Audit
Audit Companies (6)
Audit News
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News Mitigating supply risk: Having feet on the ground during COVID-19
Having personnel on the ground may be central to mitigating supply chain risks, even as the world embraces the remote approach. -
Sponsored Content Audits in the time of COVID-19 – Implications for a CMO
Travel restrictions imposed by the pandemic have limited the ability of pharmaceutical companies and health authority personnel to travel and conduct in-person inspections of contract manufacturing organizations (CMOs). Due to t... -
News GVK BIO Announces USFDA Approval for its cGMP Analytical Services Laboratory
GVK BIO, a leading global Contract Research and Development Organisation, announced today that United States Food and Drug Administration (FDA) has approved its cGMP Analytical Service Laboratory located at IDA, Mallapur Campus, Hyderabad.
Audit Products (8)
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Product Rephine’s GMP Audit Reports
Rephine provides personalised, detailed and comprehensive GMP audit reports that are recognised and accepted by QPs and regulatory authorities around the world. The Rephine list of audit reports is updated regularly.
If the audit you require is not on the list, you can review the Rephine Audit Plan... -
Product Audits
Due to recent regulatory developments concerning raw materials, suppliers, manufacturing and distribution, auditing has become a task of critical importance for Life Science businesses.PQE Group supports Pharma and MD companies in performing many types of certified audits, from routine monitoring to due dilig... -
Product Pharmaceutical Auditing Services
Auditing services for the pharmaceutical industry: Our pharmaceutical audits are conducted in accordance with the relevant regulatory texts or standards, including GMP, GDP, GLP, GCP, and GVP. We also audit against IPEC guidelines for Pharmaceutical excipients, ISO 22716 (Cosmetics — Good Manufacturin... -
Product Good Clinical Practice (GCP) auditing services
Rephine provides a high-quality service in a timely and cost effective manner, from a single advisory activity to full GCP audits, or Quality Management programme and training. Rephine provides tailor-made solutions that meet the unique needs of your organisation.
Rephine’s portfolio of GCP services incl... -
Product Commissioned GMP Audits
Rephine’s commissioned audit service gives our customers the opportunity to work with us to design exclusive audits tailored to the specifics of their operations. Customers can commission various audits including:
-API Manufacture-Excipient Manufacture
-Investigational Medicinal Product (IMP) Manu... -
Product Inspection Readiness & Support
- Inspection Event Planning
- Personnel Training and Interview Preparation
- Subject Matter Expert Support
- Post-Inspection Analysis
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Product Quality Operations Support
- Management Review
- Validation and Qualification
- Risk Management
- Laboratory Controls
- Batch Review
- Quality Engineering
- Exceptions
- Post Market Surveillance
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Product Health Authority Enforcement Response & Remediation
- FDA/EMA/Health Authority Agency Intelligence
- Rapid Response to Inspections
- Remediation Support
- On-Site Remediation Project Management
- Coordination with Regulatory Counsel
- Third-Party Support
Upcoming Events
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CPHI Korea 2022
COEX, Seoul, Korea
28 - 30 September 2022 -
CPHI Frankfurt 2022
Messe Frankfurt, Frankfurt, Germany
1-3 November 2022 -
CPHI & PMEC India 2022
India Expo Centre, Greater Noida, Delhi NCR
29 November - 1 December
Pharmaceutical Industry Webinars
Position your company at the heart of the global Pharma industry with a CPHI Online membership
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Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
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Generate high-quality, engaged leads for your business, all year round
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Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
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Your company’s profile boosted at all participating CPHI events
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An easy-to-use platform with a detailed dashboard showing your leads and performance