Preparation and Formatting of an SOP

1.0 Introduction

Standard Operating Procedures are followed in pharmaceutical companies to attain a quality product. It is a part of CGMP and GDP and written by subject matter experts.

It is defined as a set of written instructions which document a repeated activity that is intended to be followed by the employees in the organization.

Formulating standard operating procedures and using is an integral process of quality assurance process.

1.1 Objective

To formulate a procedure in preparation of an SOP

1.2 Scope

This procedure is applicable to all SOPs in the organization

1.3 Responsibility

1.3.1 Person in charge – HOD of the respective department

1.3.2 Monitoring/ supervising person – HOD QA or QA officer

1.4 Procedure

1.4.1 General

All SOPs should be computer typed

Font – Times new roman

Format – Format should be as per Annexure SOP/QA/002/1

Contents - Every SOP should have header, signature block and body

1.4.2 Header

It should be on all pages and should include company logo, name, address, concerned department

Font type – Bold

Font size – 16

Reference Number

Format – SOP/DC/YYY-Z

DC – Department code

YYY – Sequential numbering from 001

Z – Revision status starting from 0 and 1 and so on (Font size – 12, capital letters)

Supersedes

Reference number of the earlier version (Font size – 12, capital letters)

Effective Date

It is the date from which the SOP is put in practice

Format – DD/MM/YYY (DD- Date, MM – Month, YYYY - Year)

Date should be written with blue indelible ink pen

Review date

It is the date where SOP is revised

Format – MM/YYYY

It should be written with blue indelible ink pen

It is given for a maximum of 2 years from effective date

Page number

Format – X of Y

X – Individual page number

Y - Total number of pages

Font type - Capital Letters

Font size – 12

Title

It should be clear & descriptive

Font type - Capital Letters

Font size – 12

Signature block

It should be below the header & on first page of SOP

Titles in rows & columns should be in bold letters

Other text – Normal letters

Font size – 12

Name & designation should be typed; signature & date should be in blue indelible ink pen

Prepared by

Name, designation, signature of the person, User department, who drafted SOP along with date

Verified by

Name, designation, signature of the person, User department, who verified the SOP along with date

Authorized by

Name, designation, signature of the person authorizing the SOP, HOD and DGM of QA along with date

1.4.3 Body

It should contain subject matter written in capital bold letters with a font size of 12

Procedure

All the necessary steps are given in a sequence along with the instructions to be followed in order to achieve the goals of the process

It should be logically planned written with authoritative tense

The procedures should be user friendly which are easy to understand in understandable language/ English

Procedures should follow standardized terminology and should be to the point without unnecessary information

Abbreviation – This section should include the various abbreviations with their meaning

DC – Department code

PE – Personnel department

PD – Production department

MT – Maintenance department

QA – Quality assurance department

QC – Quality control department

ST – Store department

PU – Purchase department

HOD – Head of the department

QA – Quality Assurance

SOP – Standard operating procedure

DGM – Deputy General Manager

Annexure – This section includes the annexures that need to be included

Annexure – SOP/QA/002/1 – Standard Operating procedure

Reference – This section includes the reference documents list

Standard SOP format

SOP issuance logbook

1.5 Considerations in drafting SOP

1.5.1 General

SOPs should be in approved format

Each activity should have a SOP procedure given

Head of the department and the user should be consulted regarding the need for SOP for various operations and equipments

Engineering department and the user should be consulted when SOP for machine operation is prepared

Quality assurance should be consulted when SOP for validation, stability, calibration is prepared

SOPs should be in a language easy to understand and follow

1.5.2 Soft Copy

Soft copies of SOP should be controlled with a password on compact disk by corporate quality assurance department

Soft copy is stored in a separate folder as

Main folder – SOP

Sub folder – Department code like ST, QA or QC etc

Files – ANK/ PRSOP/ 001, ANK/ PR SOP etc

1.5.3 Master Copy

 Hard copies of SOP should be stored with QA unit with original signature & red stamped “Master Copy” at bottom right side corner at each page

1.5.4 Controlled copy

It is the photocopy of the master copy and is controlled by quality assurance unit for issue to user department which is stamped at blue space at bottom side of every page with blue ink as controlled copy

Copying is prohibited

Stamp is accompanied by original signature and issue date of personnel in quality assurance in black ink

1.5.5 Issuing SOP

Controlled copy is issued to user department

When SOP is not legible or not displayable or distorted then it can be recalled

It can be recalled for review also

1.5.6 SOP Review

After 2 years from date of preparation SOP is reviewed. If any change is made in the SOP like in procedures or format then it can be reviewed.

Only two reviews can be done and the same is reprinted when no changes are made to the SOP

1.5.7 SOP Destruction

For an obsolete SOP a stamp as “obsolete” is marked in red ink and from the date of absolution it is preserved for 1 year

QA personnel destroys the SOP and records it with date of destruction

This is recalled and destroyed by shredding

1.5.8 Distribution Sites

SOP copies are distributed to the following sites

Personnel & administration, Production, Quality assurance, quality control, stores and engineering

Preparation and formatting of an sop, distribution sites, quality assurance, quality control, controlled copy,master copy , sop review