Title:

Quality System Procedure for Identification &

Regal Pharmaceuticals Traceability
Document #: Issue #: Page #:
PRD/QSP/003 001 1 of 3

QUALITY SYSTEM PROCEDURE

FOR

IDENTIFICATION & TRACEABILITY

NAME DESIGNATION SIGNATURE DATE

WRITTEN/ REVIEWED
BY:
CHECKED BY:
AUTHENTICATED BY:
APPROVED BY:
REVISION NO.:
DATE OF ISSUE: 07-07-2017
 Title:
Quality System Procedure for Identification &
Regal Pharmaceuticals Traceability
Document #: Issue #: Page #:
PRD/QSP/003 001 2 of 3

PURPOSE AND SCOPE:

To ensure at any time during and after production the product is traceable and identifiable
for quality control.

RESPONSIBILITY:

Production Manager is responsible for ensuring that all product types (usable, waste,
reusable) are placed in their respective bins. He has to ensure that the products are being
properly packed in the right cartons.

PROCEDURE:

IDENTIFICATION

PURPOSE:
To ensure at any time during and after production the product is traceable and
identifiable for quality control.

RESPONSIBILTY:

Production Manager /Shift In-charge is responsible for ensuring that all product types
Usable and unusable are placed in their respective bins .Shift In- charge has to ensure that
the products are being properly available in the right place .

PROCEDURE:

IDENTIFICATION
1. For identification purpose all machines are properly coded and numbered.
2. All sections are clearly named.
3. The status of every bin is clearly written, for identification and distinguishing
between different type of products.
4. All Raw materials are ready for next process.
5. Prior to sale all products are placed in the finished good godown with proper
Identification.
 Title:
Quality System Procedure for Identification &
Regal Pharmaceuticals Traceability
Document #: Issue #: Page #:
PRD/QSP/003 001 3 of 3

TRACEABILITY

1. For traceability purpose Date. Shift and the name of person who inspected the
production is clearly written on each Product.
All products going out of the factory are recorded on Out Ward Gate Pass.

RELATED DOCUMENTS:
Out Ward Gate Pass (STR/QR/007)