Process Analytical Technology and embedding quality
The conventional approach for pharmaceutical manufacturing long-cantered on batch processing with laboratory testing conducted on collected samples to evaluate quality. This is mostly based upon agreeing how a process will be conducted in advance and then evaluating the success or failure of this through end product testing. In contrast, the Process Analytical Technology (PAT) concept […]
Quality metrics
By applying metrics consistently within the organization, companies can set up systems for monitoring and control which can help to reduce the likelihood of quality incidents from happening. The application of quality tracking can assist the organization to be more in control of its people, products, and processes. Many manufacturing establishments currently use quality metrics […]
Good Distribution Practice
Good Distribution Practice (GDP) concerns the distribution processes for pharmaceutical products that results in medics and patients obtaining access to the medications required. For the pharmaceutical organization, the distribution process occurs both upstream and downstream. Upstream are the suppliers who create goods and services used in a manufacturer’s own operations, such as raw components or […]
Data integrity
Data Integrity is a significant component of the Quality Management System; hence manufacturers should understand data integrity concerns and extend assessments of data integrity (including audit trails) to the audit of any computerized system. Data integrity is applied to maintaining and assuring the accuracy and consistency of data over its entire life-cycle. In this sense, […]
Quality Management Review
Many organizations have formal Quality Management Reviews, which take place periodically and where data is reviewed by senior management. The object most Quality Management Reviews is to provide an overview of the results from the Quality Control and Quality Assurance functions. The review forms part of an organization’s Quality Management Systems (such as is detailed […]
Application of risk management for organisation quality
Risk assessment forms a key component of any risk management program. Risk analysis and risk evaluation together represent the two fundamental parts of the risk assessment phase of a risk management process cycle. The assessment of risk involves either the quantitative or qualitative determination of one or more risks. Risks are generally recognized as being […]
Pharmaceutical Quality Management Systems
A quality management system is abroad term with meanings varying according to the type of business. In general terms, the ‘Quality Management System’ (QMS) is a collection of business processes that focus on the quality of a product and with customer satisfaction (something that extends to patient safety in the GMP context). To be effective […]
Auditing
To ensure that quality is maintained throughout the pharmaceutical or healthcare organization, frequent audits, both internal and external, are required to assess the quality and effectiveness of the processes, systems, and personnel employed by the company. Audits are an important part of quality assurance and the quality management system. In essence, the audit verifies the […]
Nitrosamines
The European Medicines Agency (EMA) has published the sixth revision of the Appendix 1 (“Acceptable intakes (AIs) established for N-nitrosamines”) of the EMA Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products (EMA/409815/2020 Rev.21). Nitrosamines are […]
Artificial intelligence
The EMA has published guiding principles that set how EU medicine regulators can use large language models (LLMs), a form of generative AI, focusing on text generation in regulatory science and for regulatory activities. Artificial intelligence is a general term referring to any machine-based system designed to operate with varying levels of autonomy and that […]