Group members:

Laraib Anjum 2231 Sana khalid 2238 Aroosa fazal-e- illahi 2266 Aaleen Fatima 2277

ICH(Q10)Pharmaceutical

quality management system

Contents: Introduction to ICH Guidelines Introduction to Q10 Pharmaceutical quality management system Scope Relationship of Q10 to GMP and ISO Objectives Enablers Design and content consideration Quality manual

Conti…. Management responsibility Management commitment Quality policy Quality planning Resource management Internal communication Management review Management of outsourced activities &

purchased materials Management of change in product ownership

Conti… Continual improvement of process

performance and product quality Goals Elements Continual improvement of the Q10 Management review of Q10 Monitoring of internal and external factors

having impact on Q10 Outcomes of management review and

monitoring Flow chart of ICH Q 10 model

ICH

Implement technical requirements for registration of pharmaceuticals for human use.

Bring together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.

ICH mission is to achieve safe , effective and high quality medicines are developed in resource-efficient manner.

ICH GUIDELINES:

Quality guidelines Safety guidelines Efficacy guidelines Multidisciplinary guidelines

QUALITY GUIDELINES: Q1:Safety Q2:Analytical validation Q3:Impurities Q4:pharmacopoeias Q5:quality of biotechnological products Q6:specification Q7:good manufacturing practices

CONTI.. Q8:pharmaceutical development. Q9:Quality risk management Q10:Pharmaceutical quality system Q11:Development and manufacture of

drug substances Q12:Life style management

1)INTRODUCTION TO ICH Q10: Q10 is comprehensive model for effective

pharmaceutical quality system. It demonstrates industry and regulatory

authorities support of an effective pharmaceutical quality system to increase quality and availability of medicines.

Q1o facilitates innovation and continual improvement.

Relationship of Q10 to … GMP requirements ISO standards ICH Q7 Regulatory approaches

2) Pharmaceutical quality management system

Scope: This guidance applies to the system

supporting development and manufacture of pharmaceutical drug substance

Pharmaceutical development Technology transfer Commercial manufacturing Product discontinuation

Q10 Objectives

Implementation of Q10 models results in achievement of 3 main objectives

Active product realization Establish and maintain a state of

control Facilitate continual improvement

Knowledge management and quality risk management

Knowledge management is a systemic approach to acquiring, analyzing, storing and disseminating information related to product, manufacturing processes and components

Quality risk management provide an approach to identifying, scientifically evaluating and controlling potential risks to quality

Design and content considerations:

Design organization and documentation must be well structured

Should be applied in manner appropriate for product life cycle stages

Should incorporate risk management principles

Provide assurance of the quality of outsourced activities and purchased materials

Conti…

Management responsibilities Process performance, product quality

monitoring, corrective and preventive action, change management, management review

Performance indicators

Quality manual Documentation approach that contain

description of pharmaceutical quality system.

Description include: Quality policy Scope of ICH Q10 Identification of Q10 processes Management responsibilities with in Q10

3) Management responsibility

a)Management commitment

b)Quality policy

c)Quality planning

d)Resource management

e)Internal communication

f)Management review

g)Management of outsourced activities & purchased materials

h)Management of change in product ownership

a) Management commitment

Responsibility of senior management to achieve quality objectives & its implementation.

Steps to achieve quality policy.

b) Quality policy

Establishment of quality policy. Facilitation of continual improvement. Communication & understanding of

quality policy. Periodically revision of quality policy.

c) Quality planning

Assurance of quality objectives. Company support for quality objectives. Company strategies align with quality

objectives. Provision of appropriate resources. Measurements of progress in quality

objectives.

d) Resource management

Provision of adequate and appropriate resources.

Appropriate application of resources.

e) Internal communication

Assurances of appropriate communication process.

Assurances of information flow. Escalation of product quality issues.

f) Management review

Continuing suitability & effectiveness of pharmaceutical quality system.

Assessment of the conclusions of periodic reviews.

g)Management of outsourced activities &

purchased materials Assessing suitability & competence of

suppliers. Defining responsibilities &

communication process for quality related activities of involved parties.

Monitoring & review of the quality of materials.

h) Management of change in product ownership

Ongoing responsibilities are defined. Essential information is transferred.

4) Continual improvement of process performance and product quality

It describes lifecycle stage goals & four specific pharmaceutical quality system elements that augment regional requirement to achieve the ICH Q10 objectives.

a) Life stages goal

i. Pharmaceutical development : Main goal of pharmaceutical

development is to design a product & its manufacturing processes to consistently deliver intended performances & meet the needs of patients & health care professionals.

Conti…

ii) Technology transfer: Its goal is to transfer a product

& process knowledge b/w the development & manufacturing & within or b/w manufacturing sites to achieve the product realization.

Conti....

iii) Commercial manufacturing: Goal of manufacturing

activities is achieving product realization, establishing & maintaining a state of control, & facilitating continual improvement.

It should assure the desired product quality , suitable process performance is achieved.

Conti….

Iv) Product discontinuation: The main goal of

activities is to manage the terminal stage of product life cycle effectively. For this predefined approach should be used to manage the activities such as:

documentation , samples , product assessment

And reporting.

(b) Q10 elements: Q10 model’s intent is to enhance these

elements to promote life cycle approach to product quality.

There are 4 elements which are involved to promote the product quality.

Conti..... The four elements are; 1)process performance and product

quality monitoring system 2) corrective action & preventive

action system 3)change management system 4)management review of process

performance and product quality.

i) Process performance & product quality monitoring system:

Pharmaceutical companies should plan for monitoring the process performance & product quality.

It provides: Assurance of continual capability of

process Control to produce a product of desire

quality

Conti....This system should: Use quality management to establish the

control strategy Facilitate the time feed back & feed

forward & CAPA. Provision of tools Identify the sources affecting

performance & quality

ii) Corrective action & preventive action system

A structured process to the investigation should be used with the objective of determining root cause.

CAPA methodology should result in product & process improvement

iii) Change management system

It ensures that continual improvement is under taken timely & in effective manner.

It has appropriate stages of life cycle. Quality mangement should be utilized to

evaluate the proposed changes Proposed changes should be evaluated

by experts. After implementation, it should be

confirmed that the change objectives were achieved.

Application of change management system:

Pharmaceutical

development

• Change is an inherit part of development & it should be documented

Technology transfer

•This system should provide documentation of adjustment made to the processduring technology transfer activities

iv) Management review of process performance and product quality

It provide the series of review at various levels of management & should include a timely affective communication to raise the appropriate quality.

It should include: Results of regulatory inspection Quality reviews Any follow up action

Application:

pharmaceutical development

• Ensure the adequacy of product & process design

Technology transfer

• Ensure the developed product and process can be manufactured at commercial scale.

Commercial manufacturing

• It should be a structured system & support the continual improvement

Product discontinuation

•Management review should include such items as product stability and product quality complaints.

5) CONTINUAL IMPROVEMENT OF Q10:

Management review of Q10. Monitoring of external and internals

factors that can have an impaction on Q10 system.

Outcomes of management review and monitoring.

MANAGEMENT REVIEW OF Q1O:

The review should include: Measurement of achievement of Q1O

objectives. Assessment of performance indicators

that can be used to monitor the effectiveness of process within the Q10.

PERFORMANCE INDICATORS assessment:

Complaint, deviation , CAPA , and change management processes.

Feedback on outsourced activities Self assessment process including risk

assessments, trending and audits. External assessment such as regulatory

inspections and findings and customer audits.

MONITORING OF INTERNAL AND EXTERNAL FACTORS THAT

IMPACT Q10:

Emerging regulations , guidance , and quality issues .

Innovations that might enhance the system.

Changes in business environment and objectives.

Changes in product ownership.

OUTCOMES : Improvement to the quality system and

processes Allocation of resources or personal

training. Revision to quality policy and quality

objectives Documentation and timely and effective

communication of the results of review Escalation of appropriate issues to senior

management.