NTA Level 5 • Semester 2 • PST05207

Standard Operating Procedures for Equipments and Machines

Quality Assurance of Pharmaceutical Products • Source Session/Topic 9

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 9: Standard Operating Procedures for

Equipments and Machines

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

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

• Define standard operating procedures

• Explain the components of an SOP

• Explain the importance of SOPs in the production of pharmaceuticals

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• LCD projector and computer

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

15 minutes Definition of Standard Operating

Presentation

2 Procedures

Buzzing

30 minutes Presentation Components of an SOP

Brainstorming,

60 minutes Presentation Importance of SOPs in the Production of

Pharmaceuticals

5 05 minutes Presentation Key Points

6 05 minutes Presentation Evaluation

PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

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: Definition of Standard Operating Procedures (15minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

• What is Standard Operating Procedures?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• Standard Operating Procedures (SOPs) is a set of written instructions that document a

routine or repetitive activity which is followed by employees in an organization. The

development and use of SOPs are an integral part of a successful quality system. It

provides information to perform a job properly, and consistently in order to achieve pre-

determined specification and quality end-result.

• SOPs must contain step by step instructions that employ must refer in daily work to

complete various tasks more reliably and consistently.

• SOPs detail the regularly recurring work processes that are to be conducted or followed

within an organization.

STEP 3: Components of an SOP (30minutes)

Activity: Brainstorming (5minutes)

ASK student to brainstorm on the following question

• What are the components of SOP?

ALLOW few students to respond

WRITE their responses to the flip chart/ board

CLARIFY and SUMMARIZE by using the content below

The following are components of standard operating procedures (SOP)

PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

• Scope-the activity which is to be covered by the SOP

• Objective-the purpose of following the procedure

• Responsibility-who will be carrying out the activity

• Procedure-instructions on what to be done

• Audit-to identify areas of improvement

STEP 4: Importance of SOPs in the Production of Pharmaceuticals

(60minutes)

The following are importance of SOPs in the production of pharmaceuticals:

• It provides people with all the safety, health, environmental and operational

information necessary to perform a job properly. Placing value only on production

while ignoring safety, health and environment is costly in the long run. It is better to train

employees in all aspects of doing a job than to face accidents, fines and litigation later.

• It ensures that production operations are performed consistently to maintain quality

control of processes and products. Consumers, from individuals to companies, want

products of consistent quality and specifications. SOPs specify job steps that help

standardize products and therefore quality.

• It ensures that processes continue uninterrupted and are completed on a prescribed

schedule. By following SOPs, you help ensure against process shut-downs caused by

equipment failure or other facility damage.

• It ensures that no failures occur in manufacturing and other processes that would

harm anyone in the surrounding community. Following health and environmental

steps in SOPs ensures against spills and emissions that threaten plant neighbors and create

community outrage.

• It serves as a training document for teaching users about the process for which the

SOP was written. Thorough SOPs can be used as the basis for providing standardized

training for employees who are new to a particular job and for those who need re-training

• It serves as a checklist for co-workers who observe job performance to reinforce

proper performance. The process of actively caring about fellow workers involves one

worker coaching another in all aspects of proper job performance. When the proper

procedures are outlined in a good SOP, any co-worker can coach another to help improve

work skills

• It serves as a checklist for auditors. Auditing job performance is a process similar to

observation mentioned in the previous item only it usually involves record keeping. SOPs

should serve as a strong basis when detailed audit checklists are developed.

STEP 5: Key Points ( 5 minutes)

• SOPs are a set of written instructions that document a routine or repetitive activity which

is to be followed.

• Components of SOP include scope, objectives, responsibility, procedures and audit.

PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

• SOPs serves as checklist for co-workers and auditors, training document, ensures no

failures occur during production and provides safety among people.

STEP 6: Evaluation (5 minutes)

• What is SOPs?

• What are the components of SOPs?

• What is the importance of SOP?

PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

References

Saluja, Gp. “Chapter-01 Standard Operating Procedure for Preparing, Revising and Using

Standard Operating Procedures SOPs .” Standard Operating Procedures and

Regulatory Guidelines: Blood Banking, 2014.

Saluja, G. (2014). Chapter-01 Standard Operating Procedure for Preparing, Revising and

Using Standard Operating Procedures (SOPs). Standard Operating Procedures and

Regulatory Guidelines: Blood Banking.

Moriarty, D. (2015). Error management and standard operating procedures for

organizations. Practical Human Factors for Pilots.

PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

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