Standard Operating Procedure (SOP) A Standard Operating Procedure (SOP) is a set of written instructions that documents routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end-result. To ensure quality control, all procedures are standardized, So SOPs are integral part of Quality assurance process. Purpose SOPs detail the regularly recurring work processes that are to be conducted or followed within an organization. They document the way activities are to be performed to facilitate consistent conformance to technical and quality system requirements and to support data quality. They may describe, for example, fundamental programmatic actions and technical actions such as analytical processes, and processes for maintaining, calibrating, and using equipment. SOPs are intended to be specific to the organization or facility whose activities are described and assist that organization to maintain their quality control and quality assurance processes and ensure compliance with governmental regulations. If not written correctly, SOPs are of limited value. In addition, the best written SOPs will fail if they are not followed. Therefore, the use of SOPs needs to be reviewed and re-enforced by management, preferably the direct supervisor. Current copies of the SOPs also need to be readily accessible for reference in the work areas of those individuals actually performing the activity, either in hard copy or electronic format, otherwise SOPs serve little purpose. SOP-Benefits a) The development and use of SOPs minimizes variation and promotes quality. b) SOPs can indicate compliance with organizational and governmental requirements through detailed work instructions and can be used as apart of a personnel training program. c) It minimizes opportunities form is communication and can address safety concerns. SOP-Writing Styles SOPs should be written in a concise, step-by-step, easy-to-read format. Information should not be overly complicated. SOP Process a) Preparation The organization should have a procedure in place for determining what procedures or processes need to be documented. Those SOPs should then be written by individuals knowledgeable with the activity and the organization's internal structure. These individuals are essentially subject-matter experts who actually perform the work or use the process. SOPs should be written with sufficient detail so that someone with limited experience with or knowledge of the procedure, but with a basic understanding, can successfully reproduce the procedure when unsupervised b) Review and Approval SOPs should be reviewed (that is, validated) by one or more individuals with appropriate training and experience with the process.

1. QUALITY MANAGEMENT SYSTEM (SOP)
MRS. NABEELA MOOSAKUTTY
ASST.PROFESSOR, DEPT. OF PHARMACEUTICS
K.T.N COLLEGE OF PHARMACY

2. Ken Croucher
THE BUSINESS INFORMATION MANAGEMENT SYSTEM THAT MANAGES QUALITY POLICIES AND
STANDARD OPERATING PROCEDURES
1991

3. A SET OF WRITTEN STEP-BY-STEP PROCEDURES
OR INSTRUCTIONS THAT MUST BE TAKEN TO
PROPERLY PERFORM A ROUTINE ACTIVITY

4. 4

5. WHERE DO WE START?

6. GENERAL REGULATIONS
ISO 9001: 2015
Good manufacturing practices
Quality System Regulations
6

7. SPECIAL REGULATIONS
ISO 14971: 2019 – risk management
ISO 13485: 2016– quality management
21 CFR 820 – GMP for medical devices
7
Pharmaceutical manufacturers must also consider the processing, packaging and storing requirements listed in 21 CFR 210/211

8. 8
FDA
LAWS
INDUSTRY
SPECIFIC
CFRs
ISO
SOPs & WIDs
QUALITY MANAGEMENT SYSTEM
GMPs QSRs Standard
s/Certif.
COMPANY
/
INDUSTRY
GOVERNMENT
NON-GOVT
ORG

9. FOOD
SAFETY
AND
STANDARDS
AUTHORITY
OF
INDIA
9

10. 10
FDA GUIDELINES

11. INTERNATIONAL STANDARD THAT SPECIFIES REQUIREMENTS FOR
A QMS
MOST POPULAR STANDARD IN THE ISO 9000 SERIES
THE ONLY STANDARD TO WHICH ORGANIZATIONS CAN CERTIFY
PLAN-DO-CHECK-ACT METHODOLOGY
PROCESS-ORIENTED APPROACH
11

12. 14 SEPTEMBER 2018
12

13. 13

14. BRIEF
EASY TO UNDERSTAND
HOW THINGS SHOULD BE DONE RATHER THAN WHAT NEEDS TO BE DONE

15. PERFORM RISK
ASSESSMENT
OBSTACLES
RISKS ASSOCIATED WITH
OBSTACLES
INFORMS THE EMPLOYEE
ANY RISKS ASSOCIATED
WITH THE PROCESS
KEY QUESTIONS
WHO PERFORMS WHAT
ROLE?
WHAT DOES EACH ROLE
DO?
WHAT’STHE GOAL OR
OUTCOME OF EACH
PERSON’S ROLE?
HAS WHAT NEEDS TO
HAPPEN BEEN EXPLAINED
CLEARLY?
ONCE AN EFFECTIVE SOP
WRITTEN
ANALYZE
UPDATE [EVERY 06 - 12
MONTHS]
ANY CHANGE
SHOLUD BE RECORDED
15

16. 16
1
2
3
DEFINE THE TASK’S GOAL AND
UNDERSTAND WHY IT NEEDS AN
SOP
IDENTIFY TASK
DEPENDENCIES
DETERMINE FORMAT
FOR SOP

17. 17
DETERMINE DOCUMENT
STRUCTURE – QMS PROCEDURE
ELEMENTS
• Title
• Purpose
• Scope
• Definitions/Glossary of Terms
• Roles, responsibilities and authorities
• Definition and listing of data and records
• Identification of changes, date of review, approval and version
• Main descriptive section
• Appendices
• References

18. 18
SAP S/4HANA Cloud
Windchill
ETQ Reliance
Vault Quality Suite

19. THANKYOU
MRS. NABEELA MOOSAKUTTY
+91 7558019985
connectnabz2021@gmail.com
LinkedIn Nabeela Moosakutty