Pharmaceutical Quality Management System (QMS) is a set

of procedures and practices that contribute to product

quality.
It targets individual processes and personnel involved in product
manufacturing and prevents them from drifting away from quality
standards such as ISO and ICH Q10.
For example, process validation studies of the pharmaceutical drugs
contain data that is used to verify whether the drug manufacturing is
carried out according to the quality steps. This ensures that the final
product contains all the attributes of a high-quality product.
Here’s everything you’ll learn:
 What is a Pharmaceutical Quality Management System (QMS)?
 Applicable Pharmaceutical QMS Regulations and Standards
 Core ISO Principles of a Quality Management System (QMS)
 Elements of a Pharmaceutical Quality Management System
 How to Streamline Your QMS Processes with an eQMS

What is Pharmaceutical
Quality Management System
(QMS)?
A Pharmaceutical Quality Management System (QMS) develops and
ensures quality procedures in various product life cycle stages such as
manufacturing and product testing.
It includes all the critical stages of drug manufacturing, including:
 Formulation
 Method development
 Facilities
 Utility system
 Equipment
It ensures that the final product is according to customer requirements, as
well as regulatory requirements to which the manufacturer is obliged to
follow. It uses monitoring methods such as Quality Assurance to prevent
quality deviation and emphasize documentation to record all problems
and their solutions.

Applicable Pharmaceutical
QMS Regulations and
Standards
The Quality Management System (QMS) is not a standard of its own. Its
definition, applicability, and practical implementation rely on other
approved standards. It’s the organization’s responsibility to adopt the
relevant standards, which depend on many factors, including geographical
location, product type, and target market.
Some of the most common standards and regulations applicable to the
Pharmaceutical Quality Management System (QMS) are described below.
International Organization for
Standardization (ISO)
The ISO is an international body involved in developing standards in
various industries, including the Pharmaceuticals. The current standard
for Quality Management System (QMS) is ISO 9001:2015, and previously it
was ISO 9001:2005.
The ISO is not involved in the inspection and certification process. Instead,
independent contractors inspect organizations for compliance with ISO
standards.
The ISO’s Committee on Conformity Assessment (CASCO) is the ISO
representative for developing standards for the certification bodies
involved in the ISO certification process.
Current Good Manufacturing Practice
(cGMP)
cGMP is a regulation enforced by the Food and Drug Administration (FDA),
the US federal agency is responsible for safe production of drugs. The
cGMP focuses on the manufacturing process.
The product must be safe for human consumption, with quantity, quality,
and purpose taken into consideration. The output must be free from
contamination, risk, and most importantly, prevent mix-up of one product
with another product.
The FDA inspects its accredited manufacturers for cGMP compliance. If
FDA finds non-compliance with cGMP regulation and serious drug
adulteration, the manufacturer is directed to recall the product. Failure to
follow the subsequent FDA directions can result in seizure, fines, and jail
time.
ICH Guideline Q10 on Pharmaceutical
Quality System
The International Council for Harmonization of Technical Requirements
for Pharmaceuticals for Human Use (ICH) is a non-profit association under
Swiss law. The ICH comprises professionals from both the manufacturing
sector and regulatory bodies.
The ICH consists of many Pharmaceutical guidelines such as:
 Validation
 Impurities
 Risk management
These quality guidelines are designated by the combination of letter Q
and specific numbers, such as Q8, Q9, etc.
The Q10 guideline is for the Pharmaceutical Quality System.
It does not intend to establish separate enforcement for the
pharmaceutical quality systems. Instead, it provides a consolidated
structure for the quality procedures based on established standards,
including:
 ISO
 cGMP
 ICH Q8 Pharmaceutical Development
 ICH Q9 Quality Risk Management
21 CFR Part 211
21 CFR are FDA guidelines for cGMP compliance, and 21 CFR Part
211 includes the cGMP requirements for finished Pharmaceuticals.
Areas this regulation covers are the following:
 Quality control
 Qualification and skills of the personnel involved
 Quality buildings and facilities
 Ventilation and filtration system
 Process equipment
 Product labels
 Warehouse requirements
21 CFR Part 11 for Electronic Records and
Electronic Signatures
Industrial automation systems have allowed recording process variables
automatically, without human involvement. The automated recording has
the advantage of accuracy and restricts tampering of data.
The 21 CFR Part 11 is a set of rules that describes how electronic records
are developed, maintained, and stored. It describes the ways of
authorizing these documents by the relevant supervisors, alternate to
manual signatures.

Core ISO Principles of Quality

Management System (QMS)
According to the ISO, there are seven quality management principles
(QMPs).
An organization doesn’t need to adopt all of these, but it depends on the
individual organization’s process requirements.
QMP 1 – Customer Focus
The first principle focuses on the customer.
The process should be optimized enough to meet existing customers’
requirements by delivering value for their money. This keeps the
customer loyal and increases the company’s revenue by attracting new
customers. The company should remain updated on the customer needs,
expectations and complaints.
QMP 2 – Leadership
The leadership principle helps to set the organization’s direction towards
success and facilitates other people to achieve these goals. It is
responsible for setting quality goals for achieving high product quality.
It is also responsible for harmonization between all departments and
personnel through open and accessible communication. It provides
training opportunities following the latest development and regulatory
requirements.
The leadership’s role in establishing a pharmaceutical quality
management system is summarized below.
 Commitment: The leadership principle is responsible for
establishing QMS and defines the roles and responsibilities of
individuals in implementing a QMS.
 Quality Policy and Quality Planning: The leadership is responsible
for establishing, and reviewing Quality Policy in line with the
company’s direction and objectives.
 Resource Management: The leadership provides adequate
resources to implement the quality and ensures that resources are
not being misused or wasted.
  Communication: The leadership ensures effective communication
across all the departments and functions.
 Review: The leadership should review and assess the process
performance and product quality.
QMP 3 – Engagement of People
People’s engagement is necessary at all levels by recognizing and
respecting them. People can be engaged in discussion with knowledge
sharing across all levels of the employee hierarchy.
One of the effective ways to judge people’s engagement is by conducting
surveys indicating people’s satisfaction levels and their commitment to the
overall process and product quality.
QMP 4 – Process Approach
This Quality Management Principle (QMP) requires that the quality
objectives of an organization should be implemented on an individual
step rather than as an actual outcome.
It starts by defining interrelated steps that impact the performance of
each other. The system is analyzed for possible risks affecting the system
on an individual basis and as a whole.
QMP 5 – Improvement
Improvement should focus on all levels of the organization, and people
should be aware of new trends in the pharmaceutical industry mainly in
areas like regulatory affairs and product development.
The management should review QMS objectives. It should track the
performance of pharmaceutical QMS by adopting systems such as:
 CAPA
 Feedback system
 Risk assessments
 Regulatory body reports
 Supplier audits
QMP 6 – Evidence-Based Decision Making
This principle relies on the objective and realistic approach in making
decisions across various processes. Real-world processes are full of
uncertainties with vulnerabilities, creating confusion for the decision-
makers.
Before taking any decision, it is important to ensure all the data points are
accurate by evaluating these data points. People carrying out the data
analysis must be experts in using various techniques and can identify
relevant data from irrelevant information.
QMP 7 – Relationship Management
The organization’s success is directly dependent on its relationship with all
its interested parties, such as the suppliers. A good relationship creates
common goals, increases opportunities for each other, and facilitates a
healthy relationship.
Each party has a different impact level, so it’s important to prioritize the
relationship level. Start by focusing on short and long-term goals.
Collaborate with the important parties by sharing information, resources,
and expertise. Give them feedback and propose ways of improvement.

Elements of Pharmaceutical
Quality Management System
There are four elements of a Pharmaceutical Quality System. The drug
manufacturer can incorporate these elements as per product life cycle
requirements, and there is no fixed scheme for applying these elements.
The four elements are:
 Process performance and product quality monitoring system
 Corrective action and preventive action (CAPA) system
 Change management system
 Management review of process performance and product quality
Process Performance and Product Quality
Monitoring System
The process monitoring system is an integral part of an organization’s
efforts in delivering a quality product. It shows the company’s
commitment to sustained resources and control.
Risk assessment techniques can be used to detect shortcomings in-
process components. Specialized tools and feedback can also be used to
perform analysis on given parameters.
An example could be detecting faults with the inspection system in Blister
Packaging Machines. The inspection system is designed to detect empty
pockets. Sometimes external factors affect the system, such as the
accumulation of dust particles on the camera lens. In this case, the
inspection system can accept all or just some empty blisters.
The inspection system is checked randomly by both production personnel
and the Quality Department to identify faults or malfunctions.
Luckily, a tool like Issue Management Software by SimplerQMS, automates
data collection, routing, and escalation of overdue activities. This makes
the performance and safety monitoring of your products and processes
much easier.
Corrective Action and Preventive Action
(CAPA) System
Corrective Action and Preventive Action (CAPA) is a system for identifying
the causes of the fault and preventing them from recurring in the future.
The CAPA can be applied in case of complaints from both inside and
outside the organization.
The CAPA structure and CAPA form can be different from organization to
organization, but mainly it consists of the following information:
 The department where process deficiency is found
 Fault detail and its implications
 A possible effect of fault on process or product
 Corrective Action to remove the problem
 Preventive action to prevent recurrence of the fault
 Due date to implement the corrective and preventive actions
 Next review date to assess the effectiveness of corrective action
See the illustrated CAPA process below.
After necessary Corrective and Preventive actions are applied, the CAPA is
sent again to auditors for approvals. Upon approval, the CAPA is closed,
and the format is made part of the records.
For example, during a routine audit, the Job Description (JD) of one of the
employees was out of date. The auditors initiated CAPA and gave time to
make the JD available in the department. The respective department
contacted the Human Resource (HR) department regarding the JD. When
JD was available, the respective department filled the CAPA by stating the
problem and proposing corrective action to avoid a similar condition in
the future. The CAPA was presented to the auditors for approval. After
approval, the CAPA format was made part of the records presented to
regulatory bodies upon investigation.
The process presented in the example above can easily be automated
with CAPA Management Software. It automates data collection, routing,
follow-ups, notifications, approvals, and escalation of overdue activities
allowing you to manage Corrective and Preventive Actions more
effectively.
Recommended Reading: What is CAPA in the Pharmaceutical Industry?
Change Management System
Different standards such as ISO and ICH promote innovation in existing
processes to increase product quality. Pharmaceutical companies must
have Change Management System to study, monitor, adapt, and approve
the change.
If the change is implemented after regulatory filings, the change in the
respective process or procedure is submitted to the regulatory body for
review and approval, as per the regulations.
For example, the supply chain department proposes to change the
packaging size to reduce logistics costs. The quality department analyzes
the packaging requirement in light of accredited regulatory bodies and
approves the change. The engineering department analyzes the current
equipment and its system to apply the change. After approvals from these
departments supply chain orders the new packaging material size to
implement in a small number of products. When these small quantities of
products are prepared, the supply chain checks for its success and
communicates it to all relevant departments.
After approval from the supply chain, the production department updates
its standard operating procedure (SOP) and communicates it to the
Quality and Engineering department. The change is made official in
change control format, with necessary approvals from the Production,
Quality, and Engineering departments. The change is then reviewed by
higher management to made part of the company’s policy and process.
Fortunately, Change Management Software by SimplerQMS makes the
change management process a whole lot easier. It allows you to
automatically track changes to SOPs, instructions, products, and product
processes. Using the software, you can easily send changes through the
approval process, and ensure that changes are implemented.
Management Review of Process
Performance and Product Quality
Management review is a process of reviewing process and product quality
across various management hierarchy levels to escalate urgent quality
and product problems. The purpose of management review is to propose
improvements in product quality and process.
The management review includes the following:
  The commitment made to regulatory bodies
 Customer complaints
 Nonconformances
 CAPA review
 Audit findings
 Process performance
 Any pending matter or follow-up from previous management review
After the management review issues are typically escalated to improve a
specific area of business.

How to Streamline Your QMS

Processes with an eQMS
The digital revolution in manufacturing industries has paved the way for
more production with less cost and time. Digital tools can take care of
routine processes without comprising product quality, allowing the
company owners to focus more on innovation and exploring new
avenues.
The manufacturing industry is already used to digital tools such as
Computerized Maintenance Management System (CMMS) and Warehouse
Management System (WMS). These tools are effectively streamlining
processes with a proven track record, and the latest addition is Electronic
Quality Management System Software for the pharmaceutical industry or
an eQMS.
Unlike other digital tools such as CMMS, where there are no or fewer
regulatory requirements, pharmaceutical Quality Management System
Software must comply with the regulatory requirements applicable for
pharmaceutical companies. Failure to which would make such a platform
useless or even shut down manufacturing operations.
SimplerQMS provides a fully compliant Electronic Quality Management
System (eQMS) for the pharmaceutical industry. This means you don’t
have to worry about different compliance requirements or spend extra
effort to make your eQMS regulatory compliant.
The eQMS developed by SimplerQMS is built on the foundations of ISO
core principles. It is compliant with all the relevant regulatory and
standards such as cGMP, ICH Q10, 21 CFR Part 211, and 21 CFR Part 11 for
electronic records and electronic signatures.
Additionally, you don’t have to validate the eQMS against the above-stated
standards. SimplerQMS platform is pre-validated and validation proof can
easily be presented during audits or inspections.
SimplerQMS Quality Management System Software solution for
pharmaceutical companies can be easily integrated into existing software
solutions such as ERP, CMMS, and WMS. This means you do not have to
spend an extra resource or upgrade existing software systems that are
already installed without disturbing your routine operations and working.
To see SimplerQMS Quality Management Software in action and learn
how it can help your organization achieve better quality management
processes book a free demo!
Final Thoughts
The pharmaceutical industry is regulated by many regulatory and
standardization bodies with a wealth of information and skills.
Accreditation or approval of these bodies means the organization has
sufficient resources and capabilities to manufacture safe, efficient, and
quality products.
Accreditation or approval of these bodies is not an easy task. It requires
massive investment in capital, infrastructure, and the human workforce.
Furthermore, it requires the right skill, knowledge, and expertise. All this is
necessary to manufacture quality pharmaceutical products and acquire
regulatory bodies’ approval by complying with their compliance
requirements.
A digital tool like an Electronic Quality Management System (eQMS) from
SimplerQMS provides a helping hand to pharmaceutical professionals to
focus more on problem-solving rather than routine documentation
processes.