Company Name
Section No.
SOP Number XX-028
Author:
111.303
111.310
111.315
111.320
Date Orig. Issued:
Date Revised:
Revision Number:
THE LABORATORY
SUPPORT FUNCTION
Date
Dept. Approval Signature:
Date
Page 1 of 7
Q.A. Approval Signature
TABLE OF CONTENTS
SECTION
PAGE
I.
PURPOSE ........................................................................................... 2
II.
SCOPE ................................................................................................ 2
III.
RESPONSIBILITIES ............................................................................ 2
IV.
INTERNAL LABORATORIES ............................................................. 2
81901650
A.
Laboratory Facilities ...................................................................... 2
B.
Staffing .......................................................................................... 3
C.
Laboratory Procedures and Documentation ................................. 3
D.
Laboratory Equipment Calibrations ............................................... 5
E.
Laboratory Equipment Calibration Records .................................. 5
F.
Laboratory Equipment Verifications .............................................. 6
G.
Calibration/Verification Failure ...................................................... 7
CONFIDENTIAL
Date
Company Name
Section No.
SOP Number XX-028
111.315
111.320
Date Orig. Issued:
Date Revised:
Revision Number:
THE LABORATORY
SUPPORT FUNCTION
Author:
Date
I.
111.303
111.310
Dept. Approval Signature:
Date
Page 2 of 7
Q.A. Approval Signature
PURPOSE
To define the requirements for laboratory operations, including written procedures
for the tests and examinations that are conducted to determine whether
specifications for raw material components, in-process materials, and dietary
supplements are met.
II.
III.
IV.
SCOPE
A.
The requirements and responsibilities contained in this SOP apply to all
internal testing laboratories, as well as to laboratories operated at satellite
plants.
B.
As applicable, these requirements must also be extended to laboratories
contracted to provide testing services, even if listed as “inactive”, but
approved service providers.
RESPONSIBILITIES
A.
The Quality Unit must ensure that laboratory services are available either
internally or through contractual agreements to ensure that all received goods
meet acceptance criteria, and that in-process materials and finished dietary
supplements meet specifications for identity, purity, quality, strength, and
composition.
B.
The Head of the Quality Unit will assign the responsibility for managing the
internal laboratory(s), as well as the responsibility for managing contract
laboratories.
INTERNAL LABORATORIES
A.
81901650
Laboratory Facilities
1.
Laboratories for chemical, physical and microbiological evaluations of
raw material components, in-process components, finished products,
packaging components and labels must be adequately sized, equipped
and staffed to provide essential technical support to the plant.
2.
Laboratories must be clean, orderly and well lit.
3.
Laboratories must be properly equipped with necessary instrumentation
for effective evaluations of raw material components, intermediate
products and finished dietary supplements.
CONFIDENTIAL
Date
Company Name
Section No.
SOP Number XX-028
Author:
111.303
111.310
111.315
111.320
Date Orig. Issued:
Date Revised:
Revision Number:
THE LABORATORY
SUPPORT FUNCTION
Date
Dept. Approval Signature:
Date
Page 3 of 7
Q.A. Approval Signature
4.
Laboratories must be effectively segregated from production, packaging
and storage areas so they are not potential sources of contamination.
5.
Laboratories must be vented externally and under slight negative
pressure.
6.
Laboratories must be secured to prevent unauthorized entry during or
outside of normal operational hours.
7.
Laboratory supplies must be stored with restricted access.
8.
All toxic supplies must be securely stored and properly labeled.
9.
Laboratory waste (chemicals and solvents) must be collected in
approved, labeled containers, and disposed of through approved
methods.
10. Microbiological testing areas must be isolated with self-closing doors,
and with access granted only to designated personnel.
11. Work with pathogenic organisms must be performed only by competent
professionals.
12. Pathogenic organisms must be protected against unauthorized use or
contact through proper storage in a locked, secured environment.
Documented inventory control and formal procedures to address any
potential breach of security must be in place.
13. Waste media from the microbiological laboratory must be autoclaved
prior to disposal.
B.
C.
Staffing
1.
Individual members of the laboratory staff must have documented
qualifications by way of specific training, certification or other forms of
credentials.
2.
Individual members of the laboratory staff must receive continuing
education training and demonstrate that they are up-to-date with current
laboratory test methods, procedures, etc. Laboratory staff training
records must be readily available for inspection.
Laboratory Procedures and Documentation
1.
81901650
Procedures must be in place for laboratory operations including:
CONFIDENTIAL
Date
Company Name
Section No.
SOP Number XX-028
111.303
111.310
111.315
111.320
Date Orig. Issued:
Date Revised:
Revision Number:
THE LABORATORY
SUPPORT FUNCTION
Author:
Date
Dept. Approval Signature:
Date
Page 4 of 7
Q.A. Approval Signature
a. Sample handling
b. Testing
c. Results reporting
d. Release/rejection procedures
e. Reference standard programs
f. Out of specification (OOS) result investigations
g. Operation, maintenance, calibration, and where necessary, cleaning
of laboratory equipment
h. Development of specifications.
i.
81901650
Method selection, development, approval and change control
2.
Development and maintenance of laboratory procedures must comply
with corporate standards for uniformity and content.
3.
Documented reviews of laboratory procedures by qualified employees
must be conducted at least every two years to verify accuracy.
4.
Testing methods used must be based on recognized and approved
analytical testing methods, and verification must be performed to
determine that they are appropriate for their intended use. Chemical
testing procedures should conform to accepted standards such as USP
(United States Pharmacopeia), AOAC (Association of Analytical
Communities), and FCC (Food Chemicals Codex).
5.
Microbiological testing procedures should meet accepted standards,
such as those established in the FDA Bacteriological Analytical Manual
(BAM).
6.
Work instructions, laboratory personnel training records, testing
procedures, and records of testing data must be maintained to verify
that monitoring is occurring, and to verify that results meet finished
product specifications and requirements. Documentation of laboratory
tests and examinations must include the results (raw data) of the testing
and examination.
7.
Laboratory testing results must be signed and dated by the analyst and
by a qualified reviewer in a timely manner.
CONFIDENTIAL
Date
Company Name
Section No.
SOP Number XX-028
Author:
111.303
111.310
111.315
111.320
Date Orig. Issued:
Date Revised:
Revision Number:
THE LABORATORY
SUPPORT FUNCTION
Date
Dept. Approval Signature:
Date
Page 5 of 7
Q.A. Approval Signature
8.
Readily-available records must be maintained showing that all internallydeveloped testing methods have been validated.
9.
Expiration dating of all testing reagents, standards and buffer solutions
must be controlled.
10. The laboratory should participate in a check sample program with a
recognized laboratory to verify reliability and accuracy of testing
conducted.
11. A documented program is recommended requiring annual crosschecking of analysts.
D.
E.
Laboratory Equipment Calibrations
1.
Routine calibrations of laboratory equipment, such as thermometers,
scales, balances, micrometers, hardness testers, etc.; and
instrumentation such as spectrophotometers, HPLCs, GCs, etc. must be
properly performed to assure their accuracy. Calibrations may be
performed by qualified employees, but preferably by licensed service
providers at least annually.
2.
A Master Calibration Schedule must be in place that at minimum lists
the laboratory equipment and instruments included in the calibration
program, calibration frequencies, and who is responsible for performing
the calibrations (internally or externally).
3.
Equipment-specific calibration procedures must be in place for all
calibrations performed internally.
4.
Individual pieces
identification.
of
laboratory
equipment
must
have
unique
Laboratory Equipment Calibration Records
1.
Accurate records must be maintained of all laboratory equipment
calibrations that contain the following information at minimum
a. Identity of instrument or control (including thermometers)
b. Calibration date
c. Calibration frequency
d. Next due date (optional)
81901650
CONFIDENTIAL
Date
Company Name
Section No.
SOP Number XX-028
Author:
111.303
111.310
111.315
111.320
Date Orig. Issued:
Date Revised:
Revision Number:
THE LABORATORY
SUPPORT FUNCTION
Date
Dept. Approval Signature:
Date
Page 6 of 7
Q.A. Approval Signature
e. Reference standard identity and certification of compliance
f. Calibration procedure
g. Calibration limits or specifications
h. Calibration readings
F.
Laboratory Equipment Verifications
1.
A program must also be in place to evaluate the performance of
laboratory equipment and instruments on a regular basis to assure
accuracy on a day-to-day basis. Requirements for equipment
verifications and verification frequencies as applicable must also be
included in the Master Calibration Program.
2.
The accuracy of laboratory thermometers used for laboratory testing
must be verified daily at the temperature range at which they are used
using an accurate intermediate thermometer that is checked against a
National Institute of Standards Testing (NIST) reference unit. Checks of
intermediate thermometers against NIST-traceable standards should be
performed at a frequency commensurate with the use of the
intermediate thermometer, but at least annually. Full documentation of
the calibration of the intermediate thermometers must be available.
3.
The accuracy of laboratory scales and balances must be verified daily
using test weights in the range of the measurements being determined.
Documentation of these checks must be available and can be part of the
routine daily records for the activity being measured.
4.
Test weights must be calibrated by a certified contractor at least
annually, or whenever they are dropped or damaged. Records,
including certificates of compliance must be available.
5.
Whenever possible, test weights should be stored in their original
containers in cabinets, drawers or shelves where they are protected
against potential damage.
6.
Equipment verifications must be documented. As an example of this
documentation, scale verifications must include the following information
at minimum:
a. Make, model and serial number of scale
b. Date of verification
81901650
CONFIDENTIAL
Date
Company Name
Section No.
SOP Number XX-028
Author:
111.303
111.310
111.315
111.320
Date Orig. Issued:
Date Revised:
Revision Number:
THE LABORATORY
SUPPORT FUNCTION
Date
Dept. Approval Signature:
Date
Page 7 of 7
Q.A. Approval Signature
c. Verifier’s name
d. Verification tolerance ranges for the different test weights used
e. Verification status – “PASS/FAIL”
f. Dated reviewer’s initials
G.
81901650
Calibration/Verification Failure
1.
When a piece of laboratory equipment has been determined to be out of
calibration or fails a verification check, it must be removed from service
immediately. The unit must be repaired and recalibrated. If repairs
cannot be made, the unit must be replaced with a proper functioning unit
that has been calibrated.
2.
There must be documentation of corrective actions when a noncalibrated or inaccurate measuring device has been used. All products
tested since the last acceptable check must be assessed to determine if
they meet specifications, or if they must be subjected to further
evaluations.
CONFIDENTIAL
Date