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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Which leads to fines in the millions of dollars per intrusion

Developments in the area of medical device software –i.e., the software that is put to use in medical devices –have been taking place at such a torrid pace that regulatory agencies such as the FDA have been unable to keep pace with them. Almost invariably, every development in medical device software brings about a new level of complexity.

Also, the classification of the device is another factor the FDA and other regulatory agencies have had to contend with: Different regulations have to be made depending on whether the software in medical devices is to be classified as a device itself, is used to alter the performance of the device, or is used for computing values. The inability of the regulatory agencies to catch up with the speed of developments in the medical device software arena has had the agency scurrying for quick solutions.

Among these are its decision to integrate the current provisions of voluntary standards developed by the National Institute of Standards and Technology (NIST), which it considers as a useful guidance for medical software professionals and voluntary information sharing organizations to meet cybersecurity challenges into its regulatory oversight. The onus of being knowledgeable about FDA regulations thus rests on firms that design and market software.

Learning on all the aspects of medical device cybersecurity

A formal learning session that examines this complex relationship is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. The speaker at this webinar is Casper Uldriks, ex-FDA Expert and former Associate, Center Director of CDRH. Participants who wish to gain clarity on these aspects of medical device cybersecurity can register for this webinar by visiting National Institute of Standards and Technology

The speaker at this webinar will seek to help participants identify the FDA’s fundamental premarket and postmarket requirements that involve software. When medical device companies go to the FDA for approval to market their product; they need to be very well informed about everything that the FDA states and requires in this regard, because, as we have examined, the burden of design factors requires well informed considerations about how medical device manufacturers protect their product’s software and how they outsmart increasingly sophisticated cyber attackers.

All-round plans

At the same time, device manufacturers also need to be totally compliant with the regulatory options and responsibilities lie with them when a cybersecurity problem is located in their device. Their responsibilities include plans about how to recover and publicly disclose cyberattacks, especially when private medical records are involved. Not getting this right leads to fines that run into millions of dollars for every breach.

So, their cybersecurity efforts should be inclusive of important factors such as these among others:

o  Design planning

o  Postmarket vigilance

o  Training for employees

o  An action plan for managing an attack.

Learning on the factors to consider

Casper will help participants identify these basic considerations at this webinar. He will explain the kind of device cybersecurity programs that protect and foster the performance of device based software or standalone software that device manufacturers need to instill in order to assure the safe use of the device. Such programs need to use the FDA’s premarket and postmarket information requirements when entering and staying in the market.

This session is of very high value to professionals who deal with some or another form of medical device software and its marketing. This includes those in Regulatory Affairs, Quality Assurance, Software Design Engineers, Manufacturing, the Complaint Department, Hospital Risk Department, and those who market their own labels.

Casper will cover the following areas at this webinar:

o  FDA’s Cybersecurity Premarket Design Information

o  FDA’s Postmarket Controls

o  Voluntary Controls

o  Cybersecurity Training

o  Recovery Plans.

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.

Understanding HACCP and risk based HACCP

Hazard Analysis and Critical Control Point (HACCP) is an important system aimed at bringing down the risk of safety hazards found in food consumed all over the world. It is an internationally recognized system. When it was enacted in January 2011 as part of the FDA’s Food Safety Modernization Act; it was considered a very sweeping piece of legislation for the food industry.

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Identification and control of potential hazards at specific point of the food chain is the soul of an HACCP system. The chain starts with production and ends with consumption. Identifying and controlling these hazards at every point of the chain is challenging in today’s world in which food has become completely globalized.

HACCP suggests the putting in place of mechanisms to control and counter the biological, chemical or physical hazards that could be present or be a potential presence in the food. The HACCP system is designed in such a way such that a company that manufactures, processes, or handles food products in any form can use HACCP for eliminating or minimizing food safety hazards present in its product to acceptable levels.

Implementation is based on two approaches

Proper implementation of the HACCP program involves food companies to implement both these:

  • Prerequisite programs
  • Implementation of HACCP plans

Prerequisite programs:

Prerequisite programs are those programs that a food organization has to put in place at its facility to ensure that all the processes that go into preventing contamination, ensuring a hygienic environment, and the optimal and scientific use of manufacturing methods and technologies and the cleanliness and hygiene of the staff involved in the production of food are proper and compliant.

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Implementation of HACCP plans:

If the prerequisite programs are required at the manufacturer-specific location; many steps and processes need to go into ensuring the quality standards of food that goes out of the facility. HACCP has suggested as many as seven steps for food is free from contamination. These are part of HACCP plans.

 

 

 

These include:

  1. Conducting a hazard analysis
  2. Identifying the critical control points
  3. Establishing a maximum or minimum limit for temperature, time, pH, salt level, chlorine level or other processing characteristics that control the hazard
  4. Establishing Critical Limits
  5. Establishing Monitoring Procedures
  6. Establishing Corrective Actions
  7. Establishing Record Keeping Procedures and Verification Procedures

Risk based preventive control is a major component of HACCP

HACCP has placed a heavy emphasis on risk in the production and transportation of food. It requires risk based preventive control. Codex Alimentarius describes risk assessment as a scientific process that takes the identification of a hazard, its characterization, assessment of the exposure to it, and characterization of risk into consideration.

Risk assessment is part of risk analysis, which in turn is described as a process into which three aspects, namely risk management, risk assessment and risk communication go. So, HACCP requires food manufacturers and transporters to take the risk causing factors into consideration at work. All these become part of risk based preventive controls.

Get the confusion cleared in implementing a risk based HACCP program

To clear the confusions in the meaning of these terms and to teach the ways of implementing them, Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar.  This webinar will clear the misunderstanding between these terms and show ways by which to implement a risk based HACCP program and ways of getting it right.

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Rotimi Toki, who is principal of Rottoks Food Safety Management Consulting Services Limited, will be the speaker at this webinar. Rotimi has provided services to some of the top brands in food service and manufacturing sectors and specializes in Quality Systems Audit, developing an integrated food safety management system based on HACCP principles. In order to gain complete understanding of the ways by which you can adapt and implement a risk based HACCP program, please register for this webinar by visiting Background of The HACCP system

Step-by-step method of developing an HACCP program

Rotimi will present a step-by-step process for developing an effective HACCP program. He will elucidate the principles and specific steps needed for this, for this is a prerequisite to building such a program. Through this process, Rotimi will show how participants can build a plan that can identify and control food safety hazards and risks specific to their product line and processes.

He will show how to determine the significance of these hazards by applying risk assessment techniques, from which a measure of risk can be obtained. This measure allows users to put appropriate control measures in place. He will clarify on the various confusions and weaknesses present in many food safety standards surrounding the determination of control measures required by HACCP.

Rotimi will cover the following areas at this webinar:

  • Background of The HACCP system
  • The CODEX Guidelines
  • Basic HACCP procedures
  • Assemble the HACCP Team
  • Describe product and identify intended use
  • Construct flow diagram and on-site confirmation of flow diagram
  • Hazard Analysis
  • Determining control measures in HACCP
  • Establish Critical Limits for each CCP
  • Establish a monitoring system for each CCP
  • Establish Corrective Actions
  • Verification procedures
  • Documentation and record keeping
  • Post-HACCP Maintenance

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.

Biotechnology concept

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.

 

How to control those risks and monitor the effectiveness of the controls put in place

Overview of this session 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, and how to create processes and procedures to implement them.

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.

risk-management-definitionIn 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

Why should you have to Attend The cost of poor product risk management can be staggering. Complaints, Medical Device Reports, recalls, and serious adverse impact to your customers can all result from poor risk management. And these types of problems expose you to regulatory inspections and citations. 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.

These are the areas covered by the speaker 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

By login with this Risk Management Techniques for Medical Devices

Which are the experts benefited by this session are as shown in the below

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

Susanne Manz 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.

How to deal with dynamic source data and the “refresh” concept

Microsoft Excel comes with a myriad of tools such as sorting, filtering, and subtotal to manage large lists of data. Yet, when it comes to analyzing all that data and doing it quickly, the MS Excel PivotTable is a very useful feature. It is particularly important and useful when the user is required to quickly create a compact summary report (based on lots of data) without needing to write complex formulas or rely on lengthy techniques.

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MS Excel PivotTable is very versatile. It is considered Excel’s best analytical tool because in addition to speed, it also comes with amazing flexibility and dynamism the data interrelationships that are being viewed can be changed. It is easier to put the PivotTable MS Excel features into practical use by actually getting down to work on it, rather than trying to pore through the instructions on the printed page, which is a visually-oriented feature based on displaying fields in different locations. It offers the ability to create a complete summary report with heaps of data in very little time without having to write complex formulas and rely on obscure techniques.

Learn about all the features and aspects of PivotTable from the MS expert

A complete learning on the numerous PivotTable capabilities and its many tools and features 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.

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Dennis Taylor, an Excel expert who has worked extensively with Microsoft products (especially spreadsheet programs) since the mid-1990’s and has taught hundreds of workshops and authored numerous works on this program; will be the speaker at this session. Just visit Excel PivotTables to register for this webinar and gain complete insights into the ways by which to put the full array of functionalities of MS Excel PivotTable.

Simplifying the use of PivotTable

The main objective that Dennis Taylor has for this webinar is to familiarize participants with the quickest and best ways to create PivotTables and Pivot Charts. These include the following capabilities:

  • How to compare two or more fields in a variety of layout styles
  • How to sort and filter results
  • How to perform ad-hoc grouping of information
  • How to use Slicers instead of filters to identify which field elements are displayed
  • How to drill down to see the details behind the summary
  • How to categorize date/time data in multiple levels
  • How to create a Pivot Chart that is in sync with a PivotTable
  • How to add calculated fields to perform additional analysis
  • How to hide/reveal detail/summary information with a simple click
  • How to create a PivotTable based on data from multiple worksheets.

He will cover these in detail. In addition, he will cover the following areas at this session on MS Excel PivotTable:

  • Pre-requisites for source data – preparing data so that it can be analyzed by PivotTables
  • Creating a PivotTable with a minimum number of steps, including the Recommended PivotTables option
  • Manipulating the appearance of a PivotTable via dragging and command techniques
  • Using Slicers to accentuate fields currently being shown (and which ones are not)
  • Using the new (in Excel 2013) Timeline feature
  • Creating ad hoc and date-based groupings within a PivotTable
  • Quickly create and manipulate a Pivot Chart to accompany a PivotTable

MS Excel users who are familiar with PivotTable concepts, but need expanded techniques to analyze lists of data are among the primary beneficiaries of this webinar, but anyone needing to know how to create PivotTables from multiple sources and use Slicers, Timelines, Calculated Fields, and Conditional Formatting will also benefit from this course.