Standard Operating ProcedurePresented By – Amey Deshpande

Guided BY – R V Kshirsagar

Overview

• Introduction • Need of SOP • Benefits of SOP• Format and Content of Sop• Writing Styles• Sop Process • Conclusion

1. INTODUCTION

• The ICH defines SOPs as ‘detailed written instructions to achieve uniformity of the performance of a specific function’

• An SOP is a set of written instructions that document a routine or repetitive activity followed by an organization

• an integral part of a successful quality system

• SOPs document the way activities are to be performed to facilitate consistent conformance and to support data quality

• SOPs Describe fundamental programmatic actions and technical actions (such as analytical processes) and processes for maintaining, calibrating and using equipment.

2. Need of SOP

• SOP help to complete various tasks more reliably and consistently•SOP clears ideas of an individual about………

What is the objective of SOP (Purpose) What are applicability and use of SOP (Scope) Who will perform tasks (Responsibility) Who will ensure implementation of procedure

(Accountability) How tasks will be performed (Procedure)

2. Need of SOP (….continued…)

1.To provide the safety, health, environmental and operational information necessary to perform a job properly

2.To ensure that production operations are performed consistently to maintain quality control of processes and products

3.To ensure that processes continue uninterrupted and are completed on a prescribed schedule

4.To ensure that approved procedures are followed in compliance with company and government regulations

cont………

3. Benefits Of Sop

6.To serve as a training document for teaching users about the process for which the SOP was written

7.To serve as a checklist for auditors8.To serve as an historical record of the how, why

and when of steps came in an existing process so there is a factual basis for revising those steps when a process or equipment are changed

9.To serve as an explanation of steps in a process so they can be reviewed in accident investigations

3. Benefits Of SOP (….cont…)

• written in a concise, step by step, easy to read and easy to follow format

• The information presented should be unambiguous and not complicated

• Use The active voice and present tense• SOP shall be simple and short• Information should be clear and explicit to

remove any doubt• Flow chart shall be used to illustrate the process

being described.

4. SOP – Writing Styles

• number of different ways to organize and format SOPs• factors which determine what type of SOP to use or

create :

5. Format And Content Of Sop

Sr. No.

Does SOP involve many decisions?

Does SOP consist of more than 10 steps?

Best format for writing SOP Examples

1 No No Simple sequential steps

SOP for balance calibration

2 No Yes Sequential steps along with Pictorial diagrams

Entry / Exit procedure

3 Yes No / Yes Sequential Steps with Flow chart

SOP for deviation management

5. Format And Content Of Sop• There should be Consistent Format for SOP• Requirement for (i) document identification and

control, (ii) accountability and traceability, (iii) responsibility must be included with every SOP

• Since there is no FDA approved format for a SOP, however there are common expectation within industry and from the FDA that assure accountability and traceability and consistency of the documents, when choosing format for a procedure consider the following

…………[cont…]

1. Company Name and Pagination2. Title3. Identification and control4. Review and Approval5. Purpose6. Scope7. Responsibility8. Procedure9. Checklists

5. Format And Content Of Sop

5. Format And Content Of Sop

Company Name and Address: Page No: X of Y

Title : SOP No: Revision No: Review Period:

Prepared By Reviewed By Approved By    

Objective/PurposeScope Responsibility Procedure

1. Sop Preparation2. SOP Review and Approval3. Frequency of Revisions and Reviews 4. Checklists5. Document Control 6. SOP Document Tracking and Archival 7. Implementing SOP 8. Management of SOP

6. Sop Process

1. Sop Preparation1. Determine procedures to be documented2. Prepared By –Individuals with knowledge of activities and internal structure of organization 3. A team approach can be followed, especially for multi-tasked processes

6. Sop Process

2. SOP Review and Approval1. Reviewed (that is, validated) by one or more

individuals with appropriate training and experience with the process

2. Immediate supervisor (section or branch chief or quality assurance officer) review and approve each SOP

3. Signature approval indicates that an SOP has been both reviewed and approved by management

6. Sop Process

3. Frequency of Revisions and Reviews 1. SOPs need to remain current to be useful

whenever procedures are changed, SOPs should be updated and re-approved

2. Systematically review SOPs on a periodic basis, e.g. every 1-2 years

3. The review date should be added to each SOP that has been reviewed

6. Sop Process

4. Checklists1. To ensure that steps are followed in order and to

document completed actions2. Any checklists or forms should be referenced at the

points in the procedure where they are to be used and then attached to the SOP

3. Copies of specific checklists should be maintained in the file with the activity results and/or with the SOP

4. Remember that the checklist is not the SOP, but a part of the SOP

6. Sop Process

5. Document Control1. Each organization should develop a system to

systematically identify and label their SOPs2. Each page of an SOP should have control

documentation notation, a short title and identification number

3. When the number of pages is indicated, the user can quickly check if the SOP is complete

6. Sop Process

6. SOP Document Tracking and Archival1. The organization should maintain a master list of

all SOPs indicating the SOP number, version number, date of issue, title, author, status, organizational division, branch, section, and any historical information regarding past versions

2. The QA Manager responsible for maintaining such files

3. This file or list may be also used during audits4. Electronic storage and retrieval mechanisms are

usually easier to access than a hard-copy document format.

6. Sop Process

7. Implementing SOP1. Everyone should follow the procedure exactly with each

and every step in detail2. it is very important to train the user otherwise individual

may interpret meaning indifferent ways. 3. While training the user, trainer should share the reason

why SOP must performed correctly4. Trainer should explain and demonstrate how each step

in the SOP will be performed and should assure them this will increase Quality of product, provide safety and accuracy increase the confidence of the user.

6. Sop Process

8. Management of SOP1. Organization shall have SOP on Preparation, approval, revision

and control of standard Operating Procedure for better control and management of SOPs.

2. Ideally, there should be a system owner who• Eliminates obsolete SOPs.• Ensures that SOPs meet their quality requirements and are

user friendly• Manages SOP change controls• Distributes SOPs• Ensures that SOPs are current• Ensures that new or changed SOPs are valid only after training

has occurred and provides training about the SOP system. • Measures system performance and periodically reports

results to management • Continuously improves the system.

6. Sop Process

• SOPs serve as a fundamental means of communication for all levels of the organization

• Not only do they involve employees departmentally, but they also allow management and employees to gain a cross-functional view of the organization

• This approach encourages employees to think about how process change may affect other functional areas

• A good system forces Employee to think through processes and examine how Procedure might affect product, personnel, production, and equipment

• It shall be noted that the best written SOPs will fail if they are not followed

7. Conclusion