pharmaceutical manufacturing scenario and self inspection

1. Manufacturing Planning and Self 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.
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2. CONTENT
o Introduction to Manufacturing
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
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3. MANUFACTURING PLANNING
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4. What is manufacturing planning ???
 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.
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5. What Make the Change in Manufacturing Sectors ??
 Customer demand for higher quality
 Agile competition
 Impact of technology
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6. Manufacturing is no longer 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
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7. Agile Competition
 Agile organization 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.
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8.  Technology is improving 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 Resources Effectively
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
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10. Element of Manufacturing Planning
1. Planning
2. Routing
3. Scheduling
4. Dispatching
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11. 11 Resource
Planning
Sales an operations
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 start with 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
Availability of
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:
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14. Identification of
key product and
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:
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15.  Key product characteristic 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
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16. 2. Relative Importance of 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
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17. Identification Of Critical Items
 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
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18. The Classification of Characteristic
 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
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19. 3. Analysis of the 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
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20. Process flow diagram of tablet manufacturing
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21. 4. Correlation of Process 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
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22. 5. Error –Proofing the 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
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23. 6. Plan for Neat 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
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24. 5S CONCEPT FOR NEAT AND CLEAN WORK PLACE24

25. 7. Validate the Measurement 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.
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26. Observed Process
Variation
Actual Process
Variation
Long Term
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
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27. Important Aspects of Manufacturing Planning for Quality
Lean Manufacturing Six Sigma Approach
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28. SELF-INSPECTION
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29. Self-Inspection
Self inspection consist of,
 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.
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30. OBJECTIVES OF SELF INSPECTION
 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.
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31. SelfInspection
Informal Daily
Immediate
Correction
Formal Quarterly Improve System
QC Internals Half Yearly
Confirm
Compliance
TYPES OF SELF-INSPECTION
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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
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33.  Performed routinely also 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.
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34.  Self-inspection team should 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
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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
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36.  Documentation
 Sanitation and 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
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37. THE SELF INSPECTION TEAM
 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
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38. CARRYING OUT A SELF-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
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39.  Follow-up action
 Effective follow-up programme
 Company management to evaluate both the report and corrective actions
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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.
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41. http://WHO_TRS_823-Annex2.pdf5.
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Accessed on -11/02/2016
6. http://www.pharmaguideline.com/2013/04/self-inspection-and-quality-audits.html
Accessed on-13/02/2016
REFERENCES

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