Good automated manufacturing practice

EISC Lab Automation Expert to Speak at A2LA 2023 on Mitigating Risk Exposure in Food Quality and Safety Through Lab Interoperability

Retrieved on: 
Monday, April 17, 2023
Food defense, Food industry, PDT, Food quality, Automation, Trust, Food contaminant, Risk, Good automated manufacturing practice, Knowledge, Safety, Consumer electronics

LAS VEGAS, April 17, 2023 (GLOBE NEWSWIRE) -- Paul Banfer , Executive Vice President and Chief Technology Officer at EISC , experts in lab automation, is set to speak at the annual A2LA Association conference in Tucson, Arizona on April 19th at 8:00 am PDT.

Key Points: 
  • LAS VEGAS, April 17, 2023 (GLOBE NEWSWIRE) -- Paul Banfer , Executive Vice President and Chief Technology Officer at EISC , experts in lab automation, is set to speak at the annual A2LA Association conference in Tucson, Arizona on April 19th at 8:00 am PDT.
  • Banfer's presentation will demonstrate how universal lab connectivity and interoperability provides early alert notifications that facilitate risk aversion in food quality and safety.
  • Banfer will focus on the key elements of automation that ensure a product’s quality, safety, and authentication with analytical instruments, devices, and sensors in Good Automation Manufacturing Practices (GAMP).
  • "I am excited to share my knowledge and experience and help attendees understand how universal, interoperable connectivity and the automation of instruments, devices, and sensors can mitigate risk exposure in food quality and safety,” states Banfer.

Qualio Launches Modern Validation Pack for the Life Sciences To Accelerate and Safeguard Quality and Compliance Processes

Retrieved on: 
Wednesday, October 19, 2022
Adoption, SAN, LinkedIn, ISO, Time, Bionics, International Organization for Standardization, Good automated manufacturing practice, ISO 9001:2015, Software as a service, Paper, CSA, Twitter, Multimedia, Certification, Food, Compliance, Industry, CEO, Patient safety, Safety, FDA, ISO 9001, View, Documentation, Public health, Medical device, Audit

SAN FRANCISCO, Oct. 19, 2022 /PRNewswire/ -- Qualio — the trusted cloud quality management system software for the entire life sciences ecosystem — is announcing availability of their Validation Pack, which will help quality professionals in the life sciences sector take a faster, less resource-intensive approach to the latest Good Automated Manufacturing Practice (GAMP) and computerized system assurance (CSA) updates from the Food & Drug Administration (FDA). In addition, Qualio is announcing ISO 9001 and 27001 certifications as part of their broader effort to help emerging life sciences companies optimize and streamline regulatory and compliance processes.

Key Points: 
  • In addition, Qualio is announcing ISO 9001 and 27001 certifications as part of their broader effort to help emerging life sciences companies optimize and streamline regulatory and compliance processes.
  • Qualio's new Validation Pack will help life sciences companies adhere to the revised GAMP and CSA guidance.
  • Qualio's new Validation Pack will help life sciences companies adhere to the revised GAMP and CSA guidance.
  • With over 500 life sciences customers worldwide, Qualio is the most trusted quality management software for teams launching and scaling life-saving products.

Two Products of Zhaoke Ophthalmology (6622.HK) Passed The On-Site Inspection for Drug Registration of The National Medical Products Administration and The GMP Compliance Inspection of The Guangdong Medical Products Administration

Retrieved on: 
Monday, May 24, 2021
Pharmaceutical industry, Good practice, Pharmaceuticals policy, Articles, Life sciences, Quality, Health sciences, Food safety, Good manufacturing practice, Inspection, Good automated manufacturing practice, Validation

The inspection verified the original records and information on the research and development as well as the manufacturing processes of the above two drug products.

Key Points: 
  • The inspection verified the original records and information on the research and development as well as the manufacturing processes of the above two drug products.
  • The Company also passed the Good Manufacturing Practice (GMP) compliance inspection conducted by the Guangdong Medical Products Administration.
  • Passing the on-site inspection for drug registration and GMP compliance is a major milestone for the Company.
  • It also validates that such systems can produce products compliant with the registration requirements in a sustained and consistent fashion.

ISPE Publishes ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

Retrieved on: 
Thursday, May 20, 2021
Health sciences, Articles, Pharmaceutical industry, Academic disciplines, Pharmacy, Project management, Risk analysis, Risk management, Security, ISPE, Medication, Good automated manufacturing practice

b'NORTH BETHESDA, Md., May 20, 2021 /PRNewswire-PRWeb/ --The International Society for Pharmaceutical Engineering (ISPE) announced the release of its latest Guide, ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry .

Key Points: 
  • b'NORTH BETHESDA, Md., May 20, 2021 /PRNewswire-PRWeb/ --The International Society for Pharmaceutical Engineering (ISPE) announced the release of its latest Guide, ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry .
  • The Guide focuses on how Knowledge Management (KM) can enable a more effective Pharmaceutical Quality System (PQS).\nThe first such guidance in the pharmaceutical industry, the Guide promotes uniting KM with Quality Risk Management (QRM) to enable better risk-based decisions.
  • It, along with QRM, is one of the two enablers of an effective Pharmaceutical Quality System as defined by ICH Q10," said Paige Kane, Guide Team Co-Lead, Director Knowledge Management, Merck & Co., Inc. (Rahway, NJ USA).
  • "\n"There are currently few resources, and no industry guidance available which address the role of Knowledge Management specifically for the pharmaceutical industry.

ISPE Gathers Global Health Authorities to Discuss Remote/Distant Assessments, Audits, and Regulatory Guidance

Retrieved on: 
Tuesday, April 13, 2021
Health sciences, Pharmaceutical sciences, ISPE, Pharmaceutical industry, Health care, Good practice, Pharmaceuticals policy, International Society for Pharmacoepidemiology, Good automated manufacturing practice

b'NORTH BETHESDA, Md., April 13, 2021 /PRNewswire-PRWeb/ --The International Society for Pharmaceutical Engineering (ISPE) will convene regulators, auditors, remote auditors, and inspectors representing 11 regulatory agencies from around the world at the 2021 ISPE Global Pharmaceutical Regulatory Summit for critical discussions on onsite inspection challenges due to COVID-19.

Key Points: 
  • b'NORTH BETHESDA, Md., April 13, 2021 /PRNewswire-PRWeb/ --The International Society for Pharmaceutical Engineering (ISPE) will convene regulators, auditors, remote auditors, and inspectors representing 11 regulatory agencies from around the world at the 2021 ISPE Global Pharmaceutical Regulatory Summit for critical discussions on onsite inspection challenges due to COVID-19.
  • "This event is another means for ISPE to provide a platform to enable these transparent conversations in the industry that includes representatives and perspectives from worldwide regulatory authorities.
  • The 18,000 Members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world.
  • Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA.

ISPE Publishes ISPE Good Practice Guide: Maintenance, 2nd Edition

Retrieved on: 
Thursday, February 11, 2021
ISPE, GxP, Good practice, Pharmaceutical industry, Pharmaceuticals policy, Good automated manufacturing practice, Clinical research

NORTH BETHESDA, Md., Feb. 11, 2021 /PRNewswire-PRWeb/ --The International Society for Pharmaceutical Engineering (ISPE) announced the release of its latest Guide, ISPE Good Practice Guide: Maintenance, 2nd Edition .

Key Points: 
  • NORTH BETHESDA, Md., Feb. 11, 2021 /PRNewswire-PRWeb/ --The International Society for Pharmaceutical Engineering (ISPE) announced the release of its latest Guide, ISPE Good Practice Guide: Maintenance, 2nd Edition .
  • This new edition reflects alignment with the ICH Q9 risk-based approach with respect to maintenance and the industry as a whole.
  • Updates include consolidating basic and good practices categories, adding clarification on terminology for users, and updating examples.
  • Purchase the ISPE Good Practice Guide: Maintenance, 2nd Edition online, available at ISPE.org/Publications/Guidance-Documents , among ISPE's other detailed education resources on a variety of industry topics.

ISPE Publishes ISPE Good Practice Guide: Equipment Reliability

Retrieved on: 
Thursday, January 21, 2021
Design for X, Materials science, Reliability engineering, Software quality, Survival analysis, ISPE, Articles, Academic disciplines, Engineering, Good automated manufacturing practice

NORTH BETHESDA, Md., Jan. 21, 2021 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (ISPE) announced the release of its latest Guide, ISPE Good Practice Guide: Equipment Reliability .

Key Points: 
  • NORTH BETHESDA, Md., Jan. 21, 2021 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (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 general reliability of equipment, and can serve as the basis for an effective reliability program.
  • "The strategy and tactics of reliability can help companies maintain the value of their equipment throughout its useful life and mission and the application of asset management principles can help companies leverage equipment towards a competitive advantage."
  • Purchase the ISPE Good Practice Guide: Equipment Reliability online, available at ISPE.org/Publications/Guidance-Documents , among ISPE's other detailed education resources on a variety of industry topics.

DGAP-News: BioMedion AG Announces the Acquisition of the Compliance Division of arivis AG

Retrieved on: 
Monday, December 21, 2020
Pharmaceutical industry, Validity, Clinical data management, Clinical research, Quality, Validation, GxP, GxP, Business, Articles, Data management, Good automated manufacturing practice, BioMedion Group, arivis AG

Berlin/Munich - December 2020 - BioMedion AG ("BioMedion" or the "Company") a global Compliance Management Software company providing controlled content and raw data management solutions for the life science industry, announces the acquisition of the Compliance Division of arivis AG ("arivis"), a provider of regulatory software and biomedical 3D and big image data software solutions.

Key Points: 
  • Berlin/Munich - December 2020 - BioMedion AG ("BioMedion" or the "Company") a global Compliance Management Software company providing controlled content and raw data management solutions for the life science industry, announces the acquisition of the Compliance Division of arivis AG ("arivis"), a provider of regulatory software and biomedical 3D and big image data software solutions.
  • Founded in 2000, BioMedion offers a suite of software used in all "good practice" areas ("GxP") where quality guidelines and regulations are imperative.
  • BioMedion offers an integrated suite of "GxP" quality, compliance, and archiving solutions including subject-matter expertise, computer system validation, and training management.
  • arivis is headquartered in Rostock (Germany) with further locations in Munich (Germany), London (United Kingdom) and Washington D.C. (United States).

ISPE Publishes ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System

Retrieved on: 
Tuesday, December 15, 2020
Prevention, Pharmaceutical industry, Articles, Change management, Corrective and preventive action, CAPA, APQ, ISPE, Preventive action, Quality management, Good automated manufacturing practice

NORTH BETHESDA, Md., Dec. 15, 2020 /PRNewswire-PRWeb/ --The International Society for Pharmaceutical Engineering (ISPE) announced the release of its latest Guide, ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System .

Key Points: 
  • NORTH BETHESDA, Md., Dec. 15, 2020 /PRNewswire-PRWeb/ --The International Society for Pharmaceutical Engineering (ISPE) announced the release of its latest Guide, ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System .
  • This is the first in the planned four-part series that seeks to improve the state of pharmaceutical quality and ensure sustainable compliance.
  • The Guide Series is part of ISPE's newest initiative, Advancing Pharmaceutical Quality (APQ) , a comprehensive program for assessing and improving an organization's quality management maturity.
  • The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System covers the key concepts of the APQ program, introduces the Assess, Aspire, Act, and Advance framework, and covers the practical application of the APQ framework to the CAPA system element by evaluating:

2020-2021 Board of Directors Installed at 2020 ISPE Annual Meeting & Expo

Retrieved on: 
Friday, November 6, 2020
ISPE, Pharmaceuticals policy, Good practice, International Society for Pharmacoepidemiology, Pharmaceutical industry, Good automated manufacturing practice

BETHESDA, Md., Nov. 6, 2020 /PRNewswire-PRWeb/ --The International Society for Pharmaceutical Engineering (ISPE) installed its 20202021 International Board of Directors during the virtual 2020 ISPE Annual Meeting & Expo , revealing a slate of strategic leaders who represent a variety of pharmaceutical industry sectors.

Key Points: 
  • BETHESDA, Md., Nov. 6, 2020 /PRNewswire-PRWeb/ --The International Society for Pharmaceutical Engineering (ISPE) installed its 20202021 International Board of Directors during the virtual 2020 ISPE Annual Meeting & Expo , revealing a slate of strategic leaders who represent a variety of pharmaceutical industry sectors.
  • The Board is responsible for the governance and strategic direction of the Society.
  • The International Society for Pharmaceutical Engineering (ISPE) is a not-for-profit association serving its Members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle.
  • Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA.