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1Manufacturing 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.
2
CONTENT
o Introduction to Manufacturingo Factors that Make Changes in Manufacturing Sectorso Importance in Manufacturing Planningo Elements of Manufacturing Planningo Initial Planning for Manufacturingo Importance of Aspect of Manufacturing Planning for Qualityo Introduction to Self Inspectiono Criteria for Self- Inspection
3
MANUFACTURING PLANNING
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.
5 What Make the Change in Manufacturing Sectors ??
Customer demand for higher quality
Agile competition
Impact of technology
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
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.
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 Technology
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
10 Element of Manufacturing Planning
1. Planning
2. Routing
3. Scheduling
4. Dispatching
11 Resource Planning
Sales an operations Planning
Demand management
Master production scheduling
Detailed capacityplanning
Detailed material planning
Material andcapacity plans
Shop-floorsystems
Suppliersystems
Enterprise R
esource Planning (E
RP
) System
Front End
Engine
Back end
Manufacturing Planning and Control System
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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 QUALITY
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Process characteristic
Product characteristic
Design for manufacturability
Process robustnessAvailability of
capable manufacturing
process
Availability of capable
measurement process
Identification of special need of
productMaterial control
Special skill required of operational personnel
Evaluation of Product Design Include the Following:
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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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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
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
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
18The 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
193. 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 OperationFacilities of Operation and Instruments to be EmployedProcess Condition to be Maintained
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Process flow diagram of tablet manufacturing
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
225. 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
236. 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. Sort2. Set in Orders3. Shine4. Standardization5. Sustain
24 5S CONCEPT FOR NEAT AND CLEAN WORK PLACE
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.
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
27 Important Aspects of Manufacturing Planning for Quality
Lean Manufacturing Six Sigma Approach
28
SELF-INSPECTION
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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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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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Self
Insp
ectio
n
Informal Daily Immediate Correction
Formal Quarterly Improve System
QC Internals Half Yearly Confirm Compliance
TYPES OF SELF-INSPECTION
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
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.
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
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
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
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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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
39 Follow-up action
Effective follow-up programme
Company management to evaluate both the report and corrective actions
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.
41
http://WHO_TRS_823-Annex2.pdf5. Accessed on -11/02/2016
6. http://www.pharmaguideline.com/2013/04/self-inspection-and-quality-audits.htmlAccessed on-13/02/2016
REFERENCES
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