SOP Template

SOP nr.:

0001

Revision nr.:

0

Release date:

26 August 2019

Author(s):

Federica Trevisanut (Explora Biotech)

Approver:

Davide De Lucrezia (Explora Biotech)

1. Scope

This section should provide a short description of why the procedure or guidance is necessary such as regulatory requirements.

2. Backgroung

This section should identify the intended audience and /or areas where the SOP may be relevant, and specific operations covered by the SOP.

3. Prerequisites

This section should provide the information needed before proceeding with the listed procedure. This may include necessary tools, documents, and/or certifications.

4. Changes since last revision

This section should indicate the parts modified in this revision with respect to the previous one. These are highlighted by underlining.

5. Role and responsabilities

Key Personnel – clearly identify key personnel that will have a primary role in this SOP and list their responsibilities as it relates strictly to this SOP. If necessary, include any contact information. If the ‘key personnel’ roles have not been assigned, provide additional information about who can take on the listed responsibility. Whenever possible, please identify the training required by the personnel involved.

Author: Staff scientist properly trained to draft, review and dissaminate standard operating procedures within the framework of ISO-9001

Approver: PI with the authority to approve, reject and witdraw standard operating procedures

MIAMI QM: Staff scientist properly trained to manage and monitor the implementation of ISO-9001 guidelines

6. Monitoring Requirments

This section should define the need, frequency, and methods of conducting required assessments and/or monitoring such as physical analysis of a covered process or internal and/or external inspections.

7. Procedure

This section should indicate the parts modified in this revision with respect to the previous one. These are highlighted by underlining.

Step ID

Description

In charge

Visuals

Ext. ref.

1

Identify stakeholders and end-users

Author

—

—

2

Define SOP’s scope and procedure

Author

—

—

3

Draft requested SOPs

Author

—

—

4

Collect feedback from endusers

Author

—

—

5

Are major revision required according to end-users’ feedback?

IF yes THEN go to step 3

ELSE go to step 6

Author

—

—

6

Submit SOP draft to approver

Author

—

—

7

Are major revision required according to approver feedback?

IF yes THEN go to step 3

ELSE go to step 8

Approver

—

—

8

Forward SOP to MIAMI’s quality manager

Author

—

—

9

Publish SOP on MIAMI website

MIAMI QM

—

—

8. Record Management

This section incorporates record management practices, defined by the consortium for the SOP.

9. References

This section should list any additional resources that may be useful in performing the procedures. These may include:

9.1 Standards

Regulatory references should be listed here

9.2 Other SOPs

SOP referred to in any other section of this SOP should be listed here

9.3 Reagents

List or reagents required to performed the SOP and their primary source of procurement and alternative source of procurement. 

9.3 Supplementary Documents

Supplementary Documents should be listed here

10. Definitions

This section should highlight and define frequently used terms and provide additional and/or relevant information needed in order to use and understand this SOP.

11. Disclaimers

Key Personnel – clearly identify key personnel that will have a primary role in this SOP and list their responsibilities as it relates strictly to this SOP. If necessary, include any contact information. If the ‘key personnel’ roles have not been assigned, provide additional information about who can take on the listed responsibility.
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