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
- 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 992 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 992 standard requirements:
- Should a test for identity and assay be performed on one filled container from each manifold filling sequence, or do you rely on the test results provided by the supplier with no further testing?
- Are there any investigations in the event of unacceptable calibration results in order to determine whether there is any impact to the quality of the product and are appropriate steps taken?
- Are all measured / weighed raw materials filled into clean and suitable containers labelled with appropriate identification and / or directly into the equipment used for bulk manufacturing?
- Has it/organization entered into administration or is it experiencing financial difficulty that has/will result in budget cuts affecting good manufacturing practice compliance?
- Are aisles and working spaces unobstructed and of adequate width to permit employees to perform jobs and protect against contamination of food by clothing or personal contact?
- Are there adequate written and approved instructions and specifications for quality critical material sampling and testing, including investigation of nonconforming results?
- Is there an appropriate quality control operation employed to ensure that food is suitable for human consumption and that food packaging material is safe and suitable?
- 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?
- Are the out-of-specification results reviewed by authorised personnel and properly investigated and is a corresponding decision about uses taken subsequently?
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 992 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:
- Activity Cost Estimates: Review ÃÂÃÂ what are some common errors in activities to avoid?
- Assumption and Constraint Log: Are best practices and metrics employed to identify issues, progress, performance, etc.?
- Activity Duration Estimates: Does a process exist to determine which risk events to accept and which events to disregard?
- Team Performance Assessment: To what degree do team members agree with the goals, relative importance, and the ways in which achievement will be measured?
- Monitoring and Controlling Process Group: What were things that you did very well and want to do the same again on the next Good Manufacturing Practice project?
- Probability and Impact Matrix: Do the requirements require the creation of new algorithms?
- Procurement Audit: Has alternatives been considered for the specified procurement Good Manufacturing Practice project?
- Milestone List: It is to be a narrative text providing the crucial aspects of your Good Manufacturing Practice project proposal answering what, who, how, when and where?
- Stakeholder Analysis Matrix: Guiding question: who shall you involve in the making of the stakeholder map?
- Closing Process Group: Just how important is your work to the overall success of the Good Manufacturing Practice project?
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
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.