Are Your IT Systems GxP/GMP Compliant?

GxP and GMP are two distinct practices relating to Quality. While GMP stands for Good Manufacturing Practice, GxP stands for Good and Practice, with the middle ‘X’ for any variable relating to the industry with which it is associated, such as Manufacturing, Clinical, IT, Storage or any other). GxP is a fluid term that represents regulations set out by the FDA for various industries and codified in the Code of Federal Regulations (CFR). The set of rules that govern these disparate industries are often called Predicate Rules.

GMPs (or cGMPs, to denote “current” or the latest) are set out and enforced by the FDA to ensure that manufacturing processes and facilities that manufacture products in the pharma, medical devices, food and beverages, and cosmetics industries are properly designed, are continually monitored, and are in a state of control in accordance with prescribed standards. 

By requiring manufacturers to adherence to the cGMP regulations; the FDA seeks to ensure that manufactured products have the necessary strength, quality, identity, and purity, and that they are safe for consumption and meet the requirements of intended use.

Quality Management Systems and their components

Quality Management System is the means through which products in the regulated environments meet their intended use. 

QMS has four core components:

o    Quality Planning

o    Quality Assurance 

o    Quality Control

o    Quality Improvement

QMS guidelines are designed in such a way that they allow the individual manufacturers to meet the QMS requirements that suit them best. A GMP audit is the method through which compliance with GxP and GMP regulations of met.

Documentation is at the core

One of the cornerstones of GxP and GMP audits is documentation. The FDA is very clear about this requirement. It goes by the dictum, “if it is not documented, it did not happen”. this sums up the importance of documentation to GMP audits through which GxP and GMP regulations are met. One other way of understanding the criticality of documentation is by the consequence of lack of proper documentation: the FDA can shut down a facility that fails to put the required, proper documentation in place.

In addition to regulations for manufacturing; the FDA also has GMP requirements for Information Technology (IT). Not only should a drug produced in a GxP/GMP compliant manner follow prescribed Information Technology practices; even computer systems that are involved in developing, manufacturing and selling of regulated products should do so.

The formal process through which changes introduced into a product or a system are done so in a controlled and coordinated manner and documented is what is called Change Control. Proper Change Control is required from manufacturers into their QMS and IT systems.

Full and thorough learning

A thorough understanding of these complex concepts relating to GMP regulations that require a documentation management system to issue, manage and control all documentation.

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That has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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FDA Import 

Comprehensive risk management is a must for medical device software

Diligent, complete and correct implementation of risk management of software used in medical devices that takes into consideration the gaps and corrects them from the start of product development is absolutely imperative. This is because of two critical reasons:

    1.      Gaps, incorrect or incomplete implementation can retard or delay or make the certification/approval of medical products impossible;

    2.      Since most activities are closely linked to the development lifecycle; almost none of it can be retrospectively performed. This renders all activities performed till the identification of gaps useless and redundant; making it necessary to start from the beginning, no matter at what stage an anomaly is discovered.

Embedding software risk management into the bigger scope of overall risk management is the way forward if these fiascos have to be avoided.

Learn the ways of doing it right from start till finish 

The proper ways of how to take all the necessary steps for designing, implementing and testing critical medical device software in a regulatory compliant environment will be the learning a two-day, live seminar being organized by GlobalCompliancePanel, a very respected provider of professional trainings for the regulatory compliance areas will impart.

Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, will be the course Director. To participate in this very important seminar, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900683SEMINAR.

In line with globally applicable standard requirements

International consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, has led to risk management being a mandatory component of almost any activity in the medical device industry. This course will explain these requirements.

Given that software risk management has to be embedded into the bigger scope of overall risk management; Markus will introduce all the steps necessary to design, implement and test critical medical device software in a regulatory compliant environment while adhering to the principles of risk management. In addition, he will also address the system level risk management and the resulting interfaces to software.

Understanding safety assurance cases

The 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place to comprehensively summarize all risk related activities and to demonstrate the safe properties of a device. Currently only required for FDA infusion pump submissions; this documentation will most likely become mandatory for all devices. This course will introduce the basic concepts and content of safety assurance cases and will illustrate their usefulness for internal and external review of safety related information.

This seminar will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. It will address the system level issues of risk management as well as the increasingly important software related issues of critical systems. The concept of an assurance case will be introduced to make the combined effort towards designing, implementing and verifying a safe device transparent. The outcome of this learning is that it will help to comply with regulatory requirements with minimized overhead and resource burden.

      

Developing Documents and Records to meet the Requirement of ISO 17025

The major challenge for most laboratories is having to develop and implement a functional Quality Management System (QMS) that not only complies with the management and technical requirements of the ISO/IEC 17025:2005 standard, but also meets the laboratory’s needs. This is why QMS is considered the soul of the ISO/IEC 17025:2005 standard.

A highly meaningful and valuable learning session on how to accomplish this is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. The Director at this two-day seminar is Michael Brodsky, President of Brodsky Consultants and a Past President of the Ontario Food Protection Association (OFPA), The International Association for Food Protection (IAFP) and AOAC International. To enroll for this seminar, please log on to    http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900445SEMINAR?developing-documents-records-SFO. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.       

Compliance with ISO is a core requirement

A QMS that complies with the management and technical requirements of the ISO/IEC 17025:2005 standard is the core criterion for accreditation, as well as the backbone of this standard. Michael will familiarize participants with how with how laboratories can accomplish this in depth.

The Quality System Manual (QMS) is indispensable in a QMS environment because, much like its predecessor –Good Laboratory Practice (GLP) –it contains the policies that the laboratory is expected to follow to achieve Quality results. However, it is only the “what to do” component of a QMS. What laboratories also need are the “how to do it” or procedures and methods, and equally importantly, the controls or evidence that it was done properly. These are the critical requirements that documentation has to address, and are what this seminar will cover.

Doesn't end with accreditation

Achieving accreditation is only half the job done, because once this has been done, the tougher part –that of maintaining the QMS –begins. The high number of non-conformances cited during the subsequent biannual audits is proof of this fact. This seminar will explain how to maintain the QMS in the long run to the satisfaction of regulatory authorities, as well as to meet the laboratory’s needs.

Those in Laboratory Management/Supervision, Laboratory Quality Development, Laboratory Quality Management,  Laboratory Quality Control and Analytical support need to ask critical questions at the time of embarking on the process of developing documents and records that meet the requirements of ISO 17025, such as:

o        Why should we want to become accredited?

o        Where do we start?

If our laboratory is already accredited, how do we ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits?

Michael will help participants at this seminar develop the critical thinking that is essential for developing documents and records in compliance with ISO 17025. 

The ISO 13485:2016 standard is new and needs to be looked at afresh

With the ISO making the final version of the ISO 13485:2016 standard available; it is now up to companies to start planning ways of implementing it. The major area in which it differs from the earlier version (of 2003) is in the extent of its alignment with the FDA’s Quality Management System (QMS) requirement. Although this version shows a higher level of this aspect; there still exist points of deviation from the FDA’s QMS, making this the area that companies that need to comply with this standard need to focus on.

In order to help such companies understand the ways of grasping the 2016 ISO 13485 standard better and to offer them insights into it; GlobalCompliancePanel, a highly reputable provider of professional trainings for the regulatory compliance area, is organizing a seminar.

A learning session to help professionals understand the ISO 13485:2016 better

This seminar will offer clarity on how to implement the new ISO 13485:2016 standard. This seminar assumes significance in the light of the fact that not only is the new regulation quite complex; for many companies, the implementation period is quite short, depending on the expiry date of their current certificate.

More details of the seminar can be had from

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900592SEMINAR

The Director of this seminar, Dan O'Leary, who has experience of over 30 years in various quality, operations, and program management in regulated industries, will offer practical implementation advice and suggestions to participants. He will explain the points at which there is both convergence and divergence between this revised standard and the FDA’s QSR requirements. He will also show that the regulatory systems in a few jurisdictions will continue to depend on ISO 13485:2016 through the Medical Device Single Audit Program (MDSAP).

Areas of concurrence and departure

Dan will describe the areas in which the US and the EU differ in this regard. It is in these: The US will participate in MDSAP, but will not expect to change its regulations. On the other hand, the EU is not going to participate. It will implement its own published version, the EN ISO 13485:2016, and will continue with the existing Notified Body system. However, the EU will implement its own set of new regulations that will replace the directives. These will lead to new regulations that will be newer versions of EN ISO 13485:2016 and EN ISO 14971:2012.

In the course of this explanation, Dan will make use of exercises and examples with which participants will understand the ways of implementing according to the new guidelines. He will also use these to help them analyze the consequences of the newly revised regulation in a few regulatory systems including MDASP and its nonconformity grading system.