In recent years, Quality Management Systems have evolved to take advantage of more modern and efficient manufacturing technologies such as cloud computing, industrial IoT, and computer vision. As a result, manufacturers are able to gain more visibility into their production processes, enabling them to identify quality defects more effectively and respond faster than ever before.
Quality management for pharma manufacturers stands at the forefront of all production and distribution processes in this industry. After all, pharmaceutical products can potentially result in a significant, detrimental impact on the end consumer.
Ultimately, standards and regulatory bodies like the U.S. Food and Drug Administration (FDA) set strict guidelines that pharmaceutical manufacturers should follow to ensure proper quality management throughout the production process.
In this post, we’ll review quality management in the pharmaceutical manufacturing industry, exploring the various quality standards and the main features of a pharma QMS.
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What is a pharma QMS?
A pharmaceutical quality management system is a digital solution that allows manufacturers to achieve and maintain quality across the various stages of production. This category of system is specifically tailored to the processes associated with the production of pharmaceuticals, and typically includes functionality for compliance record keeping and documentation.
In addition, such a quality management system also oversees the facilities in which manufacturers make pharmaceutical products. This includes the quality of the utility systems and the equipment deployed in the manufacturing process.
Taken as a whole, a pharma QMS aims to ensure that manufacturers provide customers with a product that meets the necessary requirements while streamlining the compliance procedures associated with meeting regulatory standards.
And speaking of standards…
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Quality management system standards for the pharmaceutical industry
Whereas pharma manufacturing businesses can have internal quality parameters they strive to achieve; they also have to adhere to standards and regulations set by international and regional overseers.
Although several regulators focus on pharma product quality, they also expand their oversight into other factors like the manufacturer’s location and their target market.
The most common standards applied to the pharmaceutical industry include:
International Organization for Standardization (ISO): This organization develops and institutes various standards for manufacturers as a whole. Therefore, pharma manufacturers also adhere to these standards.
The most up-to-date standard, ISO 9001:2015, concerns itself with quality management systems, guiding manufacturers on the parameters they should focus on to meet global quality benchmarks.
Current Good Manufacturing Practice (cGMP): When it comes to U.S. jurisdiction, the FDA ensures that pharma manufacturers employ high-quality product manufacturing methods.
As a result, manufacturers ensure that their pharma products are safe for humans. In addition, cGMP guidelines direct manufacturers to eliminate contamination and drug adulteration in their production processes.
ICH Q10: The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use institutes the Q10 guideline to inform pharma manufacturers in their quest for upholding quality.
Rather than developing different guidelines, ICH Q10 emphasizes the quality standards and regulations laid out by the ISO, cGMP, and other ICH stipulations for pharma quality and risk management.
21 CFR Part 211: This standard is derived from FDA guidelines on pharma quality management. Not only does it provide instruction on quality control, but it also covers employee qualifications and skills, facility and equipment suitability as well as product labels.
21 CFR Part 11: Modern manufacturing technologies allow manufacturers to automate various processes. The 21 CFR Part 11 standard provides guidance on how pharma manufacturers should develop, maintain and store digital records and electronic signatures.
Key features of a pharma QMS
A modern system makes quality management for pharmaceutical manufacturers more manageable. To achieve this, manufacturers must ensure that their quality management system embodies the following features.
Document management: Pharma manufacturing requires extensive documentation, keeping track of all production activities and personnel involvement. An ideal pharma QMS should maintain data integrity, detailing all reviews and changes.
This provides internal quality auditors and outside regulators with an accurate picture and record of quality efforts.
Corrective and preventive action: The QMS should enable manufacturers to identify ongoing issues affecting quality in the entire production process.
Furthermore, a robust quality management system allows manufacturers to avoid potential issues, deploying preventive measures to maintain quality in the manufacturing process.
Workforce training: An ideal QMS allows pharma manufacturers to identify skill shortfalls and deficiencies among personnel. This allows the business to ramp up training programs to ensure that employees have the right skills to correctly and efficiently execute their given roles.
Digital audit log and compliance: Since modern pharma manufacturers use automated processes, they leave a digital footprint and record of all actions executed during manufacturing.
An effective quality management system allows manufacturers to audit their processes by combing through the electronic record. This ensures that pharma manufacturers meet all standards and regulations stipulated by the FDA and other bodies.
When it comes to manufacturing systems, a rigid, “one size fits all” approach is almost always a burdensome mistake, leaving businesses with few options when the time comes to introduce a new product, update processes, and scale production.
With Tulip’s app-based approach, manufacturers are able to identify the pain points and challenges specific to their quality management practices that allow them to configure and scale their QMS as they see fit.
Whether your business needs a tool for work instructions, quality inspections, batch records, line clearance, equipment logs, or anything else, Tulip can be used to build the solutions your team needs to improve your quality management processes and simplify compliance.
To learn more about how leading life sciences manufacturers are using Tulip to improve their quality management efforts, reach out to a member of our team today!
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