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Premium member Presentation Transcript Standard operating Procedure (SOP): Standard operating Procedure (SOP) Alok kr vishwakarma Bipin katiyar Chandrabhan Manish Kumar Upadhyay Mahendra pal Ravi keshri M.Pharm(Pharmaceutics) PSIT ,kanpurIntroduction: Introduction 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. The term “SOP” may not always be appropriate and terms such as protocols, instructions, worksheets, and laboratory operating procedures may also be used. For this document “SOP” will be used. SOPs describe both technical and fundamental programmatic operational elements of an organizationContents of SOP: Contents of SOP Since each pharmacy operates and functions differently depending on varying circumstances, and has its own ways of carrying out certain procedures, the SOPs in different pharmacies will differ. However, the basic content, structure, and the concepts of SOPs will obviously be the same. Some of the important contents of SOPs are : Name & Address of the Pharmacy SOP number, and Date when the SOP was prepared/reviewed. Aim or Objective of the SOP Scope of the SOP (area which will be covered by the SOP) Process/Steps to be carried out, in sequential order. Whose responsibility it is to carry out the SOP. Any other useful information Name and signature of the person/s who made/reviewed the SOPs, along with date of review.Purpose: 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. 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.Slide 5: 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,Benefits: Benefits The development and use of SOPs minimizes variation and promotes quality through consistent implementation of a process or procedure within the organization, even if there are temporary or permanent personnel changes. When historical data are being evaluated for current use, SOPs can also be valuable for reconstructing project activities when no other references are available. Ultimately, the benefits of a valid SOP are reduced work effort, along with improved comparability, credibility, and legal defensibility. SOPs are needed even when published methods are being utilized. For example, if an SOP is written for a standard analytical method, the SOP should specify the procedures to be followed in greater detail than appear in the published method.Writing Style: Writing Style SOPs should be written in a concise, step-by-step, easy-to-read format. The information presented should be unambiguous and not overly complicated. The active voice and present verb tense should be used. The term "you" should not be used, but implied. The document should not be wordy, redundant, or overly lengthy. In addition, follow the style guide used by your organization, e.g., font size and margins.SOP Preparation: SOP 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. A team approach can be followed, especially for multi-tasked processes where the experiences of a number of individuals are critical.Slide 9: 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. For example, if a basic chemistry or biological course experience or additional training is required that requirement should be indicated.SOP Review and Approval: SOP Review and Approval SOPs should be reviewed (that is, validated) by one or more individuals with appropriate training and experience with the process. It is especially helpful if draft SOPs are actually tested by individuals other than the original writer before the SOPs are finalized. The finalized SOPs should be approved as described in the organization’s Quality Management Plan or its own SOP for preparation of SOPs. As per the Government Paperwork Elimination Act of 1998, use of electronic signatures, as well as electronic maintenance and submission, is an acceptable substitution for paper, when practical. Revisions and Reviews : Revisions and Reviews SOPs should be also systematically reviewed on a periodic basis, e.g. every 1-2 years, to ensure that the policies and procedures remain current and appropriate, or to determine whether the SOPs are even needed. If an SOP describes a process that is no longer followed, it should be withdrawn from the current file. The review process should not be overly cumbersome to encourage timely review. That plan should also indicate the individual(s) responsible for ensuring that SOPs are current.Checklists : Checklists Any checklists or forms 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 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 activity results and/or with the SOP.SOP Document Tracking and Archival: SOP Document Tracking and Archival The organization should maintain a master list of all SOPs. This file or database 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 (or designee) is generally the individual responsible for maintaining a file listing all current quality-related SOPs used within the organization.Slide 14: If an electronic database is used, automatic “Review SOP” notices can be sent.This list may be used also when audits are being considered. The Quality Management Plan should indicate the individual(s) responsible for assuring that only the current version is used. That plan should also designated where, and how, outdated versions are to be maintained or archived in a manner to prevent their continued use, as well as to be available for historical data review. Electronic storage and retrieval mechanisms are usually easier to access than a hard-copy document format.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. There is no one “correct” format; and internal formatting will vary with each organization and with the type of SOP being written.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 name of the applicable agency, division, and/or branch to which this SOP applies, and the signatures and signature dates of those individuals who prepared and approved the SOP. Electronic signatures are acceptable for SOPs maintained on a computerized database2.Table of Contents: 2.Table of Contents A Table of Contents may be needed for quick reference, especially if the SOP is long, for locating information and 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, including any regulatory information or standards that are appropriate to the SOP process, and the scope to indicate what is covered. Define any specialized or unusual terms either in a separate definition section or in the appropriate discussion section. Denote what sequential procedures should be followed, divided into significant sections; E.g., possible interferences, equipment needed, personnel qualifications, and safety considerations (preferably listed in bold to capture the attention of the user).Slide 19: SOPs should be clearly worded so as to be readily understandable by a person knowledgeable with the general concept of the procedure, and the procedures should be written in a format that clearly describes the steps in order. Use of diagrams and flow charts help to break up long sections of text and to briefly summarize a series of steps for the reader. Attach any appropriate information, e.g., an SOP may reference other SOPs. In such a case, the following should be included Cite the other SOP and attach a copy, or reference where it may be easily located. If the referenced SOP is not to be followed exactly, the required modification should be specified in the SOP at the section where the other SOP is cited.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. General guidance for preparing both technical and administrative SOPs follows and examples of each are located in the AppendixGuidelines for Technical SOP Text : Guidelines for Technical SOP Text Technical SOPs can be written for a wide variety of activities. Examples are SOPs instructing the user how to perform a specific analytical method to be followed in the laboratory or field (such as field testing using an immunoassay kit), or how to collect a sample in order to preserve the sample integrity and Representativeness (such as collection of samples for future analysis of volatile organic compounds or trace metals), or how to conduct a bioassessment of a freshwater site.Slide 22: Technical SOPs are also needed to cover activities such as data processing and evaluation (including verification and validation), modeling, risk assessment, and auditing of equipment operation. Citing published methods in SOPs is not always acceptable, because cited published methods may not contain pertinent information for conducting the procedure-in-house. Technical SOPs need to include the specific steps aimed at initiating, coordinating, and recording and/or reporting the results of the activity, and should be tailored only to that activity. Technical SOPs should fit within the framework presented here, but this format can be modified, reduced, or expanded as required.Guidelines for Administrative or Fundamental Programmatic SOP : Guidelines for Administrative or Fundamental Programmatic SOP As with the technical SOPs, these SOPs can be written for a wide variety of activities, E.g., reviewing documentation such as contracts, QA Project Plans and Quality Management Plans; inspecting (auditing) the work of others; determining organizational training needs; Developing information on records maintenance; validating data packages; or describing office correspondence procedures. Administrative SOPs need to include a number of specific steps aimed at initiating the activity, coordinating the activity, and recording and/or reporting the results of the activity, tailored to that activity .Slide 24: For example, audit or assessment SOPs should specify the authority for the assessment, how auditees are to be selected, what will be done with the results, and who is responsible for corrective action. Administrative SOPs should fit within the framework presented here, but this format can be modified, reduced, or expanded. In general, administrative/programmatic SOPs will consist of five elements: Title page, Table of Contents, Purpose, Procedures, Quality Assurance/Quality Control, and References. EXAMPLES SOP For Analytical Instruments: EXAMPLES SOP For Analytical Instruments Analytical SOPs are SOPs that describe exactly how the lab performs the method. There are generally three ways for the lab to create their own analytical SOPs. Option 1 : The analytical SOP may consist entirely of the referenced published analytical method Keep in mind that this option will only work if the lab follows the method exactly (very unlikely). Option 2: The lab may reference a published method and include an addendum that details exactly where the lab deviates from the published method. Note that when this option is used, the addendum must include a date of issue or a date of revision. Generally speaking, this option is considered the most practical approach for small wastewater laboratories.Slide 26: Option 3: The lab may choose to create their own SOP from “scratch”. If this option is chosen the code specifically requires that the SOP includes each of the following elements: 1. Identification of the test method 2. Applicable analytes 3. Applicable matrices 4. Method sensitivity 5. Potential interferences 6. Equipment and analytical instrumentsSlide 27: 7. Consumable supplies, reagents and standards. 8. Sample preservation, storage and hold time. 9. Quality control samples and frequency of their analysis. 10. Calibration and standardization. 11. Procedure for analysis 12. Data assessment and acceptance criteria for quality control measures 13. Corrective actions and contingencies for handling out of control or unacceptable dataSlide 28: Analytical SOPs created from “scratch” must include a date of issue or a date of revision. These SOPs can be done in any format/style the lab chooses as long as all of the required elements are included and understandable. Analytical SOPs can be kept in an “analytical methods manual”, can be included as part of the quality manual or can be kept as individual SOPs. As with all other procedures in the laboratory, SOPs should be reviewed periodically to ensure that they remain current.References: References Garner, Willa Y. and Maureen S. Barge, editors, "Good Laboratory Practices. An Agrochemical Perspective," ACS Symposium Series 369, American Chemical Society Guidance for the Preparation of Standard Operating Procedures. U.S. EPA. Current Version. Section 12 : Sample Management, Revision 0, July 2008 .Slide 30: THANKS You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.