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Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

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Unravelling the DHF, Technical File and Design Dossier

Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU’s regulatory body, the MDD.

The Design History File

The history of the Design History File is an interesting one. It evolved out of the FDA’s realization, over time and experience; that the major part of a device’s problems was happening during the design stage and change phases, regardless of whether it was a new product or a changed one. This led to the birth of the concept of Design Control, aimed at tracking, monitoring and correcting the design elements at every stage from start to finish.

cgmpForCombinationProducts

Outstanding characteristics of the Design History File

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What should the Design History File contain?

The DHF should contain the following:

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Now, the Technical File and Design Dossier

In short and simple terms, one can understand the Technical File and the Design Dossier as the EU’s version of the Design Control and the DHF. In other words, what Design Control and Design History File are for the FDA; the Technical File and Medical Device (MDD) are for the Medical Device Directive.

What should the TF and DD contain?

These files should have all the basic sections needed to support the requirements of the Medical Device Directive (MDD), Essential Requirements (for that product), and the company’s “Declaration of Conformity” for that product:

  • General Information/Product Description/EC Authorized Representative
  • Classification Determination
  • Essential Requirements
  • Risk Analysis
  • Labeling
  • Product Specifications
  • Design Control
  • Clinical Evaluation
  • System Test Reports
  • Functional Bench Testing
  • Lab Testing
  • Sterilization validation (or AAMI TIR 28 Analysis)
  • Packaging Qualifications
  • Manufacturing
  • Sterilization
  • Conclusion
  • Declaration of Conformity
  • Appendix

Differences between the Technical File and Design Dossier

At a broad level, in general terms, while the Technical File is for MDD Class I and Class II a or II b; the Design Dossier is for MDD Class III devices

While Technical Files are retained in the premises of the manufacturer or the Authorized Representative for review of the Competent Authorities or/and Notified Body; Design Dossiers need to be submitted to the Notified Body for review before the product gets its CE-marking.

 

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Design Control for Medical Devices

Design Control for Medical Devices 3

Design Control for medical devices is of utmost importance to the medical device industry. In order to get a grasp of its importance, one needs to get an understanding of what Design Control is. In simple terms, Design Control for medical devices is a set of logical and linear steps that medical device manufacturers have to take to ensure that:

  1. The medical device being manufactured is safe
  2. The medical device manufacturer follows all the steps and procedures for ensuring that the device it develops is what was meant to be developed
  3. Design controls for medical devices have to be put in place to ensure that the final product – the medical device – meets all the required and prescribed regulatory procedures and guidelines and meets the customer’s expectation

In short and simple terms, design controls for medical devices are verifiable and provable assurances that medical device manufacturers have taken adequate steps to guarantee that a medical device meets its set of required standards and procedures to ensure its safety and meet customer requirements.

FDA and ISO expectations of design controls for medical devicesBoth the FDA and the ISO have regulatory requirements from medical devices that expect some Design Control standards. The FDA’s requirements for design controls for medical devices are spelt out in FDA 21 CFR 820.30, while ISO 13485 is the standard for design controls for medical devices. Although formed by different regulatory or standards bodies; both the FDA 21 CFR 820.30 and the ISO 13485 are essentially similar. Their purview of the areas of design controls for medical devices is almost identically similar to each other. Sections of the FDA 21 CFR 820.30 and the ISO 13485 speak of requirements relating to the following in their various sections:

In just one area of design controls for medical devices, namely Design History File, there is a small difference, in that while the FDA’s regulatory requirements for design controls for medical devices include DHF; in the case of the ISO 13485, this is treated separately.

There is thus near total convergence between the FDA 21 CFR 820.30 and the ISO 13485 when it comes to design controls for medical devices.

Basic requirements of FDA 21 CFR 820.30 and ISO 13485Both the FDA 21 CFR 820.30 and the ISO 13485 have expectations for design controls for medical devices. These are the core areas:

designControlForMedicalDevices

Quality Risk Management in the FDA-Regulated Industry

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Quality risk management in the FDA-regulated industry is a vital area of regulation for the FDA. Risks to quality may arise from many sources. The FDA has entrusted itself with the responsibility of making sure that the quality of the products it regulates is maintained through a due process.

Quality risk management in the FDA-regulated industry is an extremely broad area that straddles Quality in almost all areas that the FDA regulates. The FDA has regulations for particular areas of Quality, such as pharmaceuticals, medical devices, drugs, life sciences and so on. Quality risk management in the FDA-regulated industry is aimed at utilizing core principles in many areas of health and public safety.

Benefits should outweigh the risksThe rationale for Quality risk management in the FDA-regulated industry is that the benefits a product brings for its users, namely patients, should be greater than the risk it brings in its wake. Risk, as we all know, is something like a side effect or a shadow, which accompanies the product just whenever and wherever it is used, and the products itself is unthinkable without the risk. Risk managers and regulators alike acknowledge the fact that risk is not only avoidable; it is not something that can be eliminated fully.

quality-risk-management-in-fda-regulated-industrySo, how feasible is Quality risk management in the FDA-regulated industry when it is a given that risk is inherent in any product or activity? As mentioned above; the FDA (or for that matter, any other regulatory agency) proceeds on the belief that risks can only be mitigated. This certitude is the cornerstone of formulation of policy concerning Quality risk management in the FDA-regulated industry. So, the FDA formulates best practices and regulatory requirements for containing risk.

Quality risk management as laid out by the FDAThe FDA formulates risk management strategies and best practices that help manufacturers understand the ways of risk mitigation and hazard control, so that the maximum possible safeguards are put in place to ensure risk mitigation. The FDA goads manufacturers to imbibe risk management into their core, suggesting that they make it a part of their culture.

quality-risk-management-in-fda-regulated-industryThe proper use of the principles of Quality risk management in the FDA-regulated industry is aimed at fostering compliance with regulatory requirements. Quality risk management in the FDA-regulated industry is tied to a few important principles such as Good Manufacturing Practices and Good Laboratory Practices, among many others.

The Q9 Quality risk management guidelineThe primary guidance set out by the FDA for compliance that ensures Quality risk management in the FDA-regulated industry is the Q9 quality risk management guideline. Among the fundamentals required in the quality risk management process of this guideline are:

  • Assumption of responsibilities for implementing and ensuring Quality risk management in the FDA-regulated industry by people in an organization who are entrusted with the task of decision making regarding quality
  • Initiation of a process for quality risk management
Risk assessment is a major exercise at which the following need to be taken into consideration:

quality-risk-management-in-fda-regulated-industry
Quality risk managementRisk assessment is also built on a triad of principles as part of Quality risk management in the FDA-regulated industry:

quality-risk-management-in-fda-regulated-industryFurther, the next steps in Quality risk management in the FDA-regulated industry are:

  • Risk control, consisting of issues such as:
    • Ways by which to reduce it
    • Striking a balance between risks, benefits and resources
    • Identification of possible new risks in the process
  • Reduction of risk
  • Acceptance of risk
  • Communicating of the risk in the proper manner and to the right person(s)
  • Review of the risk.

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Understanding the importance and benefits of auditing Quality Management Systems

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Auditing Quality Management Systems is a core requirement for ensuring that Quality Management Systems – defined as “…a set of policies, processes and procedures required for planning and execution” in the core business area of an organization, meaning those that impact the ability of the organization to meet customer requirements – are updated and kept in compliance with regulatory requirements. The ISO 9001 set of standards is a step towards helping organizations achieve this end.

The ISO 9001 series, aimed at facilitating and ensuring that organizations of various kinds audit their Quality Management Systems in tune with regulatory requirements set out in this standard; was first implemented in the 1980’s. Today, across the globe, over a million organizations have been certified for complying with its requirements. The ISO 9001 is a tool for auditing Quality Management Systems across all kinds of organizations: big, small or medium to one stop providers to multinational organizations that operate in various geographies.

Why is auditing of Quality Management important?

Understanding the importance and benefits of auditing Quality Management Systems2

ISO standards have been arrived at after years of practice, observation and trial and error endeavors. These standards have evolved over continuous implementation of many best practices that are suited to particular organizations based on the size of their operations and the nature of their business.

An organization that has been in the practice of auditing Quality Management Systems is said to be implementing a better way of dealing with risk management. It is also considered an organization that enjoys enhanced stakeholder and customer confidence, as well as an improved, efficient and effective management and operational systems.

More than anything else, auditing Quality Management Systems are the surest means to ensuring that products and services from an organization meet certain prescribed processes and standards. An auditing Quality Management System officially certifies that the organization task a risk-based, process oriented, streamlined approach to ensure the safety, reliability and consistency of its products and services. A company that puts auditing Quality Management Systems in place is said to be more conscious of meeting customer expectations and makes continuous efforts and improvements into its products and services and complies with the law.

Certification is proof that the organization is auditing its Quality Management Systems

Businessman with a compass holding in hand

Certification is like the proof of the pudding in Quality Management Systems audits. A company may claim to be implementing quality standards, but how does the world come to know about it? It is only through auditing Quality Management Systems certification that this happens. For a company to earn auditing Quality Management Systems certification; it has to be audited by the ISO. Upon careful scrutiny of its practices, the ISO awards the organization the 9001 Quality Management Certification.

What are the benefits of auditing Quality Management Systems certification?Certification from the world’s leading Quality Management Systems auditing certifying body gives such an audited and certified company a host of credentials and benefits. These are some of them:

auditingQualityManagementSystems

Good Manufacturing Practices are essential for ensuring quality

Good Manufacturing Practices (GMPs) constitute one of the core components that go into the manufacture and distribution of foods, drugs and other pharmaceutical products. Good Manufacturing Practices are prescribed by regulatory agencies from around the world, the FDA and the EMA being among them.

The guidelines set out by these regulatory agencies are aimed at bringing about standardization in the process of manufacture of these products and to ensure their quality. The utmost diligence of organizations that manufacture these products is called for.

goodManufacturingPracticesThe FDA attaches the highest importance to quality, since drugs and pharmaceuticals are consumed by millions of Americans for a variety of diseases and conditions. Keeping this in mind, the FDA has formulated guidelines with which manufacturing maintains set quality standards across a range of products ranging from foods to pharmaceuticals. The whole set of guidelines for manufacturing products in a variety of industries and activities is clubbed under the collective term, “Good Manufacturing Practices (GMP)”. The FDA attaches the highest importance to quality, since drugs and pharmaceuticals are consumed by millions of Americans for a variety of diseases and conditions. Keeping this in mind, the FDA has formulated guidelines with which manufacturing maintains set quality standards across a range of products ranging from foods to pharmaceuticals. The whole set of guidelines for manufacturing products in a variety of industries and activities is clubbed under the collective term, “Good Manufacturing Practices (GMP)”.

Since these best practices keep changing from time to time and the latest developments overshadow the existent ones; the FDA expects manufacturers to keep abreast of the latest regulations it passes, called cGMP, meaning “current” Good Manufacturing Practice.

No single set of standardsgoodManufacturingPracticesGMPs and cGMPs are not a single, rigid and monolithic set of standards or rules that everyone is expected to implement in their manufacturing systems. The regulatory agencies prescribe a broad set of general principles, from which a manufacturer from particular industries have to implement at a minimum level of quality requirements, the ones appropriate to it. Further, these guidelines offer options on the ways by which those regulations that are relevant to it can be accomplished. The organization needs to determine the one that suits it best for implementing that system.

Purpose of Good Manufacturing PracticesgoodManufacturingPracticesWhy the regulatory agencies take this task upon themselves is because the consumer is not in a position to identify a spurious product or one that has not been through all these scientifically designated processes. The fundamental purpose for which the regulatory agencies require adherence to the CGMP regulations is that compliance to these guidelines is a means to assuring the following:

goodManufacturingPracticesIn order to achieve this, drug manufacturers have to take all the steps needed to control the manufacturing operations. This includes establishing strong Quality Management Systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.

The FDA believes that putting all these steps and processes in place through this formal system of controls by a pharmaceutical company is a means to prevent mix-ups, contamination failures, deviations and errors. In addition to ensuring that drug products that go through these processes meet their quality standards; the cGMPs help to put in place systems with which proper design, monitoring, and control of manufacturing processes and facilities are assured.

Highlights of GMPs/cGMPsThe nature and role of current Good Manufacturing Practices can be summarized into the following:

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The GMP regulatory requirements in the EU

The EMA, being the regulatory agency for the EU; oversees the implementation of cGMP guidelines. The EMA’s guidelines apply to all the Member States of the European Union. The purpose for which these guidelines are set out by the EU is more or less the same as that for which other agencies such as the FDA lay out these rules. The essential reason for which this is done is to ensure that the pharmaceutical or any other regulated products:

goodManufacturingPracticesThe EU’s directives on GMP are listed out in its important legal frameworks and guidelines. These include:

  • Regulation No. 1252/2014 and Directive 2003/94/EC, which are for active substances and medicines for human use
  • Directive 91/412/EEC, which relates to medicines for veterinary use
  • Directive 2001/83/EC and Directive 2001/82/EC, which prescribe related provisions.

 

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Quality Assurance Auditing for FDA-regulated industries

Quality Assurance Auditing for FDA-regulated industries5

An effective audit constitutes the heart of an effective Quality System. The FDA and other regulatory agencies have emphasized this principle time and again. The purpose of an audit program is to ensure proper and thorough compliance with the guidelines set out by the regulatory agencies. A Quality Assurance audit should also ensure that the activities the company that is being audited is carrying out are within the legal guidelines and frameworks laid out by the respective regulatory authorities.

Two types of audits

Quality Assurance Auditing for FDA-regulated industries3

An organization that is in an FDA-regulated industry is required to carry out internal and external audits. The purpose of this dual type of audit is that one complements the other and the two together reinforce the audits. As the two terms indicate, an internal audit may be thought of as being a tool for self-examination. It is an audit that the organization’s own employees carry out to scrutinize the usefulness of the systems. An external audit, on the other hand, is one that is performed by an independent person who has the qualification and purpose for this kind of work. The purpose of both these types of audits is the same.

Audits based on process

Quality Assurance Auditing for FDA-regulated industries1

The core principle on which audits for the FDA-regulated industries are carried out as part of a Quality System is that since testing alone is not sufficient to ensure quality; quality should be inbuilt into the product. This approach, called the process based to auditing; has to, naturally, be based on an in-depth understanding of the entire set of processes that go into a Quality System before the commencement of the audit. A complete understanding of the processes relating to the business, control and production on the part of the auditors should be the basis to the process-based audit. Auditors then go about defining the criteria for the audit and the scope of the purpose they expect it to serve.

So, what to audit?

Quality Assurance Auditing for FDA-regulated industries

Since Quality Assurance auditing is generic to any FDA-regulated industry; a definition of what has to be audited is quite expansive. Based on the kind of the business, these are the important areas in which audit is carried out:

  • Product
  • Process
  • Quality System
  • Regulatory
  • Supplier
  • System
  • Management

The four phases of auditing

Four self-explanatory phases go into an auditing process:

  • The preparation stage
  • The performance stage
  • The Reporting stage
  • The follow-up and closure stage

Auditing of management systems

The ISO 19011

The ISO 19011

The ISO introduced the ISO 19011 management systems audit. The ISO makes it mandatory for companies to also audit the management systems along with Quality Systems. This is done to ensure completeness of the audit.

Passed in 2011, the ISO 19011 is the guiding principle for auditing a company’s management systems and the ISO standard for auditing a company’s management systems.

Full understanding of all elements of audits

A detailed explanation of the ISO 19011 and all other aspects of an ISO audit will be given at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

At this seminar, David Dills, Global Regulatory Affairs & Compliance Consultant who provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems; will be the Director.

Please log on to Quality Assurance Auditing for FDA-regulated industries to enroll for this seminar. This webinar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Benefits of participation at this seminar

Participants who attend this seminar will benefit in a myriad of ways. David will offer the following at this seminar:

  • Clear Understanding of Auditing Fundamentals
  • Understand Audit Preparation and Planning
  • Learn best techniques for Audit Performance
  • Learn best practices for Audit Reporting
  • How to address Audit Follow-up and Closure efficiently and effectively
  • Understand the requirements and expectations for being an effective auditor
  • How to develop into an even better auditor
  • How to structure, plan and manage your audits
  • How to develop your technical and non-technical skills
  • How to perform your best audit ever.

He will cover the following areas at this seminar: