Introduction

Overview
A Standard Operating Procedure (SOP) is a set of written instructions that document a 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. An authorized written procedure giving instructions for performing operations not necessarily specific to a given process, product or material (e.g. equipment operation, maintenance and cleaning; validation; cleaning of premises and environmental control; sampling and inspection).

Importance:
Standard operating procedures describe in a detailed form the activities performed in the laboratory Provide uniformity, consistency and reliability in each of the activities performed in the laboratory Reduce systematic errors Provide training and guidance for new staff development and use of SOPs promotes quality through consistent implementation of a process or procedure within the organization reduced work effort, along with improved data comparability, credibility, and legal defensibility

Writing Style
concise, step-by-step, easy-to-read format information presented should be unambiguous and not overly complicated active voice and present verb tense should be used should not be wordy, redundant, or overly lengthy

 General: Document Preparation (SOP for SOP) Preparation and maintenance of work area
Washing and sterilization Decontamination Testing area Recording and labeling Storage and discarding

What should be covered under SOP

Receipt of samples,

Laboratory operations

Receipt of reagents, standards, etc storage Preparation of reagents labeling and storage Test procedures Reference material identification,handling,storage and use Results results, deviations, errors Reports generation, distribution Archives maintenance

Staff Training, GLP, staffing pattern Equipments Indent, purchase, installation and validation Maintenance Daily checks and records Periodic calibration and validation Trouble shooting and action to be taken Annual maintenance In case of accidents action to be taken Deviations Planned deviations Unplanned deviations Variance Errors Record of all the above Action taken

What should be covered

SOP Process(steps)
Preparation
written by individuals knowledgeable with the activity and the organization's internal structure 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

Review & Approval

reviewed by one or more individuals with appropriate experience approved by the State Council signed by the President

Frequency of Revisions & Reviews

need to remain current procedures are changed, SOPs should be updated and reapproved systematically reviewed on a periodic basis to ensure that the policies and procedures remain current and appropriate, or to determine whether SOPs are even needed review date should be added to each SOP that has been reviewed

Checklists
Many activities use checklists to ensure that steps are followed in order.
SOPs should describe how the checklist is to be prepared or on what it is to be based.

 Title Page

SOP General Format

Title that clearly identifies the procedure/activity Date of issue and/or revision Name of the association Signatures and signature dates of those individuals who prepared Code : Number relating to procedure and revisions

Table of Contents
Quick reference Denotes changes or revisions made only to certain sections of a SOP Objective : Aim of the procedure clearly described

SOP General Format

Scope : The operating unit and field of application Definitions : Meaning of principle terms used Description : Operating instructions clearly described without any ambiguity, understood by all staff with flow diagrams Safety : Measures to be kept in mind when executing the SOP Types: May be written for any repetitive technical activity, as well as for any administrative procedure
Documentation : Protocol, Data sheets and measurements References : Used to draw up the SOP

Format on each page of SOP

Logo and name of the organization Department or unit issuing the SOP Title and date of issue Signature of person who drew up the SOP Signature of person who reviewed it Signature of person who authorized it Duration of validity Date of review Code Page number and total number of pages in the document

King Institute of Preventive Medicine,

Eg
Date of issue of this version:1/4/2003

National Polio Laboratory - Department of Virology,

Standard Operating Procedure - 001

RECEIPT OF STOOL SPECIMENS

Page Number 1/4

Objectives Scope

: Procedure to be followed for receiving and storing stool samples of AFP Cases. : This document contains the procedure that is adopted when stool specimens are received from cases of AFP from Tamilnadu, Andhra Pradesh, Pondicherry, Andaman & Nicobar.

Definition: Stool sample carrier marked with red for stool samples only Deep freezer 20 (1) preparation of ice pack Refrigerator No.3 for pre processing storage of samples LRF Lab request form. AFP Acute flaccid paralysis. Place of testing: Requirements: Equipment

Consumables

Registers

Tech/Scientist incharge

Checked by

Authorized by

SOP for material and reference standards control

Material Control
Specification For Raw Materials Specification For Supplies/Disposables Inspection & Acceptance Criteria For Supplies/ Disposables/Raw Material. Inventory Control Procedures For Supplies/Disposables.

SOP for Reagent and Standards Quality Control

The accuracy and precision of test results and test methods is dependant on the reliability, authenticity and control over reference standards, reagents and stock solutions..
Similarly the retrospective testing of materials and product is dependant on the protection and storage of retention samples

Primary Standards may be obtained from

National reference labs World Health Organisation (WHO) for biologicals

In House Secondary Standards

Standardised against primary standards using definitive methods

SOP for control over Standards (reference material)

Register, Logging and Inventory System
Purchased Supplied

Labelled
complete description (name, source, Lot number) strength, activity and confidence interval storage conditions

Protected (heat, light, humidity, irradiation, vibration) Custodian of Standards SOP for Standards Management
selection, standardisation, change, and control Standard Lot Number must appear in testing record

SOP for Standard Solutions & Reagents

QC Program for Incoming Lots of Reagents Standard Procedure for Preparation (BP and USP) Records of Standardisation Storage and Protection Conditions Validated expiry or re-standardisation date Complete labelling; each standard or stock solution must be labelled with:

Standard Name Batch Number Date of preparation Date of expiry Storage conditions Strength

SOP for Laboratory Control

Record Review : Quality Monitors Review & Trending Of Error Reports

Review Of Field Complaints

Review Of Quality Control Data Internal Audits : Review Trends

EQUIPMENT Material needed ( Pipette, incubator, water bath). Daily-start up Machine Daily maintenance Weekly maintenance Monthly maintenance Temperature monitoring
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