABEL

(FINISHED PRODUCT)

CONTROL SAMPLE
(FINISHED PRODUCT)
Format No……………

Color of Shading: ORANGE

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XII

UNDER HOLD LABEL

(IN-PROCESS MATERIAL/FINISHED GOOD)

UNDER HOLD
(IN-PROCESS MATERIAL /
FINISHED PRODUCT)
Product Name :
Batch/ Lot No. :
Batch Size :
Mfg. Date : Exp. Date:
Container No. : _______ of _______
Reason for Hold :

QA (Sign/Date) :
Format No……………….

Color of Shading: Yellow

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XIII

SCRAP MATERIAL LABEL

SCRAP MATERIAL
Type of Scrap :
Gross Wt.: Tare Wt.: Net Wt.:
Quantity in Nos.:
Department :

Prepared By/ Date Checked By/ Date

Format No. ……………..

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XIV

TO BE CLEANED LABEL

TO BE CLEANED

Area:

Equipment/ Accessory Code No.:

Previous Product :

Previous Batch No. :

Prepared by (Sign / Date) :

Format No…………..

Color of Shading: Red

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XV

CLEANED LABEL

CLEANED
Equipment/ Accessory Name:
Code No./ Area :
Previous Product :
Previous Batch No. :
Cleaned By/Date :
Use Before :
Checked By/Date :

Note: If not used within 07 days from date of cleaning, then

re-clean before use
Format No. …………..
Color of Shading: Light Green
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XVI

MATERIAL RETURN LABEL

MATERIAL RETURN
Material Name:
Item Code: A.R. No.:
Product Name:
Batch No.:
Gross Wt. (kg): Quantity (in Nos.):
Tare Wt. (kg):
Net Wt. (kg):

Prepared by Production Checked By QA Received By Warehouse

(Sign/Date) (Sign/Date) (Sign/Date)
Format No…………….
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XVII

UNDER BREAKDOWN MAINTENANCE LABEL

UNDER BREAKDOWN
MAINTENANCE
Equipment/ Instrument Name:
Code No. :
Nature of Breakdown :
Sign/Date :

Format No. ……………

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XVIII

AREA STATUS LABEL

AREA STATUS

Product/ Item :
Batch/ A.R. No. : Lot No. :
Batch Size :
Mfg. Date : Exp. Date :
Status/ Stage :
M.R.P. :
Signature :
Date :
Format No………….
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XIX

ON LINE REJECTION LABEL

ON LINE REJECTION
Material Name:
Item Code:
A.R. No.:
Product Name:
Batch No.:
Gross Wt. (kg): Tare Wt. (kg): Net Wt. (kg):
Quantity (Nos.):

Reason for Rejection:

Prepared By User
(Sign/Date)
Checked By QA
(Sign/Date)
Format No……………..

Color of Shading: Red

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XX

PREVENTIVE MAINTENANCE STATUS LABEL

PREVENTIVE
MAINTENANCE STATUS
Equipment/ Instrument Name:
Code No. :
Done on :
Due on :
Done By (Sign/ Date):

Format No……………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXI

UNDER PREVESNTIVE MAINTENANCE STATUS LABEL

UNDER PREVENTIVE
MAINTENANCE

SIGN : ____________

DATE : ____________

Format No……………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXII

CALIBRATION STATUS LABEL

CALIBRATION STATUS

Department:
Equipment/Instrument Name:

Code No.:

Calibrated On :

Calibration Due On :

Calibrated By (Sign/Date):
Format No…………..
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXIII

OUT OF CALIBRATION STATUS LABEL

OUT OF CALIBRATION

Department:

Equipment / Instrument Name:

Code No.:
Sign / Date:
Format No……………

Color of Shading: Red

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXIV

FOR ETP LABEL

FOR ETP
Material/Product :

Quantity (Weight / Nos.) :

Department :

Checked By : Date :

Format No………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXV

LOOSE SHIPPER LABEL

LOOSE SHIPPER

Product Name :

B. No. :

Mfg. Date :

Exp. Date :

Quantity :

Production QA
Sign/ Date Sign/ Date
Format No………………

Color of Shading: Red

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXVI

MARKET RETURNED PRODUCT UNDER HOLD LABEL

UNDER HOLD
(MARKET RETURNED)
Product Name :
Batch No. :
Mfg. Date : Exp. Date:
Total No. of Shippers :
Total Qty. (Unit Packs) :
Reason :
Date of Receipt :
Received By Name :
Prepared By (Sign/Date):

Format No…………….

Color of Shading: Yellow

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXVII

SPECIMEN ISSUANCE LABEL FOR LOG

ISSUANCE LABEL FOR LOG

Year: Department:

Log Title:

Format No.: Reference SOP No.:

Log book/ Register Serial No. particular to that area/

Total No. of Page(s):
equipment:

Area Name: Area Code No.:

Equipment Name: Equipment Code No.:

Log book/ Register Usage Period (Date):

Date of Issue:
_____________ to _____________

Issued by QA Received by
(Sign / Date): (Sign / Date):
Completed Log Submitted by Completed Log Retrieved by
(Sign / Date): QA(Sign / Date):
Format No………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXVIII

VALIDATION SAMPLE LABEL

VALIDATION SAMPLE
Product Name:
Batch No.: Batch Size:
Stage: Avg. Weight:
Sampled Qty.:

Sampled By QA (Sign):
Date/Time:
Format No……………..
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXIX

LABEL FOR SWAB/RINSE SAMPLE

SWAB/RINSE SAMPLE
Equipment Name:
Code No.:
Previous Product Name:
Previous B. No.:
Purpose of Sample: Chemical/ Microbial
Sample No.: __________ of _________
Sampled By QA (Sign):
Date/Time:
Format No…………….
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXX

DAILY VERIFICATION STATUS LABEL FOR WEIGHING BALANCE

DAILY VERIFICATION STATUS

(WEIGHING BALANCE)
Department: Date:

Code No.: ________________

Capacity: ________________ Least Count: _________

Operating Range: Min.: ____________ Max.: ___________

Verification Done On : _____________

Verification Done By (Sign / Date): ____________________

Format No…………….
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXXI

FILTER CLEANING STATUS LABEL

FILTER CLEANING
STATUS
AHU Code No.:
Pre Filter Size: Code No.:
HEPA Filter Size: Code No.:
Return Filter Size: Code No.:
Done Date: Due Date:
Checked by (Sign/ Date):
Format No……………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXXII

DISINFECTANT/DETERGENT/DEACTIVATING/SANITIZING
SOLUTION LABEL

DISINFECTANT/DETERGENT/
DEACTIVATING/SANITIZING
SOLUTION
Block Name: Department/Area Name:

Disinfectant/Detergent/Deactivating/Sanitizing agent :

Prepared on :

Valid up to :

Prepared By Checked By
(Sign/ Date) (Sign/ Date)
Format No…………….
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXXIII

LABEL OF STOCK/STABILITY SOLUTION

STOCK/STABILITY SOLUTION
Name
Preparation date
Solution for For product
Prepared By Checked By
Storage condition
Format No…………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXXIV

LABEL OF REFERENCE/IMPURITY STANDARD

REFERENCE/IMPURITY STANDARD
Name
Identification /
Purity (as specified)
Code No.
Validity of use For purpose
Labeled by Checked By
Storage Condition
Format No……………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXXV

LABEL OF WORKING STANDARD

WORKING STANDARD

Vial for the month

Name
W.S. No. Effective Date
Assay (as is) Vial No. / No. of vial. ___ of____
Water content/LOD Use Before
Prepared By/Date Checked By / Date
Storage Condition
Format No………….
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXXVI

LABEL FOR INSTRUMENT/EQUIPMENT (IN-HOUSE CODE)

INSTRUMENT/EQUIPMENT
(In-house Code)

Name: ….......................................

ID No. : …......................................
Format No…………….
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXXVII

LABEL FOR RESTRICTED ENTRY

(QUALITY CONTROL DEPARTMENT)

QUALITY CONTROL DEPARTMENT

RESTRICTED ENTRY
ONLY FOR AUTHORIZED PERSONNEL

Format No…………….
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXXVIII

LABEL FOR GLASSWARE IN USE

Name:
A.R. No.:
Test/Dilution:
Sign: Date:
Format No. …………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XXXIX

LABEL FOR COLUMN/SYRINGE/PLUNGER FLUSHING

COLUMN/SYRINGE/
PLUNGER FLUSHING

Solvent:
Date of Dispensing/Preparation:
Valid Up to:
Sign: Date:
Format No……………..
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XL

STATUS LABEL FOR HPLC/GC ANALYSIS

HPLC/GC ANALYSIS STATUS

Product Name:
Batch No./A.R. No.:
Mobile Phase:
Column No.:
Test:
Sign: Date:
Format No……………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XLI

STATUS LABEL FOR DISSOLUTION TEST

DISSOLUTION ANALYSIS
STATUS
Product Name:
Batch No./A.R. No.:
Medium:
RPM:
Test:
Sign: Date:
Format No……………..
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XLII

STATUS LABEL FOR INSTRUMENT ANALYSIS

(OTHER THAN HPLC/GC & DISSOLUTION)

INSTRUMENT ANALYSIS
STATUS
Product Name:
Batch No./A.R. No.:
Test:
Sign: Date:
Format No……………..
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XLIII

LABEL FOR KARL FISCHER REAGENT

KARL FISCHER REAGENT

Batch No.:
Valid Up to:
Sign: Date:
Format No.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XLIV

LABEL FOR METHANOL FOR KARL FISHER REAGENT

METHANOL FOR KARL

FISHER REAGENT
Batch No.:
Manufacturer:
Valid Up to:
Sign: Date:
Format No…………..
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XLV

STATUS LABEL FOR MOBILE PHASE

MOBILE PHASE STATUS

Product Name:
Batch No./A.R. No.:
Composition:
Test:
Prepared on:
Valid Up to:
Sign: Date:
Format No……………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XLVI

STATUS LABEL FOR TLC CHAMBER

TLC CHAMBER ANALYSIS
STATUS
Product Name:
Batch No./A.R. No.:
Start Time:
Test:
Sign: Date:
Format No……………..
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XLVII

SPECIMEN LABEL OF BULK FINISHED PLACEBO

BULK FINISHED PLACEBO

Product Name :

Component Excluded :

Batch No.:

Mfg. date :

Valid Up to:

Signature :

Date:

Format No……………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XLVIII

SPECIMEN LABEL OF PLACEBO FOR ANALYTICAL PURPOSE

PLACEBO FOR ANALYTICAL PURPOSE

Product Name :

Component Excluded :

Batch No.:

Mfg. date :

Valid Up to:

Signature :

Date:

Format No……………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XLIX

ISOPROPYL ALCOHOL (IPA) 70% (V/V) SOLUTION LABEL

ISOPROPYL ALCOHOL (IPA) 70% v/v

Date of Preparation :
Use Before :

Prepared By Checked By
(Sign/ Date) (Sign/ Date)
Format No………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Status Labeling Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Attachment-XLX

MATERIAL FOR DESTRUCTION LABEL

MATERIAL FOR DESTRUCTION

Material/Product :

Quantity (Weight / Nos.) :

Department :

Prepared By : Checked By :
(Sign/ Date) (Sign/ Date)
Format No………………