challenges in global quality management pptx

Nandkumar Chodankar (Ph D Tech)CEO

ASolution Pharmaceuticals Pvt. Ltd.11-A Mittal Chambers, Nariman Point

Mumbai, India, 400021

Challenges in Global Quality Management

Nandkumar Chodankar (Ph D Tech) 2

We shall Discuss

1. WHAT is Global Quality? WHAT are the Challenges?

2. WHY Management of Quality is Required?

3. WHO Manages Quality?

4. HOW Can One Manage Challenges in Global Quality?

5. WHAT Are The Variables? Can we Identify them?

6. Process Development - Most important Challenge

7. List of SOPs from The US FDA to Meet Challenges

8. Summary8/18/14

What is Global Quality? Is it One Quality Standard for

All?Is this a Challenge by itself?


One Quality All The Time

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http://www.associerge.com/the-globe-of-the-earth/satellite-image-the-world-283642/

Satellite Image The World

Global QualityOne Quality Across the Globe

WHY Management of Quality is Required?


Consequences of Quality Failure

Lack of Therapeutic Effect leading to prolonged illness or even death

Toxic and adverse reactions

Waste of limited financial resources

Loss of credibility of health care delivery system

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Concern about the quality, authenticity, performance, or safety of any

medication (and Medical device)

Nandkumar Chodankar (Ph D Tech) 7 8/18/14

Product Quality Management Challenges during manufacturing, shipping, or storage (SOPs):

Suspect Counterfeit Product (Bar coding)

Contamination (cGMP)

Defective components (Inspection)

Poor packaging or Product mix-up (Inspection)

Questionable stability (Stability Plan)

Labeling concerns (Better Supervision).

Consequences of Quality Failure


WHO Manages Quality?

Regulators (Customs, Politicians, Bureaucrats)

QU (Q A / QC/ RA?)

Manufacturer, Production

Supply Chain (Distributors, Transporters, Sourcing department)

Advertising Agencies & Media

Doctors and Nurses, other Staff

Pharmacist

Patient? (Self Medication)

Relatives and Friends

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SOPs


Are Challenges for &/or from Regulatory Authorities the Same?

India & Neighboring Countries

ROW

EU

US

Japan

Undeveloped Countries

Global Expectation: Harmonization is difficult

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HOW Can One Manage Challenges in Global Quality?


Tools made Available by Regulatory Authorities

ICH & Other Regulatory Guidelines

Quality Risk Management

Quality by Design

Process Analytical Technology

Development & Clinical Study Regulations

Review of the data Submitted

Inspections for Assurance

Pilot studies by Authorities

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Challenge -

Knowing vs.

Implementatio

n

Challenge -

Harmoniza

tion

WHAT needs to be Managed? WHAT are the Variables?

Quality by Design, Quality Target Product Profile, Critical Steps & Parameters,

Critical Variables, Quality Risk Management, Process Technology,

Continuous Validation, Patient’s Welfare

Identification Challenge


Purpose of QUTo help ensure that each medicine reaching a patient is safe, effective, & is of acceptable quality

For Primary Health Care, the most important characteristics of a pharmaceutical product are

Identity,

Purity,

Strength,

Potency,

Uniformity of dosage form,

Bioavailability, and

Stability

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Conducting Clinical studies & Quality of material used for this study is most important

Product Design (QTPP) Challenge


Comprehensive Quality Assurance Program- A Challenge

Developing Systems to have proven, safe and efficacious drug, presented in an appropriate dosage form to have longest possible shelf life

Selection of Suppliers with acceptable quality

Pharmaceuticals received from commercial suppliers and donors should meet specified quality standards at the time of delivery (Assuring & Ensuring)

Approved Packaging & Labeling

Repackaging activities and dispensing practices

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No Compromise on Storage and transportation conditions

Reporting, Documenting & Addressing Product quality concerns (prescribers, dispensers, users)

Procedures to Implement Product recall of defective products.

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Challenge: Knowing Vs Application Driving GMP from Top to Bottom

Comprehensive Quality Assurance Program- A Challenge

WHAT Are The Variables?Can we Identify them?

The Variables May be Common for APIs and

Finished Dosages


Challenges To Manage: WHAT Affects Quality?

People Involved in all activities

Equipment

Analytical Methods / Measurements

Manufacturing Technology

Quality of Materials

Environment

Packaging

Transportation & Storage conditions

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1. PeoplePeople

Method of Selection, Who, Where, What

Education, Experience, Past records & Job changes, Attitude & Aptitude, Interest, etc.

Training:

Quality Training program

Material for training

Training of staff and Trainers

Refresher course

Evaluation of training effectiveness

Performance appraisal

Training & Supervision of staff members

SOPs 8/18/14

People

Managem

ent

Challenge


2. Equipment (Qualification)

Suitability of Equipment

Qualification & Calibration

Wear & Tear of Equipment

Location & Protection of Equipment

Preventive Maintenance of Equipment

Accessories and contact parts,

Lubricants, gaskets, seals

Efficiency of Equipment

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Quality Vs Customer

Commitment

Preventive Maintenance


3. MeasurementSuitability of the measuring instrument

Qualification & calibration

Usage and life span

Location & protection

Preventive maintenance of Instruments

Accessories and machine parts,

Supporting spares, seals (lamp, columns)

Software / computer validation

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4. Process & Technology (SOPs)

Manufacturing Process: Robustness

Validated Manufacturing formula, its Technical Process Knowledge

Controls for Contamination & Cross Contamination

In-process monitoring

Specification at each stage and of the end product

Validated Analytical method for testing & Stability

Documentation to investigate

Deviation & Change Control

OOS, OOT

Continuous improvement

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5. Materials

Quality of Materials

Approved Specification & Test Methods

Approved Manufacturer & Supplier

Labeling & Packing as per

Storage conditions

Stability

Suitable Transportation & Control

Contamination in the material

Impurity Profile

Storage after dispensing a part quantity

Lot to lot variation

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6. Manufacturing Environment

Surrounding Areas

AHUs, HVACs,

Temperature

Humidity

Contamination & Cross Contamination

Dust / Particulate matter

Man, Material, Equipment, Trash movement control

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Combined Effect of Variability

1. People

2. Equipment

3. Measurement

4. Process & Technology

5. Materials

6. Environment (Facility) Identifying the criticality of each and

devising a control strategy for minimizing variability due to combined effect of these factors, during manufacturing, is the key for QRM.

Machine

Machine

Measure System

Prior Ops

Materials

Materials

Quality Risk Management

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25

Process Development

8/18/14Nandkumar Chodankar (Ph D Tech)

Robustness, RuggednessConsistency, Critical Parameters,

Controls &Efficiency

Generating Process

Knowledge

26 8/18/14Nandkumar Chodankar (Ph D Tech)

EASY MAX

Process Investigation

& Process Research

OPTIMAX

Process Optimization

FBRM

Focused Beam Reflectance MeasurementOn Line Crystal size / Polymorph Monitoring


Challenge to Development of critical Strategy for Process Modeling

Manipulated Inputs

Disturbance Inputs

Measured Outputs

Unmeasured Outputs

b) Control Representation

Manipulated Inputs Measured Outputs

Unmeasured OutputsDisturbance Inputs

Controller

a) Input/Output Representation

Process

Process

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API Manufacturing Steps

RM- Dispensing

Packaging

NIR -Identification

Air- Moisture – NIRParticle size- FBRMNIR, HPLC

NIRRaman Spectra

Critical SynthesisFTIR, HPLC, Raman Spectra

Carbon Treatment Crystallization

Filtration

Filter

HPLC, NIR

Milling / Blending Drying FBD

Load cell

GC MS Vapor lineRaman Spectra

NIR, HPLC Particle Measurement

Raman Spectra


1. Responsibilities and Procedures of QC

2. Sanitation Procedures

3. Use of suitable rodenticides, insecticides, fungicides, sanitizing agents

4. Cleaning & maintenance of equipment

5. Performance of automatic, mechanical and electronic equipment

6. Receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers & closures

7. Standards or specifications, method of testing, and method of cleaning, sterilization, and processing to remove pyrogenic properties of drug substance for drug product containers and closures

8. Production and process control 8/18/14

List of SOPs from The US FDA To Meet Challenges



9. Sampling & Testing of in-process materials and drug products

10. Prevention of objectionable microorganism in drug products which are required to be sterile

11. Prevention of microbiological contamination of drug products purporting to be sterile, including validation of any sterilization process

12. System for reprocessing batches do not conform to standards or specifications, to insure that reprocessed batches conform with all established standards, specifications, and characteristics

13. Receipt, identification, storage, handling, sampling, examination & /or testing of labeling and packaging materials.

14. Control procedures for the issuance of labels. 8/18/14


15. Packaging and labeling operations, prevention of mix-up and cross contamination, identification and handling of filled drug products containers that are set aside and held in unlabeled conditions and identification of drug product with a lot or control number that permits determination of the history of the manufacturing and control of the batch

16. Warehousing

17. Distribution of drug products

18. Laboratory controls

19. Testing and release of materials

20. Stability testing

21. Special testing requirements

22. Notification of responsible officials of investigations, recalls,

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23. Written and oral complaints procedures, including quality involving specifications and failures, and serious and unexpected adverse drug experiences

24. Holding, testing, and reprocessing of returned drug products

25. Drug product salvaging

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SummaryThe Challenges in Global Quality Management “Quality Strategy”: Product that meets Identity, Purity, Strength, Potency, Uniformity, Bioavailability, Stability and Affordability.

Harmonization of standards, product specifications and regulations is one of the major challenges for Indian Manufacturer and Exporter.

Quality failure may lead to Lack of Therapeutic Effect leading to Toxic and adverse reactions, prolonged illness or even death. This results into the loss of limited financial resources of the patient and the Loss of credibility of the health care delivery system.

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SummarySuspect Counterfeit Product, Contamination, Defective Components, Poor Packaging or Product Mix-up, Questionable Stability, and Labeling Concerns.

“Product Quality Management during Manufacturing, Shipping, & Storage” (cGMP & appropriate SOPs).

Assuring appropriate Product Design QbD, Identifying QTPP, and CQPAs, Continuous Process Validation, PAT and QRM using these throughout Product Lifecycle.

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Write & Follow SOPs


THANK YOU for your Patience

8/18/14

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