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MHRA, EU & ICH GMP Handbook with the new ICH Q7 GMP Auditor's Check List - Starting at €20.00ea

Quantity Discounts

  • 1 - 99                €20.00        $23.13

  • 100 - 249          €17.25        $19.95

  • 250 - 499          €14.66        $16.95

  • 500 - 999          €11.15        $12.90

  • 1000+               €09.42        $10.90

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A great Learning Tool for all employees, paired with GMP Training at www.gmpbootcamps.com.

MHRA Guidance
Good Manufacturing Practice and Good Distribution Practice

 

European Union EMA Good Manufacturing Practice
- EU GMPs Chapter 1 - 9
   - Pharmaceutical Quality System
   - Personnel
   - Premise and Equipment
   - Documentation
   - Production
   - Quality Control
   - Outsourced Activities
   - Complaints and Product Recall
   - Self Inspection
- Annex 1 Sterile Medicinal Products
- Annex 8 Sampling of Starting and Packaging Materials
- Annex 11 Computerized Systems
- Annex 15 - Qualification and Validation
- Annex 16 - Certification by a Qualified Person and Batch Release
- Annex 19 Reference and Retention Samples

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International Council for Harmonisation
- ICH Q7 GMPs for APIs
- ICH Q7 Auditor's Checklist
- ICH Q9 Quality Risk Management
- ICH Q10 Pharmaceutical Systems

GxP Audits

 

 

All Subject Matter Experts (SMEs) have the Experience, Training, Education and Background to support your compliance audit and remediation requirements backed by TAG, ASQ and Global Accepted Certifications!

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  • GMP Audits - API/Excipients

  • GLP Audits - QC, Testing and LIMs, 

  • Mock FDA/EMA, PAI, Pre-ISO

  • Vendors, Suppliers and Contractors

  • Pharmaceuticals / Supplements

  • Medical Devices / IVDs

  • Cosmetics

  • Biologics, Blood, Cell, Tissue

  • Validation Audits

  • Engineering Audits

  • Document Audits

  • Clinical Audits

  • Investigator Sites

  • Clinical Data Management

  • Clinical Electronic Systems

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GMP, GLP, GCP and QMS Audit and Auditing Remediation
Remediation

 

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The Auditing Group SMEs have the Experience to assist with your remediation efforts, whether satisfying a 'For-Cause' US FDA 483, Agency Warning Letter, or audit observations, we have the resources and tools to assist with your successful compliance endeavors.

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  • Project Management

  • CAPA Management

  • Procedure Development

  • Protocol Development

  • Design / Build Engineering Analysis

  • As-Built Qualifications

  • Commissioning and Qualifications

  • Validation Services

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Turn-key or Hourly SME Quotes!

Gantt Driven Project Management

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GMP Engineering, GMP, GLP, GCP and QMS Audit and Auditing Remediation
CAPA Manager, Remediation and GMP Audit, Auditing and Remediation
Training

 

 

                            The Auditing Group has                                    teamed up with GMP Boot                                Camps to provide on-site or                              Virtual training for your                                      Employees to satisfy your                                GxP requirements.

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  • Basic 1, 2, or 3-day GMP / QMS for Drug, Medical Device, Cosmetics or Dietary Supplements Training

  • Focused Training Programs - Taylored to your Company's Products, Services or Capabilities - Includes an on-site pre-training Audit of your GXP Compliance for training applicability.

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GMP Boot Camps, GMP, QMS , FDA, Webinars and onsite Training
GMP Boot Camps, GMP, QMS , FDA, Webinars and onsite Training
GMP Publications, FDA, EU, Chinese CFR Handbooks and Training
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group

The Quality Groups

Seeking Partners, Acquisitions & Investors

Contact:  partners@auditing.com

GMP Publications Regulation Handbooks
The Auditing Group GMP, GLP, and ISO Auditing, Training and Remediation Services
FDA.Com The Food and Drug Assistance Association
GMP Supplies and GMP Suppliers
GXP GMP Recruiters
GMP Suppliers and GMP Supplies
GXP Academy and GMP Boot Camps
GXP Academy and GMP Boot Camps
CAPA Manager, CAPA Management, FDA Help, Turnkey QMS, Turnkey GMP
Retail GMP Certifications
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group

Contact:  partners@auditing.com

GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group
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