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:


• Identify, respond, and monitor potential project risk and determine possible Contingency Plans for Risk Mitigation.
  
  

• Establish that your group coordinates with Supply Planning to generate Production Plan for all processes in line with approved Master Production Schedule and monitors progress.
  
  

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

• Be certain that your operation updates site files used to calculate and display project metrics as Right First Time, On Time Delivery and Schedule Adherence.
  
  

• Confirm your corporation 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.
  
  

• Help organize and clean warehouse, ensures material identification, status, location, movement, and quantities are accurate, timely and correct.
  
  

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

• Govern: work quickly and efficiently with hands continuously (reaching and performing repetitive hand wrist and arm motions).
  
  

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

• Confirm your corporation evaluates Employee Training to ensure all employees are trained on GMP, Personal Hygiene, and Manufacturing Standard Work.
  
  

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

• 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.
  
  

• Be accountable for Quality Standards of your product by supporting all quality programs and complying with all policies, HACCP, and GMP/Food Safety requirements.
  
  

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

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

• Oversee team execution and implementation in accordance with Change Control plans, methods, support Resource Planning.
  
  

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

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

• Ensure your strategy adheres to GMP, safety, personnel and departmental policies as set forth by Standard Operating Procedures and personnel manual.
  
  

• Develop departmental standards and guidelines for Change Control inputs and requirements needed to support Change Control packets.
  
  

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

• Be accountable for ensuring Supplier Quality documentation is accurate, maintained, and reflects GMP, procedural and Regulatory Requirements.
  
  

• Assure your strategy maintains GMP compliance; assures that all products are stored, segregated, and labeled properly; keeps all work areas safe, clean and orderly.
  
  

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

• 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 design leads project Team Activities and actions, monitoring progress against the established timelines and providing regular updates to the internal stakeholders and customers.
  
  

• Ensure you orchestrate; understand and follow Hazard Analysis and critical control points, (HACCP) and Good Manufacturing Practices (GMP).
  
  

• Perform final review and audit of GMP subcontractors final cost reports and cost history, and ensure that final cost reports are accurate and provide meaningful cost history.
  
  


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. How do you establish and deploy modified action plans if circumstances require a shift in plans and rapid execution of new plans?
   
   

2. What will drive GMP change?
   
   

3. How has the GMP data been gathered?
   
   

4. Can you break it down?
   
   

5. What creative shifts do you need to take?
   
   

6. How are GMP risks managed?
   
   

7. At what moment would you think; Will I get fired?
   
   

8. What are the GMP business drivers?
   
   

9. What are the personnel training and qualifications required?
   
   

10. You may have created your quality measures at a time when you lacked resources, technology wasn't up to the required standard, or low Service Levels were the industry norm. Have those circumstances changed?
    
    


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:


• 1.1 GMP project Charter

• 1.2 Stakeholder Register

• 1.3 Stakeholder Analysis Matrix


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.