Application of concepts and theories of clinical research

Protection of human subjects and everything relating to it is of paramount importance for those involved in or wanting to be involved in research dealing with human subjects or an individual’s private identifiable information. For these individuals, professionals and companies, it is extremely important to understand that there are federal regulations that must be followed.

There are also state statutes, institutional policies, federal guidance documents, and ethical codes that guide the conduct of the research. This is done to ensure that the research not only meets the regulatory requirements but also that it is conducted in an ethical manner, coming with adequate protections for the individuals who elect to enroll in the research or allow their information to be used for research.

Guidelines lack clarity

However, the challenge that this position presents is that the guidelines –which also provide interpretation of the regulations –are not always as clear as they might appear upon first reading them.

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will impart understanding on all these grey areas of human subjects. It will clarify on these regulations. To enroll for this highly educative session, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900671SEMINAR.

The Director of this seminar is the highly regarded expert on the subject, Sarah Fowler-Dixon, Education Specialist and instructor with Washington University School of Medicine. Sarah has developed a comprehensive education program for human subject research which has served as a model for other institutions.

Ways of applying concepts and theories

This two-day seminar will provide the foundation for the application, concepts and theories of clinical research.

hipaa-compliance

The speaker will not only provide a refresher of the regulations; she will also provide attendees with the opportunity to discuss and learn how these regulations, ethical codes and guidance documents get applied in different situations. This information can then be used to help attendees in their day-to-day decision making when confronted with situations or questions regarding how to handle issues that do arise (e.g. a participant not showing for a scheduled appointment, an event that is unexpected occurs, someone who does not speak wishes to enroll in the study, a participant signing an outdated consent document, etc.) when conducting human subjects.

Outcomes of the seminar

The learning acquired over these two days will help attendees learn about the historical evolution of research, and current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. This session will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. It will also discuss a variety of research including genetic, drug, device, and studies that use off-site or community partners. Current examples will be used and the audience will be invited to share their experiences and information.

 

Making sense of the FDA’s GMP and Regulatory Expectations for Early IND Products

The FDA’s recent guidance documents covering GMP requirements for Phase I products have considerably reduced some of the complexities early phase products face. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.

Although these new guidelines appear to remove the need to follow GMPs for Phase I products; the same still exists in the Food, Drug, and Cosmetic Act. As a result, the need for GMP requirements for Phase I products has not been done away with; rather, it has been altered. Now, the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.

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Get trained to understand these aspects

GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day seminar to help Directors, Managers and Supervisors in Regulatory Affairs, Quality Assurance and Quality Control get a grasp of these aspects. To enroll for this highly valuable training, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900695SEMINAR?GMP-regulatory-expectations-San-Diego. Steven S. Kuwahara, Founder and Principal, GXP BioTechnology LLC, will be the Director of this webinar.

Advice on the GMP guidance document

This presentation, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion, will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. In one source, it will present the regulations and guidelines that apply to early phase products. In some cases these may not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. Steven will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.

clinicaltrials

This course is very useful for any pharmaceutical personnel who must deal with products both in early and later phases of development, as it will make them aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have altered the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time, some of the things that may appear to have changed, have not, and personnel in the pharmaceutical sector should be aware of this. This is the learning that Steven will emphasize at this seminar.

It will cover the following areas:

  • Very Early Stages
  • GLP requirements
  • Early Pre-IND Studies
  • Meetings and Preparing for the IND
  • GMPs for Phase 1 IND products
  • Requirements for Phase 2 INDs
  • Preparing for IND Meetings

USP method transfer

USP method transfer underwent a change when the US Pharmacopoeia published the final version of its informational chapter 1224, which deals with the transfer of analytical procedures mentioned in the document entitled USP 35-NF 30. This became official in May 2012.

How is the new document different?

The US Pharmacopoeia had earlier issued the 1224 stimuli document in response to comments it received from users and professionals globally. The new version of chapter 1224, which is the general article, is different in one fundamental way in that it makes risk based assessment the criterion for the nature and scope of transfer activities. So, this new version of USP method transfer is different in one small, but very significant way.

What are the major elements of the new USP method transfer version?

The May 2012 USP method transfer recommends many new elements. Some of these are listed below:

  • The laboratories have to prepare a detailed analytical procedure with instructions that are sufficient and explicit enough to allow a trained analyst to perform it painlessly
  • All questions regarding the transfer process have to be clarified at a pre-transfer meeting between the transferring and the receiving units
  • The written analytical procedure and development validation reports have to be transferred to the receiving unit from the transferring unit
  • The transferring unit has to train staff of the receiving unit
  • A dry run of the procedure has to be conducted at the receiving unit
  • Issues that may need resolution have to be identified before the signing of the transfer protocol
  • All the required identification, calibration and qualification needed of respective analytical instruments have to be carried out
  • Compliance with relevant regulations of the laboratory systems of the two units has to be confirmed

What are the implications of failure to meet acceptance criteria?

According to the USP method transfer; failure of the sending or receiving fails to meet acceptance criteria qualifies as a serious, but not fatal error. It does not get classified under Out-of-Specification (OOS) result whose desired action is investigation into the root of the OOS. However, this requires discussion and justification of any deviation. Either of the laboratories –the sending or receiving –should investigate the reason for which the predicted acceptance criteria were not reached, and should take corrective measures. This process makes USP method transfer complete. The transfer can take place only when the acceptance criteria are met, the failure of which prevents the transfer from taking place.

Reference:

http://www.drugregulations.org/2012/05/new-usp-requirement-for-analytical.html

 

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USP 1058 analytical instrument qualification

USP 1058 analytical instrument qualification is about ensuring that an instrument is suitable for its intended use and application. While system suitability and method validation activities have specific guidelines and procedures; analytical instrument qualification is not so specific. There are conflicting opinions and viewpoints regarding USP 1058 analytical instrument qualification.

Though subjective, analytical instrument qualification is central

Analytical Instrument Qualification (AIQ) stands at the base of the components that go into data quality; the other three components being Analytical Method Validation, System Suitability Tests and Quality Control Check Samples. Why is this so? This is because a sound AIQ lies at the root of the ability of an instrument to meet its intended application. AIQ is not a standalone event in the analytical instrument qualification process. It consists of many related activities.

The four phases of AIQ

USP 1058 analytical instrument qualification requires activities to be grouped into four phases: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).In brief, these are what these phases are:

Design Qualification

According to USP 1058 analytical instrument qualification; a DQ is the documented set of activities that lay out the functional and operational specifications of the instrument. It also mentions the criteria for selection of the vendor, based on the intended purpose of the instrument. The DQ can be performed by both the manufacturer and the user.

Installation Qualification

IQmay be described as the documented collection of activities that are necessary to establish that an instrument is a) delivered as designed and specified; b) it is properly installed in the selected environment, and c) this is done in an environment that is suitable for the instrument. Whether an instrument is new or was pre-owned, or exists on site but has not been previously qualified; IQ is required.

Operational Qualification

OQ testing follows IQ. It concerns the operational part of AIQ. It is the documented set of activities with which to demonstrate the ability of an instrument to function according to its operational specification in the selected environment.

Performance Qualification

PQ is the last stage of USP 1058 analytical instrument qualification. PQ is the documented collection of activities that is necessary to show that an instrument consistently performs according to the specifications defined by the user, and is appropriate for the intended use.

References:

http://www.drugfuture.com/Pharmacopoeia/USP32/pub/data/v32270/usp32nf27s0_c1058.html

 

Contact Detail
GlobalCompliancePanel
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Fax:302-288-6884
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Sterilization

In lay terms, sterilization is understood in a number of ways. We have sterilization in economics, in family planning and in many other fields. When it comes to this term as used by the FDA; there is a specific purpose and definition. For the FDA, sterilization process controls are indispensable for validation.

Sterilization is part of inspections

Sterilization is essentially linked to inspectional objectives. The FDA states the following:  “for sterilization processes, the primary device specification is the desired Sterility Assurance Level (SAL). Other specifications may include sterilant residues and endotoxin levels.”

Important processes labs have to comply with

The FDA has a detailed set of processes that laboratories have to comply with. These are some of the more important ones:

  • The laboratory has to confirm that the sterilization process was validated after the validation study was reviewed
  • It has to review and verify the specific procedure or procedures for the said sterilization process, as well as for the methods that were used to control and monitor the process
  • If during the review of the Device History Records (which include process control and monitoring records, acceptance activity records, etc.) it is discovered that the sterilization process falls beyond the organization’s stated threshold for operating or performance parameters, the company has to do these:

–        It has to determine whether anynonconformance was taken care of in the prescribed manner; and

–        Once this is done, it has to review the equipment adjustment, calibration and maintenance

  • If the laboratory has a system in which the sterilization process is software controlled, it has to confirm that the software was validated
  • The company has to ensure that only appropriately qualified and trained personnel have to implement the sterilization process

Reference:

http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170829.htm

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GlobalCompliancePanel
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Q7 guidelines

Q7 guidelines are those guidelines issued by the ICH (International Conference on Harmonization) in relation to Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredient (API).

Q7 guidelines are very comprehensive

More than 12 years after they were mooted in November 2000; Q7 guidelines continue to be the driving force for API GMP regulations around the world. These relate a large number of areas concerning API, some of which are:

  • Quality management, which covers principles, responsibilities of the Quality Unit(s), internal audits, product quality review and others;
  • Personnel, which takes into account personnel qualifications, hygiene and so on;
  • Qualifications of Consultants;
  • Building and facilities;
  • Process equipment;
  • Documentation and records;
  • Materials management;
  • Packaging and labeling, and so on.

Need for change

Despite the good intention and comprehensiveness of these guidelines; in October 2012, the ICH Working Group issued a concept paper on the working of these guidelines. The areas of concern were about harmonization as well as some ambiguities that had crept in into the working of this guideline.

The essence of the Working Group’s observations was summed up thus: “It has become apparent, based on the approval and implementation of ICH Q8, Q9, Q10, Q11 principles into GMP of APIs that certain individual implementation approaches are leading to non-harmonized interpretation and new expectations beyond the intention of ICH Q 7”.

Many areas need reform

According to the committee, many Q7 guidelines had issues that needed to be addressed and requiring review. These include supply chain control, outsource management, monitoring of impurity profiles, quality systems, the application of the guidance to biological medicines and biotechnology products, Q7’s relationship to the Q5D Guideline on the Quality of Biotechnological Products, and expectations for manufacturing done specifically for clinical trials.

More corrective action needed

It has said at the time of the release of this report that it will suggest changes to these Q7 guidelinesafter a new working group, formed for the purpose of assessing and recommending changes, will offer its advice on suggested issues.

References:

http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm129098.pdf

http://www.raps.org/focus-online/news/news-article-view/article/2520/ich-working-group-calls-for-revisions-to-q7-guideline.aspx

 

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
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Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

 

Method transfer FDA

A method transfer is the process of qualifying a laboratory regarding its ability to carry out an analytical test procedure. For method transfer, FDA has some regulations that are simple on the face of it, but require many steps and precautions. Not being in compliance with these steps could invite investigation and corrective measures to ensure that validated method transfer is carried out.

For a lab to meet method transfer FDA has set; it has to ensure that some pre-method transfer steps are adhered to. These include:

  • Unambiguous and clear communication between the sending and receiving lab on all the aspects of method transfer
  • Nomination of ideally a single person or point of contact between the sending and receiving labs, a person who will coordinate on the details of the transfer
  • Complete and clear assessment of the method of transfer
  • Identification of the required method transfer
  • Evaluation of issues arising out of the context of the location, such as data collection systems, instruments and reagents and coagulants.

Documents to be sent by the sending laboratory

To meet method transfer for FDA requirements, the pre-approved transfer protocol of the sending laboratory will typically consist of the following documents:

  • General transfer process
  • Definition of responsibilities of both parties
  • Specifics of the acceptance data
  • A list of the methods
  • Categorization of the methods
  • A description of samples and materials
  • Description of batch and lot records
  • Definition of parameters and instrumentations

Materials to be sent by the sending laboratory

Talking about the materials to be provided by the sending laboratory, these are usually part of method transfer the FDA requires:

  • Method, which consists of system suitability parameters, rationale for chosen, parameters, step-by-step directions and safety considerations
  • Validation report
  • Reference standards
  • Samples for evaluation, and
  • Supplies that are difficult to procure

Reference:

http://www.nbchem.de/mediapool/120/1202675/data/110914_AMDVT_bn.pdf

Contact Detail
GlobalCompliancePanel
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Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539