GMP Toolkit

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Develop, initiate, maintain and revise Policies and Procedures for the operation of all Quality Assurance and Regulatory Compliance to prevent illegal, unethical and improper conduct by your organization and its employees as defined by the governing regulatory departments.

More Uses of the GMP Toolkit:

  • Assure your corporation complies; plans and implements new projects, equipment, and programs as approved by the Executive team or Project Management Organization.

  • Hire and retain great talent, develop, coach and provide challenging work for team members; support the Career Development of employees.

  • Establish that your team complies; monitors and maintains efficient flow of materials and documentation through the warehouse and manufacturing process, bottlenecks are identified/eliminated, and production batches are available  at each production step.

  • Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines.

  • Adhere to applicable corporate Policies and Procedures, quality procedures, and work instructions.

  • Drive for Continuous Improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implement changes, and verifies the effectiveness of changes.

  • Confirm your team ensures timely completion and compliance with cGMP and all other relevant organization training requirements.

  • Assure your operation performs necessary machine set up, operation, changeover, adjustment, diagnosis, repair, and preventative maintenance on production equipment.

  • Be certain that your group adheres to GMP, safety, personnel and departmental policies as set forth by Standard Operating Procedures and personnel manual.

  • Serve as a dependable technical liaison between validation and manufacturing / manufacturing support functions and systems.

  • Secure that your enterprise complies; monitors inspection and test processes/procedures in order to identify opportunities for improvement.

  • Ensure you aid; lead your organizations Quality Control team that supports incoming materials release, manufacturing support, final product release testing, stability testing, and Product Development sample analysis.

  • Participate / lead teams which impact production, increase efficiency, solve problems, generate Cost Savings, improve quality and provide new product support.

  • Ensure your organization leads project team activities and actions, monitoring progress against the established timelines and providing regular updates to the internal stakeholders and customers.

  • Execute test method, Process Validation and equipment validation test as per corresponding protocols.

  • Establish that your strategy coordinates with Supply Planning to generate production plan for all processes in line with approved master production schedule and monitors progress.

  • Recruit, hire and monitor the use of consultants in providing quality and regulatory services to your organization.

  • Organize: design, write, and execute development protocols and reports for engineering studies and clinical supplies.

  • Ensure that all warehouse employees comply with applicable procedures and regulations, and that all safety procedures are followed.

  • Provide input into development strategies to support innovation, achieve Business Objectives and maintain GMP compliance.

  • Coordinate: act as eyes and ears of the quality department to promote and coordinate good manufacturing practices (cGMP) and related good documentation practices (gdp) throughout all phases of Product Development and manufacturing.

  • Identify, respond, and monitor potential project risk and determine possible contingency plans for risk mitigation.

  • Arrange that your strategy oversees the testing and trending of the Environmental Monitoring program for operations and provides periodic reports.

  • Identify key clients aligned with the strategic focus of your organization and develop workable action and development plans to maintain existing business and seed future business opportunities.

  • Perform daily fork lift/reach lift inspections, ensure equipment is fully operational and document inspections.

  • Head: review various documentation and drawings to ensure any document changes, meet quality and validation requirements and are in full compliance with regulations and standards.

  • Be accountable for having a workplace where everyone is heard is key to good collaboration and meaningful participation.

  • Make sure that your planning updates site files used to calculate and display project metrics as Right First Time, On Time Delivery and Schedule Adherence.

  • Orchestrate: work in tandem with a Materials Management team for effective sample transfer to/from sample storage and manufacturing facilities.

  • Supervise: review the results and determines whether to accept or reject the incoming material during inspection process.

 

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


STEP 1: Get your bearings

Start with...

  • The latest quick edition of the GMP 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 GMP improvements can be made.

Examples; 10 of the 999 standard requirements:

  1. What are the top 3 things at the forefront of your GMP agendas for the next 3 years?

  2. Is it needed?

  3. What is the overall talent health of your organization as a whole at senior levels, and for each organization reporting to a member of the Senior Leadership Team?

  4. Where do the GMP decisions reside?

  5. What are your primary costs, revenues, assets?

  6. What qualifications are necessary?

  7. What is the worst case scenario?

  8. In retrospect, of the projects that you pulled the plug on, what percent do you wish had been allowed to keep going, and what percent do you wish had ended earlier?

  9. How to cause the change?

  10. What does a Test Case verify?


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 GMP book in PDF containing 994 requirements, which criteria correspond to the criteria in...

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

  • 62 step-by-step GMP Project Management Form Templates covering over 1500 GMP 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 GMP project issues be unconditionally tracked through the Issue Resolution process?

  4. Closing Process Group: Did the GMP project team have enough people to execute the GMP 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 GMP 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 GMP Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:


2.0 Planning Process Group:

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

In using the Toolkit you will be better able to:

  • Diagnose GMP 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 GMP 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 GMP investments work better.

This GMP 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.