cGMP Toolkit

Save time, empower your teams and effectively upgrade your processes with access to this practical cGMP Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any cGMP related project.

Download the Toolkit and in Three Steps you will be guided from idea to implementation results.

The Toolkit contains the following practical and powerful enablers with new and updated cGMP specific requirements:

STEP 1: Get your bearings

Start with...


• The latest quick edition of the cGMP Self Assessment book in PDF containing 49 requirements to perform a quickscan, get an overview and share with stakeholders.


Organized in a data driven improvement cycle RDMAICS (Recognize, Define, Measure, Analyze, Improve, Control and Sustain), check the…


• Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation


Then find your goals...

STEP 2: Set concrete goals, tasks, dates and numbers you can track

Featuring 993 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which cGMP improvements can be made.

Examples; 10 of the 993 standard requirements:


1. Is enough of the process covered under GMP that you are confident that the process can purge all impurities resulting from the starting material to the specification levels in the final API?
   
   

2. Is drug shortages prevention a recognized knowledge management component with defined activities, investigations, data and information supporting root cause identification and resolution?
   
   

3. Do you have processes that ensure CMOs are held to the same quality standards as internal operations and that CMO issues are communicated promptly to the appropriate decision makers?
   
   

4. Has your organization been able to integrate its quality systems with its partners while respecting the partners need to serve multiple customers and manage the internal complexity?
   
   

5. What causes an otherwise intelligent persona person who knows the difference between right and wrong to make a choice that will negatively impact themselves and the organization?
   
   

6. Have you assessed all outsourced activities and material suppliers for suitability, competence and ability to maintain supplies using principles of quality risk management?
   
   

7. When deciding on the probability and severity of occurrence, do you need to review historical data to determine how frequently a hazard occurs or base it on literature?
   
   

8. Do the programs help trainees understand the link between the supply chain and drug shortage; the importance of compliance and ensuring a continuous supply of product?
   
   

9. Are processes in place that could mitigate the unexpected, as natural disasters, or economic motivated adulteration of materials, which could impact drug shortages?
   
   

10. Why do projects that simply rely on cutting and pasting the regulations into a clients pharmaceutical quality system rarely provide perpetual compliance to cGMP?
    
    


Complete the self assessment, on your own or with a team in a workshop setting. Use the workbook together with the self assessment requirements spreadsheet:


• The workbook is the latest in-depth complete edition of the cGMP book in PDF containing 993 requirements, which criteria correspond to the criteria in...


Your cGMP self-assessment dashboard which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next:


• The Self-Assessment Excel Dashboard; with the cGMP Self-Assessment and Scorecard you will develop a clear picture of which cGMP areas need attention, which requirements you should focus on and who will be responsible for them:
  
  


• Shows your organization instant insight in areas for improvement: Auto generates reports, radar chart for maturity assessment, insights per process and participant and bespoke, ready to use, RACI Matrix

• Gives you a professional Dashboard to guide and perform a thorough cGMP Self-Assessment

• Is secure: Ensures offline data protection of your Self-Assessment results

• Dynamically prioritized projects-ready RACI Matrix shows your organization exactly what to do next:



STEP 3: Implement, Track, follow up and revise strategy

The outcomes of STEP 2, the self assessment, are the inputs for STEP 3; Start and manage cGMP projects with the 62 implementation resources:


• 62 step-by-step cGMP Project Management Form Templates covering over 1500 cGMP project requirements and success criteria:


Examples; 10 of the check box criteria:


1. Risk Register: What are your key risks/show istoppers and what is being done to manage them?
   
   

2. Schedule Management Plan: How does the proposed individual meet each requirement?
   
   

3. Human Resource Management Plan: Are adequate resources provided for the quality assurance function?
   
   

4. Activity Duration Estimates: Find an example of a contract for information technology services. Analyze the key features of the contract. What type of contract was used and why?
   
   

5. Activity Duration Estimates: Account for the four frames of organizations. How can they help cGMP project managers understand your organizational context for cGMP projects?
   
   

6. Cost Management Plan: Are the people assigned to the cGMP project sufficiently qualified?
   
   

7. Activity Cost Estimates: Will you use any tools, such as cGMP project management software, to assist in capturing Earned Value metrics?
   
   

8. Procurement Management Plan: Is it standard practice to formally commit stakeholders to the cGMP project via agreements?
   
   

9. Closing Process Group: Were sponsors and decision makers available when needed outside regularly scheduled meetings?
   
   

10. Quality Audit: How does your organization know that its processes for managing severance are appropriately effective, constructive and fair?


 
Step-by-step and complete cGMP Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:


• 1.1 cGMP project Charter

• 1.2 Stakeholder Register

• 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:


• 2.1 cGMP project Management Plan

• 2.2 Scope Management Plan

• 2.3 Requirements Management Plan

• 2.4 Requirements Documentation

• 2.5 Requirements Traceability Matrix

• 2.6 cGMP project Scope Statement

• 2.7 Assumption and Constraint Log

• 2.8 Work Breakdown Structure

• 2.9 WBS Dictionary

• 2.10 Schedule Management Plan

• 2.11 Activity List

• 2.12 Activity Attributes

• 2.13 Milestone List

• 2.14 Network Diagram

• 2.15 Activity Resource Requirements

• 2.16 Resource Breakdown Structure

• 2.17 Activity Duration Estimates

• 2.18 Duration Estimating Worksheet

• 2.19 cGMP project Schedule

• 2.20 Cost Management Plan

• 2.21 Activity Cost Estimates

• 2.22 Cost Estimating Worksheet

• 2.23 Cost Baseline

• 2.24 Quality Management Plan

• 2.25 Quality Metrics

• 2.26 Process Improvement Plan

• 2.27 Responsibility Assignment Matrix

• 2.28 Roles and Responsibilities

• 2.29 Human Resource Management Plan

• 2.30 Communications Management Plan

• 2.31 Risk Management Plan

• 2.32 Risk Register

• 2.33 Probability and Impact Assessment

• 2.34 Probability and Impact Matrix

• 2.35 Risk Data Sheet

• 2.36 Procurement Management Plan

• 2.37 Source Selection Criteria

• 2.38 Stakeholder Management Plan

• 2.39 Change Management Plan


3.0 Executing Process Group:


• 3.1 Team Member Status Report

• 3.2 Change Request

• 3.3 Change Log

• 3.4 Decision Log

• 3.5 Quality Audit

• 3.6 Team Directory

• 3.7 Team Operating Agreement

• 3.8 Team Performance Assessment

• 3.9 Team Member Performance Assessment

• 3.10 Issue Log


4.0 Monitoring and Controlling Process Group:


• 4.1 cGMP project Performance Report

• 4.2 Variance Analysis

• 4.3 Earned Value Status

• 4.4 Risk Audit

• 4.5 Contractor Status Report

• 4.6 Formal Acceptance


5.0 Closing Process Group:


• 5.1 Procurement Audit

• 5.2 Contract Close-Out

• 5.3 cGMP project or Phase Close-Out

• 5.4 Lessons Learned


Results

With this Three Step process you will have all the tools you need for any cGMP project with this in-depth cGMP Toolkit.

In using the Toolkit you will be better able to:


• Diagnose cGMP projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices

• Implement evidence-based best practice strategies aligned with overall goals

• Integrate recent advances in cGMP and put process design strategies into practice according to best practice guidelines


Defining, designing, creating, and implementing a process to solve a business challenge or meet a business objective is the most valuable role; In EVERY company, organization and department.

Unless you are talking a one-time, single-use project within a business, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?'

This Toolkit empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make cGMP investments work better.

This cGMP All-Inclusive Toolkit enables You to be that person.

Includes lifetime updates

Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.