Procedure For Procurement and storage of reference standards

1.0 Objective
To define a procedure to procure and maintain Reference or Chemical Reference substances required as per I.P. / B.P. / U.S.P.
2.0 Scope
All Reference standards that are required and used in Quality control lab at abc Pvt. Ltd.
3.0 Responsibility
3.1 Executive – Quality Control.
3.2 In charge/Head-Quality Control.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QC : Quality Control
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
G : General
5.0 Procedure
5.1 Whenever a Reference standard is required as per the prescribed procedure, a formal

requirement shall be made to the purchase dept. by mail asking for the minimum standard

pack of the Reference Standard or chemical Reference substance.
5.2 The purchase department will ask for quotation from the authorized dealers and send it to QC for approval.
5.3 Authorized suppliers will be.
LGC Promochem India Pvt. Ltd.
Unit No 401-402
5.4 Indian Pharmacopoeia Commission
Ministry of Health & family Welfare, Gov. of India,
Reference Substance division, sector 23, rajnagar Ghaziabad
5.5 Reference Standard Substances
A-21MIDC Street 3 Andheri (East)
Mumbai – 40000093
5.6 Central Drug Laboratory, (CDL)
Kolkata, India
5.7 The purchase department will raise a purchase order, to the party

stating the Reference standard or the chemical reference substance and the

quantity required, a copy of which will be received by QCL.
5.8 Once the Reference standard is received it will be recorded in a register along with

the date of receipt and quantity received. Material safety data papers and other records are filed and maintained
5.9 The Reference standard will be stored as per the conditions prescribed or under refrigerator.
5.10 The In charge chemical section (Executive QC) will be the authorized person for handling,

storage and issuance of reference standard.
5.11 Whenever there will be requirement for the use of reference standard the authorized

person as per job responsibilities will issue the reference standard by making all necessary entries.
6.0 Forms and Records
6.1 None.
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Assurance, Quality Control
8.0 History