GMP/QA CONSULTANCY SERVICES

CONTRACTOR MANAGEMENT
Ulverston GMP Consulting Ltd has valuable experience in assisting pharmaceutical companies with selection, auditing and management of contractors.  Whether your requirement is for development quantities or commercial manufacture, our response will be focused on the most cost-effective solution to achieve GMP compliance.  (For more details, click Contractor Management.)


CRITICAL PARAMETER MANAGEMENT
An expert system for proactive analysis of critical and non-critical manufacturing deviations, leading to much reduced CAPA burden and faster process flow through intermediate and API stages - also significant benefits within products manufacture (For more details, click Consultancy Services.)


INSPECTION SURVIVAL KIT
Prepare for your next FDA/Regulatory inspection by training with this proven, expert system, available for purchase through our US associate.  (For more details, click Inspection Survival Kit.)


AUDITING SERVICES
Our auditing service to clients includes an extensive report  to standards acceptable to EU competent authorities.  Deficiencies are clearly identified, together with recommended CAPAs to achieve GMP compliance.  A follow-up service is available, if required.  (For more details, click Auditing)

GMP compliance audits for:
-  Active Substances (APIs)
    -  Investigational Medicinal Products (IMPs)
          -  Marketed medicinal products
              -  Importers


QUALIFIED PERSON SERVICES
Importers of medicinal products and smaller manufacturers of IMPs require the services of a Qualified Person but may be unable to justify the cost of employing a full time, permanent QP, especially at current salary rates within the industry.  A part-time contract QP is often the cost-effective answer.

AUDITOR TRAINING
On-site and public training courses in GMP and Quality Systems auditing
- Auditing Basics
   - Tools and Techniques
        - Auditing Process
              - System Improvement

(For more details, click Auditor Training.)


GMP TRAINING COURSES FOR THE PHARMA INDUSTRY
(customised for in-house training or as part of public seminars)

-  Practical Applications of EU GMP Guide, Part II / ICH Q7
     -  Secure QA Batch Release
         -  CAPA in the Pharma Industry
              -  Critical Parameter Management
                   -  Certification and Batch Release by a QP
                        -  Product Specification File for Investigational Medicinal Products

(For more details, click GMP Training Courses)


ON-SITE ASSESSMENT AND IMPROVEMENT OF GMP SYSTEMS AND QUALITY SYSTEMS FOR APIs AND PRODUCTS
-  Application of EU GMP Guide Part II / ICH Q7
    -  GMP Standards Applicable to APIs and Products
         -  Principles of Process Flow
              -  Secure GMP-Compliant Systems
                   -  Secure QA Batch Release Systems
                        -  Secure QP Batch Certification Systems
                             -  Effective Management of Process Deviations
                                  -  Plant Cleaning / Decontamination
                                       -  Quality Risk Management

(For more details, click GMP Systems.)


COMPREHENSIVE PREPARATION AND TRAINING FOR REGULATORY INSPECTIONS
Prepare for regulatory inspections by training your staff and practice in a mock-up pre-inspection!
-  Getting Ready – Preparation and Expectation
    -  Organisation - Inspection Room & Control Room
         -  Facing the Inspector
              -  Practical Preparation for Regulatory Inspections

(For more details, click Inspection Preparation.)