Since the inception of the FDA´s Quality by Design (QbD) initiative, quality control processes are changing.
Gone are the days of manufacturing drugs and checking them for quality at the end of the "assembly line." Instead, the concept of quality control is a bit deeper. In fact, today´s concept of quality control is founded on the belief that experts who are more highly educated, more mechanically oriented/trained and more able to support continuous quality control tasks--or in other words—tasks that are performed throughout the creation of the product itself, will convert final quality controls to continuous quality controls.
Get Educated
It only takes a casual Internet search to realize how imminent a new age of quality control has become. Take for example a book advertised on the amazon.com site (i.e. Quality Through Design: Experimental Design, Off-line Quality Control, and Taguchi's Contributions) and consider its online description:
"Pioneered by Taguchi, these methods [quality control techniques] combine off-line product/process optimization and quality cost containment with appropriate statistical techniques for
experimental design and analysis. The idea is to build quality into both the product and into the manufacturing process at a pre-production stage--at the point of product development and process design."1
In other words, it is essential that quality is built into a product before a product even exists and that quality control techniques encompass not only product testing but process optimizations.
Producing this type of pre-product knowledge (essentially they are educated predictions) obviously requires specialized knowledge and talents from designers and even manufacturers. Take for example a quotation from a ngpharma.com article:
"Within QbD, processes are understood at a mechanistic level, design reflects this knowledge and quality is inherent in the product. This design incorporates knowledge of the product and the process to ensure all critical quality parameters are adequately controlled."2
Get Mechanical
One aspect of "getting mechanical" is finding those designers and other required personnel who can visualize the mechanics of a product before it is created. This of course can be difficult but express training and the consideration of new personnel with these strong visualization skills may help many pharma companies move in the direction of QbD processing.
Other quality control techniques will still include product-based testing but will become continuous as expensive and wasteful batch processing practices are done away with. Calibration practices will continue but calibration information will hopefully be automated within an automated quality system framework. This of course will require software. Pharma companies should consider seriously those software providers that can provide an integrated--and automated--quality management system that provides solutions for document control, change control, audits, CAPA (Corrective and Preventative Action), training, customer complaints management, etc.
Pharma companies will also find that adhering to PAT (Process Analysis Technology) systems will help them to adhere with current FDA regulations. The fda.gov website says the following in regard to PAT:
"The goal of PAT is to understand and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be tested into products; it should be built-in or should be by design."3
Conclusion
Education, the "mechanics of thinking" and the FDA´s support of PAT should all be information that pharmaceutical companies take seriously as they encourage the use of continuous processing and more effective quality control.
1 amazon.com/Quality-Through-Design-Contributions-Manufacturing/dp/0198519931
2 ngpharma.com/pastissue/article.asp?art=25536&issue=143#top
3 fda.gov/Cder/OPS/pat.htm#Introduction
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regard to quality control and calibration software, please feel free to contact a MasterControl representative.
Gone are the days of manufacturing drugs and checking them for quality at the end of the "assembly line." Instead, the concept of quality control is a bit deeper. In fact, today´s concept of quality control is founded on the belief that experts who are more highly educated, more mechanically oriented/trained and more able to support continuous quality control tasks--or in other words—tasks that are performed throughout the creation of the product itself, will convert final quality controls to continuous quality controls.
Get Educated
It only takes a casual Internet search to realize how imminent a new age of quality control has become. Take for example a book advertised on the amazon.com site (i.e. Quality Through Design: Experimental Design, Off-line Quality Control, and Taguchi's Contributions) and consider its online description:
"Pioneered by Taguchi, these methods [quality control techniques] combine off-line product/process optimization and quality cost containment with appropriate statistical techniques for
experimental design and analysis. The idea is to build quality into both the product and into the manufacturing process at a pre-production stage--at the point of product development and process design."1
In other words, it is essential that quality is built into a product before a product even exists and that quality control techniques encompass not only product testing but process optimizations.
Producing this type of pre-product knowledge (essentially they are educated predictions) obviously requires specialized knowledge and talents from designers and even manufacturers. Take for example a quotation from a ngpharma.com article:
"Within QbD, processes are understood at a mechanistic level, design reflects this knowledge and quality is inherent in the product. This design incorporates knowledge of the product and the process to ensure all critical quality parameters are adequately controlled."2
Get Mechanical
One aspect of "getting mechanical" is finding those designers and other required personnel who can visualize the mechanics of a product before it is created. This of course can be difficult but express training and the consideration of new personnel with these strong visualization skills may help many pharma companies move in the direction of QbD processing.
Other quality control techniques will still include product-based testing but will become continuous as expensive and wasteful batch processing practices are done away with. Calibration practices will continue but calibration information will hopefully be automated within an automated quality system framework. This of course will require software. Pharma companies should consider seriously those software providers that can provide an integrated--and automated--quality management system that provides solutions for document control, change control, audits, CAPA (Corrective and Preventative Action), training, customer complaints management, etc.
Pharma companies will also find that adhering to PAT (Process Analysis Technology) systems will help them to adhere with current FDA regulations. The fda.gov website says the following in regard to PAT:
"The goal of PAT is to understand and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be tested into products; it should be built-in or should be by design."3
Conclusion
Education, the "mechanics of thinking" and the FDA´s support of PAT should all be information that pharmaceutical companies take seriously as they encourage the use of continuous processing and more effective quality control.
1 amazon.com/Quality-Through-Design-Contributions-Manufacturing/dp/0198519931
2 ngpharma.com/pastissue/article.asp?art=25536&issue=143#top
3 fda.gov/Cder/OPS/pat.htm#Introduction
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regard to quality control and calibration software, please feel free to contact a MasterControl representative.
