Sop presentation

standard operating procedure are the important document for pharmaceutical company & organization which may follow reference copy of the manufacturing batch or lot.

1. Standard operating procedure in pharmaceutical industries Presented by Ms. Rashmi Nasare M. Pharm 1 nd yr Under the supervision of Dr. Sheelpriya Walde Professor 1

2. contents Introduction Aim of SOP Objectives Benefit Purpose SOP writing style SOP format Do’s Don’ts General format for SOP SOP Process What kind of SOP needed? Types of SOP SOP Content SOP Development 2

3. 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. A standard 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. 3

4. 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 (g ood documentation practices) . 4

5. 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. 5

6. 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

7. 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

8. 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 8

9. 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 not 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

10. 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

11. Use a simple , active language eg :- ‘weigh 10 mg’ rather than ‘10 mg should be weighed’ Include all necessary information to perform the procedure, not more. Use the fewest possible word, if different steps are involved in the activity, use bullet points If possible add visual displays (VD) such as diagrams, flow charts, pictures or table 11

12. Have a specific reader in mind. Know the type of person who will be reading the procedure & tailor the writing according to the end user. Avoid “do this or alternatively do that” Avoid “where appropriate” Make sure all technical terms & acronyms are defined under the “definition” section 12

13. 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

14. 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 SOP N WP6-QUAL-01 14

15. 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

16. 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

17. General format for SOP 17

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20. 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

21. Sop process Sop Preparation Sop Review & Approval Frequency of revisions & reviews Implementing SOP Management of SOP 21

22. Sop preparation should be written by individual knowledge with the activity & subject matter experts. Those who will perform job 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

23. 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 23

24. 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

25. 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

26. Management of SOP There should be the record for issue & distribution of the SOP’s. It is the responsibility of the process owner to Ensure that SOP’s are current. Distributes SOP’s. Eliminate obsolete SOP’s. Continuously improve the system. Ensure that SOP’s meet their quality requirement & are user friendly. 26

27. What kind of SOPs are needed? Routine instrument maintenance? Glassware washing? QAU? Computer? SOP for SOPs? Analytical method? Specific procedure for initial research project? 27

28. Types of SOP SOP’s 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 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:-highlights on the administrative process such as reviewing contract documentation & determining organizational training needs. 28

29. 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

30. Content of sop Company name & pagination Title Identification Review & Approval Purpose Scope Responsibility Procedure 30

31. 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

32. 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) 32

33. 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

34. 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

35. 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

36. SOP DEVELOPMENT 36

37. 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 in a 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 units. 37

38. 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

39. Shelf life Storage condition MBR number & date Supersede MBR number & date Effective batch number Authorization by the production & quality assurance Head Flowchart Equipment Special instructions Calculation Packing process Yield 39

40. Batch manufacturing record Batch manufacturing record (BMR) here “BMR” stands for batch manufacturing record. This is one type of document which is produce & batch specific document which gives entire picture of manufacturing history of each batch of every product. The “batch manufacturing record” is the necessary quality & GMP documentation for tracing the complete cycle of manufacturing batch or lot. The batch manufacturing record should be checked before issuance to assure that it is the correct & a legible accurate reproduction of the appropriate master production instruction. 40

41. Batch manufacturing record includes following things which is based on master formula record. Name of product Trade name Specification of raw material Name of raw material Specification of container, closure & packing material Name of items Weighment sheet Dispensing instruction List of equipment & machinery 41

42. Packaging requirement Packaging instructions Precaution to be taken Finished product specification Expiry date Review due on. 42

43. Conclusion SOP’s serve as fundamental means of communication for all levels of the organization. Not only do they involve employees departmentally, but they also allow management & employees to gain a cross- functional view of organization. This approach encourages employees to think about how process change may affect other functional areas. It shall be noted that the best written SOP’s will fail if they are not followed. A good system forces employee to think through processes & examine how procedure might affect product, personnel, production, & equipment. 43

44. reference 1) ISOP journal of pharmacy €-ISSN:-2250-3013,(P)-ISSN:2319-4219 www.isophr.org volume 5,issue 1 (January 2015),pp:-29-36 2) http://www.pharmainfo.net/reviews/SOP 3) http://www.werum.com 4) http://m.authorstream.com/presentation/gosaimadhuri-1561524-BMR 5) http://www.slideshare.net/mobile/simran4/SOP 6)Quality assurance book by D H Shah 2 nd edition pg. no.2-6 7) SOP Guideline book by D H Shah 4 th edition pg. no2-10 44

45. 45 Thank you