Standard operating procedure

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Standard operating procedure:

Standard operating procedure PRESENTED BY : SANDHYA RANI NAGABHAIRAVA 11ABISO418 M.PHARM(PA&QA) 1

CONTENTS:

CONTENTS DEFINITION SYNONYMS PURPOSE BENEFITS PROCESS SOP OF UV-VISIBLE SPECTROPHOTOMETER CONCLUSION 2

What is a Standard Operating Procedure (SOP)? :

What is a Standard Operating Procedure (SOP)? A Standard Operating Procedure is a written step-by-step procedure for an activity carried out in a particular organization. SOP specifies in writing : what should be done, when it should be done and where it should be done WHO DEFINITION: An authorized written procedure giving instructions for performing operations not necessarily specific to given product or material. 3

Synonyms of sop::

Synonyms of sop: Instructions Worksheets Laboratory Operating Procedures Standard Operating Testing Procedures Protocols Standard Procedures Operating Procedures Lockstep 4

purpose::

purpose: Detail the regular recurring work processes that are to be conducted or followed within an organization. Document the way activities are performed to facilitate consistent conformance to technical and quality system requirements, and to support the data quality. They describe the fundamental programed actions and technical actions such as analytical processes and processes for maintaining, calibration and using equipment. SOP are intended to be specific to the organization and assist that organization to maintain their quality control and quality assurance processes and ensure compliance with governmental regulations 5

Benefits::

Benefits: Helps to follow procedures systematically and uniformly. Assists to ensure GPP is followed and achieved all times. Minimizes variation and promotes quality. Indicates compliance with organizational and governmental requirements. Can be used as part of personnel training programs . Minimizes chances of miscommunication and address safety concerns. Used as checklists by inspectors during auditing. Serve as reference when historical data are being evaluated for current use and for reconstructing project activities . 6

Process::

Process: SOP preparation SOP review and approval Frequency of reviews and revisions Checklists Document control SOP document tracking and archival 7

1. Sop preparation::

1. Sop preparation: Written by individuals knowledgeable with the activity and organization's internal structure. These individuals essentially subject-matter experts who actually perform the work. Team approach can be followed especially for multi-tasked processes, where experience of number of individuals are critical. Writing in teams do not have to sit together. Each one can edit parts independently and then one person can combine the individual contributions. 8

SOP review and approval::

SOP review and approval: Should be reviewed by individuals with appropriate experience with the process. Draft SOP should be tested by individuals other than the author before finalizing. Finalized SOP should be approved by organization's quality management plan. Generally immediate supervisor such as section or branch chief and the quality assurance officer review and approve each SOP. Signature approval indicates that SOP is reviewed and approved by management. Government Paperwork Elimination Act 1998, paper can be substituted with electronic signatures and electronic maintenance . 9

Frequency of revisions & reviews::

Frequency of revisions & reviews: To be useful SOP should be current, hence should be updated and reapproved. If desired modify only pertinent section of an SOP and indicate the change of date/revision number . Should be systematicall y reviewed on periodic basis . If it describes a process no longer followed, it should be withdrawn from file and archived. Review process should not be cumbersome. Frequency of review and the individual responsible should be indicated in the organization's management plan. 10

Checklists::

Checklists: Used to ensure whether steps are followed in order or not. Used to document completed actions. Any checklists included as part of an activity should be referenced at the points in the procedure where they are to be used and then attached to the SOP. In some cases, detailed checklists are prepared specifically for a given activity. In those cases, the SOP should describe, at least generally, how the checklist is to be prepared , or on what it is to be based. Copies of specific checklists should be then maintained in the file with the SOP. 11

Document control::

Document control: Each organization should develop a numbering system to systematically identify and label their SOPs, and the document control should be described in its Quality Management Plan . Generally , each page of an SOP should have control documentation notation, similar to that illustrated below. 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 the number of pages is indicated, the user can quickly check if the SOP is complete . Generally this type of document control notation is located in the upper right-hand corner of each document page following the title page. Short Title/ID # Rev. #: Date: Page 1 of 12

Sop document tracking & archival::

Sop document tracking & 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, status, organizational division, branch, section, and any historical information regarding past versions. The QA Manager is generally the individual responsible for maintaining a file. If an electronic database is used , automatic “Review SOP” notices can be sent. This list may be used when audits are being considered. Electronic storage and retrieval mechanisms are usually easier to access. 13

PowerPoint Presentation:

Title: UV-Visible Spectrophotometer SOP (Make : Shimadzu, Model: UV-1601) Approvals: Preparer: Date: 2july,10. Reviewer: Date : 3july,10. 1 . Purpose: 1.1 . Operation of the Shimadzu UV-Visible Spectrophotometer . 2 . Scope: 2.1 . This machine is used to measure how much light of a given wavelength is absorbed by a liquid sample. 3 . Responsibilities : 3.1 . Course instructor/lab assistant. 3.2 . Students/technicians . 14 Document number: 1.3.1 Revision number: 3 Effective date: 5july,10 Page 1 of 10

PowerPoint Presentation:

4 . References: 4.1. Shimadzu UV-Visible Spectrophotometer manufacturer’s instructions 5 . Definitions: 5.1 . Cuvette: A small, transparent vessel. This is what a sample is put into for testing in the UV-Visible Spectrophotometer. 6 . Precautions: 6.1 . N/A 7 . Materials: 7.1 . sample to be tested 7.2 . cuvettes 7.3. blank solution. 15

PowerPoint Presentation:

8.PROCEDURE: 8.1. Ensure that the instrument is clean and free from dust. Ensure the instrument is connected to stabilized power supply. 8.2. Switch ON the mains and instrument. 8.3. The instrument initializes itself through various parameters and return to the MODE menu. 8.4 . The initialization will take place for about five minutes. 8.5 . Note : A warm up period of 30 minutes is desirable to get better results . 16

8.6. Measurement in Photometric Mode: (Single wave length) :

8.6. Measurement in Photometric Mode: (Single wave length) 8.6.1. Press ‘1’ to select the photometric mode when measurement at single wavelength is required. 8.6.2.To change the wavelength press ‘GOTO WL’ key in the keyboard and fill the wavelength by pressing No. key. 8.6.3.Rinse the cells with blank solution for 2-3 times and fill the cells with blank and keep it in sample holder. 8.6.4.Press ‘ AUTOZERO’ key to effect the blank correction (The measured absorbance will displayed as ‘0,000). 17

PowerPoint Presentation:

8.6.5. Remove the one cell placed in sample cell holder and fill the cell with sample solution, clean and insert in the sample cell holder. 8.6.6. The measurement screen will be displayed absorbance, by pressing START/STOP key. 8.6.7. Carry out this operation for further measurement rinsing the cell with respective sample solution before measurement. 8.6.8. Clean the cells with water or other suitable solvents (in case water is incompatible with the solution) and rinse with methanol to facilitate drying. 18

PowerPoint Presentation:

8.6.MEASUREMENT IN SPECTRUM MODE: 8.6.1. To select the spectrum mode press ‘2’ in mode selection screen and the measurement configuration screen will be displayed . 8.6.2. Select measuring mode as ‘ABS’ (Absorbance) (Default). Press ‘ 1’ and select the other mode i.e. %T (Transmittance) or E (Energy). 8.6.3. Press ‘2’ to select the wavelength for scanning range. 8.6.4. Enter the value for higher wavelength first (starting wave length) and the lower one later (End wavelength ) 8.6.5. Press ‘3’ and enter the vertical range when a spectrum is displayed. 19

PowerPoint Presentation:

8.6.6. Press ‘4’ and select the scan speed (very fast, fast, slow, very slow). Select medium speed for normal measurement 8.6.7. To overlay the spectrum Press 6 (Display mode) and select overlay option .( When more than one sample is measured and compared). The default is sequential. 8.6.8. Fill both cells (Reference and sample) with blank solution after proper rinsing with blank solution. 8.6.9. Clean the outer surface and place the cells in their respective holder. 20

PowerPoint Presentation:

9. Attachments: 9.1. Figure 1: Spectrophotometer 9.2. Figure 2: Micro and Standard cuvettes 10. History: NAME YEAR AMENDMENT 21

SHIMADZU’S UV-VIS SPECTROPHOTOMETER: (Fig-9.1):

SHIMADZU’S UV-VIS SPECTROPHOTOMETER: (Fig-9.1) 22

Figure 9.2: Cuvette:

Figure 9.2: Cuvette 23

CONCLUSION::

CONCLUSION : Standard Operating Procedures are powerful tools for seizing control of work procedures. Adopting SOP’s in an organization not only reduces work effort but also improves comparability and credibility. 24

References::

References: Good Laboratory Practices, 2 nd edition- Jurg P Seiler.pg.no: 243-257. http://www.pharmainfo.net/reviews. http ://www.epa.gov/quality . 25

Thank you :

Thank you 26

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