Standard Operating Procedures


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It gives the basic information regarding SOPs


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STANDARD OPERATING PROCEDURE Ms. Rashami V. Chaudhari M.Pharm 1 st Year Quality Assurance R. C. Patel Institute of Pharmaceutical Education and Research


Introduction A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. ICH defines SOP as “detailed written instructions to achieve uniformity of the performance of a specific function”. Other terms may also be used instead of the term SOP Protocols Instructions Worksheets


Purpose The basic purpose of SOP is to detail the regularly recurring work processes , that are to be conducted of followed within an organisation. To achieve uniformity of the performance of a specific function. Enable the people to perform their functions accurately and without mistakes. SOPs are tools to ensure that GMP are followed wherever applicable. To ensure highest standards for drug products, that have to be ultimately consumed by the patient.


Benefits Promotes quality through consistent implementation of a process or procedure within the organization. It facilitates consistency in the quality and integrity of a product or end-result. It provides information about how to perform a job properly and minimizes variations. Address safety concerns Ensures that processes continue uninterrupted It is used as a part of a personnel training program.


Obligations WHO has already made it mandatory to have the required SOPs for any manufacturing facility for grant of GMP certificate. Various legal and commercial factors also influence the manufacturer to go in providing SOPs for his facilities.

Writing Styles:

Writing Styles SOPs should be written in a concise, step-by-step, easy-to-read format. The information presented should not be overly complicated. It should be simple and short and should be conveyed clearly. The active voice and present tense verb should be used Use a flow chart to illustrate the process being described (since it is very easy to understand).

SOP Process:

SOP Process 1. SOP Preparation: SOPs should be written by individuals knowledgeable with the activity. These individuals are essentially subject-matter experts who actually perform the work or use the process A team approach can be followed, especially for multi-tasked processes

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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 The experience requirement for performing an activity should be noted in the section on personnel qualifications

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2. SOP Review and Approval SOPs should be reviewed by one or more individuals with appropriate training and experience with the process. The finalized SOPs should be approved as described in the organization’s Quality Management Plan or its Master SOP. Generally the immediate supervisor and the organization’s quality assurance officer review and approve each SOP. Signature approval indicates that an SOP has been both reviewed and approved by management.

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3. Revisions and Reviews Whenever procedures are changed, SOPs should be updated and re-approved. If desired, modify only the pertinent section of an SOP and indicate the change date/revision number for that section in the Table of Contents. SOPs should be also systematically reviewed on a periodic basis, e.g. every 1-2 years, to ensure that the procedures remain current and appropriate

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Review date should be added to each SOP that has been reviewed. If an SOP describes a process that is no longer followed, it should be withdrawn from the current file and archived. The frequency of review should be indicated by management in the organization’s Quality Management Plan. Individuals responsible for ensuring that SOPs are current should also be indicated in QMP.

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4. Checklists Many activities use checklists to ensure that steps are followed in order. Checklists are also used to document completed actions. Checklists are often presented as lists with small checkboxes down the left hand side of the page. A small tick (checkmark) is drawn in the box after the step has been completed.

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5. Document Control Each organization should develop a numbering system to identify and label their SOPs, and it should be described in its Quality Management Plan. When the number of pages is indicated, the user can quickly check if the SOP is complete. A short title and identification (ID) number can serve as a reference designation. The revision number and date are very useful in identifying the SOP in use when reviewing historical data.

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6. SOP Document Tracking and Archival The organization should maintain a master list of all SOPs This file should indicate the SOP number, version number, date of issuance, title, author, branch, section, and any historical information regarding past versions. The QA Manager is generally the individual responsible for maintaining a file listing all current quality-related SOPs used within the organization

SOP General Format:

SOP General Format SOPs should be organized to ensure ease and efficiency in use and to be specific to the organization which develops it. Where possible break the information into a series of logical steps to avoid a long list. SOP generally consists of Title Page Table of Contents Text

1. Title Page:

1. Title Page The first page or cover page of each SOP should contain the following information: A title that clearly identifies the activity or procedure An SOP identification (ID) number Date of issue and/or revision The signatures and signature dates of those individuals who prepared and approved the SOP.

2. Table of Contents:

2. Table of Contents A Table of Contents may be needed for quick reference, especially if the SOP is long T o locate the information To denote changes or revisions made only to certain sections of an SOP.

3. Text:

3. Text Well-written SOPs should first briefly describe The purpose of the work or process The scope of the work or process Responsibilities and applicabilities Summary of the method/procedure Definition of any specialized/unusual terms and explanation of abbreviations.

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Health and safety cautions QC Section: Used to check the Quality of the work that include specific assessment criteria and appropriate QC procedures. Attach any appropriate information, e.g., an SOP may reference other SOPs.

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Department SOP No. Area Revision No. Supersedes Subject Effective Date Revision Due Prepared By Checked By Reviewed By Authorized By Signature Name Date Designation xx Section Head Department Head Head QA

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SOP for HPLC Calibration 1. Purpose 2. Scope 3. Responsibilities and applicability 4. Procedure 4.1 Precautions 4.2 Calibration of Pumps 4.3 Gradient Accuracy Check 4.3.1 Method 4.3.2 Data Evaluation 4.4 Calibration of Detector 4.4.1 Wavelength Accuracy Check 4.4.2 Data Analysis 4.4.3 Detector Intensity Test 4.4.4 Method 4.5 Column Oven Temperature Check 4.6 Auto Sampler Injection Linearity 5.Definitions 6.Distribution

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Annexure: Annexure 1: Flow Rate Accuracy Annexure 2: Gradient Accuracy Check Annexure 3: Wavelength Accuracy Check Annexure 4: Detector Intensity Check Annexure 5: Column Oven Temperature Check Annexure 6: Auto Sampler Injection Linearity

Types of SOPs:

Types of SOPs SOPs may be written for any repetitive technical activity, as well as for any administrative or functional programmatic procedure, that is being followed within an organization. The types of SOPs are: Technical SOP Administrative /Fundamental Programmatic SOP

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SOPs instructing the user how to perform a specific analytical method to be followed in the laboratory how to collect a sample in order to preserve the sample integrity and representativeness Also cover data processing and evaluation (including verification and validation), modeling, risk assessment. SOPs generated for administrative tasks reviewing documentation such as QA Project Plans and QMP Writing contracts Performance assessment Also includes how to coordinate the activity and record the results as well as coordinating the team efforts. Technical SOP Administrative SOP

Master SOP:

Master SOP In addition to the various SOPs that are required, the company has to first make an SOP that defines how the various SOPs will be made, i.e. what kind of information, structure and numbering system will be included in various SOPs. It should also contain a time frame for revision of SOPs. It should identify the persons authorized for each activity (creating, checking, verifying and implementing).


References http://www. operatingprocedures . http://www.>home>business Good Laboratory Practice, Alex D. Kanarek, 3 rd Edition, M and MD Publications.

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