Pharmaceutical Regulatory Compliance
Regulatory bodies such as Medicines and Healthcare Products Regulatory Agency (MHRA), the US Department of Food and Drug Administration (FDA), the European Medicines Agency (EMEA), the Therapeutic Goods Administration (TGA) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), demand that Standard Operating Procedures are maintained and easily accessed across the organisation.
Organisations such as Reckitt Benckiser, Sanofi-Aventis and Reading Scientific Services Limited (RSSL), use Q-Pulse to help achieve regulatory compliance, improve the management of their compliance processes and information, and increase overall business efficiency.
"Q-Pulse has allowed us to look at ways and areas where we can improve, developing the business. It allows us to keep our customers satisfied with our services while maintaining levels of quality they have come to expect."
— Erik Paulsen, Quality Co-ordinator at Fresenius Kabi
Going Beyond GMP - assuring quality in the generic drug industry
For the pharmaceutical industry, the loss of revenue resulting from patent expiration – the so-called ‘patent cliff’ – has forced a shift in strategy, with pharmaceutical companies seeking to replace lost sales from drugs coming off patent by making changes to their business models.
Among the changes are: broadening product ranges or strengthening portfolios by acquiring generics producers; targeting emerging markets or areas of high growth in which patents have expired; as well as cutting costs associated with either developing innovative drugs or producing generics.
But for any of these shifts in strategy to succeed, pharmaceutical companies must be able to offer safe, effective products that are of high quality. By assuring the quality, safety and efficacy of drug products, companies can build reputation in markets and build trust with consumers.
Our white paper - Going Beyond GMP - looks at how generic pharmaceutical companies can augment GMP processes with a QMS solution to establish a framework to build market reputation, build consumer trust and increase revenue.
Ensure Data Integrity
"Good science is based on reliable observation and the data can only be relied upon if scientists are open and honest. People in the UK generally trust science because they know that experimentation is the most reliable route to knowledge. Anything that could be seen to jeopardise both the process and the trust it engenders is dangerous and needs to be rooted out."
— Sir Paul Nurse, President of the Royal Society
Data integrity is a high profile issue in the Life Sciences industry globally, partly as a result of enforcements, overseas inspections and criminal prosecutions instigated by FDA, MHRA and other European regulatory authorities.
Data integrity issues affect pharmaceutical companies everywhere. The majority of cases are caused by inefficient and fragmented business processes rather than deliberate fraud, most are captured by internal inspection and audit processes within the business and, therefore, remain buried and never come to light. However, to protect themselves from exposure to the risk of non-compliance with data integrity norms and laws such as the Food and Drug Administration Safety and Innovation Act (FDASIA), Drug Quality and Security Act (DQSA) and EU GMP, organisations must implement a risk based quality management system that drives constant improvement in product and process reliability. Helping them;
- Modernise operational processes
- Improve the overall performance of your organisation
- Reduce the risk of non-compliance
- Prevent failures and damage
- Protect your corporate, professional and personal reputation.
Check out our 'White Paper, A Nudge in the Right Direction', which discusses a systematic approach to compliance management in the laboratory.
Feeling overwhelmed by your validation requirements? Ideagen and Q-Pulse can help:
- Align your validation plan to your configured Q-Pulse system
- Customise validation content into documents which suit your internal processes and requirements
- Make an informed decision on the level of validation testing your organisation needs to perform
- Significant reduction of the time, effort and cost of your validation activities
- Maintain your validation status against any future system changes
- Develop a validation plan specific to your organisation to achieve compliance with your key regulatory requirements, including the FDA 21 CFR Part 11 and Part 820; and EudraLex Volume 4, Annex 11.