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  2. 2. Quality Sum/total of all the characteristics of a product/service that has a bearing upon the utilization of the product/service to the entire satisfaction of the end user. Quality Assurance, Quality Square Industry 2
  3. 3. Cont… Consistency • Accuracy • Precision Right result • First time • Every time Quality Assurance, Quality Square Industry
  4. 4. SOP • Standard Operating Procedure is a step by step procedure or Directions as established by a Quality Square Industry involved in facility producing a product, testing or research. • A Standard Procedure does not need explanation or publication because it is standard. Quality Assurance, Quality Square Industry 4
  5. 5. The procedure for describing the writing, revising and approving of SOPs and the control of distribution of SOPs is one of the important Quality Assurance procedure. “Quality is everyone's responsibility” - W. Edwards Deming Quality Assurance, Quality Square Industry 5
  6. 6. Purpose Of SOP [SCHEDULE M] [See Rules 71, 74, 76 and 78] • GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS. • Note: - To achieve the objectives listed below, each licensee shall evolve appropriate methodology, systems and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for production of drugs and no other manufacturing activity shall be undertaken therein. Quality Assurance, Quality Square Industry 6
  7. 7. Cont… CFR Part 211 : Current Good Manufacturing Practice For Finished Pharmaceuticals Subpart F 211.100 Written Procedures and Deviations “(a) There shall be written procedure for production and process control designed to assure that drug product have the identity, strength, quality and purity, they purport or are represented to possess.” (b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified. “ Quality Assurance, Quality Square Industry 7
  8. 8. Cont… CFR Part 820 : Quality System Regulation Sec. 820.40 Document controls. Sec. 820.70 Production and process controls. Sec. 820.80 Receiving, in-process, and finished device acceptance. • “Firms must “establish and maintain” procedures. To do so, companies should define, document (either on paper or electronically), and implement standard operating procedures (SOPs). Additionally, companies must then follow up, review, and revise these documents as needed.“ Quality Assurance, Quality Square Industry 8
  9. 9. Cont… • ISO 9001- 2008, Clause 4.2 : Documentation requirements “Documented procedure”, has to be established, documented, implemented and maintained.” • IS/ISO 14001 : 2004 , Clause 4.5.4 : Control of records “ The organization shall establish, implement and maintain a procedure(s) for the identification, storage , protection, retrieval, retention and disposal of records.” • IS 18001 : 2007 , Clause 4.4.5 : Control of Documents “ The organization shall establish, implement and maintain a procedure(s) for the Controlling all documents required by the OH&S management systems and by this standard.” • ICH Good Manufacturing Practice Guide for API Q7, Section 6 Documentation and Records “ All documents related to the manufacture of intermediates or APIs should be prepared, reviewed, approved, and distributed according to written procedures.” Quality Assurance, Quality Square Industry 9
  10. 10. Benefits of SOP 1. To perform a job properly. 2. To ensure that production operations are performed consistently. 3. To ensure that processes continue uninterrupted and are completed on a prescribed schedule. 4. To ensure that no failures occur in manufacturing and other processes for which the SOP was written. 5. To ensure that approved procedures are followed in compliance with company and government regulations. Quality Assurance, Quality Square Industry 10
  11. 11. Cont… 6. To serve as a training document for teaching users about the process. 7. To serve as a checklist for co-workers who observe job performance to reinforce proper performance. 8. To serve as a checklist for auditors. 9. To serve as an historical record for the Change over. 10.To serve as an explanation in review of accident investigations. Quality Assurance, Quality Square Industry 11
  12. 12. SOP Maintenance Quality Assurance, Quality Square Industry 12
  13. 13. A. SOP Preparation • Should be written by individuals knowledgeable with the activity and subject-matter experts. • By an individual who performs the tasks routinely or someone who is directly responsible for the performance of the task like…  Those who will perform the job  Those who will perform maintenance on equipment involved in an SOP  Engineers or others who design equipment and processes  Technical initiator  Safety personnel  Environmental personnel  Equipment manufacturers Quality Assurance, Quality Square Industry 13
  14. 14. SOP Format and Content There is no FDA approved format for a SOP. SOP AND DECISION FOR FORMAT TYPE Does SOP Does SOP involve consist of Best format for writing Sr. No. Examples many more than 10 SOP decisions? steps? 1 No No Simple sequential steps SOP for balance calibration Sequential steps along 2 No Yes Entry / Exit procedure with Pictorial diagrams Sequential Steps with SOP for deviation 3 Yes Yes Flow chart management Quality Assurance, Quality Square Industry 14
  15. 15. Typical Structure of SOP The content of a Standard-Operation-Procedure should include the following minimum • Title page • Responsibilities & accountabilities • Hester’s Logo • Procedure • Header with title of SOP • Footer • Department Name Approving Signatures • Effective date  Prepared by • Revision date  Checked by • Review date  Approved by • Page No • Stamp • Regulatory basis  Controlled Copy/Master Copy • Reference documents  QA Stamp • Purpose • Scope Quality Assurance, Quality Square Industry 15
  16. 16. Title Page 1. STANDARD OPERATING PROCEDURE 2. Logo of the Quality Square Industry. 3. Document Number 4. SOP Number 5. Title of the SOP 6. History of SOP 7. Revision Date 8. Writer 9. Replace page if any 10. Checked by 11. Approved by Quality Assurance, Quality Square Industry 16
  17. 17. Text Format of SOP • Logo of Company must be as below. Any other Logo will not be approved. • Header : from Top Distance = 0.13 • Header Table for Title: Total Height : 0.2 • Then Do Auto fit as below • Footer : From Bottom Distance = 0.13 • Paper Size = A4 • Page Margin : RIGHT , LEFT, TOP, BOTTOM = 1” Page Indent and Spacing LEFT, RIGHT, BEFORE, AFETR = 0” • Line Space: 1.0” Table should be in the following format • TABLE: Row Height Space = 2' Text Font • Font Style = Tahoma, Font Size = 10 Quality Assurance, Quality Square Industry 17
  18. 18. Quality Square Industry SOPs & Formats 180 163 160 144 140 SOP Formats 120 100 91 Quantity 80 60 38 40 30 18 20 12 13 9 9 10 10 2 4 0 Q.A. STORE PRODUCTION Q.C. LOGISTIC I.T. H.R. Department Quality Assurance, Quality Square Industry 18
  19. 19. SOPs • Master copy Original Signed copy • Controlled copy Used at actual working place • Uncontrolled copy For information purpose only • Obsolete copy For obsolete activity • Superseded copy Previous copy which is replaced with new one • Approved Copy For the Dossier and regulatory submission Quality Assurance, Quality Square Industry 19
  20. 20. SOP and Guideline • SOPs provide a specific view of all the main steps whereas guidelines are significantly more detailed. • Some SOPs have a two-tiered system that includes both SOPs and guidelines. Quality Assurance, Quality Square Industry 20
  21. 21. TITLE : Making Coffee Date of original Version : Revision Date : APPROVED BY : EFFECTIVE DATE : Making COFFEE 1. PURPOSE To make 1 cup of Coffee for the Employees wanting coffee according to the Hester site standards. 2. RESPONSIBILITIES Personnel who want to make coffee. 3. PROCEDURE 3.1 Take 500 ml S.S. Bowl, ensure the Bowl is clean and empty. 3.2 Fill the Bowl with 100 ml of potable water. 3.3 Add 2 teaspoon of Nescafe in water of Bowl. 3.4 Place the Bowl on the Stove. And lighten the Stove. 3.5 Boil for 10 minutes. (Color of the mixture will be dark brown) 3.6 Filter the mixture into the coffee cup directly. 3.7 It is ready to serve. Quality Assurance, Quality Square Industry 21
  22. 22. Guideline : Making Coffee Date : 0 1/26/07 1. Ensure Stove is working a. Check the knob of the regulator of stove, it should be in “on” position. b. Lighter or match box should be in place. 2. Wash out S.S. Bowl if needed a. Dishwashing soap is located in the cupboard under the sink. b. Use hot water and a small mount of dishwashing soap. c. Brush with a small brush located on the hook under the sink. d. Rinse thoroughly with hot water. e. Instead of S.S. Bowl one can use Aluminum Bowl too. 3. Taken out Nescafe a. Use spoon to take out the Nescafe. b. After taking out Nescafe close the container tightly. 4. Making of coffee a. Take sufficient amount of water in Bowl. b. Add sufficient amount of Nescafe to the water of Bowl. c. Place the Bowl on the stove and lighten it. d. Boil the mixture for enough till mixture get dark brown in color. 5. Filter the mixture using filter into the another vessel. a. Filters are located in the drawer directly under the stove. b. After filtration, keep the filter aside for washing in sink. 6. Serve Coffee in HOT . Quality Assurance, Quality Square Industry 22
  23. 23. Flow diagram for SOP preparation and implementation Revised Document START No Solicit feedback New Document or Cerate A Yes from affected General Agreement Change in Existing Draft Copy of Individual or Document Needed Document Group Create Draft Copy of Change order On effective date Train Affected Process Yes Submit for update master and Individuals and Release of Document Approved formal Review controlled Create Training and Approval Document procedure copies records No END Revised Document As and CO Quality Assurance, Quality Square Industry 23
  24. 24. Points of Consideration 1. Incorporate points by which one can get idea why to do that job and complete picture of the responsibilities for doing a job properly. 2. If your SOP goes beyond 10 steps, then break the long SOP into several logical sub-job SOPs. 3. Write SOPs for people who perform under different interpersonal circumstances. o Write some SOPs for people who work alone. o Write some SOPs for two or more people who work together as a team. o Write some SOPs for people who will supervise other people doing a job. Quality Assurance, Quality Square Industry 24
  25. 25. Cont… 4. Write some SOPs for people who not familiar with rules generally understood by your employees. For example, you may write for contractors, vendors or suppliers. 5. Consider the work culture within which people work. 6. Consider the age, education, knowledge, skill, experience and training, and work culture of the individuals who will be performing the SOP steps. 7. Once you have completed writing an SOP, have several workers test it and give you feedback. 8. Review the effectiveness of SOPs after a few weeks and when Processes and equipment changed and make changes as per it. Quality Assurance, Quality Square Industry 25
  26. 26. B . SOP Review & Approval • Review period for the Hester’s Document is 2 years. • SOP review will focus on the document’s content, context, format and grammar. • Review factors and criteria are :  Adherence to standards  Consistency and traceability  Readability, comprehensibility, and general understandability  Technical adequacy and feasibility of approach  Degree of completeness  Testability of requirements  Use of appropriate requirement, design, or coding techniques  Appropriate level of details Reference : Quality Assurance, Quality Square Industry 26
  27. 27. Quality Assurance, Quality Square Industry 27
  28. 28. Quality Assurance, Quality Square Industry 28
  29. 29. C SOP Revisions Routine revision • At the end of the review period by HOD concerned to the particular SOP will review and revise if required. • If there is no change then HOD just give the review report that this SOP doesn’t require review and continue the same for the next review period. During the review period revision • By the process owner with the approval of the HOD, fill up the DCC form and SOP will be revised with new revision and effective date. • As per the same Previous version will be Superseded or Obsolete. Final approval of the any type of the change in the SOP is given only by the QA department. Quality Assurance, Quality Square Industry 29
  30. 30. D Implementing SOP • The most important step for implementing the SOP in working area, train or retrain 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. • 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. Quality Assurance, Quality Square Industry 30
  31. 31. E Management of SOP • There should be the record for issue and distribution of the SOPs. • It is the responsibility of the process owner to  Ensures that SOPs are current.  Eliminates obsolete SOPs.  Ensures that SOPs meet their quality requirements and are user friendly.  Manages SOP change controls.  Distributes SOPs.  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. Quality Assurance, Quality Square Industry 31
  32. 32. Something Special about SOP The best SOP is one that accurately transfers the relevant information and facilitates compliance with reading and using the SOP & The best written SOPs will fail if they are not followed. Quality Assurance, Quality Square Industry 32
  33. 33. • Failure to follow a company’s own procedures is one of the common observation found during FDA inspection. • Employees will give many reasons why they find reading and following SOPs to be difficult and time consuming. Most of these reasons concern content, clarity and training. Quality Assurance, Quality Square Industry 33
  34. 34. Cont... Too many poor SOPs could lead to a collapse of the whole System. Quality Assurance, Quality Square Industry 34
  35. 35. Quality Assurance, Quality Square Industry 35
  36. 36. “Quality is not an act, its a Habit“ Quality Assurance, Quality Square Industry 36