NTA Level 6 • Semester 1 • PST06103

SOP on SOPs (SOP on Standard Operating Procedures)

Pharmaceutical Production • Source Session/Topic 5

Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability.

Session 5: SOP on SOPs (SOP on Standard Operating Procedures)

Total Session Time: 120 minutes

Pre-requisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Define SOP of SOPs

• Explain the components of SOP of SOPs

• Develop an SOP of SOPs

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• LCD projector and computer

• Handout 5.1: Format for SOP of SOPs

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing

STEP 2: SOP of SOPs (5 minutes)

• In order to write Standard Operating Procedure, another Standard

Operating Procedure is needed to standardize and guide the process

• The SOP that guides how other SOPs in the organization should be prepared

is known as an SOP of SOPs or a mother SOP

STEP 3: Components of SOP of SOPs (10 minutes)

• Components of the SOP of SOPs;

o Purpose

▪ The purpose of SOP of SOPs is to describe procedures for

preparation, review and approval of standard operating procedures

in pharmaceutical production

o Scope

▪ This part of the SOP of SOPs describes the way the SOP of SOPs

applies to all SOPs

o Responsibility

▪ This part identifies people (Executive/QA officers or other

designated persons) responsible for preparation, revision,

periodical review and approval of the SOP of SOPs

▪ Persons responsible for the preparation, revision and

periodic review of the SOP of SOPS

▪ Person(s) responsible for review and training of the SOP of

SOPs

▪ Person(s) responsible for approval of the mother SOP

o Procedure

▪ This part should,

▪ Specify the format of all SOPs in the organization

▪ Specify paging and placement of company logo on SOPs

▪ Specify header, content and footer of the SOPs

▪ Specify font style, font size and line spacing in all SOPs

▪ Specify numbering system (and description of characters used

in the numbering system) for the SOPs

▪ Specify placement of dates (supersedes, approval date,

effective date and review date) for SOPs

▪ Specify the signatories of various SOPs in the organization

(i.e. prepared by, reviewed by, approved by)

▪ Specify the content of SOPs

▪ Purpose, scope, responsibility, procedure, revision,

abbreviations, annexures, header, footer, as described in

session 7)

o Revision

▪ Describes revision of SOPs

▪ Provides a revision log showing revision number, effective date

and reason for the revision of each SOP revised

o Abbreviations

▪ Should show abbreviations or acronyms used in the mother SOP and

their expanded form

o Annexure

▪ Provides a list of all the annexure used in the mother SOP (e.g.

SOPs format, list of codes)

STEP 5: Developing an SOP of SOPs (90 minutes)

[pic][pic] Refer students to Handout 5.1: Format for SOP of SOPs

|Activity: Small Group Assignment (60 minutes) |

| |

|DIVIDE students in manageable groups |

| |

|ASK the students to work on the following assignment |

| |

|Prepare an SOP of SOPs for a Compounding Laboratory in your school |

| |

|ALLOCATE time for students to do the assignment and presentation |

| |

|REFER students to recommended references |

STEP 6: Key Points (5 minutes)

• SOP on SOPs is the standard operating procedure for preparation of all

SOPs in an organization

• It guides the process of preparing SOPs in all departments of an

organization

• SOP of SOPs is also known as the mother SOP

STEP 7: Evaluation (5 minutes)

• What is an SOP?

• What is SOP of SOPs?

• Mention the components of an SOP of SOPs

• Who is responsible for preparing the SOP of SOPs in a pharmaceutical

manufacturing company?

References

Escope, Adriene, (1997). Nimble documentation, the practical guide for

World class organization, Milwaukee, Wisconsin, American Society for

Quality, Quality Press

Garner, Willa Y and Mureen S. Barge, Editors, “Good Laboratory Practices.

An agrochemical perspective” ACS Symposium Series 369, American

Chemical Society

Schmidt, O. (ed) (2000) Pharmaceutical Quality systems, Interpharm Press,

Colorado.

Shayne C et al (2008), Pharmaceutical Manufacturing Handbook: Production

and processes, John Wiley & Sons

|[pic] |Handout 5.1: General Format for SOP of SOPs |

| SOP ON STANDARD OPERATING PROCEDURES |

|Title: |Copy no.: |

|Organization/Company: |Page no.: |

|SOP of SOPs No.: |Supersedes: |

| |Effective date: |

8. Purpose

9. Scope

10. Responsibility

11. Procedure

12. Revision

13. Abbreviations

14. Annexures

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