STANDARD OPERATING PROCEDURE
LOGO
TITLE
J. Snow Pharmaceuticals
Preparation of Standard Solutions and
Reagents
AUTHOR
SOP #
PAGE
Victor Frankenstein
SOLN.001.00
1 of 4
VALIDATION
REVISION#
EFFECTIVE DATE
Anthony Stark
N/A
12 January 2014
1.0 Purpose
The purpose of this procedure is to describe the general requirements for the
preparation of any standard solution and/ or any standard reagent required for
use in any and all laboratory areas of J. Snow Pharmaceuticals.
2.0 Scope
This procedure is to be enacted whenever a supply of any solution or reagent
identified as standard to operations by the requisite SOP or specification or any
other document defined as “control”, and validated for use in any and all
laboratory areas of J. Snow Pharmaceuticals.
This procedure does not cover the preparation of any solution or reagent
identified as “dedicated” or “controlled” by any other SOP, or specification, or any
other document defined as “control”, and validated for use in any and all
laboratory areas of J. Snow Pharmaceuticals.
This SOP must be used for training and for reference.
3.0 Notes
3.1 All MSDS relevant to any and all solutions and reagents generally covered by
this SOP must be read and reviewed for specific information concerning
requirements for safe use and safe handling of the relevant required components
of any and all solutions and reagents.
4.0 Records
Full, complete, comprehensive, and accurate records of the preparation of any
and all solutions and reagents covered by the SOP shall be made in
a) The Operator’s authorized lab record;
b) The designated, required Solution Book or Reagent Book;
c) The designated, required analytical instrumentation logs;
d) The designated and required instrumentation logs;
e) The designated and required equipment logs;
f) The designated and required materials logs.
5.0 References and Associated Documents
cGMP C.02.012.30
BAPR.001.00
STANDARD OPERATING PROCEDURE
TITLE
SOP #
PAGE
Preparation of Standard Solutions and SOLN.001.00
Reagents
2 of 4
INST.023.14
MSDS
OHS.001.02
OHS.002.01
OHS.003.03
OHS.004.00
OHS General Manual
6.0 Definitions
Solution is defined as any combination of one or more solutes dissolved in one
or more solvents.
Reagent is defined as any combination of one or more solutes dissolved in one
or more solvents.
Control is defined as any document such as a SOP, a specification, or a work
instruction that has been validated and approved by QA or a designate appointed
by QA, and that provides the specific requirements and materials for the
preparation of a specified solution or reagent.
7.0 Safety Requirements
For General Personal Protective Equipment, consult OHS.001.02
For General First Aid, consult OHS.002.01
For General Clean Up, consult OHS.003.03
For General Spill Clean Up, consult OHS.004.00
For additional information on Safety Requirements, consult required and relevant
MSDS in conjunction with the OHS General Manual.
8.0 Materials and Equipment
For a complete, correct, and comprehensive list of all required and relevant
materials, consult the required and relevant control documents dictated by
Specification.
9.0 Instructions
9.1 If a storage container is required, Operator will label the requisite storage
container with the following:
Solution / Reagent Name:
Operator’s Name and Initials:
Date of Preparation:
STANDARD OPERATNG PROCEDURE
TITLE
SOP#
PAGE
Preparation of Standard
SOLN.001.00
Page 3 of 4
Solutions and Reagents
Date of Expiration:
9.2 Operator will calibrate any analytical instrument, instrument, and equipment
required for the preparation of a solution prior to preparing the solution or reagent.
9.3 Operator will record any all calibration activities in the lab record and in the
requisite analytical instrument, instrument, and equipment logs.
9.4 Operator will weigh by difference any solid components of the required
solution or reagent.
9.5 Operator will record all weighing activity in lab record and in the requisite
balance log.
9.6 Operator will mix all components of the required solution or reagent in the
sequence and order, and with a all required quality control checks in accordance
with the method described by the requisite control document.
9.7 Operator will record all mixing and quality control check activities in the lab
record and in any and all requisite analytical instrument, instrument, and
equipment logs.
10.0 Data Management
10.1 Operator will confirm that the completely mixed and prepared solution or
reagent matches the specifications for said solution or reagent as dictated by the
relevant reference source.
11.0 Validation
Supervisor shall inspect, sign and date the Operator’s lab record, and any and all
relevant solution books, reagent books, materials books, analytical instrument
logs, instrument logs, equipment logs, and cabinet logs.
12.0 Revision History
N/A
13.0 References and Attachments
N/A
STANDARD OPERATING PROCEDURE
TITLE
SOP #
PAGE
Preparation of Standard
SOLN.001.00
4 of 4
Solutions or Reagents
14.0 Document Approvals
SOP AUTHOR
NAME: Victor Frankenstein
TITLE: Chemist, QC
SIGNATURE: Victor Frankenstein
DATE: 10 January 2014
SOP VALIDATION
NAME: Michal Stripe
TITLE: Senior Chemsit, QC
SIGNATURE: Michal Stripe
DATE: 11 January 2014
SOP APPROVAL
NAME: Anthony Stark
TITLE: Senior Associate, QA
SIGNATURE: Anthony Stark
DATE: 12 January 2014