Mankind Pharma Limited

Action Plan for Quality System Improvement

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TABLE OF CONTENTS

1. INTRODUCTION........................................................................................................................3
2. MANAGEMENT COMMITMENT................................................................................................3
3. COMPLIANCE ACTIONS PLAN (CAP).........................................................................................4
3.1 QUALITY CULTURE.............................................................................................................4
3.2 QUALITY UNIT DESIGN AND OVERSIGHT..........................................................................5
3.3 QUALITY & COMPLIANCE SYSTEM UPGRADES.................................................................7
3.4 TRAINING & SKILLS DEVELOPMENT..................................................................................7
3.5 GXP SYSTEMS AND IT COMPLIANCE.................................................................................8
4. CLOSING REMARKS...................................................................................................................8
5. SIGNATURE...............................................................................................................................8

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1. INTRODUCTION
As a part of improvement plan towards compliance in-line with the current regulatory
requirement, we have reviewed the systems from the development of the product to
discontinuation (e.g. development, receipt, material management, storage, testing,
release and dispatch) at Mankind Pharma limited globally concerning the manufacturing,
processing, testing and holding of drug substances and drug product.
During the review process there were some area identified for improvements in Quality
Management System (QMS).
Based on the identified improvement plan, Mankind Management has furthermore
identified the necessity to provide an action plan describing the approach, which will be
taken to ensure fundamental good documentation practices, data reliability and
management oversight in the future. Our plan includes our commitments, procedures,
actions and controls, which will ensure good documentation practices and data
reliability within the organization, including action plans to ensure that management,
supervisors, and quality unit personnel are properly trained. More broadly, the action
plan promises the delivery of a plan to implement a robust quality system, which
includes corporate quality oversight, which will enable sustainable compliance and
ensures product quality assurance.
Given that some of the noted plans relate to behaviours and Culture of Quality, Section
3 will detail the corporate level commitments, including specific planning developed for
strengthening and sustaining the overall Quality Management System and Culture of
Quality.

2. MANAGEMENT COMMITMENT
Mankind is committed to completing comprehensive review and transformation of the
Quality organization and management system. These overarching actions will address
the procedural and quality deficiencies, and they will transform the Quality Culture at
the Mankind Pharma Limited.
More specifically, these commitments include:

 Adequate number of resources for Quality Control and Quality Assurance, Quality
management and staff training, auditing, and monitoring of the Mankind facilities to
ensure compliance excellence.
 Financial capital investment for the implementation of systems like Laboratory
Information Management System (LIMS), QAMS (Change
Control/Deviation/Investigation/CAPA/OOS/Market Complaint system / Audit
Management), which facilitate compliance and enhance the transparency between
laboratory activity and quality management.

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 Ensure opportunities for enhancement are evaluated in all areas of the operation
(e.g. Six systems – Quality System, Laboratory System, Production System, Material
System, Packaging and Labeling System, Facilities, Utilities and Equipment Systems).

Mankind is confident that the identified action plan including enhancement of policies,
procedures, talent, tools and training will create a sustainable quality culture ensuring a
proactive focus for continuous improvement and product quality assurance.

3. COMPLIANCE ACTIONS PLAN (CAP)

This Compliance Action Plan encompasses the five initiatives of activity with proposed
actions and timelines, as outlined in Table 1. These identified strategic elements are
grouped into subject matter categories, which will facilitate an organized, consistent,
and comprehensive approach across all Mankind sites. The plan will ensure that items
within each identified strategic initiative area applying to the Mankind Pharma will meet
the requirements of various regulatory agencies.
Table-1
INITIATIVE PROPOSED ACTIONS TIMELINE
1. Quality Culture a) Critical Quality Attributes
b) Quality Management System On going
c) Quality Behaviours
2. Quality Unit a) Organizational Design & Completed.
Design and Recruitment
Oversight b) Metrics management March 2018
c) Self Audits and Corporate
Inspections Ongoing programme
3. Quality & Global Standard Operating
Compliance System Procedure development and March 2018
Upgrade implementation
4. Training & Skills Development & Delivery of GMP
Ongoing Programme
Development Training
5. GXP System and a) Global IT Standard Procedures
IT Compliance development and Introduction
March 2018
b) CSVC Gap Assessment and Action
planning

INITIATIVE 3.1: QUALITY CULTURE

Culture is the shared beliefs, values, attitudes, institutions, and behaviour patterns that
characterize the members of an organization. In a healthy business culture, what's good
for the company and for customers comes together and becomes the driving force
behind what everyone does. We recognize that producing a safe, high-quality product is
everyone’s responsibility. It is our intention, through continuous improvement of our
Quality System and all its elements, and through the ongoing education, training, and

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empowerment of our staff, to build and maintain a strong culture of quality in all areas
of the company.
Initiative 3.1a) Critical Quality Attributes (CQA)

Mankind Pharma applies principles of Process Validation Guideline by USFDA 2011 / CFR 211 /
ICH Q11 during the development of new products; this includes the determination of Critical
Quality Attributes and Critical Process Parameters. Reference Global SOP – Process Validation for
Drug Products (GSOP-053) & Process Validation for Drug Substances & Intermediates (GSOP-
057).

Annual Product Quality Reviews will be conducted at all sites to assure ongoing
maintenance of our commercialized products. Reference Global SOP - Annual Product
Review - Drug products (GSOP-021) & Annual Product Quality Review - Drug substances and
Intermediates (GSOP-022)

Initiative 3.1b) Quality Management System

For this initiative, Mankind Pharma will continue to build upon its platform to detect
compliance failures, implement enhancements in its processes and systems to ensure
continuous improvement and sustained compliance. This includes, but is not limited to:

 Changes in the organizational structure

 Creation of Global Standard Operating Procedures
 Electronic system implementation and enhancements (e.g. QAMS, LIMS, DMS, LMS)
 Compliance Alerts and regulatory trends program
 Metrics to measure, monitor, and improve

Initiative 3.1c) Quality Behaviours (QB)

Mankind is committed to adopting a holistic approach in which everyone at all levels,
and in all functions, is aligned with the company’s Quality policy and maintains a reliably
high-state of Quality and Compliance in all activities.
The Mankind Leadership Team will support any activities for the roll out and
implementation of this initiative in the areas below:

 Employee Mindset (shared Quality Values)

 Communication (clear Quality messaging and directions)
 Leadership (alignment, participation and reinforcement of the Mankind Quality
Systems)
 Performance Management (including Reward and Recognition for Quality behavior)
Effective Measurements, Quality & HR Systems

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 Values Stream Mapping: ‘Right for me, Right first time’, Code of Conduct – Quality
Compliance for GMP Non-Compliance reporting

INITIATIVE 3.2: QUALITY UNIT DESIGN AND OVERSIGHT

Initiative 3.2a) Organizational Design & Recruitment

The organizational design of site and functional quality operations will be aligned, where
applicable, to the Corporate Quality Organizational Structure, implemented at Mankind.
The deployment of the Quality structure will facilitate alignment of quality objectives
and sustainability across the organization and support the Leadership Site Management
Team. Where appropriate, roles, responsibilities, governance and reporting will be
refined to ensure quality oversight and accountability.

A distinct Corporate Quality & Compliance department has been introduced at Mankind
Pharma; this includes Corporate Audit, Compliance, Global Procedure and System
Management & Training.

Mr. Pravin Kumar Arora has been appointed as Sr. Vice President – Corporate Quality &
Compliance to this newly created role and provides the quality vision and leadership for
developing, implementing and supporting innovative quality solutions while enhancing
the quality culture across all Mankind sites. In this role, he reports to Mr. Arjun Juneja,
Director – Operations for all quality matters.

In addition to the new roles, additional personnel supporting Computer System

Validation Compliance (CSVC) team have been identified and are under recruitment to
strengthen Computer System Validation program and fully complying with 21 CFR part
11 and Chapter 11 of MHRA.

Initiative 3.2b) Metrics management

Mankind will implement Quality Performance Indicator (QPI) metrics and each metric
have been defined to ensure consistent reporting across the Mankind Pharma. Standard
Quality metrics will lead to better assessment of compliance health and identify areas
for improvement across the company. Reference Global SOP- Management Review -
Quality Metrics (GSOP-019).

Initiative 3.2c) Self Audits and Corporate Inspections

Self-Audits
Mankind Pharma has an Internal Audit Program (Self Audit) in place; the progress of the
established schedules at the Mankind Sites are monitored and reported to the site
leadership teams.

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Corporate Inspections
Mankind Pharma is in the process of establishing a Corporate Inspection Program for all
manufacturing sites. Reference Global SOP- Corporate Quality Audit (GSOP-073)

INITIATIVE 3.3: QUALITY & COMPLIANCE SYSTEM UPGRADE

Global Standard Operating Procedure Development and Implementation
The objective of this initiative is to assure standardization, compliance, and process
alignment across the Mankind Pharma. This initiative will ensure standardized practices
and procedures that are aligned with current and evolving regulatory and compliance
expectations, as well as current Good Manufacturing Practices (cGMP) in support of the
development, fabrication, testing, holding and distribution of Drug product / Drug
Substance.

INITIATIVE 3.4: TRAINING & SKILLS DEVELOPMENT

Develop and Delivery of GMP Training
Mankind will take measures to improve systems, enhance our control mechanisms and
ensure alignment in the delivery of GMP Training and Certification programs. The
objectives of this initiative are to:

 Develop and Deploy standardized course material across the Mankind Sites.
 Enhance and develop the required skills and competencies resulting in improved
compliance through a consistent approach in GMP training.
 Measure training effectiveness through comprehension based on examination,
practical assessments.
 Assure adequate experience trainers have been defined and training provided to
deliver courses at each individual site.

The following GMP Training Programs have been or will be deployed at the Mankind Sites,
where applicable:

 Data Reliability and Assurance Training

 Good Documentation Practices (GDP)
 Good Laboratory Practices (GLP)
 Investigation and CAPA
 GMP Updates & Trends

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INITIATIVE 3.5: GXP SYSTEM AND IT COMPLIANCE

Mankind Pharma is in the process of establishing a Global IT Procedures (GITP) for all
manufacturing sites. These GITP will cover all aspects of the Systems Qualification & IT
Compliance that will be assessed for 21 CFR Part 11 compliance for laboratory
equipment, standalone systems including: data accessibility; data reliability; data
recording; collection and archiving practices and surrounding controls.

The following areas will be assessed and verified, at a minimum:

 CSVC Gap Assessment and Action planning
 Implement electronic systems to current standards across Mankind, where
applicable
 Global IT governance, policies, procedures and processes

4. CLOSING REMARKS

Mankind Pharma will enforce the importance of adherence to current Good

Manufacturing Practice (cGMP) throughout our operations. In addition, our
commitment remains to instil a strong Quality Culture.

Mankind Pharma is confident the actions that have been initiated and/or planned will
meet regulatory agencies expectations for sustainable cGMP compliance and product
quality. Our comprehensive approach, will ensure that Mankind Pharma manufactures
and distributes products are assured to be safe, effective and reliable.

Mankind Pharma acknowledges the value of implementing quality and compliance

enhancements at our facilities. It is our commitment to continue to standardize all of
our enhanced policies, procedures, and practices with a company-wide perspective.

5. SIGNATURE
Title Name Signature Date
AGM- Corporate Quality &
Yogesh Sharma
Compliance
Vice President – Corporate Vijay Sharma
QA
Mr. Pramod
CIO- Information & Services
Gokhale
President – Operations Abhay Srivastava
Sr. VP & Head – Corporate Pravin Kumar
Quality & Compliance Arora
Director – Operations Arjun Juneja

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