GMP Publications - Code of Federal Regulation Handbooks by the FDA

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GMP Publications and The Auditing Group (TAG) has extensive experience within the FDA regulated industries working under the various standards (cGMP, cGCP, cGLP, Systems) with one goal, to provide reliable auditing, validation, consulting, training, and quality assurance services that efficiently provide the assistance needed to help our clients succeed.

At GMP Publications and The Auditing Group (TAG),  stand behind all of our audits, training services, site remediation and validation projects, even in times of ‘for-cause’.

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GMP, GCP, GLP, QS and Part 11 / Systems Audit

21 CFR Part(s) 11, 210/211, 820, ICH Q7

Food and Supplement GMP Audits

Mock FDA - EMEA Audits

Pre-Site Inspections - 'For-Cause'

Quality Assurance Audits

Quality System Audits - Part 820

SOPs, Quality Assurance and Standards Audits

GMP - Good Manufacturing Practice Audit

GCP - Clinical Audits - Regulatory Audits

Equipment Validation Documentation Audit

Software / Systems Validation Audits

Part 11 / Annex 11 Compliance

Vendor & Supplier Audits -

CMOs, Laboratories, API Manufacturers

CROs, Investigators, Monitors, and Study Sites

Database Audits, SAS, CMMS, eDC, eCFR, Safety

Project Management Services
Gantt and Timeline Development
Template Implementation
SOP Development
Development Part 11 Initiatives
 

 

example: 211, (ISBN), ...xxx-60-9,, Drug, GMP, Etc.
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