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P Aud

Good Manufacturing Practice (GMP) Audits

FDA and Mock FDA/DEA - EMeA - MHRA - NMPA (SFDA) - TGA - WHO

Pharmaceutical, Medical Device, Laboratory, Clinical, Dietary Supplements, Cosmetic and Biotechnology Industries

Tel: 001-856-437-5880 info@auditing.com Get an On-site Audit Quote Today!

GMP QMS Monthly Boot Camps



The Auditing Group, Inc. (TAG) - Auditing the Federal Regulations for GMP Publications provides TAG with an advantage, we know the LAWS and Applicability based upon Risk! This advantage provides extensive GMP Audits to meet the requirements for Global Agencies:

  • US FDA, APIs (ICH Q7) & Excipients
  • DEA Control Substances
  • Medical Device and Combination Products
  • EU and MHRA GMP Directives
  • Biologics and Drug Manufacturing
  • Laboratory Audits
  • ICH, ISO and OECD Audits
  • Hospital and JCAHO Audits
  • Chinese GMPs (NMPA) & Canadian GMPs

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

We provide:

  • Mock FDA PAI and DEA Audits
  • Clinical Investigational Products (IPs) GMPs
  • Audit Remediation Solutions and Recommendations
  • FDA 483 and Warning Letter Resolutions
  • CAPA Solutions and Management Services
  • Due-Diligence and 'For-Cause' Support
  • Back-room Agency Inspection Readiness Support
  • Audit Training Services

You purchased the handbooks from GMP Publications and now what?

1. Do you have the resources to conduct proper training against the Regulations based upon applicability?

2. Have you conducted a formal Gap Analysis against the Regulations?

If not, consider TurnKey QMS and The Auditing Group, together assisting firms to meeting and exceed GMP requirements.

Do you need to?

First, Understand the FDA Thinking;

If products, or services, or any action, in whole or in part, which may impact either directly or indirectly, is distributed, adhered, affixed, consumed, or used by a Consumer or Patient, either by Use, Ingestion, Injection, Inhalation, and/or Permeation, they must follow GMPs, or…

If a product is manufactured, or services rendered which greatly benefits the safety, health or welfare of a consumer or patient, directly, and/or indirectly, or…

If a Product or Data which may influence, form a decision for, or create an adverse reactionary event to the health, safety, welfare of a Consumer or Patient, directly or indirectly;

You must comply to the GMPs!

So, what is a Product? What are Services? What are Data? What is direct and/or Indirect impact?

Your applicability to the Federal Regulations is based upon the Product, Service or Data that you provide. And the question is, what is your applicability, directly and/or indirectly?
And this is the hardest concept to understand.

The 3 Step Approach for GMP Compliance - ART

1) Audit, (with Certificate of Audit) - The Audiiting Goup

2) Remediate, (with Certificate of Compliance) - TKQMS

3) Train (with Certificate of Attendance) - GMP Boot Camps


US FDA - WHO - EMeA - GMP - GLP - GCP

Pharmaceutical - Medical Device - Clinical - Laboratory - Part 11 - Food - Dietary Supplement

Not sure if your company can pass
a GMP, GLP, GCP, Quality Systems, - Part 11 & QSR Part 820 audit?
 

Get an independent assessment of your quality and regulatory readiness today! 


>>  Auditing Services   >>  Remediation Services

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

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 and Support Services

Gantt and Timeline Development

Validation Development and Executions

Training Services

QMS Template Implementation

Procedure and Practice Challenges

Standard Operating Procedures Development

Development Part 11 Initiatives

Design / Build Engineering Services

Certified AIA 'As-Built' Drafting Services

Process and Equipment Validation Services

Software and Systems Validation Services

Design / Build Engineering Services

 

 


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