NTA Level 6 • Semester 1 • PST06103

Standard Operating Procedure (SOP)

Pharmaceutical Production • Source Session/Topic 4

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Session 4: Standard Operating Procedure (SOP)

Total Session Time: 120 minutes + 240 minutes of Assignment

Pre-requisites

• None

Learning Tasks

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

• Define standard operating procedure (SOP)

• Explain the importance of SOP

• Outline types of SOPs

• Explain the components of SOP

• Explain the development and approval processes of SOP

Resources Needed

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• LCD projector and computer

• Handout 4.1: Sample format for Writing SOP

• Handout 4.2: Sample Guide for Writing Procedure Part of SOP

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: Meaning of Standard Operating Procedure (SOP) (20 minutes)

• Standard Operating Procedure (SOP) is a set of written instructions that

document a routine or repetitive activity which is followed by employees

in an organization

• It is a set of compulsory instructions, systems, procedures or steps

which is written so that other individuals can follow to complete the job

safely and ensure quality

• SOP maximizes operational and production requirements

• The purpose of a SOP is to carry out the operations correctly and always

in the same manner

• SOP should be available at the place where the work is performed

(original copies are securely kept)

• There are two main types of SOPs

o Technical SOP

▪ This focuses more on technical activities such as how to weigh

pharmaceutical powders on dispensing balance or how to clean a

tablet press

o Administrative SOP

▪ This type focuses on administrative processes such as reviewing

contract documentation and determining organizational training

needs

STEP 3: Importances of SOPs (10 minutes)

• Standard Operating Procedures are integral part of all pharmaceutical

industries

• To obtain a standard quality product intended for human use, the

manufactured product must have undergone through current Good

Manufacturing Practices (cGMP) rules and regulations

• SOPs are part of cGMP and Good Documentation Practices (GDP)

• An SOP guides any process, procedure or activity being performed in the

pharmaceutical plant

• SOPs minimizes variation and promotes quality through consistent of a

process or procedure even in cases of personnel changes

• SOP can be used as part of personnel on-job training as it offers

instruction on how to a job

• SOPs minimizes opportunities for miscommunication and can address safety

concerns

• A typical pharmaceutical industry has an average of 1200 to 1300 SOPs

o The guide on writing all these SOPs are provided by the Mother SOP

(the SOP on SOPs)

STEP 4: Characteristics of SOPs (15 minutes)

• SOPs have a format and length that depends on the steps that are taken to

describe the procedure of the work

o An SOP can be a simple one page hierarchical steps, graphic procedures

or a flow chart

• SOP can be written by individuals or team performing processes such as

operating a tumbler mixer or cleaning of an equipment

• SOPs are written by subject expert considering the GMP working

feasibility, accountability and authorized by authorized persons

• The SOP is meant for people who will perform a particular job

• The SOP should be written before the job is began

• SOP should be tested (and revised as needed) before putting it into final

application

• SOP should be revised when there is any change to the process or

equipment used

• SOP should be re-written when new information indicate new process or

performance

• SOP should be updated regularly depending on internal and external

factors

STEP 5: General Format of SOPs (35 minutes)

• Various formats exist for preparation of SOP

• All Standard Operating Procedures shall be written in a certain format

specified in the mother SOP (SOP on SOPs)

• Choice of a format depends on the organization and type of activity for

which the SOP is prepared

• Generally, a technical SOP consists of the following components

o Title Page

▪ This is the first page or cover page of the SOP

▪ This part contains the following information

▪ Title (which clearly identifies the activity or procedure)

▪ SOP identification number

▪ Supersedes (number of previous SOP on which the current one

is based or reviews)

▪ Date of issue and/or revision

▪ Name of the organization or company

▪ Department to which the SOP applies

▪ Signatures of individuals who prepared the SOP

▪ Signatures of individuals who approved the SOP

o Table of Contents

▪ Needed for quick reference, especially if the SOP is long

▪ It is also needed for locating information and to denote changes

or revision made only in certain sections of an SOP

o Purpose/Objective

▪ This describes the purpose of the work or process including any

regulatory information or standards that are appropriate to the SOP

o Scope

▪ This indicates what is covered e.g. this procedure is applicable

to all operation of this company (company name and location)

▪ It also includes limit to the use of the procedure

o Definition (s)

▪ Definitions of technical/scientific or unusual terms used in the

SOP

o Responsibility

▪ This designates the department directly responsible for the

activity mentioned in the SOP e.g. Head-Quality Assurance is

responsible for the implementation/compliance

o Accountability

▪ Persons to be held accountable during the implementation of the

SOP

▪ Examples, Head –Site QA

o Cautions

▪ This part indicates activities that could result in equipment

damage, degradation of sample, or possible invalidation of results

(also listed in the critical steps of the procedure)

o Interference

▪ This part describes any component of the process that may

interfere with the accuracy/quality of the final product

o Personnel Qualification/Responsibilities

▪ This denotes the minimal experience the user should have to

complete the task satisfactorily

▪ It also cites any applicable requirement e.g. certification

o Equipment and Supplies

▪ This part lists and specifies where necessary, the equipment,

materials, reagents or chemical standards required for the

procedure

o Procedure

▪ All pertinent steps, in orderly manner, and the materials needed

to accomplish the procedure

▪ The activities to be carried out as part of SOP should be

described in sentences of that are short, sequential, unambiguous

and instructive

▪ These activities are such as;

▪ Instrument or method calibration and standardization

▪ Sample collection

▪ Sample handling and preservation

▪ Sample preparation and analysis (extracting, digestion,

analysis, identification and counting procedures)

▪ Troubleshooting

▪ Data acquisition, calculations and data reduction requirement

(such as listing any mathematical steps to be followed)

▪ Computer hardware and software (used to store field sampling

records, manipulate analytical results and /or report data

▪ Data records management (e.g. indentifying any calculations to

be performed, forms to be used, reports to be written and data

and record storage information)

▪ Writing guidelines and styles such as font type, font size and

margin used in SOP should be those followed by the organization

[pic][pic] Refer students to Handout 4.1: Sample Guideline for Writing

Procedure Part of SOP, for further reading

o Quality Control and Quality Assurance

▪ Quality control activities are designed to allow self

verification of quality and consistency of work

▪ This part should describe preparation of appropriate quality

control procedures (self checks such as calibration, recounting, re-

identification) and QC materials (such as blanks, performance

evaluation sample) that are required to demonstrate successful

performance of the method

▪ Specific criteria, frequency and limits for each should be

included

o Reference(s)

▪ Here, a list is provided of all other SOPs (SOP number and title)

referred in this procedure

▪ A list of any other document (e.g. guidelines, scientific

literature, user manuals) are also listed here

▪ If no reference is used, then “not applicable” is written here

o Abbreviation(s)

▪ Here, a list of all abbreviations and/or acronyms in the

procedure shall be mentioned with detailed explanations

▪ Abbreviations used in the text of the SOP are defined here

▪ Examples: QA –Quality Assurance

o Flow chart(s)

▪ In this part, a flow chart of steps involved is mentioned with

clear decision stages

o Annexure(s)

▪ These are the formats used for recordings

▪ They all bear a unique format number for better control and

identification

▪ A list of annexure(s) is provided along with annexure number

and title

o Revision History

▪ Every SOP must contain a revision history in order to track the

changes made in the SOP from time to time

▪ This history contains the details of all the previous revisions

performed for a particular SOP

[pic] Refer students to Handout 4.2: Sample Format for Writing SOP,

for further reading

• General format for administrative or programmatic SOP include;

o Title page, table of contents, definitions, purpose, Scope, summary

of procedure, Personnel qualification/responsibilities, quality

assurance and quality control, records management, and references

STEP 6: Writing SOPs (20 minutes)

• SOP should be written in a concise, step-by-step, easy-to-read format

• Information presented should be unambiguous and not overly complicated

i.e. in a simple and clear language

• Effective writing of SOP should consider the following;

o Use of short sentences

▪ Long sentences are harder to understand and tend to include more

than one step

▪ Several short sentences are easier to understand

o Imperative writing

▪ Use of imperative instead of passive voice because imperatives in

form of command are easier to understand

▪ Example;

• Passive:

o The weight of each excipient should recorded in the batch

manufacturing record

• Imperative:

o Record the weight of each excipient in the batch

manufacturing record

o Concise

▪ Few words as possible should be used when writing SOP

▪ Short, direct sentences should be used so that readers can

quickly understand and memorize the steps

|Activity: Small Group Discussion (10 minutes) |

| |

|DIVIDE s |

|tudents into small manageable groups |

| |

|ASK students to discuss on the following question |

|Identify SOPs in the compounding laboratory of your school |

| |

|ALLOW students to discuss for 10 minutes |

| |

|ALLOW few groups to present and the rest to add points not mentioned |

| |

|CLARIFY and SUMMARIZE by using the contents below |

• SOPs in compounding laboratory;

o SOP for cleaning the compounding laboratory

o SOP for storage of raw materials in compounding laboratory

o SOP for using a weighing balance

o SOPs for using a heating facilities (e.g. water bath, hot plate,

Bunsen burner)

o SOPs for disposal of wastes from compounding activities

o SOP for labelling of finished product

o SOP for packaging of finished product

STEP 7: Key Points (5 minutes)

• Standard Operating Procedure (SOP) is a set of written instructions that

document a routine or repetitive activity which is followed by employees

in an organization

• The purpose of a SOP is to carry out the operations correctly and always

in the same manner

• SOPs are part of cGMP and Good Documentation Practices (GDP) and

therefore guide any process, procedure or activity being performed in the

pharmaceutical plant

STEP 8: Evaluation (5 minutes)

• What is SOP?

• What is the importance of SOP in pharmaceutical production?

• Mention two types of SOPs?

STEP 9: Preparation of an SOP (5 minutes)

|Activity: Take home Assignment (240 minutes) |

| |

|DIVIDE students in groups or individual. |

| |

|ASK the students to work on the following assignment |

| |

|Prepare an SOP for cleaning the compounding laboratory |

| |

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

| |

|REFER students to recommended references |

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 4.1: Sample Format for Writing SOP |

• All Standard Operating Procedures shall be written in a certain format

specified in the mother SOP (SOP on SOPs)

|STANDARD OPERATING PROCEDURE |

|Title: |Copy no.: |

|Department: |Page no.: |

|SOP No.: |Supersedes: |

| |Effective date: |

1. Purpose

2. Scope

3. Responsibility

4. Procedure

5. Revision

6. Abbreviations

7. Annexures

|[pic] |Handout 4.2: Sample Guideline for Writing Procedure Part of |

| |SOP |

• All Standard Operating Procedures shall be written in English language

• Language shall be clear, sequential, and unambiguous

• Where required, SOP shall be additionally prepared in vernacular language

for easy understanding. Content of such SOPs shall be verified and

certified for accuracy with the current approved English version. In

other words, where necessary the SOP shall be translated into the local

languages; however all such translated versions shall have the same

reference number of its original English version

• All SOPs shall be printed on “Letter” size white paper in black in “Times

New Roman” regular font style of size “12” unless specified. The font

size and font style is optional

• General alignment for paragraphs shall always be kept as “Justified”.

Line spacing between two lines shall be maintained as “5 Lines

• Military standard system shall be followed for numbering of heads and

subheads

• Signature of the procedure shall be done with Blue/black ball point pen

only. All pages shall have a border of the setting “Box” 1pt from both

top and bottom and 4pt from left and right, from the text

• The header and footer content shall be common in all pages of the

procedure excluding the formats and annexures.

• Details of header are;

• Title -A proper title that is assigned to represent the core operation

that it carries e.g. if the SOP is being prepared for operation of

cleaning a tablet press, then the title can be written as “Cleaning of

Tablet Press”

• Location -Shows the location where the procedure is prepared

• Department -In this place the name of the department preparing the

procedure is written

• Page number shall be assigned

• Effective date

o Here, the date at which the procedure becomes effective is written.

E.g. is the SOP is prepared and approved on 10th December, 2018, the

effective date shall be assigned 3-10 days from the date of approval

o The period is important to allow time for training of staff/personnel

who will follow the SOP

• Next review date

o The date of next mandatory review is set and written here. If the

review period is three years, then the SOP on cleaning tablet press

will be reviewed on 9th December, 2021.

• SOP number

o Every SOP shall be assigned a number for identification and

reference

o Numbering system varies from one company to another

o Example of a numbering system: TPC/QA/18/001-02 where

▪ TPC denotes Tablet Press Cleaning

▪ QA denotes Quality Assurance Department (name of the department)

▪ 18 denotes the year, 2018

▪ 001 denotes sequential numbering for the SOP’s prepared in the

year

▪ 02 denotes the revision number of the document

• Details of the footer are;

o The footer contains two parts;

o Part A: Signatories

▪ Prepared By:

• name and signature of the person in the department preparing the

SOP who authorizes the document, and the date on which the

document is signed

▪ Checked By:

• name and signature of the person who exhaustively verifies the

content of the SOP after it is prepared and signed

▪ Approved By:

• name and signature of the person who approves the document

including the date of approval

• Part B: Format Numbering

o This is important for identification and control of different formats

used in the company

o The font size of the number is set to 10 and positioned at the bottom

right corner of the document

o For example, the format number may be TPC/QA/18/001/F 02-01, where

o TPC denotes Tablet Press Cleaning

o QA denotes Quality Assurance Department (name of the department)

o 18 denotes the year, 2018

o 001 denotes sequential numbering for the SOP’s prepared in the year

o F denotes Format

o 02 denotes format number

o 01 denotes version number

o If the format is made for the first time, the format revision number

(shown in bold) is TPC/QA/18/001/F 02-00,and if it is revised once

then it becomes TPC/QA/18/001/F 02-02

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