The Device History Record (DHR)

The Device History Record (DHR)

The US FDA states the following:

Each manufacturer should maintain DHR’s. For what steps in the manufacturing process are these records to be maintained? It is for establishing and maintaining procedures to ensure that DHR's for each batch, lot, or unit. The purpose of this requirement is to show that the medical device is manufactured exactly as mentioned in the DMR and that the requirements are met. The FDA states that the DHR shall have in it, or will refer to where it locates these bits of information:

o   the manufacturedates

o   the manufacturedquantity

o   how much quantity was released for distribution

o   records showing acceptance that the device is manufactured in accordance with the DMR

o   the product’s primary identification label and labeling that went into each production unit; and

o   detail of all and any device identification(s) and control number(s) used in the manufacture of the device.

Important facts to remember about the DHR

It is not mandatory to keep the original DHR with the device. It is possible that due to frequent testing and other tasks carried out; the DHR can get tampered. However, before any DHR is removed, there should be a sound set of controls to retain or retrieve data. It should be kept intact, so that there is no loss of record. An authentic way of ensuring this is by having a person in the organization in charge of this aspect. That person can scan the DHR and store it into a repository.

A device that goes into distribution with a DHR is as considered a spurious one. Anyone responsible for doing this is liable for a year’s imprisonment or a penalty of up to $1000.

The manufacturer should ensure clarity on whether the product has an original DHR or the record of a rework. Rework in this case refers to the changes done on a nonconforming product to meet regulatory requirements.

On the other hand, alteration is the repair or servicing carried out on a product that has already entered distribution. 

Finally, remanufacturing is the process carried out on a conforming product to make it nonconforming. Also included under this is anything that is done to the device to alter its characteristics. All these three types of work on the device should be recorded in the DHR and maintained.

References:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.184

http://www.mddionline.com/article/clarifying-device-history-record-issues

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

QBD Analytical Method

QBD Analytical Method

ICH Q8 (R2) describes the nature of Quality by Design (QBD). QBD is a systematic approach to pharmaceutical manufacturing and development. Based on exact science with incontrovertible evidence, QBD aims at bringing about product and process understanding and process control. QBD seeks to bring all these about by beginning with predefined objectives.

Structure

The flow of processes in a QBD approach would typically be thus:

1.      selecting the product profile

2.      defining the critical quality attributes (CQA)

3.      performing risk assessment by linking raw material attributes and process parameters to CQAs

4.      cultivating a space for design

5.      arriving at a control strategy

6.      accomplishing product lifecycle by making continual development an integral part of it.

Analytical methods used in QBD

Both analytical and advanced analytical methods are used in QBD to achieve the end result of product and process development.

Analytical methods:In using analytical methods, QBD makes use of measurement of Critical Quality Attributes of everything relating to the product –the raw materials, intermediaries and the final product. Secondly, it supports risk assessment based on these qualities.

Advanced analytical methods: In order to achieve and enhance greater manufacturing control, a QBD uses analytical methods, which form the basis of Process Analytical Technology (PAT) and Real Time Release Testing (RTRT). This is done for process monitoring and for achieving continual improvement.

What purpose do these analytical methods achieve?

Precise analytical methods help achieve the following:

o   they help aggregate the selected product profile

o   they enable exact measurement of product CQAs and the intermediaries used in the process

o   they help identify and fix measurements and controls used in the process

o   they provide inputs with which to track and trend processes, leading to continual improvement in the process and the product.

Reference:

http://www.isranalytica.org.il/Isranalytica2012/2012%20CMoore%20Isranalytica%20Analytical%20QBD%20%28Tel%20Aviv%29.pdf

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

OHSAS 18001 Gap Analysis Audit

OHSAS 18001 Gap Analysis Audit

OSHA stands for Occupational Safety and Health Administration. OSHA 18001 is the international standard that ensures safety and health at the workplace. It is the organization that has to show compliance with the provisions set out in this standard by ensuring that it is implementing OSHA 18001 at its workplace.

The aim of carrying out OSHA 18001 is to ensure that there is good management of work-related safety and ergonomics at the workplace. It seeks to reduce accidents and work-related health issues.

What is the role of gap analysis?

Gap analysis is all about determining if the organization’s safety management systems sit in sync with the requirements set out in OSHA 18001. Like all other gap analyses; OSHA 18001 gap analysis audit too, should be done before an organization puts its safety system in place. This is because of the obvious reason that it makes sense to carry this out at an earlier stage than later.

The aim of the gap analysis is to prevent future gaps and maladjustments into the organization’s safety systems. Carrying out this audit is also helpful in identifying areas of safety that matter most to employees, gauge the resources needed for carrying this out, and acting on these.

Documentation is at the heart

When an OSHA auditor visits your place, make sure that your documents on safety are in place. Make sure you have all the details they will ask for, such as the number of employees in the workplace; safety measures in place till now; the number, if any, of employees with physical challenges, and what has been done to address them, and the like.

References:

http://www.aviva.co.uk/risksolutions/consultancy/health-and-safety/bs-ohsas-18001-gap-analysis.html

http://rynmag.co.za/index.php/understanding-ohsas-18001-gap-analysis-audit/

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

ISO 13485 vs. ISO 9001

ISO 13485 vs. ISO 9001

One of the most commonly countered questions in the medical device industry is: ISO 13485 vs. ISO 9001. They are often confused for each other. But they are never the same, although they have many common requirements.

ISO 13485 is part of ISO 9001 family of regulations

When understanding ISO 13485 vs. ISO 9001, we have to understand that both standards are part of the ISO QMS, and must meet general requirements. These general requirements merely state that “the organization shall establish, document, implement and maintain a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard”.

ISO 13485 flows from ISO 9001. While ISO 9001 is a general standard for third party assessment, ISO 13485 is that part of this standard that is specific to the medical devices industry.

Critical differences

The crux of ISO 13485 vs. ISO 9001 lies in the application. ISO 13485 includes some specific requirements for medical devices and excludes those requirements of ISO 9001 that are not appropriate for regulatory requirements. So, although similar on the surface, these two standards work in tandem, but are yet exclusive to each other in many respects.  Organizations which claim that their medical devices meet ISO 13485 requirements cannot claim that their organization automatically meet ISO 9001 as well.

The ISO wanted to make the 13485 specific to the medical devices industry. It wanted to remove the complexity associated with the 9001 and make a standard that was usable by organizations of varying sizes, was easily comprehended, was compatible with management systems such as ISO 14001, and had a direct relationship with the activities that went into running a business. The ISO 13485 standard has achieved all this, and thus is a continuum of the ISO 9001 standard with the necessary refinements.

Difference in terms of operation

ISO 13485 must define document retention times based on organizational and regulatory requirements, while 9001 must record retention times based on organizational and regulatory requirements.

Reference:

http://www.slideshare.net/riteshreddych/differences-between-iso-13485-and-iso-9001

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

ISO 13485 internal audit

ISO 13485 internal audit

So, you are in the medical devices industry, and one of the first items you would come across in your profession is having to deal with an ISO 13485 audit. What is the ISO 13485, and what does it take to audit it?

Understanding the ISO 13485

First things first. Let us get to the root of the matter: What is ISO 13485? The ISO describes the ISO 13485 thus:

“ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services”.Thus, it is clear that ISO 13485 concerns itself with regulatory requirements for QMS.

Does my organization need an independent auditor for ISO 13485?

ISO 13485 requires many important parts. Some of these are:

o   Compliance Audit Program

o   Policy Audit Program

o   Procedures Audit Program

o   Process Audit Program

o   Records Audit Program

What is given here is only a small sample of the parts required to be audited. Come to think of it: Would your organization have the time or resources to implement these complex audits? Being in the medical device industry is strenuous to say the least. On top of it, apart from having to work on your core business, do you think it is wise to allocate resources for intricate tasks such as audits?

Think of having an independent organization/auditing company/individual who will be dedicated for this exclusive task. Does it not make your task easy and efficient?

References:

http://www.iso.org/iso/catalogue_detail?csnumber=36786

http://www.praxiom.com/iso-13485-audit.htm

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

ISO 13485 Gap Analysis

ISO 13485 Gap Analysis

Gap analysis is an important aspect of the ISO 13485 audit. The ISO 13485 standard lists out requirements for a wide-ranging management system for the manufacture and design of medical devices. When a medical device organization performs a gap analysis, it is analyzing the gaps that exist in its QMS vis-à-vis that prescribed in ISO 13485.

Why do the gap analysis?

Performing the gap analysis is obviously of very high importance to a medical device company. It helps the business understand the shortfall it has in relation to meeting regulatory requirements set out by ISO 13485. It helps it identify areas of insufficiency.

When should it be done?

It is best advised that organizations carry out the gap analysis before its final QMS is put in place, because identifying gaps at this stage is prudent. When carried out at this stage, it saves resources and time by nipping in the bud issues that could pile up later on. When gap analysis is not done at this stage, it becomes difficult to implement a QMS. As the old saying goes, a stitch in time saves nine!

How to do it?

It is always a great idea to get an ISO consultant to perform your organization’s gap analysis, because the professional knows best. By dedicating that person for this task, you could not only get a neat job done; you could also save on time and your own company resources.

Performing the gap analysis requires answering a set of questions relating to the QMS. The consultant will frame a set of questions that he/she will get you to answer. Some of these questions typically are of this nature:

o   Has the requirement been met?

o   Has the gap been identified?

o   Has remedial action been taken, or is it not necessary?

If the answer is “no” to any of these, it means that further action is necessitated. Leaving your ISO 1385 gap analysis to an expert requires your active support and cooperation.

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

The Device Master Record (DMR)

The Device Master Record (DMR)

The Device Master Record (DMR) is what may be described as the complete documentation required in the manufacture of medical devices that meet quality standards. The DMR, along with the Device History Record (DHR), is an extremely important element of the Quality System Regulation (QSR) in relation to FDA cGMP.

Inputs and final product

 The DMR constitutes the raw ingredients of the QSR. It is what goes into the QSR, while the DHR shows how these ingredients worked to deliver the final product. It needs to come with a Standard Operating Procedure (SOP), which defines the exact contents of the DMR, which will pave the way for the creation of an SOP for DHR, as well. One of the primary uses of a DMR is that being a master record; it tells employees the specific functions that need to be performed in the manufacture of a particular medical device.

No hard and fast rule about arrangement

Section 820.181 of the FDA spells out the requirements for DMR. A very important component of this section is that it does not make the type of arrangement of information about the device watertight. It gives sufficient freedom to manufacturers of medical device in that they are free to write information about it in any manner they like, so long as it is easily accessible.

Device specification –the core of the DMR

The foundation or what may be called the preface to the contents of the DMR is device specification. This section of the DMR briefly lists out all important details of the external nature of the device. Usually, a DMR device specification has the following:

o   the device's product trade and common name(s)

o   intended use(s)

o   environmental limitations and product stability

o   important components and formula (if applicable)

o   performance characteristics and theory of operation

o   physical characteristics

o   regulatory classification

o   user safety characteristics.

References:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122576.htm

http://www.globalcompliancepanel.com/control/w_product/~product_id=600076LIVE

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

USP 1225

USP 1225

Quality levels of pharmaceutical items are set out in various test procedures and instruments. US pharmacopeia, which deals with specifications of drugs and other pharmaceutical products, uses the following criteria to assess the method validation of these products:

o   accuracy

o   precision

o   specificity

o   detection limit

o   quantitation limit

o   linearity

o   range

o   robustness

Types of test methods

USP 1225 establishes the types of test methods. These are:

o   assay

o   identification

o   testing for impurities – quantitative

o   testing for impurities – limit

o   performance

Specificities of USP 1225

Failure to meet regulatory expectationsunder USP 1225 typically invites statements such as “Failure to establish accuracy, sensitivity, specificity, and reproducibility of test methods employed by your firm”, which will be the explanation the FDA gives for failure of compliance, leading to the issuance of a 483. Such an observation reflects the lack of understanding of the nuances of method validation on the part of the analyst.

The way out

Test methods that meet USP standards are essentially about common sense. The analyst has to understand and identify the foundational aspect of test validation –the intended use of the test method. This is what enables her to categorize the test method into one of the types prescribed by the USP. This will be the gateway to a clearer understanding of the guidance set out in USP 1225. This is because the underlying matter is that the analyst must prove that the method performs exactly as intended. This is what forms the basis of the above criteria and test methods.

References:

http://www.drugfuture.com/Pharmacopoeia/usp32/pub/data/v32270/usp32nf27s0_c1225.html

https://www.globalcompliancepanel.com/control/w_product/~product_id=600472LIVE?channel=mailer&camp=webinar&AdGroup=atlas-conferences.com

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

ISO 14001 –the management’s responsibilities

ISO 14001 –the management’s responsibilities

ISO 14001 deals with an organization’s environmental policy.  This instrument has been designed to ensure that organizations achieve and demonstrate sound environmental performance. An organization has to assess the impact of its business on the environment and shape its environmental policy accordingly, so that it contributes to sustainable development.

Management’s role

The management in an organization is the prime player in implementing environmental actions laid out by ISO 14001. Many of them undertake their own environmental performance and audits, but they have to be consistent with what is required of this standard. This ISO standard requires that organizations implement an Environmental Management System (EMS). It requires the organization’s top management to define and enforce the organization’s EMS. The most important points of this policy are that the organization should have an EMS that reflects the nature of its products and is appropriate and proportionate to them and that there is transparency in the policy, meaning that it is made public.

Implementation and operation

In implementing its EMS; the organization should designate a person who will oversee the policy. The environmental policy should be implemented on the organization’s infrastructure, such as buildings, its facilities, drainage tanks and so on.

The organization will appoint a competent, knowledgeable person who has the skill, knowledge and experience to carry out this policy. They could also be trained for the purpose of carrying out the organization’s EMS.

Transparency and introspection

It is very important for the organization to ensure transparency in its policy by internally communicating the goals and objectives of the policy to all employees. It should document every action it takes on the EMS by constantly evaluating the impact of its actions in relation to the environment. It should analyze this in relation to the impact of what its non-actions will have on the environment. It should also make adequate responses to onsite emergencies such as proper storage of inflammable materials.

Reference:

http://www.cait.cn/ISO14000/biaozhun/bzwj/200808/P020081104476975314192.pdf

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Aspects to look out for in your ISO 13485 Quality Manual

Aspects to look out for in your ISO 13485 Quality Manual

Each and every organization that implements ISO 13485, an important ISO standard, has to have a Quality Manualin place. The ISO 13485 sets out requirements for a complete management system for organizations that are in the business of designing and manufacturing of medical devices.

Since ISO is essentially about documentation; a medical device company’s objectives must be clearly defined and documented in its Quality Manual. ISO 13485 states that a Quality Manual must be created and maintained. Three very critical aspects need to be documented:

o   procedural requirements

o   planning, operation and control of processes

o   records that are required to comply with the ISO 13485 Standard

Management Commitment and Responsibility

As part of ISO 13485, a medical device company’s management is responsible for implementing an effectiveQuality Management System (QMS). This, along with its commitment to enforce it, should be part of the Quality Manual. The Quality Manual should reflect commitments of the Quality Policy, which should be on these lines:

It should establish aQuality Policy. This policy should reflectthe purposes of the organization and should be aligned to it.

The Quality Policy must make sure that the organization’s quality objectives are established and adhered to.

The management should periodically conduct management reviews.

It should ensure that resources are made available for this work.

It should meet customer requirements.

Management should identify, document and communicate to the rest of the organization the responsibility and authority to define, implement and monitor processes.

Management has to appoint a representative whowill be assigned the oversight of creating awareness of customer requirements. This representative should also ensure that the processes needed to implement and maintain aQMS are put in place and maintained.

Management should take every step towards facilitating internal communication.

One of the most important tasks for the management is to review the QMS to ensure that it is suitable, adequate and effective. This review is based on a number of parameters, the most important of which are feedback, process performance and product conformity. It should also ensure CAPA.

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

The ICH Q 7 A–important sections

The ICH Q 7 A–important sections

The ICH Q 7 A is a globally harmonized GMP guideline for Active Pharmaceutical Ingredients (API). This guideline covers all GMP aspects of manufacturing, quality control and trading of both chemical and biological ingredients of a drug.

The Q 7 was arrived at by the International Conference of Harmonization (ICH), which is why it gets its name. Adapted in November 2000, it came into being after three of the world’s leading medical device markets, namely the EU, Japan and the US agreed to it.

Although a comprehensive guideline that covers almost all aspects of GMP for API in its 19 section; a few sections are more important than the rest. It makes sense to be aware of these sections and implement them for day-to-day use.

1.      Introduction and glossary: Most people only glance at this section and its sub-sections, but it contains very important details. For instance, it contains unique definitions, especially those on API starting materials and manufacturing. Unique definitions by experts are carried here. They help to properly apply the intent of Q 7.

2.      Buildings and facilities: Extremely important because it contains reference to minimum quality of potable water, closed systems and contact utilities.

3.      Process equipment and cleaning:This states that contact surfaces of all materials should not be able to alter the quality of the product or the material beyond stated or established requirements.

4.      Production and in-process controls: This section is vital because it states that deviations need to be documented under API GMP.

5.      Process Validation: Undoubtedly the most critical section of GMP, because this is what qualifies and validates a process. It also carries important issues such as qualification vs. validation.

6.      Rejection and reuse of materials: Q 7 is perhaps the only document that precisely defines these terms. But for this, there would be considerable confusion about what we would be doing under API GMP.

7.      Agents: Outcome of the Haitian situation in the mid-1990’s, where children died from glycerubecontamination; this requires maintenance and traceability of records and processes from manufacturer to user.

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Is a completeDevice History Record a must?

Is a completeDevice History Record a must?

This is the same as asking if a teacher needs to complete her entire syllabus for the class. There is considerable debate in the medical devices industry circles about whether some portions of a DHR can be done away with.

Please, please, do not take the DHR for granted. Of course, if inviting a recall is on top of your mind, go ahead and skip any of these steps:

1. The exact date of manufacture of your device, batch, or lot;

2. The precise numbers of the devices you manufactured;

3. Out of these, the actual number that was accepted and taken up for distribution;

4. Most important: All records that show that your support devices are being manufactured as specified in the DMR;

5. Another very important one: Make sure you have included a copy of the ACTUAL product label consisting of carton and/or pouch, along with the product’s Directions for Use;

6. Whatever extracontrol numbers, identification, or serial thatyou may have included.

So, why miss out on any critical information? Just make sure that all these are retained in your DHR. Never ever forget this: You are safe when you document. It is not only your best protection against errors in the process which you can identify at that exact stage and set right at the exact place; it also makes sure FDA cannot catch you by the scruff of your neck. What greater defense to show the FDA than your actual documented records? The FDA is there to check your compliance with QSR, and let us make it easy for them.

http://www.medicaldevicesummit.com/Main/Blogs/57.aspx

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

The ISO 13485 -what is it?

The ISO 13485 

For anyone in the medical devices industry; the real buzzword perhaps is ISO 13485:2003. What is it? How does it matter to the industry? What are its exceptions?

The medical device industry, given its enormous impact on human health and welfare; is highly regulated all over the world. In the leading blocks, namely the US, EU and Canada; it is regulated by the FDA, European Medical Devices Directives and the Canadian Medical Device Bureau respectively. In addition, ministries of health regulate this industry around the world.

What is it?

ISO 13485:2003 sets out the quality system standards for this industry. This standard sets out “…requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.”(http://www.efrcertification.com/iso13485.php)

What is the aim of ISO 13485:2003?

The main aim of ISO 13485:2003 is to foster harmonized regulatory requirements for quality management systems in medical device. Thus, it is mandatory for all medical device organizations to conform to what is set out in ISO 13485:2003, no matter what size or type it is.

Exclusions

Only those design and development controls that are permitted to be excluded from regulatory requirements can be excluded the quality management system. When such exclusions are allowed; alternative implementations set out by these regulations have to be applied. The organizations that make these alternative arrangements have the responsibility of ensuring that claims of conformity with this standard reflect exclusion of design and development controls.

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Foundations of Good Documentation Practices for GMP

Foundations of Good Documentation Practices for GMP

Good Documentation Practices (GDP), although indispensable for GMP practices; often gets overlooked. In relation to CAPA, validation, investigation and such other practices; GDP seems to be getting the scantest attention. Important though these programs are; none of them is complete without GDP or is a substitute for it.

The golden rule of documentation

The golden rule, or what may be said to constitute the very foundation of GDP, is this FDA dictum: “If it isn’t written, it didn’t happen”. Regulatory professionals could change it to:  “If it isn’t written clearly, it didn’t happen either”. It is not just writing down; it is how we write down what we write down too, that matters as much. This should serve as the basis for understanding the nature and importance of GDP. Look at the use of the word “clearly”. When your documentation is not clear about what it says; it is as good as non-existent.

Calls for documentation in several places

21 CFR Part 211 of the FDA is perhaps the best guide to documentation. Its various sections talk about the need for good documentation. Sub Section 211.100, Subpart F, which talks about Production and Process Controls, uses the words, “shall be documented”. Sub-Section 111 follows it up with “…shall be justified and documented”. In other words, justification for anydocumentation must precede the documentation.

21 CFR Part 211’s other sections, namely 211:100, 111, 130, 160, 165, 184 and 188 –all these are equally clear about GDP requirements. 

So, if despite so many mentions, we are unable to implement GDPs; how is the FDA to blame!

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Regulatory Compliance Training –what should you look for?

Regulatory Compliance Training

Regulatory compliance training is an important element of Continuing Professional Education (CPE). As the title suggests, CPE is for professionals who have been in the industry for a few years, and who need to keep upgrading and enhancing their skill sets to meet changing industry needs, requirements and challenges.

What to look for in your regulatory compliance training provider

Professionals who need regulatory compliance training need to look for a few aspects when choosing their provider. The training provider should offerregulatory & compliance trainings that have these fundamental qualities:

Quality matters

The trainings should be of high quality, meaning experienced trainers who know the industry in and out should form the faculty. When such professionals are on board, they know which the most suitable and relevant topic for the industry is. They would be aware of the latest trends and movements in the industry

Mode of dissemination

Second, the regulatory compliance training must consist of simple, cost effective courses that are tailored to regulatory professionals’ exact needs. Obviously, professionals know most things about the industry. Why would they need training that is fundamental and states the obvious? They need that extra, which is why they enroll for the course. Experts should be able to offer this.

User friendly format

Format is another important criterion. Choose a regulatory compliance training provider who offers you a choice of formats. Most such trainings are done online live, but some also offer in-person, live seminars that could be spread over a day or two. You can choose the one that suits you better. Some regulatory compliance training providers also offer recorded formats of the training sessions.

Look out for interactivity

A very important element to look out for is to see if your online regulatory compliance training provider also offers you good opportunities for interaction with the Expert at the end of the training session. This session is often the most part of the training, as the participant will be free to ask and clarify doubts of any kind relating to the topic.

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

The August ’12 guideline on Refuse to Accept Policy for 510(k)’s

The August ’12 guideline on Refuse to Accept Policy for 510(k)’s

On August 10, 2012, the FDA issued new guidelines on Refuse to Accept Policy for 510(k)’s. This updated guideline, which is currently a draft, will supersede earlier guidelines on the subject, namely Center for Devices and Radiological Health’s Premarket Notification (510(k)) Refuse to Accept Policy, dated June 30, 1993, and 510(k) Refuse to Accept Procedures (K94-1) blue book memo, dated May 20, 1994 when completed.

A two-week deadline to the FDA

What is this new guideline? It offers the FDA a 15-day window to inform manufacturers of medical devices who have applied for premarket notification of their devices, whether their submission is administratively correct. What this means is that manufacturers should take note of checklists issued by the FDA based on regulatory requirements. These cover traditional, abbreviated and special 510(k)’s.

Not every element is mandatory

Based on these checklists, a manufacturer should submit applications for premarket approval of its devices. If there is a particular part of the required guideline that is not submitted, it should offer a justification to the FDA explaining the rationale for non-submission of this particular item. Typically, elements which are not applicable to all devices, such as in the case of biocompatibility testing are ones that normally get excluded.

What does the FDA do?

Within 15 days of receiving a submission for premarket approval, the FDA has to issue a notice to the manufacturer, stating that the submission is fine administratively. This does not amount to validation of the product, nor that the product met regulatory requirements. What this endorsement means is that the FDA certifies that the manufacturer met the right submission procedures. This means that the right steps for submission were followed. This in no way amounts to product approval, which is a long and winding procedure for which the FDA is not set any deadline.

It should indicate to the manufacturer if any element is missing in the submission. If the submitter fills in the missing information; a new submission is not necessary. If no response is had from the FDA in two weeks; it can be assumed that the submission was technically alright. This does not prevent the FDA from responding with its set of reservations even after two weeks, although such cases are rare.

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/08/fda-issues-new-refuse-to-accept-policy-for-510ks.html

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

CAPA

CAPA

CAPA, short for Corrective Action, Preventive Action or Corrective and Preventive Action; is a set of processes an organization takes to set right nonconformities. It seeks to address the root causes of problems that may have contributed to nonconformity. It is a major regulatory problem area, since medical devices are very heavily regulated and need to conform to strict standards. It is hence a major aspect of GMP.

How big is the CAPA problem?

CAPA comes second among the FDA's top ten 483 items under QSIT, at 30 percent, below 40 percent for management. This of course, is because many CAPA problems come under management. So, the point is that CAPA is a major factor in inviting 483s from the FDA. The FDA expects a medical device company to have a proactive CAPA system which will enhance the processes in your product.

How does a medical device company minimize the risk of inviting a 483 for its CAPA? It cannot always hold user error responsible. The two most important elements it must incorporate are a Human Factors Engineering and Product Redesign program.

Correction vs. corrective action

Two important aspects of CAPA need to be taken into consideration.

What is correction, and how is it different from corrective action? “Correction” refers to repair, rework or adjustment of an existing nonconformity.

Corrective action, on the other hand, is the elimination of the causes of nonconformity. This is a little like the difference between treating symptoms and curing in medicine.

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

CAPA SOPs

CAPA SOPs

With the FDA and the other regulatory authorities becoming more and more stringent in the expectation of their corrective and preventive action (CAPA), especially in the pharmaceutical sector; it is necessary for companies to be adhering to standards and reporting or eliminating nonconformities. They have to take utmost care in ensuring that these elements areidentified, fully investigated to their root cause and properly assessed:

o   deviations/non-conformance

o   annual product reviews

o   external and internal audit observations

o   product complaints

o   recommendations

o   regulatory issues

The way to do this is to have a Standard Operating Procedure (SOP) in place. According to the International Conference on Harmonization (ICH), SOPs are “detailed, written instructions to achieve uniformity of the performance of a specific function”.

Purpose of a CAPA SOP

The purpose of a CAPA SOP is to establish a system for the recording and capture of data for the purpose of analyzing it for trends, and then work on them for continuous improvement. It should consist of Corrections, Corrective action, Investigation(s) and Root Cause(s) determination. It should also take into consideration the impact on inventory; preventive actions; verification/validation; change control; success evaluation; monitoring effectiveness and review by senior management and follow-on activities.

Who does it?

The SOP should be headed and driven by the senior management, and should percolate to all departments. The senior management should not only make SOPs; they must also be responsible for implementing and reviewing it periodically.

Flow

The flow of an SOP is always subjective and depends on the intuition and comfort level of the manager. Generally, a senior manager could think of the following flowchart:

o   Complaints

o   Non-Conforming Material Report (NCMR)

o   Trends

o   Audits

While these above could be the “start and end” of the process; the following could be the activities taken up for SOP:

o   Initiation of Computer Assisted Report (CAR)

o   Perform Root Cause Analysis (CAR)

o   Estimate and record failure

o   Determine the CAPA that needs to be taken

o   Verification and Validation CAPA

o   Record order of changes.

After these, analysis needs to be made taking the following action points:

o   Has the problem been fixed?

o   Does it need to be monitored?

Of course, this is only a thumb rule. As mentioned earlier, there exist several ways by which a CAPA SOP can be carried out; this is just a sample.

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Common challenges of CAPA implementation

Common challenges of CAPA implementation

CAPA is undoubtedly at the heart of a Quality System. Hence, it is expected that this system has to be dependable and solid, if not perfect. It is both these; yet, there are numerous challenges as to its implementation.

Although a good CAPA implementation is the most desirable outcome of a Quality System audit; it cannot be denied that Quality professionals face a major issue when it comes to some aspects of CAPA. Some of the most important of these are listed here:

1.      It looks at what is wrong, and not why it is wrong. This makes the system shaky at its very foundation. In other words, it addresses the symptoms, not the cause.

2.      Ambiguity and subjectivity is another root problem of CAPA. It is the kind of system that allows for multiple and vague interpretations of many aspects of the system, making it something that can be bent at will.

3.      CAPA documentation rarely reflects current status. The level of documentation is almost never proportionate to the work CAPA documentation performs.

4.      CAPA is very rigid in its implementation. It requires multiple approvals, several signatures, many of which may ultimately never be used; and formation of too many CAPA committees.

5.      Another very important problem with CAPA is that alignment with Quality Policy, Quality Objectives and Business Objectives is absent, making it somewhat of an asynchronous documentation.

http://www.asqlongisland.org/seminars/2010_11_05_CAPA_TimMohnWritingCAPAs.pdf

http://medxu.com/medcon/files/2011/04/a.-Jimenez-Ongoing-Challenges-of-a-CAPA-System.pdf

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

FDA Device History File vs. EU Medical Devices Directive Technical Files

The FDA has built the DHF around control. This is the defining factor. It has designed GMPs around this. For the FDA, the DHF shows design output as a product of design input. It traces the device’s development history, and how design requirements were met in accordance with 21CFR 820.

FDA DHF shows design history between research and development, something of a grey, overlapping area. Now, if a company decides to commercialize a product that it was earlier researching; or if some other change happens to the product, that is from when design control takes over. Design Controls also demand that the principles of design control are met and that the product is under change control. In other words, it shows a sequence of events over a period of time.

For the FDA, DHFshould be proven by the design history. US FDA Design Control Documents include

o   design planning

o   design input

o   design changes

o   design reviews

o   design verification/validation

o   design transfer –all of these have to be demonstrated in the DHF.

This is in contrast to the parameters set out in the EU’s Medical Device Directive (MDD), whose technical file shows conformance with that device’s “essential requirements”. The EU Council Directive 93/42/EEC (Medical Device Directive), in its Annex VII, EC Declaration of Conformity, has clear guidelines on conformity on the part of the manufacturer. It states that the technical documentation must include:

o   a general description

o   design drawings, diagrams/descriptions

o   methods of manufacture

o   risk analysis results

o   essential requirements/standards met

o   methods of sterilization, where applicable

o   results of design verifications/validations/test results

o   labels/instructions for use.

As a reading of these points suggests, the emphasis is on different aspects of documentation between the two systems.

Contact Detail

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801