T.Y.B.Sc.

(Biotechnology)
Semester- VI
Paper IV: Advanced Industrial Biotechnology

Unit 4: Quality Control and Biosafety

Subject in-charge: Miss. Malika Ahuja

What is SOP?
SOP → Stands for “Standard Operating
Procedure”
Definition:
Set of written instructions that document a routine
or repetitive activity followed by an organization
Introduction
● Integral part of a successful system.
WHY????!!!!
→ Provides individuals → good job performance,
facilities, consistency, quality
● Other terms :- Protocols, Instructions, Worksheets,
etc.
● SOP = Technical + Fundamental elements
Contents of SOP
EVERY INSTITUTE HAS DIFFERENT NORMS,
YET
BASICS REMAIN THE SAME
● Structure, concepts, content
> Name & Address > Scope
> SOP number & Date > Process
> Aim > Responsibility
> Useful information > Name & Signature
Purpose of SOP
● Recurring work process conducted or followed
● Activities for consistent conformance → technical &
quality requirements
● Specific to organisation → maintain QA, QC
● Write Correct SOP
● Follow the SOP
● Review & reinforcement → by direct supervisor
● Current copies → readily accessible for reference
SOP Preparation
● Procedures that need to be included
● Written by an expert in the activity
● Follow team approach
● Written in detail
● Mention the experience required
● Mention additional training if necessary
General Format
● Ensure ease & Efficiency
● No one “correct” format
1. Title Page
2. Table of Contents
3. Text
Types of SOP
1. Repetitive technical activity
2. Administrative functional programming
3. General guidance
Guidelines for Technical SOP
● Written for activities
● How to perform a method
● Representativeness or conducting
bioassessment
● Data processing & Evaluation
● Citing published methods
● Important steps
Guidelines for Administrative SOP
● Variety of activities
● Contracts, QA, Project plans, etc.
● Developing information
● Major elements of administrative SOP are:
→ Title Page
→ Table of Contents
→ Purpose
→ Procedure
→ QA/ QC
→ References