Understanding and applying ICH Q3A and Q3B

The ICH Q3A and Q3B are guidances on dealing with impurities in new drug products. These documents have been issued by the FDA and are updates of earlier versions on the same topic that were prepared by the ICH, which this FDA guideline complements. This is why the documents get their name. The FDA keeps revising these documents from time to time. After every revision, the latest version carries the added taxonomy of “R” to denote that the guidance is a revised one.

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The Q3A and the Q3B are two revised guidelines that relate to impurities in drugs. Impurities can happen due to a number of reasons. These are some of them:

  • Raw materials
  • Byproducts
  • Residual solvents
  • Reagents
  • Product reactions
  • Catalysts
  • Foreign impurities
  • Product degradation

The ICH guidelines Q3A and Q3B deal with the ways of addressing organic and anorganic substances, respectively.  They both follow the principles of reporting, identification and qualification of impurities at defined limits. They both exclude impurities arising out of the excipients of drug products.

Scope of Q3A

The scope of the Q3A guideline is limited to testing of impurities in new drug substances. It concerns itself with the content and qualification of chemical substances in new drugs. It is not meant for products derived from herbal, crude, animal or plant, or semi synthetic origin. It is also not for products in the clinical trial stage or for addressing extraneous contaminants, polymorphic forms or enantiomeric impurities.

Scope of Q3B

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The scope of the Q3B guideline differs in some ways from that of Q3A. It is meant for the content or qualification of degradation products. It excludes products of all the sources that Q3A does, and additionally also excludes impurities arising from excipients or extractables/leachables of the container closure system.

Thorough and full understanding of these guidelines

It is to offer a complete and thorough knowledge of how to apply the Q3A and Q3B guidelines that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar. Greg Martin, who is the President of Complectors Consulting (www.complectors.com), which provides consulting and training in the area of Pharmaceutical Analytical Chemistry and served as Director of Pharmaceutical Analytical Chemistry (R&D) for a major Pharma company for a number of years during his over 25 years of experience in the pharmaceutical industry; will be the speaker at this webinar.

To gain clear insights into how these ICH/FDA guidelines apply to your laboratory or area of work, please register for this webinar by visiting Applying ICH Q3A and Q3B for Control

All about the guidelines and regulatory expectations

The objective of this webinar is to provide participants with an understanding of the regulatory expectations for controlling impurities and degradants, including DNA reactive/potential genotoxic impurities, in drug substances and drug products.

Participants who complete this course will be able to:

  • Understand regulatory expectations regarding impurities, degradants and potential genotoxic impurities in pharmaceuticals
  • Understand what specifications will conform to regulatory expectations
  • Develop a process for reporting impurities and addressing OOS situations

Greg will cover the following areas at this webinar:

  • Landscape of impurities requiring control in pharmaceutical products
    • General impurities: elemental impurities, residual solvents, microbiological
    • Drug-related impurities process impurities, degradants, potentially genotoxic impurities
  • Process Impurities
    • Understanding ICH Q3A
    • Where impurities originate
    • How impurities are characterized
    • How specifications are developed
    • How impurities should be reported
  • Degradants
    • Understanding ICH Q3B
    • Where degradants originate
    • How degradants are characterized
      • Potential genotoxic impurities
    • How specifications are developed
    • How degradants should be reported
  • Questions and discussion

How to Comply and how to Protect Privacy

The General Data Protection Regulation (GDPR) –codified as Regulation (EU) 2016/679 – is an important law concerning the protection of data of all people living in the European Union (EU). Through the GDPR regulation; all the legislative and secretarial bodies of the EU, namely the European Parliament, the Council of the European Union and the European Commission, fortify and toughen and unify all aspects of data protection for all individuals within the European Union (EU).

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Another area that is addressed by the GDPR is the export of personal data to regions outside the EU. The core purposes for which the GDPR is enacted are twofold:

  • Giving control back to citizens and residents over their personal data
  • Simplifying the regulatory environment and bringing about uniformity and unity in data protection regulations across the EU to facilitate the ease of doing global business within the EU.

The GDPR will be the new law without requiring members to endorse it

The GDPR came into effect when the European Commission adapted the proposal for its creation on January 25, 2012. When the GDPR comes into effect and becomes enforceable from 25 May 2018 after a two-year transition period after being adopted on 27 April 2016; it will replace the data protection directive that has been in use in the EU from 1995: Directive 95/46/EC.

The all-powerful nature of this regulation can be gauged from the fact that it does not require legislative support from any of the EU members. It straightaway becomes law and will be directly binding and applicable from the date of its enforcement.

Benefits of the new legislation

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The GDPR will come with many advantages:

  • It will offer greater and clearer insight into Personally Identifiable Information (PII) processing within the company
  • It will boost security controls and unify these across the 27 EU members
  • It brings about increased customer confidence, since there are stronger safeguards for data protection
  • It will relax the process of doing business in the EU

Drawbacks of the GDPR for companies that want to do business in the EU

While the primary objective of the GDPR is smoothing the laws for allowing global businesses in the bloc; it comes at a rather expensive price tag: If companies fail to comply with the GDPR provisions on data protection, they end up coughing up two percent of their worldwide revenues in penalties!

These are some of the other pain areas of the GDPR:

  • Provisions stipulate fines of up to € 20 million
  • Inviting a host of complicated lawsuits
  • Loss of reputation
  • A host of liability cases

These facts about the GDPR make it necessary for companies in any line of business that want to gain access to the huge EU market to get a complete and clear grasp of the nuances of this new legislation. This is absolutely necessary if they have to avoid the consequences of noncompliance.

Get to understand the ways of the GDPR

This is the learning that a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering. Derk Yntema, who has over 15 years of experience in ICT and security-management and has demonstrated capacity to implement innovative security programs that drive awareness towards information security and strengthen organizations and proven knowledge of privacy legislation and helping companies towards privacy compliance, will be the speaker at this session.

To get a full and proper understanding of the GDPR and how it affects your business, please register for this webinar by visiting Security Controls up to level

At this webinar, which will be of very high value to professionals such as Board of Directors, Supervisory Board, CxO’s and Compliance Managers/Officers; Derk will cover the following areas:

  • What is Privacy?
  • How to Protect Privacy
  • What is PII?
  • What is in the GDPR (General Data Protection Regulation)
  • How to Comply.

Sources of contamination that exist in a clean room environment

Aseptic technique is one of the methods used in eliminating or at least minimizing contamination in pathogens. It is also used to make compounding sterile products. Sterilized equipment, sterile apparel, high degree of processing, and cleaning on a continuous basis make up the important procedures used in aseptic technique.

The main aim of aseptic technique in cleanrooms is to ensure that the sterile product is sterile, safe and effective. Ensuring this is all the more important for injections that are administered to patients. Aseptic technique is suited for application in any clinical setting. Infections can be caused when pathogens come into contact with the patient through a number of sources such as equipment, the environment, or the personnel in the cleanroom.

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The fact is that any patient is potentially vulnerable to infection. Further, certain conditions such as injuries caused by accident, immune disorders that upset the body’s natural defenses and extensive burns increase the susceptibility of the patient to greater levels of infection. Surgery, urinary catheters, drains and the insertion of intravenous lines are common situations that require the use of aseptic technique.

A learning session on all the areas of aseptic techniques

All the core aspects of aseptic techniques and the ways of applying them in a cleanroom environment will be the topic of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. The speaker at this webinar is Danielle DeLucy, who owns ASA Training and Consulting, LLC, which provides pharmaceutical and biologics-based companies with training and Quality Systems assistance that helps them meet regulatory compliance.

Please enroll for this webinar by visiting Aseptic Technique and Cleanroom Behavior

Why are cleanrooms built the way they are?

This course will review proper cleaning, gowning and ways to avoid the common sources of contamination that exist in a cleanroom environment. It serves as a good refresher for those personnel that are familiar with the way to properly work in the cleanroom. Danielle will explain the rationale behind designing cleanrooms the way they are and how this design helps in ensuring proper contamination control. She will review some of the proper methods of contamination control, such as cleaning and gowning.

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At this webinar, which is of high value to those involved in contamination control, such as aseptic operators, aseptic sample handlers, personnel who work in a Biological Safety Cabinet (BSC) and their management and Quality Assurance counterparts; Danielle will impart the following learning objectives:

  • Definition of Aseptic Processing (AP)
  • Terminal Sterilization vs. AP
  • Proper Personnel Behavior in a Cleanroom
  • Facility Design and how it impacts the product
  • A review of proper environmental monitoring practices and systems used
  • Aseptic Technique &clean room behavior.

Understanding opportunities in NAFTA

The North American Free Trade Agreement (NAFTA) came into being on the first day of 1994. While the US and Canada had been having free trade agreements that go back at least three decades culminating in the US-Canada Free Trade Agreement of January 1, 1989; NAFTA became a reality following Canada’s entry in 1991 into the bilateral talks between the US and Mexico, creating the trilateral FTA.

One of the primary objectives of the NAFTA was the elimination of a number of duties and restrictions, which were the stumbling block to free trade between the three neighbors of North America.

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Duties on eligible goods traded among these North American markets are almost reduced or eliminated. NAFTA negotiated and created the Rules of Origin with the purpose of determining the eligibility for favorable treatment under the Agreement. The intention behind the Rules of Origin was to also exclude third countries from obtaining benefits by simply passing goods through North America.

NAFTA’s Rules of Origin are based on the 1988 US-Canada, by which FTA goods generally must undergo sufficient processing within North America if they have to merit a change in tariff classification.

NAFTA has chapters covering a host of aspects of trade, such as:

  • Rules of Origin
  • Protection of intellectual property rights
  • Customs procedures
  • Investment
  • Procedures for dispute settlement
  • Trade in services
  • Agriculture and sanitary and phytosanitary measures
  • Government procurement

Understanding NAFTA is important for businesses in North America and beyond

For businesses in not just North America, but also Asia and Europe, a thorough grasp of the present and emerging NAFTA opportunities and challenges is essential for formulating a sound business strategy. If they have to gain advantage and exploit the huge North American market; they need to be aware of the way the regulations and laws concerning NAFTA operate.

All the aspects of the NAFTA will be explained in detail at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

The speaker at this webinar is Douglas Cohen, Senior Manager, Global Trade and Contracts at Worldwide Trade and Legal Associates (WWTL), who has been at the forefront of international trade and transactions with positions in private law practice, US Department of Commerce, the European Union, IATA, and American Airlines, where he has developed significant expertise in import-export operations and compliance, global transactions, international negotiations, intellectual property, and cross-cultural business communication.

To benefit from the rich experience that Douglas brings into his areas of trade, please register for this webinar by visiting North American Free Trade Agreement (NAFTA)

Full explanation of Rules of Origin and the Certificate of Origin

At this webinar, Douglas will help import-exporters in understanding the NAFTA requirements. This understanding and the way the rules, especially the Rules of Origin, apply will help the participants to take advantage of NAFTA to reduce their costs. The way in which import-exporters classify their potential NAFTA products has major implications for their overall costs of doing business and their profit margin.

Douglas will show how participants can properly complete the NAFTA Certificate of Origin so that they gain advantages such as being able to receive duty free treatment and preventing errors that can result in severe civil/criminal penalties by each countries customs administration. He will also explain how to prepare for a NAFTA audit.

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Douglas will cover the following areas at this webinar, which will be of great benefit to those who currently trade in North America, those considering trading within North America, compliance departments, import-export departments, Trade Consultants, Chambers of Commerce, Business Development Centers, and Foreign Trade Agencies:

  • Fundamentals of NAFTA
  • How do you take advantage of NAFTA to obtain duty free treatment for your NA trade?
  • What is the intent of the NAFTA rules of origin?
  • What is the applicable rule of origin in NAFTA?
  • How do you obtain the certificate of origin?
  • Recordkeeping Requirements
  • Questionnaires, Verifications, Audits

How to create processes and procedures to implement them

Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971.

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You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products. A rigorous risk management process can prevent serious problems and costs for your company.
In this webinar we’ll cover:

  • Overview and Definitions
  • FDA Expectations
  • ISO14971 Regulation
  • Linkages to Design Controls, Production Controls, Investigations, and CAPA
  • Risk Management throughout the product lifecycle
  • Common mistakes
  • Best Practices

Many companies have even experienced class action law suits because of product quality issues. An effective program of risk management can help you proactively identify and mitigate product risks. A good risk management process can help you methodically identify, mitigate, and monitor risk throughout the product life-cycle. By visiting this Management Techniques for Medical Devices

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Here the areas will be covered by the Susanne Manz

  • Overview of the ISO14971 standard as it applies to medical device companies
  • Integrating the new standard with ISO 13485 as part of your overall QMS
  • Conducting a review of the intended use of your device
  • Stages of Risk Management as well as Tools and Techniques
  • Identifying hazards in your product or production process, and estimating their severity
  • Judging the probability that harm may occur from those hazards
  • How to control those risks and monitor the effectiveness of the controls put in place

Those who will be benefited by the session as listed in the below

  • Design Engineer
  • Manufacturing Engineer
  • Quality Engineer
  • R&D Personnel
  • R&D Project Managers
  • Quality Managers
  • Auditors
  • Regulatory Affairs Specialist
  • R&D Manager

It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements.

Susanne Manz MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.

Why is credit card surcharge an issue for businesses?

The credit card surcharge issue has always been a tricky one in the US. Back in 2005, this issue was the subject of an antitrust lawsuit, and the resultant judgment, which came in mid-2012 prohibited credit card surcharge in ten States. Another 12 States are in the process of implementing their laws.

Although credit card regulations have traditionally opposed surcharging; companies have been circumventing merchant rules to ensure that credit card surcharge continues to be made. Even as State laws will continue to override networks merchant rules; companies have been looking out for ways to skirt the laws.

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The credit card surcharging issue in the US

Why is credit card surcharge an issue for businesses? It is because the credit card surcharge is the last link in the payment chain and causes a business that makes use of this facility to incur expenses. In simple terms, this is the checkout fee that gets added to every consumer’s shopping bill whenever a credit card is used to make payments for the purchases made at the business. Businesses are not willing to bear this expense and like to pass it on to the consumer.

The court judgment of 2012 permitted charging of credit card surcharge for certain card transactions from January 2013. As a result, there has been a change in not only merchant processing transactions but also of credit card usage. The settlement makes it mandatory for businesses that levy the credit card surcharge to follow requirements relating to consumer disclosure and to set limits on the amounts for which the surcharge is collected.

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They should also notify Visa and their acquirer of their decision to charge credit card surcharge a month before they begin to levy the surcharge. These rules vary from State to State, and the business is free to choose which brands of its outlet it wants to keep the credit card surcharge.

Clear the confusions about the issue

A more detailed and clear understanding of this topic will be offered at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. Ray Graber, a highly experienced professional in the payment industry, who brings deep and profound understanding of the way banking and finance converge with technology, will be the speaker at this webinar.

Please register for this webinar by visiting What are the Stipulations for Compliance

Clarifying the important issues relating to credit card surcharging

Ray Graber will offer clarity on the changes in the rules and will explain who benefits from the changes, and how these changes are going to affect the retailers and customers. He will explain the perils of an uninformed reaction to surcharging by end-user organizations. He will show why it is important to first look at the big picture of credit card surcharging, since end-users should also educate suppliers about the economics of card acceptance, pointing out the savings possible and other benefits. Suppliers should not be adding a surcharge when they are reaping the rewards. Ray will explain how they might overlook the benefits of card acceptance, as well as the cost of other payment methods like checks and cash.

Being of high value and importance to every level of employee who works in the credit card industry, such as financial officers, small business owners, corporate risk officers, internal auditors, operational risk managers, credit card program administrators, CPA’s and attorneys and legal staff; this session will cover the following areas:

  • What changed in the rules?
  • Why did it change?
  • What rules apply to surcharge?
  • Survey results
  • Who may benefit?
  • Will this change anything?

Understanding GLP’s and their relationship with GMPs and SOP’s

Good Laboratory Practices (GLP’s) are a series of federal regulations passed in the US by the FDA under 21 CFR Part 58. In addition, Environmental Protection Agency (EPA) also has formed GLP’s both for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in 40 CFR Part 160 and for Toxic Substances Control Act (TSCA) in 40 CFR Part 792.

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GLP’s are Quality Systems that relate to the processes and conditions that organizations carrying out nonclinical studies concerning health and the environment have to comply with. The objective of creating these processes and conditions is to ensure proper planning, performance, monitoring, recording, archiving and reporting of these studies. GLP’s are not just guidelines; they have the effect of a law.

The intention of framing GLP’s is that a minimum standard has to be established for conducting nonclinical laboratory research. This acts as the basis for research or marketing of products that are regulated by the FDA or the EPA. Typically, products that come under GLP’s include:

  • Animal food additives
  • Medical devices that are meant for human use
  • Biological products
  • Pesticide products
  • Human and animal drugs
  • Electronic products

Cosmetic products do not come under GLP’s.

An understanding of GMPs

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Good Manufacturing Practices or GMPs are quality assurance standards which ensure that consistency and control go into the manufacture of products and that these products are in accordance with their quality standards that are required for their Intended Use and in conformity with the Market Authorization or the specifications that the product has to have.

What are SOP’s?

Standard Operating Procedures (SOP’s) are detailed written instructions that are aimed at bringing about maximization of safety and efficiency in the operations of select types of organizations such as:

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  • Pharmaceuticals
  • Clinical research
  • Emergency response
  • Government
  • Power

 

 

 

 

How are GLP’s related to GMPs and SOP’s?

Do GLP’s, GMPs and SOP’s have a close relationship with each other? How are they, all being vital elements of the industries to which they relate, connected with each other? GLP’s have nothing to do with GMPs, but what about SOP’s? What is the nature of the similarities between these and what are their differences?

This will be the important learning a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer. At this webinar, the speaker is Joy McElroy. During the over 20 years of working in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification, which has enabled her to write and execute Equipment Qualification and Validation Protocols for several well-known companies.

To comprehend the nature of the relationship between GLP’s, GMPs and SOP’s, please register for which webinar by visiting Associated with GMPs and SOPs

Comparison and differences between GLP, GMP and SOP

Professionals such as Quality Assurance Personnel, Quality Control Personnel, Research and Development Personnel, Regulatory Affairs Personnel, Project Managers, Manufacturing Managers, Validation Engineers, Internal Auditing Personnel, Microbiology Personnel and Auditors will learn everything from:

  • What GLPs are
  • Why they were created
  • The objective of GLP’s
  • How they relate and are associated with GMPs.

Joy will explain what GLP’s are and help participants understand and compare the differences with GMPs.