Quality in the Pharmaceutical Industry- A Literature Review Reham M. Haleem, Maissa Y. Salem, Faten A. Fatahallah, Laila E. Abdelfattah PII: S1319-0164(13)00111-4 Our team of highly qualified and experienced technical staff will work with you to develop and deliver testing and analytical solutions to add value to your product or project. While some aspects of the pharmaceutical quality system can be company-wide and others site-specific, the effectiveness of the pharmaceutical quality system is normally demonstrated at the site level.
The quality of pharmaceuticals has been a concern of the World Health Organization (WHO) since its inception. ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Standards Organisation (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”. By Jan Paul Zonnenberg, Pharmaceutical and Life Sciences Consulting Partner, PwC. Senior managers in the drug industry are responsible for the effectiveness of this system, which is known as the Pharmaceutical Quality System (PQS). The pharmaceutical industry has proposed fitness for use —meaning that the drug meets its prespec- ified quality attributes or regulatory specifications. An efficient system can help manage all the records, workflows, and processes in a certain order that will eventually improve overall product quality. B. 4.

CI and QbD. Pharmaceutical companies describe quality as being one of the make or break factors in the success of the company as a whole. Quality Policy (a) Senior management should establish a quality policy that describes the overall intentions and direction of the company related to quality. Pharmaceutical Quality Control Testing Lucideon's pharmaceutical quality control testing and validation laboratories are fitted with state-of-the-art analytical equipment and testing facilities. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality Policies The FDA initiated the drive for continuous improvement in the pharmaceutical industry in 2004, attempting to unite the industry in a drive for better business practices, and more streamlined enterprises; reducing waste and recognizing opportunities.. Mar 21, 2018 Quality Coordinator Specialist November 2006 to May 2007 Bausch and Lomb Pharmaceutical － Tampa, FL. Also explains and justify why the regulations need to be followed and why others are not followed in the pharmaceutical industry. Quality: Today, many within the industry think of the terms quality and compliance as interchangeable.
At PwC, we, however, believe that quality is much more than compliance and … Pilgrim’s solutions for a quality management system software for the Pharmaceutical industry are developed on SmartSolve's Platform for Compliance. This notion is derived from the fact that a high-quality product, which is produced from the highest quality ingredients will yield better results which are desired by both the prescriber and the buyer. IT Management / Smart Industry Improving Digital Quality in the Pharmaceutical Industry Technology is helping to de-mystify the digital landscape and drive quality throughout the product life cycle. How the quality manual will be used in the pharmaceutical industry to ensure the quality management is achieved within some set regulations in time. The setting of global standards is requested in Article 2 … pharmaceutical quality system should incorporate appropriate risk management principles. (b) The quality policy should include an expectation to comply with applicable regulatory requirements and should facilitate continual improvement of the pharmaceutical quality system. Since the world has gathered together to harmonize its practices and guides and the launching of the FDA current good manufacturing practices – the cGMP; for the 21st century – there has been a growing awareness for the significance of the quality of the pharmaceutical products ( Woodcock, 2004 ). Performed In-Process inspection and released filling and packaging operation Monitored and conducted GMP compliance inspections and audits of manufacturing and packaging area (including compounding, aseptic core and pharmacy areas) Provided support to quality investigations. First, we need to define quality, digital and AI. Opting for a pharmaceutical quality management software for Pharmaceutical industry is a considerable decision when it comes to the life of an individual. SmartSolve's Platform Services , Enterprise Integration , and Configuration Tools make it easy to extend workflows and forms, integrate processes, and tailor capabilities as the demands on your pharmaceutical quality management system grow.

matters that individually or collectively influence the quality of a product.