Save time, empower your teams and effectively upgrade your processes with access to this practical Good Distribution Practice Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any Good Distribution 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 Distribution Practice specific requirements:
STEP 1: Get your bearings
- The latest quick edition of the Good Distribution 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 995 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 Distribution Practice improvements can be made.
Examples; 10 of the 995 standard requirements:
- Is there a written procedure for clearing the packaging area after each packaging operation, and cleaning before the next operation, especially if the area is used for packaging different materials?
- Is there a documented approach for the design and modification of equipment for the handling of pharmaceutical starting materials including location, operation and maintenance of equipment?
- Is there a procedure for handling returned goods, including proper identification, segregated storage, testing, and Quality Unit involvement in the evaluation and determination of fate?
- Is there a process in place to consider if deviations of calibration of quality critical equipment have had an impact on the quality of product since the last successful calibration?
- Are there complete written and approved instructions for performing testing of final product that specify methods, equipment, operating parameters, and acceptance specifications?
- Are there adequate written and approved instructions and specifications for quality critical material sampling and testing, including investigation of nonconforming results?
- Is there a written stability program, approved by the Quality Unit that specifies sample size, storage conditions, testing intervals, and tests to be performed?
- When the responsibilities of the Quality Unit that have been delegated to other personnel, what controls have been put in place to ensure proper implementation?
- What controls are applied to assure that the excipient conforms to the documented specifications when the excipient is manufactured using a continuous process?
- What records are kept to demonstrate that GMP training is conducted in a timely manner for new and temporary employees as well as consultants and contractors?
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 Distribution Practice book in PDF containing 995 requirements, which criteria correspond to the criteria in...
Your Good Distribution 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 Distribution Practice Self-Assessment and Scorecard you will develop a clear picture of which Good Distribution 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 Distribution 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 Distribution Practice projects with the 62 implementation resources:
- 62 step-by-step Good Distribution Practice Project Management Form Templates covering over 1500 Good Distribution Practice project requirements and success criteria:
Examples; 10 of the check box criteria:
- Project Performance Report: To what degree can all members engage in open and interactive considerations?
- Scope Management Plan: Have the procedures for identifying variances from estimates & adjusting the detailed work program been followed?
- Risk Register: What would the impact to the Good Distribution Practice project objectives be should the risk arise?
- Procurement Management Plan: Is it possible to track all classes of Good Distribution Practice project work (e.g. scheduled, un-scheduled, defect repair, etc.)?
- Procurement Audit: Is procurement execution duly monitored and documented?
- Cost Management Plan: Does a documented Good Distribution Practice project organizational policy & plan (i.e. governance model) exist?
- Project Portfolio management: Annually (or more frequently) prioritize the overall Good Distribution Practice project portfolio?
- Procurement Management Plan: Is there general agreement & acceptance of the current status and progress of the Good Distribution Practice project?
- Quality Audit: How does your organization know that its system for examining work done is appropriately effective and constructive?
- Initiating Process Group: How is each deliverable reviewed, verified, and validated?
Step-by-step and complete Good Distribution Practice Project Management Forms and Templates including check box criteria and templates.
1.0 Initiating Process Group:
- 1.1 Good Distribution Practice project Charter
- 1.2 Stakeholder Register
- 1.3 Stakeholder Analysis Matrix
2.0 Planning Process Group:
- 2.1 Good Distribution 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 Distribution 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 Distribution 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 Distribution 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 Distribution Practice project or Phase Close-Out
- 5.4 Lessons Learned
With this Three Step process you will have all the tools you need for any Good Distribution Practice project with this in-depth Good Distribution Practice Toolkit.
In using the Toolkit you will be better able to:
- Diagnose Good Distribution 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 Distribution 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 Distribution Practice investments work better.
This Good Distribution 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.