cGMP Toolkit

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Closely collaborate with Quality and Compliance, and Facilities and Engineering to maintain a high level of cGMP compliance and safety through the effective monitoring and reporting of metrics.

More Uses of the cGMP Toolkit:

  • Lead: industry standards for commissioning, qualification, and operation of facilities and utilities for cGMP manufacturing.

  • Be accountable for ensuring that all test data is gathered and recorded in accordance with cGMP requirements.

  • Be accountable for the Quality and cGMP compliance of the area by ensuring cGMP is followed in area of responsibility.

  • Write manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.

  • Assure your organization employees must also maintain complete and accurate records, in accordance with cGMP.

  • Ensure all operations are executed in cGMP compliant manner and meet organization standards.

  • Be accountable for supporting process development, design, scale up, technology transfer, and start up of CGMP manufacturing.

  • Perform or support cGMP lot release, in process, and stability testing using various software packages.

  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

  • Ensure you do understand and adhere to SOPs and cGMP compliance regarding materials control in multiple storage locations and conditions.

  • Supervise: industry standards for commissioning, qualification, and operation of facilities and utilities for cgmp manufacturing.

  • Provide leadership and oversight to the capital team to ensure a cGMP facility is built to meet regulatory and client requirements.

  • Maintain compliance with applicable cGMP regulations, vendor guidelines, engineering.

  • Assure the analytical team follows applicable cgmp requirements and your organizational sops.

  • Be certain that your organization assures that production operations are performed according to cGMP and ISO 9000 standards.

  • Perform review, audit, and approval of manufacturing batch records and protocols to ensure production records are complete, accurate, and documented according to written procedures and cGMP requirements.

  • Lead process development, design and improvement in the manufacturing of consumable products or support of processes/equipment used in a cGMP manufacturing environment.

  • Identify, prioritize, and execute quality improvement efforts to continually improve efficiency, effectiveness, and compliance with applicable cGMP regulations.

  • Initiate: review requirements and enforces procedures to ensure cGMP and regulatory compliance.

  • Assure cGMP success through effective tech transfer and support of cGMP manufacturing.

  • Be accountable for writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.

  • Warrant that your organization operates production equipment and performs duties under compliance of cGMP manufacturing.

  • Ensure you do lead the design, commissioning and implementation of control and automation engineering projects in cGMP manufacturing areas and supporting labs.

  • Provide technical guidance and support based on overall project plans with the development of products in compliance with design controls, processes in compliance with Good Manufacturing Practices (cGMP).

 

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 953 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 953 standard requirements:

  1. How do the alternative inspection methods and new way of working apply to re inspection of facilities, specifically when corrections have been made based on findings from previous inspections?

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

  3. 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?

  4. What does the DS cGMP rule require you to do with rejected components, packaging, and labels, and with rejected products received for packaging or labeling as a dietary supplement?

  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. Do the small scale batches need to be manufactured in accordance with all cGMP regulations, or is it acceptable to manufacture the small scale batches in a research setting?

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

  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. What does the DS cGMP rule require regarding automated, mechanical, or electronic equipment that you use to manufacture, package, label or hold a dietary supplement?

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


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 953 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 Audit: For this risk .. what do you need to stop doing, start doing and keep doing?

  2. Risk Audit: Do you have position descriptions for all office bearers/staff?

  3. Cost Estimating Worksheet: Identify the timeframe necessary to monitor progress and collect data to determine how the selected measure has changed?

  4. Scope Management Plan: How difficult will it be to do specific activities on this cGMP project?

  5. Quality Management Plan: Is the steering committee active in cGMP project oversight?

  6. Team Operating Agreement: How will you resolve conflict efficiently and respectfully?

  7. Project Management Plan: What happened during the process that you found interesting?

  8. Probability and Impact Assessment: Are staff committed for the duration of the cGMP project?

  9. Team Operating Agreement: Confidentiality: how will confidential information be handled?

  10. Project Scope Statement: Is the cGMP project organization documented and on file?

 
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.