2010GMP

Xiaoyu

GMP

GMP

GMP

GMP

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GMP

GMP

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GMP

1.GMP

2.GMP
GMP

GMP

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1.GMP

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2.

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3.

Failure to have sufficient personnel with the necessary education, background,

training, and experience to assure that all activities required by 21 820 are correctly
performed, as required by 21 CFR 820.25(a).
For example:
a. The job description for the Director of Quality Systems requires that the person have
a Bachelor of Science degree in technical or engineering
discipline. The person holding the position does not have this type of degree, but rather
a Business Administration degree.

FDA Abbot

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GMP

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GMP

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*
*

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Project
Sponsor

Project
Director

Project
Manager

Project
Team

Steering
Committee

Project Definition A

Communication
Plan

Business
Requirements

Status Reports

A means that the person (or role) approves the deliverable.

R means that the person (or role) reviews the deliverable.
C means that the person (or role) creates the deliverable. (Usually there is only one
person who
is responsible for creating a deliverable, although many people may provide input.)

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QCHPLC

98.52%

98.45%

98.40%

98.13%

98.41%

98.19%

RSD=0.07%

RSD1.0%

RSD=0.27%
RSD=0.22%

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QC

HPLC

2005XX2009

2009-08-10
XX
HPLC

HPLC

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Qualification Document for Calibration Coordinator
Individual Name: John Doe

Position: Calibration Coordinator

Activity
Hierarchy

Description

Requirements

Background for John Doe

Job

Calibration Coordinator

At least 2 years of
college-level
education to include
college algebra

Requirement fulfilled: John has an A.S.

degree from the community college with
both college algebra and calculus
coursework completed.

Key
Duties

Coordinating the routine

calibration of
manufacturing and testing
instrumentation;
maintaining calibration
reference standards,

At least 2 years of
experience
conducting
instrument
calibration in a cGMP
environment.

Requirement fulfilled: John has 18 month

experience actually conducting calibration
work in a pharmaceutical company, but
previously worked for 7 years as an
instrument technician in the electronics
industry

Specific
Tasks

Calibrating thermometers
Calibrating scales.
Documenting reference
standard calibration

Specific training on
the required
procedures

Completed documentation available

Based on my review of the requirements for Calibration Coordinator position and the education,
experience, and training for John Doe, I certify that he is qualified to fulfill the job requirements for this
position:
Approved by/Date ______________________ (Dept Manager)

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GMPEHS

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GMPEHS
EHS

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GMPSOPSOP
EHS

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1.GMP
GMPGMPICH Q7GMP

2.SOP

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GMPSOP
SOP

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GMP
SOP


EHS

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EHSGMP

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BC
A/B

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A/B

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