What is Quality Management system for pharmaceutical industry?

Figure:01: Pharmaceutical Quality Management System

Quality management system in pharmaceutical industry is a wide range concept, directly or indirectly influence the quality of the product. Quality management is defined as the aspect of management that determines and implements the “quality policy” i.e. overall intention and direction of an organization regarding quality as formally expressed and authorized by top management.

Quality Management of the pharmaceutical product is the prime
responsibility of the manufacturer. Manufacturing of medicinal products should
be performed with identity, quality, purity and efficacy; having objective to
ensure that products are consistently produced and controlled to the quality
standards appropriate and fit for their intended use. 

What is Quality Management system…… ?

Pharmaceutical Quality
Management system is the main component to achieve this objective. So now a
question arises what is Quality Management system?

Figure:02: Pharmaceutical Quality Management System

Pharmaceutical
Quality management system should be defined and documents appropriately. Quality
manual or equivalent document should be established by the pharmaceutical
manufacturer that defines the intentions and goal towards the quality of the
products. 

Quality manual also defines the role and responsibility of management.
Senior management has essential role to ensure an effective Pharmaceutical
Quality System is in place. This leadership should make sure the support and
commitment of staff at all levels and sites within the organization to the Pharmaceutical
Quality System.

ICH (International Conference on Harmonization) Says…..

International Conference on harmonization (ICH) guidance i.e. ICH Q10 describes a
wide-ranging model for a valuable Pharmaceutical Quality management system
(QMS) based on ISO quality concepts, includes Good manufacturing practices, Pharmaceutical
development and Quality risk management. 

This wide-ranging model of ICH Q10 for pharmaceutical quality
system can be implemented throughout the different stages of a product
life-cycle. The product life-cycle includes the following technical activities
for new and existing products; Pharmaceutical
Development, Technology transfer, commercial manufacturing and product
discontinuation.

Quality
Management System is
required within an organization to manage various activities along with the
manufacturing operations like development, marketing, purchasing, warehousing
and distribution. Therefore a quality management system is required to be
established, documented and implemented within the organization for continual
improvement.

Quality
management is the corner stone of the compliance to GMP. This is required to
ensure the consistency of the process, Quality with the continual improvement. This
is also required to ensure that adequate quality standards are followed and
maintained.

Pharmaceutical
manufacturers are operating in the environment, which is subject to constant
changes. These changes require adaptation to new situations. A system called as
QMS (Quality Management System)
helps pharmaceutical manufacturer respond to changes and be ready for the
future developments.

A
QMS enables a company to implement effective, efficient, transparent and simple
processes and structures to achieve continual compliance. In addition, this
will benefit the company’s business in terms of improved quality, optimized
costs, inspection readiness and customer satisfaction.

The
performance of the Quality Management System is the responsibility of every
person involved in all activities related to the company’s API business.

Figure:03: Elements Pharmaceutical Quality Management System

A
documentation system remains an essential component of a Quality Management
System. To run the Quality Management System it is required to define the
documentation which includes; Quality Policy, Quality Manual, Documented
procedures and Documents and records.

The
documentation created to run a Quality Management System and to comply with GMP
requirements should fulfill criteria in respect of responsibility, functionality,
feasibility and knowledge. It should be interface with other departments and
customers (if applicable).

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.