cGMP Toolkit

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Monitor key Quality System metrics, process indicators, and overall health of the cGMP Quality Management System (QMS) to proactively identify and address Quality Systems or product issues and ensure its continuing stability, effectiveness, and improvement.

More Uses of the cGMP Toolkit:

  • Manage work with process development team and operations organization to successfully transfer process to cGMP facility to manufacture products.

  • Assure the analytical team follows applicable cGmp Requirements and your organizational SOPs.

  • Ensure you conceptualize; lead the design, commissioning and implementation of control and automation engineering projects in cGMP manufacturing areas and supporting labs.

  • Be accountable for supporting process development, design, scale up, technology transfer, and start up of cGMP manufacturing.

  • Provide training and support to Product Development personnel during the development and scale up of formulations on cGMP equipment.

  • Perform tasks in a manner consistent with the safety policies, Quality Systems and cGmp Requirements.

  • Maintain compliance with applicable cGMP regulations, vendor guidelines, engineering.

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

  • Ensure you educate; understand and adhere to SOPs and cGMP compliance regarding materials control in multiple storage locations and conditions.

  • Provide leadership and oversight to the capital team to ensure a cGMP facility is built to meet regulatory and client requirements.

  • Perform review, audit, and approval of manufacturing batch records and protocols to ensure production records are complete, accurate, and documented according to written procedures and cGmp Requirements.

  • Write manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGmp Requirements.

  • Be accountable for assuring that all test data is gathered and recorded in accordance with cGmp Requirements.

  • Be accountable for the Quality and cGMP compliance of the area by ensuring cGMP is followed in area of responsibility.

  • Ensure all operations are executed in cGMP compliant manner and meet organization standards.

  • Organize validation activities with related areas, samples collection, Data Analysis and Involved in the development of SOPs and validating laboratory equipment as per cGMP regulations.

  • Identify, prioritize, and execute Quality Improvement efforts to continually improve efficiency, effectiveness, and compliance with applicable cGMP regulations.

  • Lead process development, design and improvement in the manufacturing of consumable products or support of processes/equipment used in a cGMP manufacturing environment.

  • Make sure that your team operates production equipment and performs duties under compliance of cGMP manufacturing.

  • Establish: review requirements and enforces procedures to ensure cGMP and Regulatory Compliance.

  • 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).

  • Initiate: compliance closely collaborate with quality and compliance, and facilities and engineering to maintain a high level of cGMP compliance and safety through the effective Monitoring And Reporting of metrics.

  • Be certain that your organization complies; employees must also maintain complete and accurate records, in accordance with cGMP.

  • Steer: Industry Standards for commissioning, qualification, and operation of facilities and utilities for cGMP manufacturing.

  • Perform or support cGMP lot release, in process, and stability testing using various software packages.

  • Ensure your group assures that production operations are performed according to cGMP and ISO 9000 standards.

  • Assure cGMP success through effective tech transfer and support of cGMP manufacturing.

  • Perform inventory transactions and support Inventory Management functions using ERP System in a cGMP environment.

  • Manage work with process development team, quality and operations organization to successfully transfer process to cGMP facility to manufacture products.

  • Be accountable for writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGmp Requirements.

 

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


STEP 1: Get your bearings

Start with...

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

Examples; 10 of the 999 standard requirements:

  1. What are the cGMP tasks and definitions?

  2. What are the long-term cGMP goals?

  3. In the case of a cGMP project, the criteria for the audit derive from implementation objectives, an audit of a cGMP project involves assessing whether the recommendations outlined for implementation have been met, can you track that any cGMP project is implemented as planned, and is it working?

  4. Are the key business and Technology Risks being managed?

  5. What may be the consequences for the performance of an organization if all stakeholders are not consulted regarding cGMP?

  6. How would you define the culture at your organization, how susceptible is it to cGMP changes?

  7. How do you promote understanding that opportunity for improvement is not criticism of the status quo, or the people who created the status quo?

  8. What are the operational costs after cGMP deployment?

  9. Is there any additional cGMP definition of success?

  10. What cGMP metrics are outputs of the process?


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

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

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

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

1.0 Initiating Process Group:


2.0 Planning Process Group:


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 cGMP 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 cGMP 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 cGMP project with this in-depth cGMP Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose cGMP 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 cGMP 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 cGMP investments work better.

This cGMP 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.