Posts in e-GMP

cGMP – Design & Development Plan (General ) – ISO 13485:2016 (5) Clause 7

May 23rd, 2019 Posted by e-GMP, Requirements Management, Standards and Regulations 0 thoughts on “cGMP – Design & Development Plan (General ) – ISO 13485:2016 (5) Clause 7”

Most device manufacturers find the concept of design control confusing. However, design control is better understood now as a result of better structure. The foundation for every product quality is the design process. Similar to a building, the better the foundation, the lesser the risk of collapse. In terms of design, the final product is dependent on the design process.

The design control process can be implemented for medical devices, manufacturing equipment, and operation, and software systems can make use of a similar process.

Below is a diagram of the waterfall system of design.

Waterfall Design System

 

The diagram depicts a simplistic version of an approved FDA control guidance. The design is typically more complicated due to several elements developing at the same rate. However, the waterfall diagram does serve the purpose of aiding understanding of the operations of the design process.

Common Mistakes in Design Development

One of the prominent mistakes to make is to assume that design control is the same thing as the development process. Although, the development process is a vital part of design control, a more accurate description for design control is to envision it as a lifecycle.

By picturing design control as a lifecycle doesn’t mean that design control will cover requirement for feasibility or marketing. While these processes are vital to the product development process, regulations are in place to monitor product design rather than concern itself with the success of the product in the market. Regulations are more about the safety of the design product instead of the general welfare of the business.

It is important to differentiate between the design input requirement and the marketing requirement and feasibility studies. The design input requirement is also known as the product concept document.

Document Approval

A common problem that most organization face is the approval of documents. There is always a reluctance to approve product design documents as they have to create a room for change and improvement on the document. However, by maintaining control over the document, the approval process tends to become tedious. The goal of control is not to restrict flexibility but to ensure that every phase of the design process is sync, especially when dealing with cross-functional teams.

Typically, approval can be given for revision 1 of a document with To-Be-Determined (TBD) values in certain sections. Meanwhile, teams can start preliminary drafts for the second revision of the document. Subsequent sections will address the core elements of the design control process. However, implementation of the process will depend on the following;

  • The maturity of the company.
  • Product complexity.

It is worth noting that most organizations prefer to breakdown these processes into individual (SOPs). But, it is possible to have a document that covers all the requirement of several elements of the design and development control process.

cGMP (ISO13485:2016) – Validation Master Plan (VMP)

April 18th, 2019 Posted by e-GMP 0 thoughts on “cGMP (ISO13485:2016) – Validation Master Plan (VMP)”

Part of the GMP,  a Validation Master Plan (VMP) is a way to clearly define or layout the requirements for process validation and the justification for those validations to better help medical device manufacturers. Organizations seeking control or methodology to a specific process, often make use of a validation master plan.

An integral part of a company’s Quality Management System especially if the company specialized in biotechnology, pharmaceutical, and medical device manufacturing, is the validation of their process, product, and facility.

The VMP differs from the Standard Operational Procedure (SOP). VMP is used to prioritize objectives, makes plans on the steps to take for a particular procedure while getting the steps ready for approval. On the other hand, the (SOP) showcases the exact procedure to follow to complete approved tasks. Also, the VMP records the total work put into supporting a process, and it includes; apparatus, benefits, activity, prerequisite, and strategy.

Although, by FDA Quality System Regulation (21 CFR 820), Validation Master Plan (VMP) does not require a formal prerequisite. However, it is beneficial to have a top quality VMP to execute an efficient procedure validation program.

What is Validation Master Plan?

A Validation Master Plan is part of the Good Manufacturing Practices (GMP) requirement as it pertains to biotech, medical device companies, and pharmaceuticals. The VMP is a report that chronicles and stipulate methods and equipment that require approval, the reason they are needed and the plan to ensure that a particular process is completed. Also, the person responsible for the validation process is mentioned in the report.

Owning a VMP will go a long way in ensuring that you can overcome several difficult scenarios that are sure to come up in very regulated areas.  FDA auditors requesting for detailed documentation or procedures, equipment, and validation plan is not uncommon in the industry. While, it isn’t a formal request to have a validation plan, having one prepare will reduce the chances of attracting a warning letter from the FDA.

The Purpose of a Validation Master Plan

The life cycle of the manufacturing validation process is discussed in the VMP, and it best to integrate the legal paper with the VMP to better improve the overall outcome. Likewise, VMP can be regarded as a project planning tool.

The VMP proofs to be beneficial in prioritizing goals, predicting the necessary capital, provide insights and timeline for specific projects. In addition to that, the VMP helps to track effort and document approval status for products, various activities, equipment, benefits, activities, and prerequisite.

Finally, the VMP helps to keep an overall agreed upon record for instrument approval system and general procedures. The plan can be easily given to controllers to justify approval impacts. Also, medical device manufacturers can leverage on the VMP to show that they manufacture medical devices with the focus on quality while ensuring that the manufacturer bears the responsibility for the manufacturing system quality.

What Makes UP a Validation Master Plan?

Ideally, the VMP should consider risk and include the likely effects of the current manufacturing practice on product quality. In so doing, the VMP will be able to pinpoint the procedures that require approval and in what order the validation be executed.

Risk assessment does help identify which procedures that do not need approval, using Orcanos RISK management system. Therefore, it is important to survey and examine the effect of each manufacturing process has on the quality of the final product. If justification is needed for any additional prerequisite and extension that may have been added to the validation, then the VMP can be of help.

What should be in a Good Validation Master Plan?

The Code of Federal Regulations does not have any VMP facts. However, Guidance for Industry has suggested the following be incorporated into a standard VMP;

  • All likely review and simultaneous validation activity.
  • The request, time, area and need for validation activities
  • A report that helps communicate the validation approach to the organization.
  • A detailed account of the timeline, procedures, events, and facilities.
  • Details of departments that have consented to the project.
  • A reference that describes all designs for a validation training program
  • Details on people capable of providing SOPs approval, VMP, conventions, those surveying task, and monitoring tracking systems.
  • There should be details and copies of all approval plans, current SOPs, approval reports, and conventions, pressing strategy records and much more similar information.

Components of a Validation Master Plan (VMP)

  • Table of Contents: Table of contents offers a glimpse into what in the VMP, the critical areas as well as direction to the relevant data.

Sample TOC:

1   PURPOSE.

2   SCOPE.

3   STANDARDS, GUIDELINES & APPLICABLE DOCUMENTS.

4   INTRODUCTION.

5   METHOD.

6   PROCEDURE.

7   ACCEPTANCE CRITERIA.

8   RESPONSIBILITIES.

9   VALIDATION SUPPORT SYSTEM.

10    LIST OF APPENDIXES.

11    PROCESSES DESCRIPTION.

12    PROCESS VALIDATION DECISION.

13    QUALIFICATION & VALIDATION FLOW DIAGRAM:

14    VMP TRACKING SCOPE.

15    APPENDIX NO.2 ABUTMENT PRODUCTION FLOW CHART.

  • Authorization and Title Page (dates with approval signatures): The title page will have document number, version, the title, clearly defined management agreement s and QA, these are provided automatically by Orcanos eDMS system for Document Control.
  • Validation Plan: The VMP will help identify why validation is required, what should be validated, where, when and how the validation should be done. The plan will also include a step of procedures broken into the section as well as which methods are vital to the project.
  • Abbreviations and Glossary: Technical terms and organization terminologies will be explained in this section.
  • Approach and Purpose of Validation: The purpose of the VMP clearly states with supporting logical statements the validation approach. The document must be detailed and concise to make for a comfortable and comprehensive read for the end users. The reason for the VMP’s showing of frameworks, procedures, equipment, and structured execution can be explained by the approval approach. However, the proposal does assure that validations will be executed by the approved protocol that is written. With the assurance of reliable method and arrangements of the framework, change of control and capability I bound to exist. Following this approach, all products are sure to follow a well-documented risk evaluation assessment when it comes to their manufacturing procedure and framework.
  • The Scope of Validation:  Scope covers utilities, systems, processes, procedures, equipment that might impact the final product during manufacturing as it pertains to VMP. Based on the documented risk evaluation, the scope must capture extensively the frameworks, procedures, utilities, and strategies that will be validated. Likewise, who and what should be stated clearly in the scope. It is vital that from start to finish of the VMP, readers can understand the scope.
  • Outsourced Services: In the VMP, services that relate to the management and selection of qualifications, calibrations, and activities performed by a third party.
  • Roles and Responsibilities:  this part of the plan will contain details of the role the VMP department concerning the preparing of validation protocols, change control documents, tasks reports, validation SOPs, maintenance and storage of validation-based documents. VPM will be kept by during manufacturing and designing through convention deviation, approval convention, tasks reports, and control records while the QA will be approving and reviewing protocol deviations, SOPs for consistency with cGMPs, task reports, validation protocols, approval to implement and consistency with procedures and policies.
  • Deviation management invalidation: Methodology for documenting deviations must be addressed in the VMP.  Also, when a deviation occurs during approval, it is to be noted and studied to examine methods or features of the approval convention to determine what corrective action to take and what endorsement for approval should be expected (CAPA), using Orcanos electronics CAPA Management system.
  • Risk management principles in validation: With relations to the validation process, risk management principles should be included in the VMP.  The assessment should cover design, deployment and the entire lifecycle of a planned project, using Orcanos RISK management system according to the ISO 14971:2012.
  • Change Control in Validation: A change management (ECO) system must be in place to cater to any changes that may impact the validated process and be documented in the Validation Master Plan, using Orcanos ECO management software.
  • Training: The VMP must define personnel that would be involved in a project, the qualifications they need and training they must undertake to ensure they perform excellently, using Orcanos Training management system.
  • All Validations: This is the totality of the VMP, and it includes an analytical method, cleaning, processes, equipment, premises, computer validation, qualification, utilities, and revalidation, using Orcanos Validation management system.

A general overview of the details contained in the VMP includes vital areas such as manufacturing areas, central plant, and material storage. Similarly, connections and illustration should be part of the VMP and differentiate between regions, for instances Non-GMP regions against GMP regions. Other things to be considered or incorporated include; general acknowledgment criteria, major advances in hardware, procedure, frameworks and any other changes that need to be part of the VMP.

  • Validation Matrix: The Validation Matrix is to list all the necessary validation throughout the facility. Using a matrix, timelines to execute crucial approvals will be a reality.
  • References: There must be rundown records of all activities, directions, execution, and capabilities in the VMP, using Orcanos traceability tools.

Quality Assurance is top-priority for everyone who is part of the medical industry, hence the need for the Validation Master Plan (VMP). As part of our Orcanos system and services, we handle OQ, IQ, and PQ protocol using the Orcanos testing system. Reports from our system can be generated in any format and data settings. Orcanos eGMP provides full-scale capabilities to allow any organization to conduct it VMP obligations using the Orcanos eFroms system along with its build in process automation infrastructure and increase organization efficiency by 10’s% and reduce risk during the production process.

 

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Audit Preparation and Participation as Part of the eGMP

March 30th, 2019 Posted by e-GMP, regulation compliance 0 thoughts on “Audit Preparation and Participation as Part of the eGMP”

In this post, we will discuss how to maintain a constant state of audit Readiness for unexpected audits, as well as what you can do to prepare before the audit commences.

Gathering commonly requested items ahead of time we will also take an in-depth look at the role of the audit coordinator and provided detailed recommendations for the audit Operation Center.

Next, we’ll talk about how to handle the audit itself including the opening meeting gathering documents for the auditor answering the auditor’s questions laboratory facility tour and the exit meeting.

Maintaining Audit Readiness

As some audits can be performed without notice or it’s very short notice the laboratory should operate under a state of audit readiness at all times if you do receive a notice of the audit there are a number of things that can be done before the audit commences.

  • Review your Laboratories SOPs on receiving inspectors and handling inspections.
  • Review past inspection reports, and attempt to identify items that may be a particular interest or concern to the inspectors.
  • Try to determine the identity of the auditors and their area of expertise.
  • Assign each inspector a host.
  • Determine, as far as possible, the scope and methods of the audit, this will often be discussed during the initial meeting.
  • Book rooms for the auditors and a room to act as the operation center.
  • Identify subject matter experts for each area together with substitutes.
  • It is not unknown for auditors to request to observe a demonstration of a particular method. This may, in particular, happen during a client audit when the client wishes to assess the competency of the laboratory to perform a particular test.  It would be good practice to identify someone with significant experience to perform any demonstrations before the audit commences.
  • Establish as much as possible a tour route.
  • Walk through the tour route and check all of the following:
    • Instrument log books instrument status and calibration status.
    • The expiry date of chemicals, reagent, mobile phases and solvents – remove or revise all out-of-date reagents.
    • For laboratory glassware, in particular, confirm the calibration markings on volumetric glassware are clearly visible.  Also, confirm that the correct grade of glassware is being used and be able to confirm this with the documentary evidence.

Review testing schedules, it is best to concentrate on routine work during an audit, especially a regulatory audit, and avoid working on more challenging activities such as investigations.

Using Orcanos eQMS system allows you to control electronically the audit readiness and allow you to stay focus on the daily tasks. Orcanos provides a set of reports you can have free access to such as:

  1. Audit Readiness – SOP Annual Review (Effective Date > 300 days)
  2. Audit Readiness – Previous Process Checks with Low Grade (1 – 3)
  3. Audit Readiness – Deviation Summary Reports
  4. Audit Readiness – Complaint Investigation Report
  5. Audit Templates
  6. Many more…

It is a good practice to have such documentation readily available on site. If necessary Orcanos eQMS system will allow recalling all such documentation electronically with no need to go onto the remote site. Orcanos system will preserve your data for at least 15 years and more so no need to archiving.

 

 

NOTE: These recommendations are also applicable for Good Laboratory Practice (GLP) required by the ISO 13485:2016 and now by the new MDR and MDSAP.

Orcanos 4.0 new release now includes a complete training program plan to support the GMP process

January 8th, 2019 Posted by e-GMP, Requirements Management Tool 0 thoughts on “Orcanos 4.0 new release now includes a complete training program plan to support the GMP process”

Orcanos 4.0 new release now includes a complete training program plan to support the GMP process. The Orcanos new release involves a set of optional training tasks with a list of topics and agenda to be covered in order to be in compliance with the GMP. These training topics are covering Medical Device and Pharma producers including Cannabis growers who need to comply with the enforcement of the strict regulations by the legislation of the local government.

Orcanos as a world leader in the eGRC and eQMS and ALM market happy to get you the list of topics in a specific each subject area according to your professional demands, please simply click www.orcanos.com to get your FREE edition.

Some covered subjects below:

  1. Quality Assurance
  2. Microbiology
  3. GMP in Pharmaceutical Development
  4. GDP
  5. Computer Validation
  6. GMP for APIs and Excipients
  7. Medical Devices
  8. Packaging
  9. GMP in Biotechnology
  10. Regulatory Affairs
  11. Quality Control
  12. Sterile / Aseptic Manufacturing
  13. Technical Operations
  14. Validation
  15. GMP Basic Training Courses
  16. Data Integrity

Here are some of the benefits of using Orcanos  as the foundation of your e-GMP system:

  • Automation and Standardization: With Orcanos eGMP software, you can standardize all documents-based processes and automate distribution/routing, review, follow-up, escalation, and approval of documents. It makes search and retrieval of documents faster and easier.
  • Centralized Platform: Orcanos can serve as a centralized platform for all quality documents and records critical to eGMP compliance, making it essentially your eGMP system. Orcanos is web-based so authorized users have access to the system from virtually anywhere 24/7 not holding your production line and allow granting confirmation service without the local presence or human resources.
  • Connectivity: Orcanos is unlike other eGMP software solutions in the sense that it can connect all quality processes, including document control, training control, audit management, nonconformance management, CAPA, MRB, DHR and change control. This connectivity will help ensure that quality and other issues will not fall through the cracks.
  • Mobile Access: With Orcanos adoptive technology, users can access the system using a tablet or a smartphone. This capability is a distinct advantage of Orcanos over other eGMP software solutions and it can be very helpful for users out in the field or those constantly traveling. Those users will be able to participate in documents-based processes critical to eGMP compliance even when they are not in their local office.
  • Validated System – Orcanos is a validated system that no customization requires any effort invalidation. It is fully CFR 21 Part compliance system and already servers many customers around the world.

 

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