Q7 and Other Requirements for Active Pharmaceutical Ingredient (ASM) GMP

In late 2016, the FDA published the revised the Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guidance for Industry. The aim of this revision is to address Good Manufacturing Practices (GMPs) for a Quality Management System for Active Pharmaceutical Ingredients (API’s). Another of its aims is to help companies ensure that they meet the requirements of API quality and purity characteristics. While replacing Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; this guidance amends the International Council for Harmonization (ICH) codification from Q7A to Q7.

All aspects of API manufacture are addressed by this revised guidance. These include:

o  The principles set out for Quality Management

o  The quality unit’s responsibilities

o  Activities relating to production

o  Internal audits

o  Product quality reviews

o  Qualifications expected from personnel

o  Their hygiene standards

o  The qualification that consultants need to have.

The GMP requirements for facility design and construction and equipment used are also included in this FDA Q7 GMP guidance for API revision. Several other API manufacturing topics are also part of this revision. Some of these include:

o  Management of materials

o  Process controls

o  Laboratory controls

o  Packaging

o  Storage and distribution

o  Validation

o  Change Control.

Clarity on the FDA’s revised standard

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will explain the FDA’s API Quality System revision in detail.

Eyal Lerner, owner of ELC Consulting Services which offers the pharmaceutical and medical devices industries support in all quality related issues, will be the speaker at this webinar. To gain understanding of how to apply the FDA’s revised API Quality Systems GMP requirements; please register for this webinar by visiting API (ASM) GMP

Explanation of API quality requirements

This webinar will explain the basic requirements and fundamentals of API QS. It will review the quality requirements for API in accordance to global API GMP- ICH Q7. The explanations will be based on practical experience and other relevant guidelines. Eyal will review the requirements of FDA and EMA. All the areas such as materials, Active Pharmaceutical Ingredient and Advanced Starting Materials (ASM) will be discussed along with their definitions. He will also explain the distinctions between these.

Administrative issues such as registration issues concerning filling, annual review and change report to file would be discussed. In this section, Eyal will lay emphasis on the section: “Registration standard: Common Technical Document (CTD)”, as it relates to the ICH M4.

Anyone, whose work concerns the area of development and manufacture of API, such as those in R&D, Regulatory Affairs, Quality Assurance and Quality Control, who wish to get an in-depth background and understanding of API QS; will find this webinar valuable.

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Nitinol-based Medical Devices 2017 Global Market Expected to Grow at CAGR 10.50 % and Forecast to 2021

About Nitinol-based Medical Devices

Nitinol-based medical devices are made of nitinol, an alloy of nickel and titanium. The use of nitinol-based stents and guidewires has improved procedural outcome. The nitinol alloys are corrosion resistant and are highly accepted in the medical device industry. The global medical devices market has been growing extensively over the years. With increasing investment in research and development (R&D) for manufacturing nitinol-based medical devices, the use of these devices has increased rapidly in the recent years.

Covered in this report

The report covers the present scenario and the growth prospects of the global nitinol-based medical devices market for 2017-2021. To calculate the market size, the report presents a detailed picture of the market by way of study, synthesis, and summation of data from multiple sources.

The market is divided into the following segments based on geography:

• Americas

• APAC

• EMEA

Technavio’s report, Global Nitinol-based Medical Devices Market 2017-2021, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market.

Continue here to full Article http://snip.ly/z0mtf

 

 

A common technique plots the data to help detect trends, cycles, and shifts

Some of the functions of medical device manufacturers include:

o  Analyzing complaints

o  Processing data

o  Evaluating nonconformances

o  Utilizing other quality data sources.

The main purpose of this analysis, done using appropriate statistical methodology, under §820.100, is to identify the cause of nonconforming products and other quality problems. Time series analysis is one such family of these tools. Also called trending analysis, time series analysis uses visual methods to plot data over time.

A common technique plots the data to help detect trends, cycles, and shifts. The major use of these valuable methods is that they can help anticipate problems before they occur and demonstrate the effectiveness of corrective actions.

A webinar from Compliance4All on time series analysis

Dan O’Leary, President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management, will be the speaker at a webinar that analyzes time series analysis. This webinar is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Please visit methods when the data has a time based order to register for this webinar on time series analysis.

Full explanation of time series analysis

At this session, Dan will explain the graphical methods. In addition, he will also demonstrate some analysis techniques using Excel. Some special cases including data smoothing using moving averages, analysis with a lag function, and statistical process control (SPC), will be explained. By attending this webinar, participants will be able to gain understanding of time series analysis and some Excel capabilities to help perform the analysis. These tools are valuable for improvement projects and reporting information to management.

When the appropriate method is not clear, data analysis can be difficult. At this webinar, Dan will explain the methods when the data has a time based order. Excel includes functions and methods that can one can use to analyze the data and present it in a meaningful way.

Meaningful objectives

In this webinar, which will be of immense use to professionals who use statistics in their quality requirements, such as Quality Engineers, Manufacturing Engineers, Design Engineers, Data Analysts, Auditors, CA&PA Specialists, and Quality Managers; Dan will impart the following objectives:

o  Using run (trend) Charts

o  Determining a Linear Trend

o  Data Smoothing (Moving Averages and Lag Functions)

o  Using variables Control Charts(x-bar & R).

A clear process for compliant laboratory OOS investigations

The core of successful operation by a drug maker is laboratory testing. current Good Manufacturing Practices (cGMP) regulations require a drug manufacturer to use laboratory testing as a tool to validate that everything that goes into a laboratory product, such as in-process materials, finished materials, and containers adhere to set specifications. When all these are done, a major challenge for laboratories is in how to deal with a test that shows an Out of Specification (OOS) result.

Out of Specification results are viewed very seriously by the FDA

The FDA is uncompromising when it comes to dealing with Out of Specification results in laboratories. Its inspections of laboratory operations are very meticulous. It requires complete adherence to its guidances on how the laboratory has to investigate its Out of Specification and Out-of-Tolerance observations.

The ways by which finished Out of Specification products have to conform to set specifications, safety standards and other quality standards are specified in cGMP regulation Sec 211.165. Any lab whose result fails to do this gets summarily rejected. Another iteration of these cGMP regulations is that any unexplained deviation from the set specifications of a batch or its contents, whose test results show an Out of Specification result, will be subject to thorough investigation. Whether batches have only been manufactured and are yet to be distributed, or already are; the same rule applies.

Ways of dealing with Out of Specification results

This is the protocol that the cGMP regulation makes for dealing with Out of Specification testing:

o  Out of Specification testing is mandatory for the release of a test batch

o  The batch in which an Out of Specification result is confirmed gets rejected

o  The company’s Quality Assurance (QA) will have to state the reasons for the release of a batch that has an element of ambiguity in the result, and has to justify it.

The requirement that current Good Manufacturing Practices need to go into the manufacture of both active pharmaceutical ingredient and finished pharmaceuticals is stated in Section 501(a) 2 (b) of cGMP guidelines on Out of Specification. Also, all aspects such as active pharmaceutical ingredients, raw material testing, in-process and stability testing and Process Validation come under the ambit of the cGMP guidelines.

The FDA guidance on Out of Specification relates to the following products:

o  Human drugs

o  Combination products

o  Biology and biotechnological products

o  Type A medicated articles

o  Transplantation of human tissues

o  Finished products & active pharmaceutical ingredients

o  Medicated feed

o  Dietary supplements

o  Veterinary drugs

Out of Specification needs to be understood fully first

A reading of the above attests to the fact that a thorough understanding of the nature of the issues relating to Out of Specification results needs to be made for a laboratory to meet the required results. All the concerned persons should have complete knowledge of the FDA expectations for Out of Specification results.

It is this knowledge that needs to be applied to put in place procedures that define a complete, scientifically sound investigation of each Out of Specification and Out-of-Trend laboratory observation, as well as for establishing evidence that laboratory personnel conform to the procedures.

A proper learning session on dealing with Out of Specification results

A webinar from Compliance4All, a leading provider of cost-effective professional trainings for all the areas of regulatory compliance, will be providing learning on these aspects.

Jerry Lanese, an independent consultant who focuses on Quality Systems and the components of an effective Quality System, will be the speaker. Please visit Out-Of-Specification Laboratory Results to enroll for this highly educative session.

Tools for dealing with Out of Specification results

The speaker of this webinar will help participants build a basis for the implementation of adequate procedures that help avoid Out of Specification results. He will also review existing procedures and practices. Any laboratory personnel, who need understanding of the steps that a compliant laboratory has to take to handle the investigation of Out of Specification test results, will find this session very useful.

The ways in which the laboratory has to interface with other units through the laboratory investigation process will be explained. The speaker will dwell mainly on the FDA guidance on handling OOS laboratory results and will suggest a clear process for compliant laboratory Out of Specification investigations.

The following areas will be covered at this webinar:

o  Why the regulators are concerned about the handling of OOS investigations

o  The FDA model for handling OOS investigations

o  Commonly accepted terminology such as repeat testing and retesting

o  How the laboratory can meet regulatory expectations for OOS investigations.

o  The interaction between the laboratory and other units in the organization.

How to Recognize the Hazards of Blood Borne Pathogens

Bloodborne pathogens are those microorganisms present in the human blood that carry infection. These infections can cause disease in humans. The major bloodborne pathogens that cause infections in humans are:

o  Hepatitis B (HBV)

o  Hepatitis C (HCV)

o  Human immunodeficiency virus (HIV)

Although these are the main disease causing pathogens; there are many more. So, hospital staffs who deal with patients who are infected by bloodborne pathogens need to take extra care with regard to cleanliness and hygiene, since their chances of exposure to these pathogens are extremely high.

Apart from healthcare workers, other vulnerable populations that could come into contact with bloodborne pathogens consist of emergency workers, who are usually the first responders to people with these infections, and housekeepers who are required to maintain the bedding and other paraphernalia of people with bloodborne pathogens.

 

 

Detailed regulations from the CDC

Needless to say, regulatory agencies prescribe a heavy dose of regulation for the way in which to handle bloodborne pathogens, whether it is patients or the materials related to them that are being handled. Prominent agencies and departments that have guidelines on these aspects include the Centers for Disease Control and Prevention (CDC) and Occupational Safety and Health Administration (OSHA). Both OSHA and the CDC have guidelines on how workers at healthcare settings, who come into contact with patients with bloodborne pathogens, need to take safety precautions. The guidelines set out by the CDC cover all aspects of preventing bloodborne pathogens, such as:

o  The number of individuals in the patient population that are infected by bloodborne pathogens

o  The type of blood contact and its numbers

o  The particular pathogen that is involved

o  The nature of the exposure and the amount of blood in it

o  The virus in this exposed blood

The CDC guidelines are given to employers on how to they need to tackle bloodborne pathogens taking these factors into consideration. Important preventive steps that need to be taken, in line with the guidelines set out by both the CDC and OSHA include:

o  Use and disposal of needle sticks

o  Taking care to prevent exposure to injuries from sharps

o  The right protective gear to be used, such as gloves, other kinds of protection for important parts of the body, the right kind of clothing to be used, and the proper ways of using them, so that infection may be prevented through the nose, eyes, skin or mouth

o  What to do when exposure occurs

o  How to implement the proper reporting procedures

o  How each of these bloodborne pathogens have to be dealt with separately

o  The proper use of vaccines, when present

o  The proper procedure for treatment, when infection happens due to exposure

o  How to prevent bloodborne pathogens from infecting pregnant women

Learn the ways of implementing the important guidelines

All the actual ways of going about implementing the guidelines set out by the CDC and OSHA 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 very valuable and important learning session is Danielle DeLucy, who owns ASA Training and Consulting, LLC which provides pharmaceutical and biologics-based companies with training and quality systems assistance in order to meet regulatory compliance.

Please register for this webinar by visiting Bloodborne Pathogen Safety

Making the biosafety program more effective

This webinar will offer complete learning on the best ways to approach biosafety and on how to implement an effective management program for blood borne infections, safety and health, laboratory safety, infectious material and blood infection. This session is particular useful for personnel who work in a laboratory exposed to viruses or bacteria that are biological hazards. Danielle will explain how to optimize their Biosafety program and offer them a framework for setting up a successful management policy.

Danielle will cover the following areas at this webinar, which personnel such as EHS Staff, Occupational Health Staff, Laboratory Staff, Team Leads, Supervisors, Managers and Business Owners will find very valuable:

o  Review the regulations and guidelines recommended by the Centers for Disease Control and Prevention (CDC) for work with biological materials and, specifically, with blood borne pathogens

o  Provide up to date information about what constitutes blood borne pathogens from infectious materials, as well as other potentially infectious materials

o  The webinar provide answers about how to prevent exposures, deal with spills or exposures should they occur, and the how to recognize the hazards of blood borne pathogens

o  A thorough description of the types of infections of concern for blood borne pathogens, how one might be exposed, the differences between blood born infections and other potentially infectious materials, methods for dealing with potential exposures or spills, and the requirements from OSHA to protect workers from exposure or to track exposures if they occur.

What is the legal language of the FDA form 1572 or Device equivalent?

Form FDA 1572 is one of the primary documents needed when carrying out a clinical trial. Also called the Statement of Investigator; Form FDA 1572, called just 1572 informally, is a contract between the Principal Investigator (PI) and the FDA. This form contains all details of the subjects, as well as commitments from the PI.

It is a contract in which the Principal Investigator, the person who is in charge of the clinical trial, gives an undertaking to the FDA giving it the assurance that she will comply with all the requirements set out by the regulatory agency with regard to the trial.

By signing the FDA form 1572, which relates to IND studies, or the “Statement of the Investigator, which is meant for IDE studies; the PI is submitting herself to all the appropriate regulations, as this is a legally binding document by which they commit themselves to follow all of these.

The 1572 is meant to serve two important purposes:

It is a way of helping the FDA, as well as the sponsor of the study to qualify the PI, i.e., it gives the FDA and the sponsor of the study the opportunity to understand the Principal Investigator’s qualifications and ability to carry out the research in terms with the purposes it seeks to fulfil. It is also a way to verify that the site at which the clinical study is being carried out is appropriate for the study.

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The Form FDA 1572 also has another important purpose to fulfil.  It takes an undertaking from the Principal Investigator that the requirements set out by the FDA will be met during the trial. Failure to adhere to these commitments is considered a criminal offence, as something amounting to making false statements, and is liable for legal action under the terms set out in 18 USC 1001. This form has to be submitted whenever the sponsor selects the Principal Investigator to take charge of a clinical trial that is being conducted as an investigational new drug (IND) meets the criteria set out in 21 CFR 312.53 (c).

Other documents

Further, other documents such as 21 CFR 312.50, which deals with the General Responsibilities of Investigators, 21 CFR 812.100, which deals with the Responsibilities of Investigators for Biologics, and 21 CFR 812.110, which deals with the Responsibilities of Investigators for devices, need to be adhered to.

All these documents set out the general and specific responsibilities that the Investigators have when conducting a clinical trial. These start from who can qualify to be considered a PI to what qualification criteria sub investigators and research staff need to have.

A proper understanding of Form FDA 1572

FDA Form 1572 is thus an extremely important document that needs to be complied with fully if the clinical trial has to be considered compliant with the regulatory requirements. A full understanding of all the aspects that go into this will be spelt out at a webinar that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing.

This webinar educates participants about the due diligence that investigators and their staff about their regulatory and legal responsibilities. Charles H. Pierce, a consultant in the Clinical Research/Drug-Device Development arena, will be the speaker at this webinar. In order to gain complete knowledge of this valuable guidance document, please enroll for this webinar by visiting signs the FDA form 1572

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There are nine statements in the FDA form 1572. Seven out of these begin with “I agree”. These are the important elements named in the 1572:

  • 21 CFR 50 (Protection of Human Subjects)
  • 21 CFR 56 (Institutional Review Boards)
  • 21 CFR 312 (Investigational New Drug Application/IND)
  • For Device studies, 21 CFR 812 (Investigational Device Exemptions/IDE) is added in place of 21 CFR 312.

The GCP Guidelines of E6 (4) and the Compliance Program Guidance Manual (CPGM) 7348.811 outline additional responsibilities. It makes sense for PI and sponsors to comply with the principles of Good Clinical Practices (GCP), and to also use their common sense.

Charles will give a proper understanding of all these at this webinar. He will cover the following areas at this webinar:

  • The Investigators role in the clinical research process
  • The difference between AEs and SAEs and the reporting requirements of the investigator
  • Why the investigator maintains a list of staff signatures?
  • Why the investigator files the signed and dated protocol?
  • Why the investigator is responsible for the IC process?
  • What is the legal language of the FDA form 1572 or Device equivalent?
  • Why is Financial Disclosure information important?

What is the history of the drug / device regulations?

How to Achieve the best Outcome in an Audit

An internal audit, as we all know, is carried out for a number of specific purposes, the main one among which is to assess the adherence to the industry guidelines for quality and processes. Helping the organization meet the requirements of processes and standards, which are usually issued by regulatory agencies and other relevant bodies and boards, is the main aim of an internal audit. An internal audit seeks to bring about quality through standardization of many of the processes that go into the product.

In the context of the food industry, this adherence is all the more important, because food contamination is quite a serious issue in all parts of the world. According to statistics from the Center for Disease Control and Prevention (CDC); about one in seven Americans, or close to fifty million, get sick from consuming contaminated food. More than an eighth of a million people get hospitalized for this reason, and some 3,000 people lose their lives due to food contamination in the US every year.

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The major challenge in food contamination is to identify the source of the contamination. Since we humans eat a variety of foods in our meals, it is difficult to zero in on the exact source. Our food is usually consumed in variety, and most of it is from different and varied sources. If all of our food were derived from just one source, this task would have become interminably easier. But this is not the case; hence, the problem in identifying the source of the food contamination.

Means for ensuring quality

An audit is a sure method of identifying and preventing food contamination. An audit is a continuous process that is planned, specified, and carried out at set intervals and documented to determine the quality of a product. A food audit does all this to food products. It adds strength to the process of preparing, distributing and consuming food, and provides confidence that the food that we consume meets the standards set out for its quality and safety and has gone through the prescribed processes. This is the essence of a food audit, and this is described as such by the Global Food Initiative.

The main aims of an internal audit for food are twofold:

Apart from helping a food facility to locate and set right issues pertaining to the Quality Management Systems; a food internal audit identifies a problem before it gets detected by an external audit, and rectifies it. Doing so at this stage will prevent the problem from reaching the end consumer. All these conditions can be met when the internal audit is objective, is done with commitment and conviction, reviews the quality programs, and is comprehensive.

  • An effective food internal audit also ensures that the facility is adapting and implementing quality systems, which leads to involving top management into making improvements over time.
  • The FDA, many regulatory agencies from around the world and the ISO –in the form of 19011, and to a lesser extent, the ISO 9001, 14001 and 22000 –all have standards for food safety. An internal food audit should ensure that these are being complied with.

Get complete understanding of internal food audits

All the finer aspects of an internal food audit 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. At this webinar, the speaker is Ruth M Bell, a Food Safety/Quality and HACCP Management Consultant, Auditor and Trainer based in the UK.

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To derive the benefit of the deep and varied experience that Ruth Bell brings to food quality, food technology and food audits; please enroll for this webinar by visiting Food Technology for Non-Technologists

The purpose of this webinar is to provide Internal Auditors with an overview of the tools and information they need to carry out thorough and productive audits. Ruth will give them the knowledge of how to achieve the best outcome in an audit. The learning from this session will help internal auditors gain knowledge of:

  • What an audit is and why they’re carried out
  • The skills and qualities needed by an auditor
  • Audit documentation and preparation
  • Audit techniques
  • How to judge non-conformances

This is a session that is highly useful for those involved directly in food quality audits or those who work with them. These include HACCP Team Members, Technical Managers, Production Managers, Engineering Managers, and Consultants.

Although meant for internal auditors, those planning to become Internal Auditors in the food industry, and Consultants; the learning from this webinar will benefit just about anyone involved in the auditing process, be they auditees or supervisors.

Ruth will cover the following areas at this webinar:

  • Audit Process
  • Audit Preparation
  • Audit Techniques
  • Questioning Techniques
  • Non-Conformities and Corrective Action Close Out
  • Audit Follow-up and Close Out.