Steps to Implementing a Quality

Management System (QMS)

Moving Small to Mid-Size

Organizations Towards Success Topics:
Across the life science industry, many development companies and research • What is Quality? 
and development (R&D) organizations do not have a quality department or
• The Challenge in Pursuing
even a specific quality function in their early stages of development. Science
R&D While Growing
and research-driven activities require a high degree of flexibility and may
a Company 
demand fast reviews of development stages – at times, even reconsideration
• Implementation of a Quality
of the development program or project termination. That environment does
Management System 
not seem to promote the acceptance for a quality function because it may
impose bureaucracy, overly formalized processes, rigidity, and may be • How to Implement a QMS
interpreted as an organizational burden, hindering the intended exploration that is of the Right Size for
and fast-paced development. the Current Stage and Fit
for Purpose? 
But does it really? Considering R&D activities, it is of utmost importance to
perform very good science. This minimizes trial and error while optimizing
the number of studies and exploratory experiments so researchers can gain
the most knowledge in the least amount of time. Doing science right the
first time gives a great advantage. Additionally, having the information and
knowledge in well-controlled, accessible systems or structures would enable
an organization to swiftly advance through the development stages, gaining
an edge on delivering the desired investigational–and ultimately marketable
–drug product. This description compares very closely to a definition of quality.
What is Quality?
Fulfilling customer expectations and meeting The existing guidances help set the framework for research
requirements, regardless of whether the customer is conduct and outlines the performance requirements.
internal (i.e., project management) or external (i.e., Established quality principals allows for well supported
regulatory authorities) would define a suitable and high processes and a culture embracing procedural aspects.
level of quality. Translated into pharmaceutical terminology This also fosters an understanding of effectively driving
and the development process steps, as shown in Figure activities forward, rather than policing or limiting them.
1, we could say it is in the perspective of good science Quality transforms the developmental path from a gravel
practice (GSP) in early development stages. road to a smoothly paved road, allowing for fast-paced
action while providing helpful orientation boundaries.
Implementing quality early in the discovery phases supports
development and evolves the following development The Challenge in Pursuing R&D
stages. In the pre-clinical development stage, we find more
While Growing a Company
guidance and regulations (ref. 21 CFR 58, good laboratory
During research and development, there are challenges
practice). Developmental success then leads to the onset
start-up companies and growing research companies
of the clinical program and applied good clinical practice
may face. Figure 2 shows the competing factors for
(GCP), for which expanding regulatory documentation is
growing companies.
referenced (ref. 21 CFR 312, investigational new drug
application; ICH E6(R2), GCP). With the onset of On one side, we see the company’s organizational
investigational drug product manufacturing for any kind development as it started with basic layout and functional
of development study, the need for good manufacturing design. As the company grows with activities, number of
practice (GMP) arises (ref. 21 CFR 210/211 General GMP staff, functions, and developed processes will all increase.
for Drugs; 21 CFR 600 Biological Products; 21 CFR 860 This may be a linear process of growth as the company
Medical Devices). develops and builds managerial processes and structure.

Figure 1. Development process and growing support for quality systems.

Validation due Exploration/ Pre-clinical In vitro/in vivo Investigational Phase I

Targeting Pharmacology
diligence development research testing new drug (IND) clinical

Management Oversight

Good scientific practice (GSP)

Quality Oversight

Good labratory practice (GLP) Good clinical practice (GCP)

Good manufacturing practice (GMP)

QUAL ITY MANAGEMEN T SYST EM (Q MS)

2 of 6
Figure 2. A Quality Management System connects between company development and dynamic development activities.
Figure 2. A Quality Management System connects between company development and dynamic development activities.

Company Development
Organizational
Building growth
Responsibility departments
Personnel and tasks
Functional growth
Initiation definitions
(startup)

Quality Management System Support

Exploration
Development
Pre-clinical
research Pharmacology
IV/IV Investigational
new drug (IND) Clinical
Phases New drug
application Marketed
I, II, III drug product
(NDA)
Project Development

On the other side of the figure, there are all the activities The International Council for Harmonisation (ICH) Q10
occurring on a singular or multiple development projects. defines such a holistic approach as the pharmaceutical
Such projects can be at different stages in development, quality management system and considers it to be the
jump back and forth between stages, or even enter and support system accompanying the drug product
leave the organization at different stages. This is a very throughout its lifecycle. All this to ensure the relevant
dynamic, and at times, circular process requiring a high knowledge and information is under the organization’s
degree of flexibility. control. Understanding this, the product lifecycle spans
from early development all the way up to commercialized
As one of the main elements in managing that challenge,
product’s discontinuation in the market. Information
an organization should turn to a systematic approach of
management and risk evaluation are included as enabling
applying instructions and a framework of descriptions
factors when maintaining a high level of quality in all
which offer guidance to the organization and align towards
stages and activities.
harmonized execution of processes.
One of the most important aspects of a QMS is it is the
Implementing a Quality Management System fabric of conduct and the supportive approach guiding
Such a systematic approach is achieved by establishing a all activities. Not surprisingly, the QMS implementation
quality management system (QMS). Through this system, is generally started with establishing an organization’s
quality becomes the supportive harmonization and quality commitment.
oversight instrument, helping to organize and control
the ever-growing knowledge in development projects/
program.

3 of 6
The benefits of establishing quality and a QMS with the How to Implement the Right QMS for the
onset of development activities can be summarized in Current Stage and is Fit for Purpose?
the following arguments:
Whether an organization is growing or has recently merged,
• Expressed commitment to quality in the organization it’s imperative to strengthen their processes through a
• Guidance for conducting work systematic approach on the foundation of quality. This can
• Harmonized approach in handling and executing be done through effectively implementing a QMS tailored
processes to meet the organization’s needs and preparing to adopt
this approach. A staged approach to building a QMS sets
• Effective and efficient processes that enable flexibility
a strong foundation and allows for growth to support the
• Documented procedures which assure organizational investigational product’s development phases.
alignment
• Structured approach in going through the different In this phased approach, there is an element of linearity
development stages as the organization may grow along with the QMS. It also
offers the flexibility of stage-appropriate implementation
• Compliance with regulatory guidance and laws
to account for the dynamic process as the drug development
• Aligned regulation implementation throughout the progresses, or if any product is already at a stage when
organization more advanced or additional quality systems should
• Avoiding surprises by later stage first interaction with be present. Therefore, the stage appropriate approach
authorities offers a solution to the challenge described in Figure 2.
• Reproducibility of action
Research teams should adopt a management system based
• Process oversight, harmonized to establish and on carefully evaluating their organization’s current state
manage data and its need for regulatory compliance in the ongoing
• Data traceability development phases.
• Control and oversight of any third party the company In most cases, the implementation is divided up into
may interact with three to five phases, shown in Figure 3, which also allows
• Structured management of information and for the organization to embrace the systematic approach
documentation in well-defined archives  and assure proper training and personnel adherence.

4 of 6
Figure 3. Stepwise Implementation of QMS, tailored to state of company and development.

STEP 1: Basics

In this first phase the basics of the QMS will be defined and a suitable set of policies and standard operating
procedures (SOPs) established. The organizational structure to support implementation may also be reviewed.
Covered aspects may include but may not be limited to:
• Quality Commitment • Qualification and Training
• Document Management • Records and Data Management

STEP 2: Growing QMS

The second phase should seamlessly continue the implementation of the QMS and expand into additional
topics which may support the company in their conduct of development activities. With the basics being
embedded in the organization the consecutive aspects may include:
• Risk Management • Supplier Management • Auditing

STEP 3: Pre-clinical Stage

When development is advancing towards pre-clinical stages the next level of quality processes should
be established. In many cases oversight of service companies needs to be assured and next level data
and information is gained. Important elements of this phase may be:
• GLP oversight of vendor • Management Review • Issue Management

STEP 4: IND and Clinical

In preparation of reaching the investigational new drug (IND) application and clinical phases in development
of the investigational drug product the fourth phase of the QMS implementation can be initiated. This phase
may be more extensive as many aspects of GCP and GMP for manufacturing investigational drug product
should be included:
• IND Application • Trial Management • CRO and CDMO Oversight

STEP 5: Later Stage Clinical Development and GMP

Conducting clinical development during the well-known set of three phases quickly demands a more detailed
set of procedures for handling GMP requirements and the expectation of compliance to GCP regulation. In
these phases it also makes a significant difference if the company is producing investigational drug product or
delegating this to contract development manufacturing organization (CDMO). If production may be an
in-house task the need arises to add procedures covering cGMP regulations to manage the facility, material,
packaging, manufacturing, quality control, and general quality systems.

5 of 6
Figure 4. ReadyQMS implementation in support of the development process.
Figure 4. ReadyQMS implementation in support of the development process.

Validation due Exploration/ Pre-clinical In vitro/in vivo Investigational Phase I

Targeting Pharmacology
diligence development research testing new drug (IND) clinical

Management Oversight

Good scientific practice (GSP)

Quality Oversight

Good labratory practice (GLP) Good clinical practice (GCP)

Good manufacturing practice (GMP)

QMS QMS QMS QMS QMS

Step 1 Step 2 Step 3 Step 4 Step 5

Q U A LIT Y M A NA GE M E NT SY STE M ( Q M S)

In Figure 4, the Ready QMS implementation is beginning, the pharmaceutical industry always relies
included in the alignment of the development stages. on quality in all activities.

Making quality not just an expectation, but an intrinsic

Conclusion and foundational element of company culture, will
The focus on quality in the activities of any organization enable effective and efficient development of new
should certainly continue beyond this description of (investigational) drug products and improve the
initial phases for implementation. As mentioned in the functionality of any organization.

Written By: Dr. Steffen Engel, Managing Expert, Quality Center of Excellence

Supported by Advarra Consulting

Tailored to meet the unique needs of the client, Advarra’s ReadyQMS solution integrates the
people, processes, methods, systems technology and mastery required to design and implement
a framework that will successfully guide the organization in both the short and long term.
• Fit-for-purpose approach that does not over-burden a biopharma company
• Carefully curated, regulatory compliant documents that reflect the outsourcing strategy
• Cross-functional quality expertise support the development program and internal teams
• Risk-based methodology to focus on important, critical-to-quality issues
• Expert training to elevate organizational understanding of critical quality indicators and how to track them

Review Services • Consulting Services • Research Technology