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.

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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

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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

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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.

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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

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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

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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

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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.

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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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