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standard operating procedure pharmacy


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

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

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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 . School of Pharmacy, RK University 3
  • 4. 1. If it isn‟t written down, it didn‟t happen.2. If it isn‟t written down properly, it didn‟t happen either.3. Don‟t forget rules 1 and 2.
  • 5. • 3rd layer in documentation• 1st GLP and 2nd Company policies Q.A. Documentation GMP Q.C.
  • 6. 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. 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. School of Pharmacy, RK University 7
  • 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. School of Pharmacy, RK University 9
  • 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. School of Pharmacy, RK University 10
  • 11. Safety To Deal & With FundamentalPrecaution Complaints Analytical method Types Prep. Of Reagents of SOP Instruments/ Q.A. Methodic equipment & apparatus School of Pharmacy, RK University 11
  • 12. 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. 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. School of Pharmacy, RK University 13
  • 14. DO 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. School of Pharmacy, RK University 14
  • 15. Continued…. 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. School of Pharmacy, RK University 15
  • 16. DO NOT DOIntroduce acronyms without explaining what it means.Don‟t use the word “may”, “if possible” as it implies that the usercan do something under conditions. Instead be positive and tellthem what to do. School of Pharmacy, RK University 16
  • 17. Company name and pagination.The company name and pagination (e.g. page 4 of 7) must appear onevery page.TitleThe title should be descriptive. The title should use directive languageto declare what is being done to what.Identification Procedures must be easily identified by giving unique number andversion number. This identification number of the SOP supportsaccountability of the document throughout the facility and over time asit changes. School of Pharmacy, RK University 17
  • 18. Continued….Review and approval All SOPs shall have space for signature of initiator (theperson who has written the SOP) Reviewer (The persons who hasreviewed the SOP) and approver (Quality Assurance Head of theorganization).Purpose The purpose or objective of the procedure should restate andexpand well written title. Expand or qualify the directive languageused in the title (e.g. to describe the operation procedure ofcompression machine) School of Pharmacy, RK University 18
  • 19. Continued….Scope The scope should provide limits to the use of procedure. The scope shallbe 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 19 School of Pharmacy, RK University
  • 20. 1. Sop Preparation 2. SOP Review and5. Management of Approval SOP SOP PROCESS 3. Frequency of Revisions and 4. Implementing Reviews SOP School of Pharmacy, RK University 20
  • 21. SOP Preparation 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. School of Pharmacy, RK University 21
  • 22. Environmental Performs the job Equipment personnel manufacturers Who will/can write SOP? Performs maintenanceSafety personnel Technical initiation on equipment School of Pharmacy, RK University 22
  • 23. SOP Review and ApprovalSOPs should be reviewed by one or more individuals withappropriate training and experience with the process especially helpfulif draft SOPs are actually tested by individuals other than the originalwriter 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, wheneverprocedures are changed, SOPs should be updated and re-approved. Ifdesired, modify only the pertinent section of an SOP and indicate thechange date/revision number for that section in the Table of Contentsand 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 remaincurrent and appropriate, or to determine whether the SOPs are evenneeded. 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 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. School of Pharmacy, RK University 26
  • 27. Continued….Ideally a system ownerEliminates obsolete SOPs. (Which is not needed)Ensures that SOPs meet their quality requirements and are userfriendly.Manages SOP change controls.Distributes SOPs.Ensures that SOPs are current.Ensures that new or changed SOPs are valid only after training hasoccurred and provides training about the SOP system.Measures system performance and periodically reports results tomanagement.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 equipmentWHAT: What is needed to perform the test. The list should be completely specific. School of Pharmacy, RK University 28
  • 29. School of Pharmacy, RK University 29
  • 30. Semisolid Vanishing Cosmetics cream Gel & Jellies Cream Paste Tooth paste Cold cream Plaster Nail lacquers Suppository Lipstick Face wash School of Pharmacy, RK University 30
  • 31. Liquid dosage form Oral ParenteralMonophasic BiphasicSimple Solutions Suspension Emulsion Drops (Solid in (Liquid in Syrups Liquid) Liquid) Elixirs School of Pharmacy, RK University 31
  • 32. Jacketed Kettle Mixing & storage• Steam heated Filter press tanks/Vessels• Gas heated• Electrically heated Pilfer proof cap sealing machineLiquid/Jar/Tube Commonfilling equipment Equipment As per GMP Deionizer Planetary mixer Colloid Clarity tester Triple roller mill/Emulsifier mill/Ointment mill School of Pharmacy, RK University 32
  • 33. Pilfer Proof Cap Sealing Machine School of Pharmacy, RK University 33
  • 34. SOP for Cleaning of Vessels Fill the tank with hot tap water (50 -60 C). Pass the steam through jacket to raise the temperature. Drain this water. Fill the tank with water-detergent mixture (0.1% Teepol solution). Heat and drain this water. Use plain hot water to rinse the tank at least twice.Clean the exterior of the tank with warm plain water & interior with freshly collected distilled water. Pass the steam through the jacket to make it dry. Clean lid & place it over tank. Label appropriately. School of Pharmacy, RK University 34
  • 35. Continued….  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 :- Title :- Cleaning of manufacturing Ref. No :- Vessel. Version :- Name of Mfg. :- I D No :- Department :- Page No :- Effective Date :- Review Date :- Prepared By Approved By Authorized By School of Pharmacy, RK University 35
  • 36. SOP for Mixing of Aqueous & Oily phase Check the closure of all the outlet valves and “cleaned” label. Open the inlet valve & Transfer the aq. And oil phase from their respective mixing tanks.Start heating and agitation at predetermined rate for specified time period. Locate mixing process intermittently through sight glass. Stop agitation and heating after the specific time gap. Allow the product to cool at specified temperature and homogenize it. Transfer the finished product to filling unit. Record the details of processing. School of Pharmacy, RK University 36
  • 37. SOP for Packaging & Labeling Assure the cleanliness & dryness of the container. Open the lid.Place the containers below the nozzle of syringe on a conveyer belt. Adjust the volume to be filled in each container. Switch on the filling machine. Check the filling process intermittently. Switch off when process is complete. Replace the lid. Stick the label. Keep the containers in final container. Record the details of packaging and labeling. School of Pharmacy, RK University 37
  • 38. SOP for Liquid mixing Ensure that tank is closed & has „cleaned‟ status label where “use before date” has not lapsed. Ensure that the bottom valve of the tank is closed. Open the top lid of the mixing tank/storage tank provided for loading the material. Transfer the purified water & required material as per BMR of the particular of the particular batch. Close the lid of the mixing tank/storage tank.Run the stirrer for the time duration mention in the respective manufacturing record, speed adjustment can be done. After completion of mixing, switch off the stirrer. Affix the status label. School of Pharmacy, RK University 38
  • 39. SOP for Filtration (Filter Press) Check the equipment clean and ready for use.25 liter of syrup to be filtered is taken in a tank and 1 kg filter aid is suspended in it. This slurry is pumped into the chamber and air is displaced from the top. Stop outlet when syrup starts coming out.Remove the filtrated syrup from the bottom outlet of the chamber and recirculate until the out coming filtrate is clear. Connect the main compound to the filter press pump and open the valve. Filter the outcoming into storage tank, which is previously cleaned. Label the tank suitable. School of Pharmacy, RK University 39
  • 40. SOP for Rotary Bottle Washing Machine Remove glass piece if present.Fill the respective tank with fresh DM water. Ensure that stainless steel tray is properly cleaned before loading the bottles. Inspect the broken bottles and reject is found before sending for washing.Choose the correct size of holder and fix on the stainless steel platform. Turn the pump switch and adjust the pump pressure of each pump with the help of control valves.Place the bottles in inverted position on empty nozzles which are to be washed, whenwashing is completed unload the washed bottles in aluminium clean perforated tray in inverted position. Dry the washed bottles in oven at 120 C for 1 hour. School of Pharmacy, RK University 40
  • 41. Conclusion 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. School of Pharmacy, RK University 42
  • 42. References1. sops.html2. sop-back-bone-pharmaceutical-industries3. Equipment.aspx4. School of Pharmacy, RK University 43
  • 44. School of Pharmacy, RK University 45