Quality management system (QMS) is the linking system between customer requirement and customer satisfactions. Universal goal of quality system is the consistent manufacturing of safe and effective products.
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| Quality management system |
As per ICH Q10 : management responsibility,
Continual improvement of process performance, continual improvement of product
quality and continual improvement of pharmaceutical quality system via
management review are the key components of the pharmaceutical quality management system.
What
are the Elements of Quality management system?
Quality
management system is having four arms by which it runs; each part having
similar king of Impact on the development and run of Quality management system.
- Management
Responsibility - Resource
management - Product
realization - Measurement,
analysis and improvement
Management
responsibility
Management responsibility is one of the essential elements of
Pharmaceutical Quality management system,
WHO says Quality management system
should facilitate senior management / Top management to achieve quality
objectives set by the management in the form of quality policy.
✅It
is responsibility of top management of the firm to manage the design, Implementation and management of the quality system, with the combination of
good manufacturing practices and good business practices.
✅ Leadership
should show strong and visible support for the quality system and ensure its
implementation throughout the organization.
✅ Organizational structure is important to identify the
problems and apply the rectifications.
✅ Quality
system building is required to ensure the compliance with the good
manufacturing regulations developed by the various regulatory authorities; this
includes Change procedure, Document control procedure, scientifically sound and
appropriate written controls for Operating procedures, Test specification,
plans.
✅ Establishment
of policies and procedures to run the quality system is the best way to
articulate the vision on management towards quality to all levels of the organization.
✅ A strong commitment to quality is required by the management in the
organization that could be defined as a Quality Policy.
✅ Management
review system; any system seeks a robust review system to run effectively and
adequately. Hence, for an effective quality system it is required to review
performance of the system by top management with a planned schedule.
✅ Management
quality system review strategy should includes; Product review, process review,
customer requirement.
Quality
Metrics data evaluation can be the best way to review the Quality system by the
management; FDA (US) published Draft guidance on the same Learn More..
Why
Quality management system review is required?
Review
of quality system benefits to the quality
system;
🅰 To
improve the quality system.
🅱 To
improve manufacturing process and products as per the customer and regulatory
requirements.
🅲 Rearrangement
of the resources.
Resource
Management
Resource
allocation and management helps to develop a Quality Management system with the established quality goals and to
run quality system complying the good manufacturing practice regulations.
🔅 Sufficient
resource should be allocated for quality system and operational activities.
🔅 Skilled
personals are the backbone of quality system, personals those are part of the
quality system should be qualifies to perform the operations those are
allocated to them.
🔅 Identification
and selection of the personal should be done based on their scientific and
technical knowledge, technical understanding, and product and process
knowledge.
🔅 Continued
training is critical component to ensure that the employee remain proficient
with respect to the current Good Manufacturing practices requirements. Training
should be focused on function specific and related regulatory requirements.
🔅 Facility
and equipment are the main technical resources of an organization as well as
for quality management system.
🔅 Technical
resources also includes technical man power like engineers, development
scientists etc. those understand the technical problems, risk factors and the
manufacturing process related to the products.
🔅 Technical
resource like facility, equipment should be qualified, calibrated, cleaned and
well maintained as well, this is important for the intended product identity,
strength, quality and purity.
Product
realization
Management
is having responsibility to review the product and its performance over the time
of periods;
🔅 A
product developed by the manufacturer should define / introduced from the
design stage to delivery stage. Process of designing includes development of
the product and process which should be documented in terms of responsibility
for designing or changing products.
🔅 Quality
management system includes
documentation of the products includes its life history as well, i.e.
designing, development, manufacturing, Quality controls, monitoring, validation,
Product stability, packaging, Storage, product distribution etc. QMS approach
starts from the starting material to end product. Input material examination
also includes supplier verification along with the supplied material quality.
🔅 Each
and every material being used for the manufacturing of the product is having
significant amount of impact on the quality of the end product. Hence, Quality
of the input material must be in-line to the product or process requirement
designed during the development.
🔅 Various
Regulatory Agencies all over the world
suggest Supplier qualification and
periodic audit of supplier. An audit should also include a systematic
examination of the supplier’s quality system to ensure that reliability is
maintained.
🔅 In
a robust quality system, production and process controls should be designed to
ensure that the finished products have the identity, strength, quality, and
purity they purport or are represented to possess.
🔅 Process
performance need to be monitored during the manufacturing with the established
manufacturing process. Under a quality system, written procedures should be
followed and deviations from them should be justified and documented to ensure
that the manufacturer can trace the history of the product.
🔅 Discrepancies
may be detected during any stage of the process or during quality control
activities. Not all discrepancies will result in product defects; however, it
is important to document and handle discrepancies appropriately.
🔅 A
discrepancy investigation process is critical when a discrepancy is found that
affects product quality. Hence, it is important to acknowledge the non
conformance.
Documentation
process could be helpful to the management for the review of product, process
performance over the time of periods.
Evaluation
process for Continual improvement of process performance
Various
parameters are there to ensure the continual improvement of the process like;
🔅 Quality
Management system
approaches defined continually monitoring trends and improving systems. This
can be achieved by monitoring data and information, identifying and resolving
problems, and anticipating and preventing problems. Trending analyses can help
focus internal audits.
🔅 Internal audit at
planned intervals is required to evaluate effective implementation and
maintenance of the quality system. Effective decision-making in a quality
systems environment is based on an informed understanding of quality issues.
🔅 Elements
of risk should be considered relative to intended use of a product. Risk
management is used as a tool in the quality
management system for development of product specifications and critical
process parameters.
🔅 Corrective
action can be taken for system / process improvement with respect to the
identified risk. It is essential to determine what actions will reduce the
likelihood of a problem recurring.
🔅 Preventive
action should be evaluated and recorded, and the system should be monitored for
the effectiveness of the action. Problems can be anticipated and their
occurrence prevented by reviewing data and analyzing risks associated with
operational and quality system processes, and by keeping abreast of changes in
scientific developments and regulatory requirements.
Final
wards; Implementation
of the Quality Management System (QMS) approaches as defined in the various
regulatory agencies may help to get the desired quality of the product as well
it helps to achieve the goal i.e. “Customer Satisfaction” as per the “Customer
Requirement”.