Validation in accordance with ICH guidelines


Professionals in the field of statistical analysis need a clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits. Along with these, process and quality controls, as well as ICH Q8 and Q9 also need to be properly and thoroughly understood.

The ICH tripartite-harmonized ICH Guideline on Text, which was previously coded as Q2A, finalized in October 1994 under Step 4, is the guideline the ICH has set out for analytical methods validation. The aim of this guideline is to identify the validation parameters that are required for a number of analytical methods. This guideline also lays down the characteristics and parameters that need to be taken into consideration when validating the analytical procedures that are included in the registration applications.

Likewise, the ICH tripartite-harmonized ICH Guideline on Methodology, which used to be previously coded as Q2B, finalized in November 1996 under Step 4, is the ICH guideline on procedures and acceptance criteria in calibration limits. This guideline extends the ICH guideline on Text, or what is called Q2A (mentioned above) to comprise the actual experimental data required, along with the statistical interpretation, for the validation of a variety of analytical procedures.

Current Step 4 for process and Quality Control

For process and Quality Control, the extant guideline is the Current Step 4 version of the ICH-harmonized Tripartite Guideline. The final draft of this guideline has been recommended for adoption to the regulatory bodies of the three biggest pharmaceutical markets in the world, namely the US, the EU and Japan.

In order to achieve harmonization in Quality, professionals have to meet critical milestones. These include conducting stability studies, the way the studies define relevant limits for the testing of impurities, and following a more malleable approach to pharmaceutical quality that is based on the principles of Good Manufacturing Practice (GMP) risk management. ICH’s Quality guidelines on harmonization relating to Quality cover the following areas:

Get professionally trained on the areas of Validation in accordance with ICH guidelines

Considering the complexity and the breadth of the issues associated with these techniques, which cover both the pharmaceutical and clinical applications, and considering that these techniques apply to a number of area such as stability testing, outlier analysis and risk management; it is necessary and important to undergo professional trainings with which professionals in these areas can clarify a number of doubts.

This is the learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be imparting. This training will be led by Dr. Alfred Bartolucci, who serves as Emeritus Professor of Biostatistics at the University of Alabama. To enroll for this seminar, please register by logging on to Validation in accordance with ICH guidelines . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A clear and deep understanding of statistical concepts

Depth and clarity of understanding of the statistical concepts used for investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and Quality Control, along with ICH Q8 and Q9 will be the main thrust of this seminar.

This seminar is not a course in statistics, but offers an introduction to an applied approach to the statistical techniques used, and how to reasonably interpret them. This learning will help participants address the various challenges facing pharmaceutical and biotechnology companies when they have to quantify results in a meaningful interpretable manner through tabulations and graphical presentations.

In addition, Dr. Bartolucci will also focus on another important area: What the different regulatory agencies expect of the quantification and development of a sound statistical monitoring of a properly utilized, effective, and efficient process control. He will familiarize the participants with the critical aspects of the statistical methods and explain to them the practical application of these guidelines.


Good Manufacturing Practices are essential for ensuring quality

Key Takeaway:

GMPs are critical for the manufacture and distribution of foods, drugs and other pharmaceutical products. These need to be implemented diligently by organizations that are involved in these products.

Quality is a great concern for a manufacturer and consumer of any product. To ensure that quality is maintained across a variety of products ranging from foods to pharmaceutical products; a few guidelines are required. These guidelines are collectively termed Good Manufacturing Practices(GMP).

Not a uniform set of standards

It needs to be understood that GMPs are not a uniform or homogeneous set of rules for everyone to follow. These are general principles laid out for ensuring that there is a minimum level of quality requirements to be fulfilled.

Agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products recommend these guidelines. These guidelines can be accomplished in many ways, and it is up to the organization to find out the one that suits it best and implement that system.

In essence, Good Manufacturing Practices can mean the following:

  • GMPs are set practices that manufacturers need to put in place to ensure that their products meet specified quality standards.
  • GMP guidelines consist of the minimum requirements that food product, drug or pharmaceutical manufacturers have to meet to assure that their products are of the prescribed quality and cause no harm or risk to those who consume them or the public at large
  • Regulatory agencies in several countries oversee their respective countries’ and global Good Manufacturing Practices. Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) are usually analogous to GMP
  • In many countries, legislations require pharmaceutical and medical device manufacturers to comply with GMP procedures. Many require these organizations to create their own GMP guidelines that are line with their legislations.

Basic points in GMP guidelines

These are the current GMP compliance requirements for pharmaceuticals (some of these guidelines overlap with those for medical devices)



Tips and Suggestions on interacting with FDA Officials and Premarket Approval (PMA)

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance.

What makes preparing premarket submissions that win regulatory approval challenging? It is the fact, acknowledged by the FDA itself, that the PMA is the most stringent type of device marketing application required by the FDA. The PMA should be secured from the FDA before the company markets the medical device. The FDA gives its approval of the PMA for a Class II medical device only after it determines that all the elements necessary for assuring that the application has enough scientific confirmation that it is safe and effective for the intended uses it is going to be put to. Preparing premarket submissions thus is an onerous task by any stretch of imagination.

Another element of preparing premarket submissions that win regulatory approval

Another aspect of preparing premarket submissions is the 510 (k). The 510 (k) is essentially a kind of premarket submission that is made to the FDA to show that the device that a manufacturer intends to market is at least as effective and safe as a legally marketed device of its equivalence, already in the market, that is not subject to PMA. The FDA calls this principle the substantial equivalency (SE) and the device that is used as the reference for equivalence, the predicate device. The requirements governing SE are contained in 21 CFR 807.92(a) (3).

On top of all these, regulatory professionals have the responsibility of creating preparing premarket submissions that should not only convincingly demonstrate the ways of stating and explaining regulatory arguments for their device to the U.S. FDA reviewer for getting the approval; they should also be presentable and well-organized, without being cluttered or confusing.

Professional trainings for preparing premarket submissions that win regulatory approval

Given all these, it goes without saying that a completely thorough understanding and knowledge of the relevant U.S. FDA laws, regulations and requirements is absolutely necessary for regulatory professionals. This in-depth understanding can be had only from thorough training, which is indispensable if the medical device company is to win a clearance or approval.

The ways by which to do this is the core learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will impart. The Director of this seminar is Subhash Patel, a very senior regulatory professional and founder of New Jersey-based MD Reg Consulting LLC, which serves medical device industry clients in all aspects of global regulatory affairs specific to their needs.

To enroll for this highly valuable training session on how to successfully prepare 510(k)/Pre-IDE/IDE and PMA premarket submissions that secure clearances and approvals from the FDA, please register for this seminar by visiting Tips and Suggestions on interacting with FDA Officials and Premarket Approval (PMA) . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The grasp needed for preparing premarket submission that win regulatory approval

At this seminar, Patel will demonstrate the grasp that regulatory professionals in the medical devices industry need for working with the FDA officials during the review and approval process of their submission. He will offer a complete understanding of the major aspects of FDA premarket submissions.

While knowledge of the regulatory process is one thing; medical device companies also need to know how to set and state regulatory arguments for their device in a most convincing manner to the FDA reviewer. This knowledge will be part of this course. In the process of explaining how to prepare premarket submissions that win regulatory approval; Patel will also offer tips and suggestions to participants on how to work effectively with the U.S. FDA officials during review and approval process of their submission.

During the course of these two days, Patel will cover the following core elements of how to prepare premarket submissions. He will explain the following:

o  History and background of U.S FDA Laws and Regulations

o  Classify Your Device

o  Choose the Correct Premarket Submission for your device

o  Compile the Appropriate Information for your Premarket Submission

o  Author and Prepare your Premarket Submission

o  Submit your Premarket Submission to the FDA

o  Interact with FDA Staff during Review and Approval

o  Complete the Establishment Registration and Device Listing