SOP template and preparation (SOP ID: 0001)

SOP ID:

0001

Revision nr.:

0.0

Release date:

August 26, 2019

Last release date:

October 29, 2019

Author(s):

Federica Trevisanut (Explora Biotech)

Approver:

Davide De Lucrezia (Explora Biotech)

1. Scope

e.g. Standard protocol for the Purification of a PCR using Wizard® SV Gel and PCR Clean-up kit.

2. Background

3. Prerequisites

Wizard® SV Gel and PCR Clean-up kit (208/CH)
Centrifuge
Ethanol 95%

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 responsibilities

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

Approver (Ap): PI with the authority to approve, reject and withdraw standard operating procedures

MIAMI Quality Manager (QM): MIAMI authorized Quality Manager

Operator (Op): Staff scientist properly trained to execute the standard operating procedure

6. Monitoring Requirements

7. Procedure

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	–	–
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

9. References

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

REAGENT	1st Source
PCR using Wizard® SV Gel and PCR Clean-up kit (208/CH)	PROMEGA Cat # A1222
Ethanol 99% (39/CH).	Sigma (Cat n° 02860)

9.4 Sequences

9.5 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

This Standard Operating Procedure (SOP) was developed based on a compilation of best available information, knowledge, experience, and general industry practices to provide guidance to MIAMI staff in performing the activities defined herein, in a consistent and standardized manner. This document does not contain regulatory or statutory requirements unless specified. The MIAMI consortium has made every attempt to present the information in a clear and concise manner for a variety of users. However, the MIAMI consortium is not responsible for the misuse or misinterpretation of the information presented herein. Under no circumstances shall The MIAMI consortium be liable for any actions taken or omissions made by non-MIAMI users of this document. In general, this document should be used as a reference. Differences may exist between the procedures referenced in this document and what is appropriate under project-specific conditions. This document does not represent an endorsement of practitioners or products mentioned in the document.

MIAMi-project