Standard Operating Procedure (SOP)Before SOP- STANDARD OPERATING PROCEDURE [SOP] “Set of written instructions that is followed routinely or repetitively. Created culture where Quality objectives are Transparent, well understood, and Undoubtedly these goals can be achieved by certain sets of Procedures called as “Standard Operating Procedures”. * Back bone of Pharmaceutical Industries. SOPs descnbe both technical and fundamental programmatic operational elements of an organization that would be managed under a work plan or a Quality Assurance (QA) Project Plan . >In simple terms SOP is... >» A written process >A way for the clinical site to perform a task the same way each time it is completed.a] FDA’s three golden rules on proper documentation 1. [fit isn’t written down, it didn’t happen. i) If it isn*t written down properly, it didn’t happen either. o Don’t forget rules | and 2.mi \ ] Reasons for having SOPs > To provide people with all the safety, health, environmental and operational information. > To ensure that processes continue uninterrupted and ra completed on a prescribed schedule and maintain quality control of processes and products. 5 > To ensure that no failures occur in any processes. >To ensure that Approved procedures are followed in compliance with company and government regulations. >» To serve as an historical record of the whole process which is done and have a basis of that when the process is changed. rovide training and guidance for new staff.SOP - AIM FOR QUALITY + Standard Operating Procedure is a set of step by step written instructions intended to document how to perform a routine activity. * Back bone of pharmaceutical industry. ‘ Integral part of Quality assurance(QA). + Provides details of appropriate quality, cost and time constraints.OBJECTIVES * To maintain the quality contro! and quality assurance. * To serve as a training document for teaching users about the process for which the SOP was written. + To facilitate consistent conformance to quality system requirements and to support data quality. * To provide guidelines for accurate and timely data collection. + Uniformity of performance.41. Standard Operating Procedure - Introduction Objectives Benefits Types of SOP SOP Writing Style DO's Don'ts SOP Content SOP Process SOP for Tablet Compression 2. Master Formula Record - ContentSOP WRITING STYLE * SOP’s shall be written in a concise, step by step, easy to read follow format. + Information should not be complicated. The active voice, and present verb tense should be used. * Should be simple and short. + Routine procedures that are short and require few decisions can be written using simple steps format. + Long procedures consisting of more than 10 steps, should be written along with graphical format or hierarchical steps. + Procedures that require many decisions should be written along with flowchart.CONTENT OF SOP +» Company name and pagination * Title * Identification + Review and approval + Purpose * Scope + Responsibility + ProcedureSOP PROCESS SOP Preparation SOP Review and Approval Frequency of revisions and reviews Implementing SOP Management of SOPStandard Operating Procedure Template Document Storage Locallon/ Source: Document Nor SOP Griginator: ‘Approving Position: Effective Date: Name: Name: Last Edited Dane: Signature: ‘Signanare: - Purpose Scope . Responsibilities . Materials [Past 1] [Noformation “A’] (Oma 6} Tool . Related Documents Gther:SOP - TABLET COMPRESSION + Clean the compression machine as per respective SOP. *Make sure that the compression area has been clean properly. + Clean the dust extractors, its pipes, racks, door frames and return filters of Air Handling Unit. + Check it visually for intactness and absence of leakage. +Intimate quality control department to collect swab samples as per requirements. + After receiving the approval from QC department put “cleaned label” to all equipments.Introduction + Definition: - Standard operating procedure is a step by step procedure or directions as established by a quality square industry involved in facility producing ,testing or research. » Astandard operating procedure does not required or need Explaination or publication because it is standard. » SOP is the set of step by step written instructions intended to document how to perform routinely. ~ They are the back bone of pharmaceutical industry.==> Continued... ~ They are the back bone of pharmaceutical industry. ~ Integral part of QUALITY ASSURANCE (QA). ~ Provides details of appropriate quality, cost & time constraints. » Standard operating is an also part of CGMP & GDP (Good documentation practices).Aims of the sop » Create the culture where quality objectives are transparent & well understand. » To achieve quality output. » To achieve uniformity of performance. » To achieve uniformity of quality.OBJECTIVES » To maintain the quality control & quality assurance. » To serve as a training document for teaching users about the process for which the SOP was written. » To facilitate consistent conformance to quality system requirements & to support data quality. » To provide guidelines for accurate & timely data collection. ® Reduce miscommunication & failure to comply with industry regulation. » To carry out operations correctively & always in same manner. 6benefits » To provide people with all safety, health, environmental & operational information necessary to perform the job properly. » Serves as a training document for users. » Minimizes variation & promotes quality. Steps can be reviewed in accident variations. » Useful tool for training new members of staff. » SOP assist to ensure that GMP is followed & achieved at all times. » SOP’s help to assure the quality & consistency of the services, & thus minimize harm to the patient. 7 |Purpose of sop > Describe how to perform routine activities + Provide & training aid + Guide & standardize working procedures + Ensure quality & integrity of data generated /information captured » Reconstructions/repeatability + Provide an auditing toolSOP writing style » Write one SOP per study-related activity. Ex:- Performance of lumbar puncture, handling, transport & storage of CSF sample, microscopic detection of trypanosomes etc... Do nat mixed too many activities in one SOP. » Make sure you are familiar with the procedure to be described in the SOP. If you are not, ask somebody who performs the procedure regularly to show it to you. » Describe in detailed how the procedure is being carried out 9> List of the steps in chronological order as in the example below Making a cup of tea:- 1. collect a cup & saucer. 2. place teabag into cup 3. boil water in kettle 4. add water to cup & teabag 5. allow tea to infuse 6.remove teabag 7. add milk & sugar (if desired) 10,SOP format » Each SOP format should have a unique identifier which include:- ~ The number of the work package under which the SOP is being developed » An acronym referring to the type of the procedure (LAB; for laboratory SOP, DOC; for SOP related to documentation management, CLIN; for clinical SOP, DATA ; for SOP related to data management, QUAL; for SOP related to Quality assurance (QA) & Quality control (QC) » The number of the SOP 13WP6-this SOP being written under WP6 QUAL-this SOP is related to quality 01-this is SOP n°1 of the quality type If the procedure is lengthy one, then the description of the procedure can be split up & placed under smaller headings. On each page of the SOP indicate: The SOP number, the version number & date The page number & the total number of pages 14Persons having authorization may include:- » Nominee of local staff, expert in his own field & familiar with GMP » General manager (Production) » General manager (Quality Control) » General manager (Quality Assurance) » Nominee of management (may be technical director) 20,Sop preparation should be written by individual knowledge with the activity & subject matter experts. » Those who will perform jab » Those who will perform maintenance on equipment involved in an SOP » Technical initiator » Safety personnel » Engineers or others who design equipment & process » Environmental personnel » Equipment manufacturers 22,Sop process » Sop Preparation » Sop Review & Approval » Frequency of revisions & reviews » Implementing SOP » Management of SOP 24SOP review & approval Review factors & criteria are:- Adherence to standard Consistency & traceability Readability, comprehensibility,&@ general understandability Technical adequacy & feasibility of approach Degree of completeness Testability of requirements Use of appropriate requirement, design, or coding techniques Appropriate level of details a3}SOP Revisions Routine revision:- » At the end of the review period by HOD concerned to the particular SOP will review & revise if required. » If there is no changes then HOD just gives the review report that this SOP doesn’t require review & continue the same for the next review project. 24,Implementing SOP » The most important step for SOP in working area, train or retain the user. » While training the user, trainer should share the reason WHY, SOP must performed correctly. People are much more to follow when they understand importance of procedure. 25 |Management of SOP » There should be the record for issue & distribution of the SOP's. » It is the responsibility of the process owner to v Ensure that SOP's are current. v Distributes SOP’s. v Eliminate obsolete SOP’s. y¥ Continuously improve the system. ¥ Ensure that SOP’s meet their quality requirement & are user friendly. 26,What kind of SOPs are needed? ® Routine instrument maintenance? » Glassware washing? » QAU? » Computer? » SOP for SOPs? » Analytical method? » Specific procedure for initial research project? ZFTypes of SOP » SOP’s may be written for any repetitive TECHNICAL a as well as for any administrative or functional program procedure, that is being followed within an organizatior » The types of SOP’s are: 1)Technical SOP:-focuses more on technical activities such as how to collect a laboratory sample & how to fix the R2 engine. 2) Administrative/fundamental programmatic SOP:-hightigh' on the administrative process such as reviewing contract documentation & determining organizational training nReasons for having SOP’s » To provide people with all the safety, health, environmental & operational information. » To ensure that no failure occur in any processes. » To ensure that approved procedures are followed in compliance with company & government regulations. » To serve as an historical record of the hole process which is done & have a basis of that when the process is changed. » Provide training & guidance for new staff. 29,Content of sop » Company name & pagination » Title » Identification » Review & Appraval » Purpose » Scope > Responsibility » Procedure 30,3)Identification: -procedure must be easily by giving unique number & version number. This identification number of the SOP supports accountability of the document throughout the facility & over time as it changes. 4) Review & approval:-all SOP’s shall have space for signature of « Initiator (the person who has written the SOP) « Reviewer (the person who has review the SOP) » Approver (quality assurance head of the organization) 372Content of sop 1)Company & pagination:- the company & Pagination (e.g. page 4-9) must appear on every page. 2)Title :-the should be descriptive. The title should use directive language to declare what is being done to what. 31,5) Purpose :- the purpose or objectives of the procedure should restate & expand will written title. Expand or qualify the directive language used in the title (e.g. to describe the operation procedure of compression machine. ) 6)Responsibility :-Who is responsible for performing the work described? Who is responsible for implementing the procedure? 33,7) Scope:- The scope should provide limits into the use procedure. » Where is the SOP to be used & where is not applicable, e.g. Area, process, department, stage? » Who is the sop for & aimed at, e.g. Operator, manager, QA person? » Are there any specific limitations or expectation that need to be called out? 8) Procedure:- described the procedure in a step by step, chronological manner. Use active verbs & direct statements. 34How to use SOP’s » Manager use SOPs to communicate to staff & explain how to perform certain company operations. » Employees can use SOPs for reference when learning to complete certain tasks according to established protocols. » Regulatory agencies, such as the food & drug administration, use SOPs when determining whether a company’s processes meet agency standards. » Section of fundamental principles can be include ; = Preliminary steps that must be done before beginning of actual procedure. = Safety consideration. * The chronological instructions. = Calculations. 35SOP DEVELOPM gular revow Validation process ure feedtgh sonsiered Ssope Ealstig o¢ uw? ‘why it nea Sita the ebjesive? Wha eit est Lanavege iis Eauthg bromtye “Eyluhar tga 0 my Totgeteddsibusion Ensure comaretarnlan re-eaiting layout Testes flly Aston ea and ev Row chars | stint irra aps v ‘Siemple Uist 36Master batch record + Master batch record, also known as Master Production Records. + Dietary supplements manufacturing facilities are required to create these documents & keep them on file, but what exactly is the FDA looking for ina Master Batch Record. + Master batch record contains all information about the manufacturing process for the product. + Master batch is prepared by the research & development team of the company. + MBR is used as reference standard for preparing batch manufacturing record by manufacturing 7 units. 4Master batch record Should include- Product details:- » Name, logo & address of the manufacturing company. » Dosage form name. » Brand name. » Generic name. « Product code » Label claim of all ingredients © Product description © Batch size » Pack size & packing style » Manufacturing process 38.eed) ele) Analytical method Preparation of Reagent Quality Assurance For operating instruments, equipment and apparatus Safety & Precautions Methodic Receiving and registration of sample Fundamental SOP To deal with complaints» Write in present tense. don’t use past tense, condition of future tense unless you have good reason to do so. » Avoid ambiguity & be concise. » Reduce the word count where possible without changing the meaning of the text. » Highlights exceptions. Use a symbol to flag that this is an exceptions & how to handle it. ® Highlight warnings & use a longer or a warning icon. 15Don'ts ® Introduce acronyms without explaining what it means. » Don’t use the word “may”, “ if possible” as it implies that the user can do something under conditions. Instead be positive & tell them what to do. 16,© 3" Jayer in documentation * 1 GLP (Good Laboratory Process) and 2™ Company policies + GMP ( Good Manufacturing Practices) ____» Documentation