ISPE Good Practice Guide: Equipment Reliability
Media & Press Releases

ISPE Publishes ISPE Good Practice Guide: Equipment Reliability

22 January 2021
ISPE announced the release of its latest Guide, ISPE Good Practice Guide: Equipment Reliability. This Guide offers best practices with respect to equipment reliability, addresses specific opportunities for the pharmaceutical industry beyond the...

Assessing Environmental Impact of Biopharmaceutical Manufacturing

18 February 2021 - 18 February 2021
Assessing Environmental Impact of Biopharmaceutical Manufacturing Consistent with the overall industry trend to reduce environmental impact in manufacturing operations, GSK’s Biopharmaceutical Product Development and Supply team have implemented...
Conceptualizing a Streamlined Performance Assessment – The St.Gallen APQ Benchmarking Tool
iSpeak Blog
Conceptualizing a Streamlined Performance Assessment – The St.Gallen APQ Benchmarking Tool

The ISPE APQ Assess, Aspire, Act and Advance Framework will be complemented with an OPEX Benchmarking and ICH Q10 maturity assessment tool specifically developed for use with the APQ program by the University of St.Gallen, Switzerland. Used in conjunction with the APQ self-assessment tools for quality management maturity, the pre- and post- benchmarking activities offer objective evidence of...

Regulatory Requirements & Expectations for Cleaning & Disinfection of Controlled Manufacturing Areas

9 April 2021 - 9 April 2021
Cleaning and disinfection processes are often undervalued. This presentation reviews the regulatory requirements and ‘best practice’ recommendations for cleaning and disinfection of controlled manufacturing areas. The pertinent regulations and...

Lessons Learnt from the Discovery of Nitrosamines in Drug Products

25 March 2021 - 25 March 2021
Regulatory observations are clearly demonstrating the safety concerns about unexpected peaks, or unknown components discovered in related substance analyses, which are typically performed using chromatographic techniques. However, they may also...

How to Trend & Analyze Environmental Monitoring Data

20 March 2021 - 20 March 2021
Part 1: EM Trending Requirements Overview on requirements and guidelines on EM data analysis Considerations for EM data analysis using computerized system versus manual systems including speed of analysis, accuracy, volume of data Routine...

The New Annex 1 – Reach the Required Level of QRM Before Being Inspected

5 March 2021 - 5 March 2021
Although QRM is not new (cf. CHQ9 - 2005), the regulatory focus on QRM will increase with the arrival of the European Medicines Agency’s Annex 1, which was reviewed by the US Food and Drug Administration, the World Health Organization, and the...

Determination of Appropriate GMP's for Excipients

26 February 2021 - 26 February 2021
While regulations regarding GMP for APIs clearly define compliance needs, the responsibility for defining necessary GMPs and controls for excipients in a specific medicinal product rests with the Manufacturing Authorization Holders (MAH)...

Cleanroom Cost, Quality & Environmental Sustainability

19 February 2021 - 19 February 2021
Maintaining and improving GMP compliance of cleanroom manufacturing operations is a mandatory requirement for all pharmaceutical manufacturers. In addition, cost and sustainability of manufacturing operations are an increasing focus, especially given...

Investigating Endotoxin Contamination in Pharmaceutical Water Systems

12 February 2021 - 12 February 2021
The presence of endotoxin in sterile pharmaceutical products presents a significant risk to patients. The primary source of endotoxin is pharmaceutical grade water, due to the potential for Gram-negative bacteria to be present. The water source of...
Subscribe to