PJI Biotech 

PJI Biotech

  Strategic Quality and Regulatory Management Consulting


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China issues the rule of accepting overseas clinical trial data of drugs

Posted on October 26, 2018 at 12:45 AM Comments comments (0)
The China National Drug Administration issued the Guiding Technical Principles for the Acceptance of Overseas Clinical Trial Data of Drugs (Principles) on 10 July 2018, which standardize the rule of accepting the overseas clinical trial data of drugs. According to the Principles, overseas clinical trial data provided by applicants for drug registration in China shall be complete, correct, true and traceable. The process of obtaining the overseas clinical trial data shall comply with both the Go... Read Full Post »

Out of Specification (OOS) Results and Trending Program

Posted on October 26, 2018 at 12:45 AM Comments comments (0)
MHRA guidance for handling OOS results was recently updated and is available on MHRA website. FDA guidance for handling of OOS was initially issued in 1998 as draft and was finally issued in 2006. MHRA guidance on handling OOS results was initially published in 2013 and was updated to add handling of microbiological OOS. MHRA guidance is complementary to FDA guidance and provides flowcharts for OOS investigations. There are 3 phases of an OOS investigation. During Phase 1 and 2, investigation i... Read Full Post »

Brexit on Horizon

Posted on October 26, 2018 at 12:45 AM Comments comments (0)
We have been hearing about Brexit for quite some time. Brexit is impacting the life science industry in the UK and EU in several ways but mainly by causing regulatory uncertainty and patient access to medicine or supply chain impact. EMA issued a guidance on 24 November 2017, for market authorization holders to transfer current UK based market authorizations (MA) to different legal entity in EEA, which needs to be completed by March 2019. The MHRA position will be clear after further negotiat... Read Full Post »

Change Management

Posted on October 26, 2018 at 12:40 AM Comments comments (0)
Change Management is a critical quality system during the drug development and commercial phase of a pharmaceutical product. Post-approval changes are first categorized as minor, moderate and major based on product quality, product efficacy and patient safety risk. The second is risk-based categorization of regulatory communication as prior approval supplement (PAS) or notification. Any changes to established conditions (EC) in common technical document (CTD) necessitates submission to regulator... Read Full Post »

Regulatory and Quality Intelligence

Posted on October 26, 2018 at 12:30 AM Comments comments (0)
An organization's ability to learn, and translate that learning into action rapidly, is the ultimate competitive advantage. Jack Welch There are 4 key attributes of successful compliant companies. 1. Rigorous internal audit program 2. Effective CAPA 3. Robust quality and regulatory intelligence system that provid... Read Full Post »

Data Integrity

Posted on February 7, 2018 at 11:35 AM Comments comments (0)
Regulators around the globe have issued guidances on data integrity in last five years (1-5). This is not something new. Guidances have been in place since drug development started. However, it has surfaced as a key issue in the last five years during regulatory inspections of raw materials and drug suppliers overseas. In simple terms, data (paper or electronic) should be complete, consistent and accurate throughout the data life cycle, i.e. from raw data generation and recording through use, m... Read Full Post »

Brexit and Pharma Industry

Posted on February 6, 2018 at 7:50 AM Comments comments (0)
The United Kingdom decided to withdraw from the European Union on 23 June, 2016. The two-year process of leaving the EU on 29 March, 2019 was triggered on 29 March, 2017. Medicines and Healthcare Products Regulatory Agency (MHRA) issued an updated briefing to pharmaceutical companies in January 2018, indicating that current regulatory relationship remains unaffected. The UK will continue to be full member state until March 2019 and will fulfill its responsibilities as a member state until th... Read Full Post »

Mutual Recognition of Inspections between EU and US Authorities

Posted on January 22, 2018 at 9:35 AM Comments comments (1)
The European Union (EU) authorities and the Food and Drug Administration (FDA) signed the mutual recognition agreement (MRA) in February 2017, which enters into force on 01 November, 2017. The agreement is an annex to the EU-US MRA, which was signed in 1998 but is not yet implemented. This MRA will allow EU and US regulators to rely on each other GMP inspections and share inspection outcomes. Additionally, after transition phase, it will waive any requirements for importation batch release t... Read Full Post »

Emerging FDA Drug Inspection Trends in 2016

Posted on January 31, 2017 at 9:55 AM Comments comments (1)
Regulatory observations (483) over past years has forced quality executives to be on their toes. The top 5 key issues for 2016 are related to inadequate procedures and investigations, laboratory controls and aseptic processing. 1. Procedures not in writing and fully followed. 2. Lack of scientifically sound laboratory controls. 3. Thorough investigation of discrepancies and failures. 4. Absence of written procedures. 5. Deficient environmental monitoring system. How can these be preven... Read Full Post »