standard operating procedure pharmacy

this is the introduction of the sop used in the pharmaceutical field...thank you....

1. A SEMINAR ON INTRODUCTION OF STANDARD OPERATING PROCEDUR E (LIQUID & SEMI SOLID DOSAGE FORMS MANUFACTURING EQUIPMENTS) Prepared By: SAGAR SOMAIYA M.PHARM(SEM-1) ROLL NO. 2 DEPARTMENT OF PHARMACEUTICS 1 School of Pharmacy, RK University

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3. 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 describe 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 . Standard operating procedure [Sop] School of Pharmacy, RK University 3

4. FDA’s three golden rules on proper documentation If it isn’t written down, it didn’t happen. If it isn’t written down properly, it didn’t happen either. Don’t forget rules 1 and 2.

5. Position of SOP in total documentation 3 rd layer in documentation 1 st GLP and 2 nd Company policies Q.A. GMP Q.C. Documentation

6. Objectives To describe the responsibilities of the coordinating center for managing and monitoring the participating sites. To provide guidelines for accurate and timely data collection, resolution of data clarifications (queries). To detail the regularly recurring work processes that are to be conducted or followed within an organization . To facilitate consistent conformance to technical and quality system requirements and to support data quality . School of Pharmacy, RK University 6

7. School of Pharmacy, RK University 7 Continued…. To maintain their quality control and quality assurance processes To ensure compliance with governmental regulations. To serve as a training document for teaching users about the process for which the SOP was written.

8. Why it is Essential ? An integral part of successful quality system . Plant’s effectiveness and efficacy. Regulatory requirement. To ensure that production operations are performed consistently to maintain quality control of processes and products . To ensure that processes continue uninterrupted and are completed on a prescribed schedule . School of Pharmacy, RK University 8

9. Provides information to perform job properly . To provide people with all safety, health, environmental and operational information necessary to perform job properly . Also provides, consistency (very imp. In any of the field) Gives information in order to achieve pre-determined specification and quality end-result. Minimizes variation and promotes quality. Steps can be reviewed in accident investigations . Serves as a training document for users . Benefits School of Pharmacy, RK University 9

10. School of Pharmacy, RK University 10 Continued…. SOPs assist to ensure that GMP is followed and achieved at all times. SOPs assist the pharmacy personnel to know who does what, and when, thus avoiding confusion, and function overlapping. This also takes care of accountability and responsibility. SOPs help to assure the quality and consistency of the service, and thus minimize harm to the patient. SOPs are useful tools for training new members of staff. SOPs give clarity to the pharmacy personnel, to follow steps/procedures, systematically, and uniformly .

11. Types of SOP Prep. Of Reagents To Deal With Complaints Q.A. Methodic Safety & Precaution Analytical method Fundamental Instruments/ equipment & apparatus School of Pharmacy, RK University 11

12. SOP WRITING STYLE SOPs shall be written in a concise, step by step, easy to read and 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, with few decisions should be written along with graphical format or hierarchical steps. School of Pharmacy, RK University 12

13. School of Pharmacy, RK University 13 Continued…. Procedures that require many decisions should be written along with flow chart. Requirement for document identification and control, accountability and traceability responsibility must be included with every SOP; this can be achieved by providing consistent format.

14. While Writing SOP… Write in the presence tense . Don’t write in the past, conditional or future tense unless you have good reason to do so. Avoid ambiguity. Be concise. Keep the words short and get to point. Move from one step to another step in logical manner. Highlight exception. Use a symbol to flag that this is an exception and how to handle it. DO School of Pharmacy, RK University 14

15. School of Pharmacy, RK University 15 Highlight warning. Again warn users that caution must be used in this scenario. Warning must stand out; use a larger font or a warning icon. Reduce the word count where possible without altering the meaning of the text. Continued….

16. 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 and tell them what to do. DO NOT DO While Writing SOP… School of Pharmacy, RK University 16

17. INSIDE THE SOP Company name and pagination . The company name and pagination (e.g. page 4 of 7) must appear on every page.   Title The title should be descriptive. The title should use directive language to declare what is being done to what. Identification Procedures must be easily identified by giving unique number and version number.  This identification number of the SOP supports accountability of the document throughout the facility and over time as it changes. School of Pharmacy, RK University 17

18. School of Pharmacy, RK University 18 Review and approval All SOPs shall have space for signature of initiator (the person who has written the SOP) Reviewer (The persons who has reviewed the SOP) and approver (Quality Assurance Head of the organization ). Purpose The purpose or objective of the procedure should restate and expand well written title. Expand or qualify the directive language used in the title (e.g. to describe the operation procedure of compression machine) Continued….

19. Scope The scope should provide limits to the use of procedure. The scope shall be written in such a way that it answers following questions…. Are there certain samples that are appropriate to test by this method? Do these operations apply only to certain equipment or certain departments? Is there a limit to the capacity, volume, or throughput of the procedure? State to what areas this procedure does apply and does not apply? Responsibility Who is responsible for performing the work described? Who is responsible for implementing the procedure?   Procedure Describe the procedure in a step by step, chronological manner. Use active verbs and direct statements School of Pharmacy, RK University 19 Continued….

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21. The organization should have a procedure in place for determining what procedures or processes need to be documented. SOPs should be written by an individual who performs the tasks routinely or someone who is directly responsible for the performance of the task. SOP Preparation School of Pharmacy, RK University 21

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23. SOP Review and Approval SOPs should be reviewed by one or more individuals with appropriate training and experience with the process especially helpful if draft SOPs are actually tested by individuals other than the original writer before the SOPs are finalized. School of Pharmacy, RK University 23

24. Frequency of Revisions and Reviews SOPs need to remain current to be useful. Therefore, 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 and the document control notation. 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. School of Pharmacy, RK University 24

25. Implementing SOP The most important step for implementing the SOP is in working area, train or retrain the user. Everyone should follow the procedure exactly with each and every step in detail, it is very important to train the user otherwise individual may interpret meaning in different ways. 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. Trainer should explain and demonstrate how each step in the SOP will be performed and should assure them this will increase Quality of product by providing safety and accuracy which will ultimately increase the confidence of the user. School of Pharmacy, RK University 25

26. Management of SOP School of Pharmacy, RK University 26 Organization shall have SOP on Preparation, approval, revision and control of standard Operating Procedure for better control and management of SOPs. Generally , administrative aspects of the SOP system such as distribution and filing are well managed. On the other hand, overall system management, frequently characterized by the lack of a system owner, is generally poor. If a system owner exists at all, his or her responsibilities are limited .

27. Continued…. Ideally a system owner Eliminates obsolete SOPs. (Which is not needed) Ensures that SOPs meet their quality requirements and are user friendly. Manages SOP change controls. Distributes SOPs. Ensures that SOPs are current. Ensures that new or changed SOPs are valid only after training has occurred and provides training about the SOP system. Measures system performance and periodically reports results to management. Continuously improves the system.

28. Name of facility_____________________________________ page .......... of.... SOP Number ________ Title _________________________________________________ Revision number ________ Written by ______________________________ Edited by __________________________ Authorization signature ________________________ Department _______ Date___________ Effective date __________________________________Replaces ____________________ Purpose : WHY : Why is this procedure written. Why is it being performed. Scope WHEN : Indicate when this procedure needs to be performed. WHERE : Indicate where this procedure applies. Responsibility WHO: Who performs the procedure, who is responsible to see it is performed correctly. Materials and equipment WHAT : What is needed to perform the test. The list should be completely specific . School of Pharmacy, RK University 28

29. Introduction of Semisolid & Liquid dosage forms School of Pharmacy, RK University 29

30. Semisolid Cosmetics Cream Cold cream Vanishing cream Tooth paste Nail lacquers Lipstick Face wash Gel & Jellies Paste Plaster Suppository School of Pharmacy, RK University 30

31. Liquid dosage form Oral Monophasic Simple Solutions Drops Syrups Elixirs Biphasic Suspension (Solid in Liquid) Emulsion (Liquid in Liquid) Parenteral School of Pharmacy, RK University 31

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33. Pilfer Proof Cap Sealing Machine School of Pharmacy, RK University 33

34. SOP for Cleaning of Vessels School of Pharmacy, RK University 34

35. Label should include following details: Name of equipment :- Date 7 time of Cleaning :- Name of operator :- Name & batch no of previous product :- Name & batch no of next product :- Checked by :- Continued…. School of Pharmacy, RK University 35 Title :- Cleaning of manufacturing Vessel. Ref. No :- Version :- Name of Mfg. :- Department :- Effective Date :- I D No :- Page No :- Review Date :- Prepared By Approved By Authorized By

36. SOP for Mixing of Aqueous & Oily phase School of Pharmacy, RK University 36

37. SOP for Packaging & Labeling School of Pharmacy, RK University 37

38. SOP for Liquid mixing School of Pharmacy, RK University 38

39. SOP for Filtration (Filter Press) School of Pharmacy, RK University 39

40. SOP for Rotary Bottle Washing Machine School of Pharmacy, RK University 40

41. SOP for Aseptic Liquid Filling School of Pharmacy, RK University 41

42. SOPs serve as a fundamental means of communication for all levels of the organization. Not only do they involve employees departmentally, but they also allow management and employees to gain a cross-functional view of the organization. This approach encourages employees to think about how process change may affect other functional areas. A good system forces Employee to think through processes and examine how Procedure might affect product, personnel, production, and equipment. It shall be noted that the Best written SOPs will fail if they are not followed. Conclusion School of Pharmacy, RK University 42

43. http ://aboutgdp.blogspot.in/2010/05/standard-operating-procedures-sops.html http://www.pharmainfo.net/reviews/standard-operating-procedures-sop-back-bone-pharmaceutical-industries http://pharmatips.doyouknow.in/Articles/Pharmaceutical-Equipment.aspx http://en.wikipedia.org/wiki/Standard_operating_procedure http://pharmaceuticalsops.blogspot.in/2010/09 / References School of Pharmacy, RK University 43

44. AIM HIGH THANK YOU