Validation the complies with ICH guidelines

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 is required from professionals in the field of statistical analysis. They also need to have a proper understanding of process and quality controls, as well as ICH Q8 and Q9.

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

When it comes to procedures and acceptance criteria in calibration limits, the ICH guideline is the ICH tripartite-harmonized ICH Guideline on Methodology, which used to be previously coded as Q2B. This was finalized in November 1996 under Step 4. 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

The current guideline for process and Quality Control 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.

Meeting critical milestones is required for professionals who want to achieve harmonization in Quality, professionals. 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 are among these milestones. ICH’s Quality guidelines on harmonization relating to Quality cover the following areas:

o  Stability

o  Analytical Validation

o  Impurities

o  Pharmacopoeias

o  Quality of Biotechnological Products

o  Specifications

o  Good Manufacturing Practice

o  Pharmaceutical Development

o  Quality Risk Management

o  Pharmaceutical Quality System

o  Development and Manufacture of Drug Substances

o  Lifecycle Management.

A thorough training session on the areas of Validation in accordance with ICH guidelines

It is important and necessary for professionals in this area to get proper guidance, 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.

A seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will offer this learning. Dr. Alfred Bartolucci, who serves as Emeritus Professor of Biostatistics at the University of Alabama, will be the Director of this seminar. Please visit Validation the complies with ICH guidelinesto register for this valuable learning session. 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

Dr. Bartolucci will offer in-depth and clear learning 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, as well as with ICH Q8 and Q9.

Although not a course in statistics, this seminar will offer an applied approach to the statistical techniques used and will show how to reasonably interpret them. Participants can use this learning to 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.

Another area of importance at this seminar is the expectations of different regulatory agencies regarding the quantification and development of a sound statistical monitoring of a properly utilized, effective, and efficient process control. It will familiarize the participants with the critical aspects of the statistical methods and explain to them the practical application of these guidelines.

Quality guidelines –ICH

Quality guidelines –ICH.

Short for International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; the ICH is a collaborative project whose objective is to discuss scientific and technical aspects of pharmaceutical product registration. The regulatory authorities of Europe, Japan and the United States, as well as experts from the pharmaceutical industry across these three blocs have come together to form the ICH and carry out its stated objectives.

Aim of avoiding double work

The ICH essentially seeks to bring down, and wherever possible, eliminate the need to replicate the work done during the testing carried out for medicines. It seeks to harmonise and homogenise all the steps needed for research and development of new medicines in these three regions, so that costs come down and more effective ways of testing for and producing medicines can be brought about.

Quality guidelines

ICH has guidelines on Quality, as it has on other aspects such as safety, efficacy and multidisciplinary aspects. It has been issuing Final Guidance Documents for nearly two decades now. The ones pertaining to Quality come under guidelines whose names start from “Q”, symbolising Quality. Depending on their order, these guidelines bear titles that start from “Q”. So, Quality Guidelines start from Q1A and go on adding alphabets for additions into the guidelines.

From November 2005, the ICH Steering Committee has been implementing a new codification system for ICH Guidelines that it adopted that month. This is done to ensure that there is greater logic, consistency and clarity in the numbering/coding of ICH Guidelines.

As of now, this is how the codified guidelines for Quality, as laid out by the ICH, look:

• Stability Q1A – Q1F

• Analytical Validation Q2

• Impurities Q3A – Q3D

• Pharmacopoeias Q4 – Q4B

• Quality of Biotechnological Products Q5A – Q5E

• Specifications Q6A- Q6B

• Good Manufacturing Practice Q7

• Pharmaceutical Development Q8

• Quality Risk Management Q9

• Pharmaceutical Quality System Q10

• Development and Manufacture of Drug Substances Q11

• Cross-cutting Topics

References:

http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf

http://www.ich.org/products/guidelines.html

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065005.htm

http://en.wikipedia.org/wiki/International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Use