By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount. This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.

1. Role of Quality Systems
and audits in
pharmaceutical
manufacturing
environment
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3. Quality Management System
Formalized system that
documents processes, procedures, and
responsibilities for achieving quality
policies and objectives.
• ISO 9001:2015 Most recognized and
implemented quality management system
standard in the world.
• QMS serve many purposes, including:
 Improving processes
 Reducing waste
 Lowering costs
 Engaging staff
 Setting organization-wide direction
Principles of QMS
1. Customer Focus
2. Leadership
3. Engagement of People
4. Process Approach
5. Improvement
6. Evidence Based Decision Making
7. Relationship Management
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4. Quality Audit
Systemic and independent examination to
determine whether activities and related results comply
with planned arrangements and whether these
arrangements are implemented effectively and are suitable
to achieve objectives.
Types Of Audit
1.Internal Audits
2.External Audits
3.Regulatory Audits
Objective
• Evaluating conformity of requirements to ISO 9001.
• Evaluating conformity of documentation to ISO 9001.
• Determining effectiveness in meeting requirements and
objectives.
• Meeting any contractual or regulatory requirements for
auditing.
• To provide the Audit team with an opportunity to improve
the Quality system.
• To meet the regulatory requirement.
• To permit listing of the audited organizations Quality
systems in a register.
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5. cGMP Regulation
• cGMP regulations for the manufacture of
pharmaceutical products are contained in 21
CFR Part 210 and 211.
• Part 210 specifies the scope and applicability of
the cGMP regulations and define terms used in the
regulations
• Part 210 also indicates that the regulations
establish “ minimum” cGMP requirements
and that products that are not manufactured
under cGMP are adulterated.
• Part 211 contains specific GMP requirements for
finished pharmaceuticals and is divided into
Subparts A– K
A. Scope
B. Organization and Personnel
C. Buildings and Facilities
D. Equipment
E . Control of Components and Drug
Product Containers and Closures
F. Production and Process Controls
G. Packaging and Labeling Control
H. Holding and Distribution
I. Laboratory Controls
J. Records and Reports
K. Returned and Salvaged Drug Products
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6. Duties of Quality Control Unit under cGMP Regulations
• The cGMP regulations assign specific duties to the
quality control unit,
• Have the responsibility and authority to approve or
reject all components, drug product containers,
closures, in-process materials, packaging material,
labeling, and drug products and the authority to
review production records to assure that no errors
have occurred or, if errors have occurred, that they
have been fully investigated.
• The organization must assure that the quality
control unit has adequate laboratory facilities for
the testing and approval or rejection of
components.
• Also responsible for approving or rejecting all
procedures or specifications impacting on the
identity, strength, quality, and purity of the drug
product.
• This includes review and approval of procedures
for production and process control, including any
changes to these procedures. These procedures, and
the responsibilities and procedures applicable to
the quality control unit within the organization,
must be written and followed.
• Written procedures describing the handling of all
written and oral complaints regarding a drug
product are required.
• The review should include a determination if the
complaint represents a serious and unexpected
adverse drug experience, which is required to be
reported to the FDA. A written record of each
complaint must be maintained in a complaint file.
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7. Quality Assurance function
• Quality means the product requirements or
attributes that have a bearing on the product’s
specified requirements.
• Quality assurance activities are those processes
and activities conducted to assure that a product
or service consistently satisfies its requirements
and is fit for its intended use. In the
pharmaceutical manufacturing environment, this
means the activities conducted to assure that the
pharmaceutical product ’s identity, strength,
purity, potency, and other quality attributes
conform to approved specifications.
• Development of quality systems and risk
management approaches to better assure product
quality and fitness for use.
• Pharmaceutical product manufacturers are
increasingly interested in implementing these
approaches because they allow the manufactures
to apply newer quality management principles
that they believe enable them to more effectively
assure product quality and better allow
harmonization with evolving international
regulatory quality system requirements.
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8. Quality System Approach
• Involves a coordinated approach to the management
of quality related activities as processes that work
in conjunction with one another to provide
assurance that the product meets its specified
requirements. It involves:
• It involves:
 A management commitment to quality that is
communicated throughout the organization
 Identifying quality requirements using risk
management and other methods as appropriate
 Developing a quality policy, plan, objectives
 Establishing an organizational structure with
identified responsibilities and authorities that allows
quality objectives to be met
Providing the resources needed to meet quality
objectives
Developing the required systems and processes
Establishing methods for the ongoing objective
evaluation of the performance of systems and
processes including quality auditing
Initiating corrective and preventive actions as
needed to assure that quality objectives are
consistently and reliably met
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9. • The use of risk management techniques
 identifying product requirements,
 establishing processes and process control and
monitoring methods,
 evaluating quality data, identifying appropriate
corrective and preventive actions to address quality
problems,
 and for other quality related activities can increase the
overall efficiency and effectiveness of the quality
system.
• The FDA has recognized the value of and encourages
a risk based quality systems approach for the
manufacture of pharmaceutical products.
• In association with this initiative the FDA has
published reports and guidance documents that
collectively provide information that can be used by
pharmaceutical product manufacturers in
implementing a quality systems and risk management
approach to pharmaceutical cGMP regulations
compliance
• In implementing this initiative, the FDA has made it
clear that it does not impose new regulatory
requirements on manufacturers. The FDA has
provided information and guidance that is intended to
serve as a bridge between the 1978 regulations and
current quality systems by explaining how
manufacturers implementing such systems can do so
in full compliance with the cGMP regulations.
• .
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10. What comes under modern quality system
• In a modern quality system, the organizational unit
responsible for quality related activities within the
organization generally has a central role in the
development and management of the overall quality
system.
• These activities can include quality control, quality
assurance, quality planning, and quality improvement.
• Current quality system models involve quality related
activities and terms that are not included in the cGMP
regulations.
• Further, quality as a professional discipline is
evolving.
• It is, therefore, important for organizations adopting a
quality systems approach to unambiguously define the
terms and quality concepts they will be using and to
include these definition as appropriate in training all
staff in the organization who will be involved in
quality related activities.
• This will help assure effective communication
throughout the organization and with vendors and
others (e.g., regulatory agencies, third - party
auditors) who interact with the organization on
quality related matters.
• Regulatory definition should be recognized, and the
use of nonstandard or outdated terminology should be
avoided to the extent possible..
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11. FDA guidance on the quality systems approach to pharmaceutical cGMP regulations
(pharmaceutical QS guidance) includes the following definition:
1. Quality Assurance (QA)
Proactive and retrospective activities that
provide confidence that requirements are
fulfilled.
2. Quality Control (QC)
The steps taken during the generation of a
product or service to ensure that it meets
requirements and that the product or service is
reproducible.
3. Quality Management (QM)
Accountability for the successful
implementation of the quality system.
4. Quality System (QS)
Formalized business practices that define
management responsibilities for organizational
structure, processes, procedures, and resources
needed to fulfill product/service requirements,
customer satisfaction, and continual
improvement.
5. Quality Unit (QU)
A group organized within an organization to
promote quality in general practice.
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12. • The FDA has stressed that the release of the pharmaceutical QS
guidance document does not impose new regulatory requirements on
manufacturers but encourages manufactures to adopt a quality
systems approach to cGMP compliance because of the potential
benefits. An appropriately designed and implemented quality system
can do the following:
Reduce the number of (or prevent) recalls, returned or salvaged
products, and defective products entering the marketplace
Harmonize the cGMP regulations
When coupled with manufacturing process and product knowledge
and the use of effective risk management practices, handle many
types of changes to facilities, equipment, and processes without the
need for prior approval regulatory submissions
Shorter and fewer FDA inspections by lowering the risk of
manufacturing problems
Provide the necessary framework for implementing quality by
design.
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13. Management Responsibility
• Current quality system models assign management a
major role in the deployment and operation of a
successful quality system. In such systems, major
management responsibilities include the following:
• Provide leadership by establishing a commitment
to quality that is supported by all levels of
management and is communicated throughout the
organization
• Create an organizational structure with clearly
defined responsibilities and authorities to perform
quality functions associated with achieving quality
objectives
• Building and documenting a quality system to
meet specified quality and regulatory requirements
and achieve quality objectives
• Establishing a quality policy and objectives, and
quality plans that are aligned with the organization ’
s strategic plans and communicate this throughout
the organization
• Reviewing the system by establishing appropriate
accountability systems within the organization to
monitor and report quality data and system status
to management and assure that appropriate
corrective and preventive actions are taken in
response to quality problems using effective
change control procedures and documented
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14. Recourses
• The appropriate assignment of resources is
essential and critical in a pharmaceutical
manufacturing environment.
• Inadequate staffing, training, manufacturing
equipment and facilities, environmental controls,
analytical equipment, and other resources can be
sources of variability leading to the production of
product that does not meet specified
requirements.
• Modern quality system standards specifically
address the issue of resources by requiring the
organization to determine and provide the human,
infrastructure, and work environment resources
necessary for the quality system.
• The FDA discusses the need for adequate
resources in developing, implementing, and
managing a quality system that complies with the
cGMP regulations.
• Management is responsible for identifying
resource requirements and providing resources
accordingly, including providing training that is
appropriate to the assigned activities.
• Personnel should understand the impact of their
activities on their assigned duties and be familiar
with cGMP requirements and the organization’s
quality system.
• Current quality system models employ a risk
based and data - driven approach to the
development of QS system requirements to assure
their adequacy.
• The FDA notes that the cGMP regulations place
as much emphasis on processing equipment as
testing equipment and contain specific
requirements for the qualification, calibration,
cleaning, and maintenance of production
equipment that may be a higher standard than
most non pharmaceutical quality system models.
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15. Recourses
• The cGMP regulations require the QU to be
responsible for reviewing and approving all
initial design criteria and procedures pertaining
to facilities and equipment and any subsequent
changes.
• In the control of outsourced operations, the
cGMP regulations require that the QU approve
or reject products or services provided under a
contract.
• Under current quality system models, the
organization must follow a formal vendor
qualification process to qualify outsource
providers and verify through inspection or
other appropriate means that the provider is
capable of meeting the requirements of the
organization.
• To comply with the regulation, these
operations should be conducted by the QU.
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16. Reference
• Siegel E.B.; Barquest J.M.; et al, Pharmaceutical Manufacturing Handbook,
John Wiley Publication Pg. No. 202-212
• Kaur J. Quality audit: Introduction, types and procedure [Internet]. Pharma
Pathway; 2017. Available from: http://pharmapathway.com/quality-audit-
introductiontypes-and-procedure/.
• https://asq.org/quality-resources/quality-management-system
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17. STAY HYDRATED and BE HAPPY
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