Category: News & Blogs

Current Vacancy

Quality Specialist/Trainer Required We are seeking a qualified QA Specialist Trainer in the pharmaceutical industry to join our team and lead the development of training modules. In the context of importing goods or services, the role of a Responsible Person (RP) is vital for ensuring that all activities align with relevant regulations, quality standards, and […]

Application of Critical Analysis in Deviation Management- 9 reasons why

  Application of Critical Analysis in Deviation Management- 9 reasons why Introduction The Medicines & Healthcare Products Regulatory Agency (GMDP Symposium 2016) stated the common deficiencies found in deviation management systems and CAPAs as listed below: Deviations were not adequately documented and investigated, consequently the appropriate CAPAs were not implemented.   The investigations lacked the […]

Data Integrity Work Shop

I attended a work shop on Data Integrity; this is a very challenging area for majority of pharma companies, these challenges vary from company to company. This is also a major area of focus for the regulatory bodies. Embedding data integrity in pharmaceutical QMS not only instils complete confidence in pharmaceutical products by the end […]

MHRA GMDP Symposium

I will be at the MHRA GMDP Symposium event 06 & 09 December. An opportunity to share concerns and learn directly from the MHRA. The GMDP event is ideal for pharmaceutical industry professionals in quality control and quality assurance, regulatory and compliance involved in manufacturing medicines and is complemented by the GDP event which covers […]

Data Integrity: Asset or Liability

Data Integrity: Asset or Liability   Introduction Data integrity (DI) is fundamental in any pharmaceutical quality system; this ensures that medicines are of the required quality, safety and efficacy. Data integrity refers to the overall completeness, accuracy and consistency of data during its entire life cycle.  The data lifecycle considers the entire phases in the […]

The Importance of Data Integrity in Pharmaceutical Quality Management System

  The Importance of Data Integrity in Pharmaceutical Quality Management System The MHRA (2015) states  “Data integrity (DI) is fundamental in a pharmaceutical  quality  management system which ensures that medicines are of the required quality and the data governance system should be integral to the pharmaceutical quality system described in EU GMP chapter 1.” Furthermore […]