Good Manufacturing Practice Toolkit

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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).

More Uses of the Good Manufacturing Practice Toolkit:

  • Adhere to Good Manufacturing Practices and safety standards.

  • Ensure you research; delegated adhere to Good Manufacturing Practices and safety standards.

  • Ensure you advance; Good Manufacturing Practices Root Cause Analysis safety awareness and intervention Problem Solving.

  • Follow all documented Good Manufacturing Practices.

  • Maintain work area in an organized and clean manner ensuring safety and Good Manufacturing Practices are met.

  • Confirm your operation ensures people and processes comply with safety requirements, current Good Manufacturing Practices, organization Policies and Procedures.

  • Be accountable for departmental compliance in accordance with Good Manufacturing Practices, ISO and other strategic quality objectives.

  • Ensure you audit; Good Manufacturing Practices.

  • Maintain Good Manufacturing Practices, housekeeping standards and safety precautions.

  • Follow SOP and standard analytical procedures to meet Good Manufacturing Practices.

  • Establish that your venture participates in monthly/quarterly/annual training for Good Manufacturing Practices, Health And Safety, and Compliance.

  • Follow SOP and standard analytical procedures to meet Good Laboratory Practices and Good Manufacturing Practices compliance.

  • Steer: act as a facilitator/coach in areas as Quality Control techniques, Good Manufacturing Practices, and Product Quality/safety.

  • Evaluate: cGMP (current Good Manufacturing Practices).

 

Save time, empower your teams and effectively upgrade your processes with access to this practical Good Manufacturing Practice Toolkit and guide. Address common challenges with best-practice templates, step-by-step Work Plans and maturity diagnostics for any Good Manufacturing Practice 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 Good Manufacturing Practice specific requirements:


STEP 1: Get your bearings

Start with...

  • The latest quick edition of the Good Manufacturing Practice 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 999 new and updated case-based questions, organized into seven core areas of Process Design, this Self-Assessment will help you identify areas in which Good Manufacturing Practice improvements can be made.

Examples; 10 of the 999 standard requirements:

  1. Which Good Manufacturing Practice data should be retained?

  2. Do the Good Manufacturing Practice decisions you make today help your organization in three years time?

  3. What does verifying compliance entail?

  4. Are controls defined to recognize and contain problems?

  5. How do you transition from the baseline to the target?

  6. Are the criteria for selecting recommendations stated?

  7. What is your Good Manufacturing Practice strategy?

  8. What Good Manufacturing Practice services do you require?

  9. What are the operational costs after Good Manufacturing Practice deployment?

  10. Have you made assumptions about the shape of the future, particularly its impact on your customers and competitors?


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 Good Manufacturing Practice book in PDF containing 994 requirements, which criteria correspond to the criteria in...

Your Good Manufacturing Practice 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 Good Manufacturing Practice Self-Assessment and Scorecard you will develop a clear picture of which Good Manufacturing Practice 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 Good Manufacturing Practice 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 Good Manufacturing Practice projects with the 62 implementation resources:

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

Examples; 10 of the check box criteria:

  1. Cost Management Plan: Eac -estimate at completion, what is the total job expected to cost?

  2. Activity Cost Estimates: In which phase of the Acquisition Process cycle does source qualifications reside?

  3. Project Scope Statement: Will all Good Manufacturing Practice project issues be unconditionally tracked through the Issue Resolution process?

  4. Closing Process Group: Did the Good Manufacturing Practice project team have enough people to execute the Good Manufacturing Practice project plan?

  5. Source Selection Criteria: What are the guidelines regarding award without considerations?

  6. Scope Management Plan: Are Corrective Actions taken when actual results are substantially different from detailed Good Manufacturing Practice project plan (variances)?

  7. Initiating Process Group: During which stage of Risk planning are risks prioritized based on probability and impact?

  8. Cost Management Plan: Is your organization certified as a supplier, wholesaler, regular dealer, or manufacturer of corresponding products/supplies?

  9. Procurement Audit: Was a formal review of tenders received undertaken?

  10. Activity Cost Estimates: What procedures are put in place regarding bidding and cost comparisons, if any?

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

1.0 Initiating Process Group:

  • 1.1 Good Manufacturing Practice project Charter
  • 1.2 Stakeholder Register
  • 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:

  • 2.1 Good Manufacturing Practice Project Management Plan
  • 2.2 Scope Management Plan
  • 2.3 Requirements Management Plan
  • 2.4 Requirements Documentation
  • 2.5 Requirements Traceability Matrix
  • 2.6 Good Manufacturing Practice 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 Good Manufacturing Practice 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 Good Manufacturing Practice 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 Good Manufacturing Practice 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 Good Manufacturing Practice project with this in-depth Good Manufacturing Practice Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose Good Manufacturing Practice 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 Good Manufacturing Practice 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 Good Manufacturing Practice investments work better.

This Good Manufacturing Practice 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.