What is Pharmaceutical Quality Management System (QMS)?

We know what scares you most- the slightest thought of your drugs not meeting the quality requirements or failing to adhere to the tight government requirements, or unable to address customer demands…

Scary… Isn’t it??

Heavy penalties, legal issues, and product recalls are some of the consequences of failing in any of the above situations mentioned. And, not-to-mention, the threat to human lives. Unarguably, when it comes to pharmaceutical manufacturing, quality is of the utmost importance. It is quality and quality alone that gives patients confidence to make the next purchase. The patients expect only quality medicines that are safe and effective, and free from any contamination and defect, since it is about their life.

Any failure to create safe and effective medications or satisfy quality standards can be very costly for pharmaceutical producers, resulting in recalls, losses, and even credibility issues with their reputation. This is primarily the reason why manufacturers are constantly under intense pressure to implement the strictest standards for complete quality control in the pharmaceutical business. And, the apt solution for meeting these standards and managing the entire quality-oriented operations is Quality Management System for Pharma.

Let’s know each and every specific thing about it –

Defining Pharma Quality Management System 

A formalized system that documents pharma-related processes, procedures, and responsibilities in achieving quality policies and objectives is defined as a quality management system (QMS). A QMS helps in coordinating an organization’s operations to match customer and regulatory requirements and continuously enhance effectiveness and efficiency.

It focuses on the specific personnel and processes associated with the manufacturing of products and prevents them from straying from quality standards like ISO and ICH Q10.

In other words, it’s Pharma QMS, which ensures that the drugs or medicines manufactured are of top-grade quality, free from contamination and defects, and are safe and effective to use.

Major Quality Challenges in Pharmaceutical Manufacturing without pharma QMS

In today’s challenging business environment that involves cut-throat competition, pharma manufacturers need to make efforts to manage production ramp-up, comply with stringent quality as well as compliance regulations, and offer safe and quality products to their customers. The right blend of Pharmaceutical QMS with pharma operations can be the apt solution for the manufacturers.

Some of the challenges that might bother pharma manufacturers are listed below:

And all these in one way or other lead to quality issues!

Features of Quality Management Systems in Pharmaceutical Industry

The use of quality management systems in the pharmaceutical industry is important as it ensures that the final product meets both customer requirements and industry standards. It focuses on documentation to keep track of all problems and fixes and employs quality assurance techniques to prevent quality deviations.

Let’s know some incredible features that pharma QMS offers:

– Non-conformance – This feature can efficiently capture, manage, report, and track, non-conformances from internal/external sources, and perform root cause analysis.

– CAPA – By leveraging CAPA, pharmaceutical manufacturers can recognize quality-related issues, execute containment actions, prevent a recurrence, and evaluate the results of root cause elimination.

– Complaint Management – This function helps in managing and checking every customer complaint related to product quality throughout its entire lifespan, from investigation to resolution.

– Document Management –This feature stores, creates, tracks, retrieves, and manages all types of organizational documents all through the value chain.

– Compliance Management – Using this feature, manufacturers get a clear list of requirements, with automated alerts for potential issues, and manage regulatory compliance with ease.

– Risk Management –With risk management functionality, businesses can assess future risks and their impact, and drive continuous process improvement through risk control and mitigation.

Audit Management –Audit Management automates and streamlines the entire audit process so as to plan, schedule, and conduct audits of any kind.

Benefits of using QMS for Pharmaceutical

If properly implemented, pharma quality management software benefits all tiers of structures, methods, techniques, policies, procedures, processes, and resources, ultimately bringing obligations, schedules, relationships, contracts, and agreements into compliance with environmental, quality, and product safety standards.

Read the QMS software implementation assessment checklist, by clicking here.

How BM QualityMaster helps pharma manufacturers?

BM QualityMaster is an efficient pharmaceutical QMS that benefits businesses by establishing a quality culture through its varied set of modules that guarantees integrity, manages documents in less time and at a lower cost, develops products more quickly, easily identifies and solves problems, confirms supplier quality, and upskill workforce through efficient training.

BM QualityMaster provides the skills that organizations need to sustain quality across the product life cycle, from brand-new medicine research to post-market safety monitoring. To request a demo or for additional information, contact us by clicking here. You can also write to us at – contact@bmqualitymaster.com