The document discusses the role of quality management systems in the pharmaceutical industry. It outlines that implementing quality management systems like ICH Q10 helps ensure pharmaceutical companies deliver safe, high-quality products to market. ICH Q10 has three main objectives: 1) ensuring product quality, 2) establishing process control, and 3) facilitating continual improvement. It also discusses key aspects of quality management systems like quality planning, assurance, control, and improvement. Audits, corrective actions, and change control are emphasized as important parts of an effective quality system.
The document discusses the role of quality management systems in the pharmaceutical industry. It outlines that implementing quality management systems like ICH Q10 helps ensure pharmaceutical companies deliver safe, high-quality products to market. ICH Q10 has three main objectives: 1) ensuring product quality, 2) establishing process control, and 3) facilitating continual improvement. It also discusses key aspects of quality management systems like quality planning, assurance, control, and improvement. Audits, corrective actions, and change control are emphasized as important parts of an effective quality system.
The document discusses the role of quality management systems in the pharmaceutical industry. It outlines that implementing quality management systems like ICH Q10 helps ensure pharmaceutical companies deliver safe, high-quality products to market. ICH Q10 has three main objectives: 1) ensuring product quality, 2) establishing process control, and 3) facilitating continual improvement. It also discusses key aspects of quality management systems like quality planning, assurance, control, and improvement. Audits, corrective actions, and change control are emphasized as important parts of an effective quality system.
The document discusses the role of quality management systems in the pharmaceutical industry. It outlines that implementing quality management systems like ICH Q10 helps ensure pharmaceutical companies deliver safe, high-quality products to market. ICH Q10 has three main objectives: 1) ensuring product quality, 2) establishing process control, and 3) facilitating continual improvement. It also discusses key aspects of quality management systems like quality planning, assurance, control, and improvement. Audits, corrective actions, and change control are emphasized as important parts of an effective quality system.
Pharmaceutical Industry Monika khatri1, Dr. R.B bodla2, Bhargavi singh3 P P P P P
Department of Quality Assurance, Delhi institute of pharmaceutical science and research, Saket , New delhi- 10017, India E.mail: khatrimonika97@gmail.com
Abstract: Pharmaceutical industry is one of the most regulated industries. The implementation of quality
management system in pharmaceutical industry supports in imparting quality finished products
to the market. This review article elaborates about pharmaceutical quality unit, ICH Q10, its
objectives, elements and pillars. Audits, CAPA, Change control and Management review is
also discussed in this review article.
Key words : Quality management, Pharmaceutical industry, Pharmaceutical management, ICH
Q10.
Introduction
Delivering the quality and safety products to market is the foremost need of pharmaceutical
industry. Failing to its adherence can lead to credibility and brand image loss of the organization
in product recall cases. There are several regulatory agencies such as the Food and Drug
Administration, which looks upon the quality and safety aspects of pharmaceutical products.
Each pharmaceutical industry needs to adhere these standards to sell their products in the
respective country. One such standard is the International Conference on Harmonization Q10
model, which elaborates the efficient pharmaceutical quality system elements. It also emphasizes
on the management responsibility and continual improvement (Neetu Dubey, 2011).
99 IJISET - International Journal of Innovative Science, Engineering & Technology, Vol. 7 Issue 2, February 2020 ISSN (Online) 2348 – 7968 | Impact Factor (2019) – 6.248 www.ijiset.com
What is Quality in Pharmaceutical industry?
There is no single definition of quality. It can be defined by the individuals in their own ways.
The only parameter, which is common in all, is the satisfaction. The manufacturer needs a
product which meets predetermined specifications. Thus, meeting the specifications by a product
represents its quality. Pharmaceutical industry should not compromise with quality as the
humans will utilize these drug products. Thus, safety, purity, identity and quality of product is
required. Various guidelines suggest specifications and rules to be adhered by each
pharmaceutical organization. Application of quality management system elements ensures
highest possible quality level with less recall or adverse events (Percy, 2010).
To develop quality system
To describe the processes in
standard operating procedures To perform investigations generated through non- compliance activities
To inform top management
through periodic reviews To approve or reject the documents, processes and activities
To verify the quality
system compliance through To review the processes, audits documents, activities for cGMP compliance
Fig. 1 Responsibilities of a pharmaceutical quality unit
1. ICH Q10
The US, Japan and the European Union accepts the ICH Q10 model, which is recommended, but
not mandatory. Its foundation includes the ICH Q7 guideline, International Organization for
Standardization (ISO) QMS standards and regional good manufacturing practice requirements.
100 IJISET - International Journal of Innovative Science, Engineering & Technology, Vol. 7 Issue 2, February 2020 ISSN (Online) 2348 – 7968 | Impact Factor (2019) – 6.248 www.ijiset.com
An effective QMS implementation with ICH Q10 model can support in enhancement of quality
expectations. ICH Q10 implementation must have continuous improvement using innovation
throughout the product lifecycle. This can support the association between manufacturing
activities and pharmaceutical development. The ICH Q10 compliance reflects the quality
available within an organization.
1.1 Objectives of ICH Q10 model:
The ICH Q10 model has developed with three major objectives which include:
1. Product realization including system implementation, which ensures quality attribute
adherence by a product.
2. Establishment and maintenance of state of control to design and use effective system to
monitor and control product quality and process parameters. It ensures process continuation
capability.
3. Continual improvement facilitation to identify and implement various changes related with
product quality and process parameters. It also includes innovation to fulfil the quality
requirements of pharmaceutical quality system (S Sharma, 2014).
2. QMS elements:
The pharmaceutical industry involves several individuals and various activities to produce
specific products. Effective QMS system implementation ensures smooth functioning of each
process which is required to meet the regulatory compliance. The QMS directs the organization
regarding the quality parameters. It covers all the processes related with pharmaceutical industry
101 IJISET - International Journal of Innovative Science, Engineering & Technology, Vol. 7 Issue 2, February 2020 ISSN (Online) 2348 – 7968 | Impact Factor (2019) – 6.248 www.ijiset.com
such as drug sampling, objectives and policy, analysis and reporting of samples, system
procedures, etc. QMS elements includes four facets;
2.1 Quality planning
The process to include company policy into procedures, processes and instructions to get
assessable objectives and requirements.
2.2 Quality assurance
Plan the activities and its implementation as a quality system part to conform the products
manufacturing as per quality parameters.
2.3 Quality control
The process to monitor and rectify to ensure the development of quality products.
2.4 Quality improvement
Performance evaluation which also includes the systemic and methodical actions for
improvisation (Priyambada Pandey, January).
Sample retention
Formulation Product process discontinuation
Product Analytical Method storage Development
Product Quality control release and quality assurance
Fig. 2 continual improvement
102 IJISET - International Journal of Innovative Science, Engineering & Technology, Vol. 7 Issue 2, February 2020 ISSN (Online) 2348 – 7968 | Impact Factor (2019) – 6.248 www.ijiset.com
3. ICH Q10 pillars:
The pillars of Q10 are accountable for its foundation and includes:
3.1 Process performance and product quality monitoring system
a. Pharmaceutical companies must develop and execute a system to monitor product quality and
process performance to have a maintained state of control. A control strategy encouraging
effective CAPA can be developed using quality risk management.
b. QMS solution can be audits which ensure continuous monitoring and quality system tracking.
It imparts a benchmarking quality way for various product lines and processes. GMP audits can
uncover any gaps in system. It also streamlines various operations to identify the compliance
efficiency in the system.
3.2 Corrective and Preventive action system
Corrective actions can correct the non-compliant events and risk management guides to measure
those actions.
3.3 Change Management system
3.4 Management review of process performance and product quality
Application of these Q10 pillars along with additional tools by pharmaceutical companies
support in effective QMS implementation.
4. Audits
Regular audits of different operational areas and departments can be scheduled through
company’s QMS. The audit outcomes can be linked with corrective action to determine the
current compliance status of organization and improvement areas.
103 IJISET - International Journal of Innovative Science, Engineering & Technology, Vol. 7 Issue 2, February 2020 ISSN (Online) 2348 – 7968 | Impact Factor (2019) – 6.248 www.ijiset.com
The products are approved following the specification conformance through testing while
meeting the safety guidelines. The non-conformance feature in Q10 permits the tracking,
monitoring, reviewing and dispositioning of non-conforming products. A corrective action can
be directly generated through the original non-conformance in order to correct systemic issues. It
ensures the non-conformance process streamlining and enhances the end product’s safety.
5. CAPA system:
According to ICH Q10, there must be a CAPA system for complaints, product rejection, audits,
non-conformance. The investigation and determination of root causes of events can be done
through CAPA system. Corrective actions and verification of effective actions can be done using
CAPA system.
104 IJISET - International Journal of Innovative Science, Engineering & Technology, Vol. 7 Issue 2, February 2020 ISSN (Online) 2348 – 7968 | Impact Factor (2019) – 6.248 www.ijiset.com
5.1 Corresponding QMS solution – risk assessment:
The number of CAPAs can be reduced by the utilization of Risk assessment feature. It helps in
filtering out events having critical impact on the organization from that of non-critical events.
Risk mitigation tracking is incorporated under the risk assessment event which ensures the risk
reduction through corrective and preventive actions.
Risk portfolios can be built up by the companies for individual products with the continuous
improvement concept. Past adverse events history along with the risk ranking linked with each
event can be observed using risk portfolio. Pharmaceutical organizations can take assistance
from the previous risk assessment portfolios to eliminate or minimize adverse events.
6. Change Management System:
Continuous improvement of product requires changes in product lifecycle. According to ICH
Q10, each organization must have a change management system to effectively evaluate, approve
and implement the required changes.
6.1 QMS solution: Change Management
A pharmaceutical organization can start the change process through the implementation of
change management feature. The change can be the outcome of a non-conformance, a corrective
action, post-market feedback, an audit or any similar quality incident. Quality data can be taken
and incorporated into project plan for change management (Gaurav Pratap Singh Jadaun, 2015).
7. Management review:
Management reviews ensure the effectively management of process performance and product
quality throughout the lifecycle. It also imparts assurance that the quality and compliance is
105 IJISET - International Journal of Innovative Science, Engineering & Technology, Vol. 7 Issue 2, February 2020 ISSN (Online) 2348 – 7968 | Impact Factor (2019) – 6.248 www.ijiset.com
completely met by the organization. Management reviews is a medium through which senior
management can be aware about the quality concerns on timely basis.
7.1 Corresponding QMS solution: Reporting system
There is a huge data available in QMS related to corrective actions, audits, non-conformance,
adverse events, etc. There can be missing links on continuous improvement in the absence of
clear mode to evaluate the data. It can lead in delaying of management’s decision-making
abilities.
Reporting system feature supports the organization to better understand the quality challenges
and take effective decisions to produce quality and safe products. It can assist in problem
isolation, progress tracking, result comparison, summarization and data analysis.
7.1.1 Automated systems
Various inherited benefits can be achieved using automated QMS systems such as process
streamlining with maximum efficiency. Some of the major benefits include:
Scalability: Each Pharmaceutical organization is not limited to only one facility. Various
facilities are available at different sites. An effective QMS must impart the processes which can
fulfill the needs of each facility through a common platform available at corporate location.
Flexibility: The system must be flexible enough to adapt to business processes. The seamless
change and improvisation can be effectively done using automated QMS system. A centralized
administrative feature can assist in effective QMS functioning of various departments,
operational areas, and specific business processes (Percy, 2010).
106 IJISET - International Journal of Innovative Science, Engineering & Technology, Vol. 7 Issue 2, February 2020 ISSN (Online) 2348 – 7968 | Impact Factor (2019) – 6.248 www.ijiset.com
Conclusion
An effective pharmaceutical QMS can be achieved specifically through Q10 guideline
implementation. Adoption of ICH Q10 though, not mandatory, can permit a pharmaceutical
organization to comply and continuously improve with the regulations.
The major Q10 elements and specific points to implement QMS features have been
elucidated in this article. The discussion and application of four QMS pillars- process and
product monitoring system, CAPA, change management system and management review are
also covered.
References
1. Lachman L, Hanna SA, Lin K Quality control and assurance. The Theory and Practice of Industrial Pharmacy. 2nd Edn, Varghese Publishing House, Bombay, India, 1976, pp. 804-855. 2. Q10 Pharmaceutical Quality System , U.S. Department of Health and Human Services Food and Drug Administration Centre for Drug Evaluation and Research (CDER) Centre for Biologics Evaluation and Research (CBER) , 2009; 2-19. 3. Gaurav Pratap Singh Jadaun, H. K. Quality Management System in Testing Laboratories. Journal of Pharmaceutical Quality Assurance, 2015,53-56. 4. Neetu Dubey, H. G. . Pharmaceutical Quality Management System: Current Concept . Journal of Advanced Pharmacy Education & Research,2011, 120-124. 5. Percy, B. . Best Practices of a Pharmaceutical Quality Management System . Informa UK Limited, 2010 6. Priyambada Pandey, A. G. (January). Quality Management System in Drug Industry: A Review. Biomedical Journal of Scientific & Technical Research, 2018. 7. S Sharma, R. B. . Pharmaceutical Quality Management System: A review. International Journal of Drug Regulatory Affairs, 2014, 67-78.
