Quality Management System(QMS) in Pharmaceutical Industry

Quality Management System (QMS) in pharmaceutical industry  Course Details

Class -1: Introduction on QMS

Class -2: Discussion on deviation handling

Class-3: Discussion on Out of specifications and out of trends

Class-4: Discussion on Change control handling

Class-5: Discussion on handling of market complaints

Class-6: Root cause investigation and methodologies 1

Class-7: Root cause investigation and methodologies 2

Class-8: Risk management

Class-9: Corrective actions and preventive actions and Effectiveness monitoring

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 which the manufacturer is obliged to follow.

It uses monitoring methods such as Quality Assurance to prevent quality deviation and emphasizes quality system documentation to record all problems and their solutions.

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.

Role of Quality Management System (QMS) in the Pharmaceutical Industry

In the Pharmaceutical Industry, the Quality Management system (QMS) is an important aspect as the quality of the pharmaceutical products or the drugs is very critical and important as it defines the quality, purity, meeting specification, and safety which is finally involved when it is related to about life and in demand of today’s scenario. Quality management system in the pharmaceutical industry is a continuous, innovative, and documented process that plays an important role because of the criticality of the various functions involved and also opting for quality management system software.

The quality management systems process starts from the very initial stage of manufacturing which can help to manage all the work records, flows, and various processes in a definite order which will eventually improve overall product quality. To maintain a quality system in pharmaceutical products with internationally harmonized guidance ICH Q10 describes a model for an effective pharmaceutical quality system that governs the concept of the current pharmaceutical quality management system. ICH Q10 and its implementation for the industry is an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of health and throughout the product lifecycle to facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.

Importance of Quality Management system (QMS)

The quality Management system has significantly impacted the Pharmaceutical market globally and had made significant changes in the pharmaceutical Industry. ICHQ10 guideline to be applied in a way that is appropriate and proportionate to each of the product lifecycle stages which help as the supporting systems for the development and manufacture of pharmaceutical drug substances, active pharmaceutical ingredients (APIs)) and drug products, including biotechnology and biological products.

For pharmaceutical companies to have efficient quality management systems should have control of the processes from the initial stages i.e. selection of raw materials which are to be used to manufacture the final product as this will help to control the impurities at the initial level and would help to have control on the quality of the final product from the starting stage. Further, the assessment of the product is very important to have a good quality management system to analyze the product before it gets approved as it helps to have the final checklist for the materials and the processes in line.

The quality management system QMS also ensures that all the products manufactured and supplied are as per the regulatory standards as it allows the check on all parameters of the products which confirms their quality and are as per the regulatory compliance. Pharmaceutical industries have the QMS software which helps with the scheduled follow-up for every defined checklist to the final product which strictly adheres to regulatory compliance, also the selection of the raw materials, its quality, supply schedule, time delivery, vendor approval, etc. The QMS software also helps the pharmaceuticals to have product investigation which is another important aspect to have proper quality products.

The Quality management system helps the companies to have a corrective action plan and also preventive measures which further help the pharmaceutical industry to identify the resources which are affecting the processes and also the quality of products and further help in improvement to reduce the possible variations. Quality management systems for the pharmaceutical industry are a tool to measure, to have controlled parameters that leads to quality product, perfect design for the process development, and finally leads to meeting the customer specification.

The quality management system helps in assuring quality and into its processes, objectives, and the required parameters like monitoring, corrections, process, and product to achieve the quality of the product. The QMS in pharmaceuticals helps manufacturers to perform the root cause analysis and with corrective and preventive action plans helps to take actions for the queries and issues raised by the customer and can be noted for future audits, reviews, inspections, and self-inspections. QMS in a way helps the organization to have a strong module that manages the total workflow in the operations like schedules, preparations, continuous tracking, and updating for the entire year.

QMS is followed and applicable for all pharmaceutical development like commercial plant manufacturing, control of materials, utilities, equipment, process development, plant scale-up, analytical method development, Active pharmaceutical ingredients (API), Impurity isolation and detection, drug product, biotechnology, and the biology products, which includes the pharmaceutical development, analytical development, manufacturing process, and the technology transfer and finally includes the Quality control, quality assurance, and distribution, etc. QMS will definitely help the organization to improve, reduces errors, and costs, identification, and supports resolving the issue at the earliest.

Quality Management system (QMS) in the pharmaceutical industry is a systematic approach as it is needed to maintain the quality throughout the process flow when it is considered in the context of Pharma and quality. QMS is an important aspect as the quality of the pharmaceutical products or the drugs are very critical and important as it defines the purity, meeting specification, and safety which finally involves when it is related to life and demand of today’s scenario. Quality management in the pharmaceutical industry is very important because of the criticality of the various functions from the initial stage of manufacturing to the final product. QMS is the requirement of today and cannot be avoided.

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