Labeling

1.0.          OBJECTIVE:  

            To lay down the procedure for status labeling in production area.

2.0.          SCOPE:

This SOP shall be applicable for all the departments of tablet and capsule department at COMPANY LOCATION

3.0.          RESPONSIBILITY:

3.1.            Production Officer.

3.2.            QA Head shall be responsible for entire activities.

4.0.          PROCEDURE:

4.1.      Status labels are used for the identification of an object, an article, drugs & chemicals etc.

4.2.            Status labels are used in the pharmaceutical industries at various stages of the drugs like storage, dispensing, manufacturing, packing and their distribution. It is also used for the           identification of drugs & chemicals and their intermediates during the inprocess or at various stages of their generation.

4.3.            All Stage labels shall be printed in a legible manner .The label shall carry all the prescribed details about the product.

4.4.            Each step in the manufacturing and packing shall identified by an appropriate status label.

4.5.            Labels applied to the containers, equipments & premises shall be clear, unambiguous & in the company’s agreed format. It is often helpful to use different colors in addition to the wording on the label to indicate the status for example :  (Quarantine, Released, Rejected, To be cleaned, cleaned, Ready for use, Not in Use , Under Maintenance) etc.

4.6.            All labels shall be stored in a appropriate storage condition area and according to requirement usage record should be maintained.

5.0.          ANNEXURE:
Annexure-I      : Stage wise label (Under Process, under maintence, Not in Use, To be cleaned,                              Cleaned, Hold ,Approved, Rejected).

Annexure-II    : Labeling Issuance Record

6.0.          REFERENCES: Nil

7.0.          ABBREVIATION:

Abbreviation used	Full form of abbreviation used
QA	Quality Assurance
SOP	Standard Operating Procedure

8.0.          DISTRIBUTED TO:

Engineering Department

Quality Control Department

Microbiology Department

Manufacturing Department

Warehouse Department

9.0.          REVISION HISTORY:

Revision	Change Control No.	Reason for the Modifications

Annexure-I : Stage wise label (Under Process, Under Maintenance, Not in Use, To be cleaned, Cleaned, Hold ,Approved, Rejected).

COMPANY NAME				LOGO
UNDER PROCESS
Product	:		B. No.	:
Date	:		Stage	:
Gross Wt.	:		Net Wt.	:
Tare Wt.	:		Container No.	:	of
Checked By (Prodn.)	:		Ref. SOP-QAD-011-02

COMPANY NAME				LOGO
TO BE CLEANED
Equipment / Area Container Name	:		ID No.		:
Previous Product	:		B. No.		:
Date	:		Clean Before		:
Checked By (Prodn.)	:		Ref. SOP-QAD-011-02

COMPANY NAME						LOGO
REJECTED
Product / Equipment Name		:
B.No. / ID No.	:		Date	:
Stage	:		Container No.	:	of
Reason	:
Done By (QA)	:				Ref. SOP-QAD-011-02

COMPANY NAME					LOGO
CLEANED
Equipment / Area Container Name	:		ID No.	:
Previous Product	:		B. No.	:
Cleaned On	:		Due Date	:
Checked By (Prodn.)	:		Ref. SOP-QAD-011-02

COMPANY NAME							LOGO
NOT IN USE
Equipment / Instrument / Area / Facility  Name			:
ID No.	:				Date	:
Previous Product	:				B.No.	:
Reason	:
Checked By (Prodn.)	:
Checked By (QA)	:					Ref. SOP-QAD-011-02

COMPANY NAME					LOGO
HOLD
Product / Equipment Name		:
B.No. / ID No.	:		Date	:
Stage	:		Container No.	:	of
Reason	:
Done By (QA)	:				Ref. SOP-QAD-011-02

COMPANY NAME	LOGO
Sample Labels
Name of Product:
Batch No.
Mfg. Date:
Exp. Date:
Stage:
Sample Qty:
Sampled By:                                                                                         Ref. SOP-QAD-011-02

COMPANY NAME					LOGO
STAGE - READY FOR
Binding / Lubrication / Compression / Coating / Filling  / Labeling / Packing
Product Name	:		Date	:
B. No.	:		B. Size	:
Gross Wt.	:		Net Wt.	:
Tare Wt.	:		Container No.	:		of
Checked By (Prodn.)	:		Shift	:
Checked By (QA)	:			Ref. SOP-QAD-011-02

COMPANY NAME		LOGO
UNDER MAINTENANCE
Equipment/Instrument/area: Facility Name
ID No:	Date:
Previous Product:	B. No:
Reason :
Checked:
Checked By(QA)                                                          Ref. SOP-QAD-011-02

Annexure-II    : Labeling Issuance Record

Sr.No	Type of Labels	Department	Quantity Issued	Issued By (QA)	Received By	Balance Quantity