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Manufacturing planning and self inspection in pharmaceutical industries
- 1. Manufacturing Planning andSelf Inspection in Pharmaceutical Industry PRESENTED BY: Ms. Sahoo Sumita Gopal Quality Assurance Techniques semester II GUIDED BY: Prof. Arun Maruti Kashid Asst. Professor, Pharmaceutical Chemistry Sinhgad Technical Education Society, SINHGAD INSTITUTE OF PHARMACY, NARHE,PUNE. 1
- 2. CONTENT o Introduction toManufacturing o Factors that Make Changes in Manufacturing Sectors o Importance in Manufacturing Planning o Elements of Manufacturing Planning o Initial Planning for Manufacturing o Importance of Aspect of Manufacturing Planning for Quality o Introduction to Self Inspection o Criteria for Self- Inspection 2
- 3.
- 4. What is manufacturingplanning ??? A Manufacturing Planning is a methodology designed to manage efficiently the Flow of material, Utilization of people and equipment, and to respond to customer requirements. By utilizing the capacity of suppliers, internal facilities, and in some cases that of customers to meet customer demand. 4
- 5. What Make theChange in Manufacturing Sectors ?? Customer demand for higher quality Agile competition Impact of technology 5
- 6. Manufacturing is nolonger simply about making physical products. Changes in consumer demand, the nature of products, the economics of production, and the economics of the supply chain have led to a fundamental shift in the way companies do business. Customers demand turn “dumb” products into “smart” ones, while products increasingly become platforms and even move into the realm of services. Customer Demand for Higher Quality 6
- 7. Agile Competition Agileorganization is able to respond to constantly changing customer demand by: changing from one product to another quickly. Manufacturing goods to customers orders in small lot size. Customizing goods for individual customers. Using expertise people and facilities. 7
- 8. Technology isimproving quality by providing a wider variety of more consistent output. Technology makes job complex but enable to obtain high quality . Impact of Technology8
- 9. Utilize the ResourcesEffectively Makes flow of Production Steady Estimate Production Resource Maintain Necessary Stock Levels Co-ordinate Departmental Activities Minimize the Wastage of Resource Improves Labor Efficiency Facilitates Quality Improvement Reduce Production Cost Importance of Manufacturing planning 9
- 10. Element of ManufacturingPlanning 1. Planning 2. Routing 3. Scheduling 4. Dispatching 10
- 11. 11 Resource Planning Sales anoperations Planning Demand management Master production scheduling Detailed capacity planning Detailed material planning Material and capacity plans Shop-floor systems Supplier systems EnterpriseResourcePlanning(ERP)System Front End Engine Back end Manufacturing Planning and Control System
- 12. Planning startwith review of product design and then process design. While planning for manufacturing first the planning of product designing is done followed by its review in development process. There is clear advantage to having a new product design reviewed by operations personnel before the design is finalized for the market place . INITIAL PLANNING FOR QUALITY12
- 13. Process characteristic Product characteristic Design for manufacturability Process robustness Availabilityof capable manufacturing process Availability of capable measurement process Identification of special need of product Material control Special skill required of operational personnel Evaluation of Product Design Include the Following: 13
- 14. Identification of key productand process characteristic Relative importance of product characteristic Analysis of the process flow diagram Correlation of process variables with product result Error-proofing the process Plan for neat and clean workplace Validate the measurement system Reviewing the Process Designing Include Following: 14
- 15. Key productcharacteristic are the features that the product has to meet customer's needs. Key process characteristic are those that will create the key product characteristic. Product and Process characteristic can be identify by: Inputs from Market Research Quality Function Development Design Review Failure Mode and Effect Analysis 1. Identification of Key Product and Process Characteristic 15
- 16. 2. Relative Importanceof Product Characteristic The relative importance of product characteristic can be establish by two technique: 1. The Identification of Critical Items 2. The Classification of Characteristics 16
- 17. Identification Of CriticalItems Critical items are the product characteristics that requires high levels of attentions to ensure that all requirement are met. The company identifies Quality sensitives parts by using criteria such as part complexity and high failure rate parts. For such parts special planning include: 1. Supplier involvement before and during the process 2. Process capabilities studies 3. Reliability identification 17
- 18. The Classification ofCharacteristic In this system the relative importance of characteristic is determine and indicates on drawing and documents. The classification can be: - Functional - Non-functional The classification of characteristic used the criteria such as: - Reflect safety - Operating failure - Performance - Service - Manufacturing 18
- 19. 3. Analysis ofthe Process Flow Diagram A process design can be reviewed by laying out the overall process in a flow diagram . By using such flow diagram it becomes possible to divide the flow into logical sections called workstations. For each work station they prepare a formal documents such as: Operation to be Performed Sequence of Operation Facilities of Operation and Instruments to be Employed Process Condition to be Maintained 19
- 20. Process flow diagramof tablet manufacturing 20
- 21. 4. Correlation ofProcess Variables with Product Result A critical aspect of planning during manufacturing is to discover the relationship between process features or variables & product features or results by data analysis. This enables the planner to create process control features, include: Limits and Regulating Mechanism on Variables To Keep Process in Steady State To Achieve Specified Product Result 21
- 22. 5. Error –Proofingthe Process Element of prevention is the concept of designing the process to be error free through “error proofing’’. Type Objectives Example Elimination Eliminating the possibility of error Redesigning the process or product so that the task is no longer Replacement Substituting a more reliable process for workers Using robotics Facilitation Making the work easier to perform Color coding parts Detection Detecting the error before further processing Developing the software Mitigation Minimizing the effect of the error Using fuses for over loaded circuits 22
- 23. 6. Plan forNeat and Clean Workplace The good workplace always provide the prevention of defects, prevention of accidents, and elimination of time wasted in searching for tools, documentation, and other ingredient of manufacturing. The frame work to create a neat and clean workplace is called as 5S. The 5S stand for: 1. Sort 2. Set in Orders 3. Shine 4. Standardization 5. Sustain 23
- 24. 5S CONCEPT FORNEAT AND CLEAN WORK PLACE24
- 25. 7. Validate theMeasurement System In order to minimize the error and demand to obtain low defect levels, it is important to understand the capability of the manufacturing process and measurement process. The planning and control of the measurement process is the part of six sigma approach. The variation in the measurement process can result in wrong predicting of quality, hence to evaluate measurement capabilities and to determine whether measuring equipment is accurately measuring process output becomes important. 25
- 26. Observed Process Variation Actual Process Variation LongTerm Process Variation Short-term Process Variation Measurement Variation Variation due to Operation Reproducibility Variation due to Gauge Accuracy Stability Linearity Repeatability Possible Source of Variation 26
- 27. Important Aspects ofManufacturing Planning for Quality Lean Manufacturing Six Sigma Approach 27
- 28.
- 29. Self-Inspection Self inspection consistof, Periodic detailed examination of condition Working procedure by a team from production site, with a aim of verifying that good pharmaceutical manufacturing practise are being applied and, propose any necessary corrective measures to responsible management. 29
- 30. OBJECTIVES OF SELFINSPECTION Production workers are made to fell more responsible for the quality of their work Feedback on performance is immediate, thereby facilitating process adjustments. The cost of a separate inspection department can be reduced. Elimination of a specific station for inspecting all products reduces the total manufacturing cycle time. 30
- 31. SelfInspection Informal Daily Immediate Correction Formal QuarterlyImprove System QC Internals Half Yearly Confirm Compliance TYPES OF SELF-INSPECTION 31
- 32. PURPOSE OF SELF-INSPECTION To evaluate whether a company’s operations remain compliant with GMP. Assists in ensuring quality improvement. The programme should Cover all aspects of production and quality control Being designed to detect shortcomings in the implementation of GMP Recommend corrective actions Set a timetable for corrective action to be completed 32
- 33. Performed routinelyalso on special occasions such as : Recalls Repeated rejections When a GMP inspection is announced by the national drug regulatory authority Procedure should be documented for Effective follow-up programme. 33
- 34. Self-inspection teamshould consist of personnel who: Can evaluate the situation objectively Have no conflict of interest, have no revenge in mind Should have experience as observers of a self-inspection team before becoming a team member Can be lead self-inspector with experience as team member 34
- 35. CRITERIA FOR SELF-INSPECTION Written instructions must provide minimum and uniform standard Covering all aspects of GMP: Personnel Premises including personnel facilities Maintenance of buildings and equipment Storage of starting materials and finished products Equipment Production and in-process controls Quality control 35
- 36. Documentation Sanitationand hygiene Validation and revalidation programmes Calibration of instruments or measurement systems Recall procedures Complaints management Labels control Results of previous self-inspections and any corrective steps taken 36
- 37. THE SELF INSPECTIONTEAM The team appointed by management, with: Authority and member from different areas of experience Sufficient experience May be from inside or outside the company Experts in their own field Familiar with GMP Team members can be selected from: Quality assurance /Quality control Production & Engineering Planning & inventory control 37
- 38. CARRYING OUT ASELF-INSPECTION Frequency should be at least once a year. May depend on company requirements Size of the company and activities Report prepared at completion of inspection, including: Results Evaluation Conclusions Recommended corrective measures 38
- 39. Follow-up action Effective follow-up programme Company management to evaluate both the report and corrective actions 39
- 40. REFERENCES 1. Gryna F.M., Chua R. C., Defeo J. A., Juran’s quality planning and analysis for enterprise quality, 5th edition, Tata McGraw-hill, 396:423. 2. Juran J. M., Early J. F., Coletti O. J., Quality planning process, 2nd edition, McGraw-Hill, 125:240. 3. Sharma D., Sharma J., Production Planning and Control, International Journal of Scientific Research Engineering &Technology (IJSRET),Volume 3, 2014, 319:321. 4. Schroeder R.G., Linderman K., Liedtke C., Choo A.S., Six sigma:Definition and Underlying Theory, Journal of Operational Management, 2008, 536:554. 40
- 41. http://WHO_TRS_823-Annex2.pdf5. 41 Accessed on -11/02/2016 6.http://www.pharmaguideline.com/2013/04/self-inspection-and-quality-audits.html Accessed on-13/02/2016 REFERENCES
- 42.