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Introductions
Stephanie Winstead
Training Coordinator, Quality Control
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Participant Introductions
Introduce yourself and tell what department
you work in.
Describe what your role/responsibility is
pertaining to standard operating
procedures (SOPs).
Compile two to three questions you would
like to have answered today.
Select a spokesperson to introduce each
person in the group, tell what their role is,
and review the list of the SOP related
questions your group compiled.
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SOPs: The Basis for Control
Managements interpretation on the
steps necessary to comply with good
manufacturing practices (GMPs).
Describe how to perform and document
tasks.
Describe personnel responsibility.
Provide a consistent approach to GMP
compliance.
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SOP requirements may appear to go
beyond what is expected by GMPs.
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SOPs
GMP
REGULATIONS
The Law Requires Written Procedures
Approximately how many times does 21CFR
Part 211 (GMPs) state procedures...shall be
in writing, there shall be written procedures,
or written procedures shall be established?
a. 12
b. 25
c. 9
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The Law Requires Written Procedures
Approximately how many times does 21CFR
Part 211 (GMPs) state procedures...shall be
in writing, there shall be written procedures,
or written procedures shall be established?
a. 12
b. 25
c. 9
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The FDA expects us to:
Define the mechanism of
CONTROL in our organizations
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Develop standard procedures that facilitate
CONTROL
Maintain a STATE OF CONTROL (Train
personnel and monitor compliance with
GMPs)
Types of Standard Procedures
Policies
Standard Operating
Procedures
Work Instructions
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Types of Standard Procedures
Attachments
Templates
Forms
Checklists
Diagrams
Photographs
Protocols
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Small Group Exercise
Read the SOP provided.
Answer these questions:
Do you consider this an effective SOP?
What makes an SOP effective?
Select a spokesperson to present
your groups answers to the
class.
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What makes an SOP Effective?
The end result of performing the procedure meets
requirements.
It accomplishes its intended purpose.
It is relevant to the tasks conducted by the
company.
The language of the SOP is relevant to the users.
It guides users to perform the tasks in a compliant
manner.
It can be read and understood by users.
It can be followed by company personnel.
It is well-integrated with other procedures
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The SOP on SOPs
Document Format
Content
Numbering
Review and Approval
Effective Dates
Issuance
Distribution and Control
Biennial Review
Change Control
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