ACRP Meets in Seattle for 2011 Global Conference

April 29, 2011

ACRP Seattle

ACRP Meets in Seattle for 2011 Global Conference

Seattle, WA plays host to the Association of Clinical Research Professionals’ (ACRP) annual Global Conference. ACRP is one of the larger professional organizations focusing on clinical trials and expects 2,000 participants. It will be the first time I have attended their Global Conference and I am looking forward to it. There will be sessions on “Introduction to Imaging in Clinical Trials” and on “Distance-Based Learning for Foreign Study Coordinators.” GxP Perspectives will be there for the entire conference (the pre-conference workshops have already begun) and among the sessions I look forward to is “Comparative Effectiveness Trials.” I am going to try to blog at least twice during the conference on issues I think are of concern to GxP Perspectives readers. If I am super industrious maybe I will blog from the ACRP Global Conference every day.

Here is a new feature that ACRP is offering:ACRP is pleased to announce that for the first time ever, two live-feed Plenary Sessions from the ACRP Global Conference & Exhibition will be broadcast FREE of charge. Join us May 1 for the Regulatory Affairs Public Forum featuring representatives from global regulatory agencies addressing issues facing clinical trials. Join us May 2 for Innovation & Global Health, a discussion by Tachi Yamada, MD, President, Global Health Program, Bill and Melinda Gates Foundation.

For more information visit the ACRP Website on the Plenary Sessions

ACRP clinical trials

Do You Have a Guest Commentary for
GxP Perspectives?

Another highlight will be the May 1st session on “Your Site Doesn’t Need 60 SOPs, But How Many Does It Need?” The speakers are Christine Pierre, RN and Steven Steinbreuck, MPH and the author of a Guest Commentary on GxP Perspectives on Informed Consent Requirements. Remember, I am always looking for a good Guest Commentary. Send me a note and ask me how-

Leave a Comment to Submit a Guest Commentary!

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On the Blogroll: Top 40 Websites (and Tweeters) on the FDA, by FDAZilla (Yes, we made the list.)

Moriah Consultant’s Blog – Commentary by Michael Hamrell, one of the conference speakers
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Conferences: Pharma/Bio Boot Camp on the eTMF on 20-21 May 2011 in Philadelphia


FDA & EU Requirements for Documentation & Approval of GMP Procedures

April 23, 2011

FDA documentation requirements

FDA Requirements for Signatures & Documentation

What does the FDA require for the documentation, signature, and approval of standard operating procedures (SOPs)? Are the requirements the same for Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP)? As it turns out, the answer is no. FDA has different regulatory requirements for GCP, GMP, and GLP regulations. In this Guest Commentary Kathie Clark describes the FDA and EU requirements for documentation and approval of GMP procedures. And understanding the basics of good documentation helps in any area of FDA regulated industry.

Guest Commentary:

Approval & Signature Requirements for GMP Documents, by Kathie Clark

Complete, accurate and clear documentation is key to maintaining compliance in a Good Manufacturing Practices (GMP) environment. Documentation is needed to define quality management principles, describe specific procedures, and maintain records that demonstrate that procedures were followed. Together, these directives, procedures and records demonstrate that a manufacturer is operating in a state of control, defined as “A condition in which the set of controls consistently provides assurance of continued process performance and product quality” .
GMPs specifically require that “The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.” But what does this mean in terms of required signatures?

Some people may be surprised to find that the US GMPs only require signature (or initials) for a handful of documents. The following are the specific GMP signature requirements:

FDA documentation GMP signature

What Procedures are Required?

§ 211.182 Equipment cleaning and use log. The persons performing and double-checking the cleaning and maintenance (or, if the cleaning and maintenance is performed using automated equipment under § 211.68, just the person verifying the cleaning and maintenance done by the automated equipment) shall date and sign or initial the log indicating that the work was performed.

§ 211.186(a) Master production and control records. …master production and control records for each drug product, including each batch size thereof, shall be prepared, dated, and signed (full signature, handwritten) by one person and independently checked, dated, and signed by a second person.

§ 211.186(b)(8) Master production and control records. A description of the drug product containers, closures, and packaging materials, including a specimen or copy of each label and all other labeling signed and dated by the person or persons responsible for approval of such labeling.

§ 211.194(a) Laboratory records. The initials or signature of the person who performs each test and the date(s) the tests were performed. The initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.

§211.188(a) Batch production and control records. An accurate reproduction of the appropriate master production or control record, checked for accuracy, dated, and signed

documentation and signatures for FDA requirements

Review and Approval Process for GMPs

What’s the impact? Although some documents require signature according to regulations (CFR) in the US, a closer read indicates that the real emphasis is on defining and following a sound review and approval process, and being able to provide evidence of this, for all documents. There is no indication that you are out of compliance if an SOP or specification does not display handwritten or electronic signatures, as long as a valid process was followed for the document.

In Europe, GMPs would initially seem to set the bar higher as they state that “Documents containing instructions should be approved, signed and dated by appropriate and authorised persons.” However, a closer look at recent revisions made to EudraLex, The Rules Governing Medicinal Products in the European Union Volume 4, to support electronic signatures for GMP indicates that electronic signature requirements in Europe (for GMP documents) are less stringent that in the US:

Electronic records may be signed electronically. Electronic signatures are expected to:

a. have the same impact as hand-written signatures within the boundaries of the company,
b. be permanently linked to their respective record,
c. include the time and date that they were applied.

documentation and approval for FDA

Documentation for
Review, Approval,
& Release

Since there is no explicit requirement for the signature to appear in the document, this could be interpreted as an electronic approval recorded in a document management system. In summary, recommendations based on a review of the guidance include:

• Ensuring that the process to review, approve and release any GMP document is clearly defined in writing and followed consistently.
• Reviewing the signature requirements in the region in which you operate and determine the most efficient way to meet them.
• If you are not already using an electronic system to manage your documentation, considering the return on investment you may be able to achieve from cost reductions in the “Four Ps” of paper, printing, postage, and processing. If you must print, courier and archive paper documents to comply with the regulations, the cost can be significant.

Kathie Clark is Director, Product Management at NextDocs Corporation, where she is responsible for NextDocs’ Quality Management and Regulatory SharePoint-based document management solutions.

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READ THE GMP DOCUMENTS:

PHARMACEUTICAL QUALITY SYSTEM Q10, International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 4 June 2008

21 CFR 212.22 Responsibilities of quality control unit

EudraLex The Rules Governing Medicinal Products in the European Union Volume 4, Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Chapter 4: Documentation, Revision January 2011

EudraLex The Rules Governing Medicinal Products in the European Union Volume 4, Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 11: Computerised Systems, Revision January 2011

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On the Blogroll: The AssurX Blog recently posted this interesting article about FDA Inspections

Barry A. Friedman discusses FDA Warning Letters for APIs in China and clinical trial materials in the U.S..

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FDA EU documentation

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FDA Enforcement: The Four Elements of Proof

April 16, 2011

The four elements of Proof FDA

FDA Enforcement:
The Four Elements
of Proof

What is FDA required to document to initiate an enforcement action? What proof is necessary to establish clear and significant violations of the regulations? What elements of noncompliance do FDA field investigators need to establish that a Warning Letter, seizure, injunction, consent degree, or prosecution is required? FDA has basic requirements that should be documented during an inspection: they are called the Four Elements of Proof. When reviewing a Form FDA 483, Inspectional Observations, it should be compared against these basic required elements for consistency, relevancy and significance. Let’s look at the Four Elements of Proof, sometimes referred to with the acronym JIVR.

FDA four elements of proof

Does FDA Have Jurisdiction?

JURISDICTION: For FDA to take an enforcement action, it needs jurisdiction. We know that FDA regulates drugs, medical devices, and biologics/vaccines. However, It isn’t always simple. There is a strict definition of “drug” in the Food, Drug & Cosmetic Act. That is the reason FDA lost at the Supreme Court with the first attempt at asserting jurisdiction over tobacco in the 1990s. It was “a question of intent,” which is also the title of former Commissioner Dr. David Kessler’s fascinating book on his time at FDA. Laws and regulations usually have a section for “definitions.” Take some time to read them. It will help you understand the way FDA interprets inspections and when to seek enforcement actions.

FDA enforcement four elements of proof

An Early FDA Inspection: Railroad Watering Points

INTERSTATE COMMERCE: One of the principal functions of the United States government is to regulate interstate commerce. Railroads were the principal means of interstate transportation when FDA was founded and an important area of FDA concern. And just try to document medical oxygen in interstate commerce. I once had a promotion delayed for three months because as a Bioresearch Monitoring investigator, I was dealing with the biopharmaceutical and medical device industries where interstate commerce is basically assumed. So I had to go out to a couple of medical gas repackers and collect DOC Samples (a DOC sample consists of paperwork, not a product) to establish that I could document interstate commerce. (See Warning Letter Below for Interstate Conveyance Sanitation.)

four elements of proof

What is the Violation?

VIOLATION: There should be a “clear and significant” violation of the regulations to put something on a 483 or Warning letter. If the laboratory normal range for the inclusion/exclusion criteria for blood glucose is 80-120 Mg/DL and the result is 121 that is a clear violation. Is it significant? I think not. Determining significance is not an easy task. It is something that may need discussion during an FDA inspection. Patient, professional discussion of the issue is usually the best approach. Your FDA field investigator may not have experience in the specific therapeutic area or technical issues of the inspection. It isn’t always easy conducting an FDA inspection and establishing the four elements of proof and the significance of the violation. And remember, You cannot determine the root cause of a problem if you don’t know what the violation is. What is the Violation? Find it in the regulations.

FDA four elements of proof

Regulations Assign Responsibility

RESPONSIBILITY: Regulations assign responsibility. In clinical trials they are assigned to sponsors, investigators, and IRBs. In GMPs and postmarket activities responsibilities are assigned to the “applicant” and the manufacturer of a regulated product. In the GLP regulations, responsibility is assigned to the testing facility. Responsibility is a Big Deal to an FDA investigator. It is just as important to ask, “Whose regulatory responsibility is it?” as it is to ask, “What is the Violation?” Without regulatory responsibility you cannot determine who should recommend the actions necessary to correct a regulatory error.

There you have it. The four elements of proof. The basic requirements for FDA enforcement.

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Interstate Conveyance Sanitation Warning Letter
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News from FDA: There is a new Proposed Rule (proposed change in regulations) from FDA on the Disqualification of Investigators. This proposed rule modernizes and harmonizes current regulations. The Final Rule will probably look quite similar.
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On the Blogroll: GxP Perspectives made the list for Top 40 Websites (and tweets) on the FDA. This comes from FDAZilla. I think it is a pretty good list.

Also: David Spero has an excellent post called The Art of Motivation on his blog. This isn’t about regulations, its about people.

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FDA Clinical Trials: Quality Considerations for Pivotal Studies

April 9, 2011

clinical trials considerations pivotal

When Should Quality Begin?

When should quality preparation begin for a pivotal phase III clinical trial? About once a month I get a call asking for help for a clinical trial because its time to get ready for FDA inspections. I ask “When will the application be filed?” The response? “Soon, very soon.”

It is a good thing to prepare for an FDA inspection. It is even better to prepare at the beginning, reviewing the quality considerations necessary to do the job right by “frontloading quality.” Here are some things I think you should consider. (Please take the survey at the end)

Phase III Considerations for Compliance with the FDA Bioresearch Monitoring Program: by Carl Anderson

The U.S. Food and Drug Administration conducts inspections of clinical trials as part of their Bioresearch Monitoring program. Although all FDA regulated clinical trials are subject to inspection, the large majority of inspections are the result of an application for the approval of an investigational product. Results of an FDA “Bimo” inspection can have a direct impact on the review and approval of an NDA, PMA, or BLA by the agency. FDA conducts inspections of clinical trials for two primary reasons:

1. To ensure the integrity of data submitted to the agency in support of an application.

2. To protect the safety, rights, and welfare of human participants in clinical trials.

The regulations that the FDA enforces for clinical trials are collectively known as the good clinical practice (GCP) regulations. They include 21 CFR Parts 11, 50, 54, 56, 312, 314, 601, 812, and 814. They can be found on the web at: http://www.fda.gov/oc/gcp/regulations.html. In particular FDA Bimo inspections cover the specific responsibilities required of sponsors and investigators covered by 21 CFR 312 Subpart D: Responsibilities of Sponsor and Investigators. For medical devices they are contained in Part 812.

The primary guidance document used for GCPs is the International Conference on Harmonization E6: Good Clinical Practice: Consolidated Guidance. This document is the international standard and the primary GCP regulation in many countries. ICH documents for clinical studies including E6 can be found at the link on the bottom

There are two types of GCP inspections that are of concern for sponsors. The first type is the inspection of clinical investigators at the sites where research is conducted. The majority of FDA inspections are of the investigators. The second type is the inspection of the sponsor or contract research organization. This is a routine inspection for medical device sponsors and is becoming more common at drug sponsors. Although most inspections are at clinical sites, in the event that serious deficiencies are documented, there can be directed inspections of sponsors that can result in serious regulatory action.

clinical trial consideration pivotal

QA for the Data Lifecycle

Prior to beginning a pivotal study the sponsor should establish a system of clinical quality assurance. This is a recommendation, not a requirement, of FDA. E6 defines quality assurance (QA) as: “All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and applicable regulatory requirement(s).” Among the most important QA activities are the following:

Clinical trial materials. They should be produced in compliance with good manufacturing practice (GMP) regulations and qualified by an onsite audit.

pivotal clinical trial

Increased Enforcement of
Part 11

Computerized systems including eCRFs. There are many forward looking systems available for electronic case report forms (CRFs) including systems that are internet based. These vendors are not regulated by FDA and do not receive regulatory inspections. The burden is on the sponsor to determine if the vendor provides GCP compliant services. All should be qualified by an onsite audit.FDA has started looking a lot closer at eCRF systems.

Site management organizations (SMOs). These are unregulated organizations that provide support for clinical investigators and recruit study subjects. FDA inspections of sites using an SMO have frequently been cited for noncompliance with GCPs. SMOs should also receive onsite audits.

Central IRBs. These commercial institutional review boards have a better record than SMOs. However, the protection of human participants in research is a central FDA concern. Commercial IRBs should be qualified by an onsite audit.

Randomization services. This might not require an onsite audit and qualification, but the sponsor needs to critically determine that the vendor can supply the required services.

pivotal considerations for phase III clinical trials

QA Audits of Clinical Sites

Audits of clinical sites. ICH E6 states that: “The sponsor’s audit plan and procedures for a trial audit should be guided by the importance of the trial to submissions to regulatory authorities…” The sponsor should audit a pivotal clinical trial throughout the data lifecycle. In particular the sponsor should audit problematic sites during the study. It is the sponsor’s responsibility to “secure investigator compliance” if the investigator is violating GCPs. This was the first violation cited on the Sanofi-Aventis Warning Letter and has historically been a major violation cited on FDA Warning Letters to sponsors.

Top enrolling sites should always be audited during the course of the study because of their increased importance for a successful study and the likelihood that the site will receive an inspection by FDA. The sponsor should also audit sites that may be inspected by FDA at the conclusion of the study including data outliers, sites with a history of noncompliance, and sites that do not have a history of FDA inspections.

Database audits The sponsor’s data management activities should have independent QA review. This should include a qualification audit if data management is contracted out. An excellent resource for data management is the Society of Clinical Data Management. They publish a Good Clinical Data Management Practices Guide which is available for purchase on their website below.

Trial master file (TMF) audits: A TMF consists of the Essential Documents section of ICH E6. There should be QA review periodically throughout the study. The failure to adequately document a clinical trial will hinder any application to FDA. The agency field investigators have a saying that, “If it isn’t documented then it didn’t happen.” Take a look at the TMF page at the top of the blog for additional resources.

Pivotal clinical trial considerations

Conduct Regular GCP Training

GCP training: The sponsor should have a training program that includes initial and continuing training on good clinical practice. The training program should be in writing and training should be documented. At least once a year staff members should attend an outside conference, meeting, or workshop that includes clinical trial professionals that are not the sponsor’s employees.Peer-to-peer interactions are necessary to develop staff

GLP audits: The FDA conducts routine surveillance audits of nonclinical test facilities. An FDA inspector may randomly select a study of the sponsor to track as part of that inspection. Protocols and final reports are collected and sent to FDA headquarters as part of the inspection. The sponsor should always qualify a nonclinical laboratory used for GLP studies submitted to the agency. The new FDA Sponsor Compliance Program (see previous post) gives instructions for looking at nonclinical studies during GCP inspections at the sponsor.

Sponsor audits and mock FDA inspections

pivotl phase III clinical trials

Always Prepare for an FDA Inspection

Finally, a sponsor should conduct audits of their clinical management department and conduct “mock FDA inspections” in preparation for the regulatory audits that will inevitably take place after the NDA, PMA, or BLA is filed. Preparing for a regulatory inspection is invaluable for effectively hosting any regulatory agency, in particular FDA. Medical device sponsors need to remember that FDA typically inspects sponsors submitting a PMA. Drug sponsor inspections are on the increase. The “OAI” violation rate for inspections of medical device sponsors was 33% in fiscal year 2007. OAI stands for “official action indicated” the most serious classification.

An OAI classification can cause FDA to delay or reject an application.

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Please take a short 3-question survey to help GxP Perspectives improve! Survey begins 22 SEP 2011

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This just in: Request for Comments- Exculpatory Language Used in Informed Consent, a joint FDA and OHRP draft guidance document (September 2011)

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Society for Clinical Data Management

ICH Guidance Documents
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On the Blogroll: PharmTech Talk has had a number of interesting blog posts of late.
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FDA clinical trials pivotal studies

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SOPs in Europe: Required for GCPs?

April 1, 2011

SOP Europe requirements

SOPs for Clinical Trials in Europe

What are the differences in SOPs for clinical trials in Europe and the United States? Despite the fact that FDA and the European Medicines Agency are increasing their cooperation and collaboration there are still some formidable obstacles. One is the difference in regulations. The other is how much influence ICH E6: Good Clinical Practice: Consolidated Guidance has in different parts of the world. Today we have a Guest Commentary from The SOP Doctor, Dr Marie McKenzie Mills MICR, CSci, CBiol, MSB, a clinical scientist and trainer from the United Kingdom. She is here to give us a European perspective on SOPs. In 1996, Marie established McKenzie Mills Partnership (MMP), providing consultancy services including training, medical information, medical writing, and clinical research.

I will be publishing a post in Marie’s blog this weekend. Trans-Atlantic Cooperation!

Also: Please take the survey at the bottom of the post!

Guest Commentary

Is there a legal requirement to have SOPs for GCP in Europe?

by Dr Marie McKenzie Mills MICR, CSci, CBiol, MSB

Back in January, in his post “reflecting on the TMF”, Carl mentioned that the ICH Topic E6 Guideline for GCP may not appear to receive the same emphasis from some regulatory authorities as in the past. His post raised a flag about whether there’s a GCP standard other than ICH E6 GCP, which got me thinking. In Europe, a similar concern often pops up along the lines of: which GCP should we be following? So here goes with my answer, particularly for those of us affected by European legislation, with a wee bit of context to explain it.

In Europe, ICH GCP was adopted in July 1996, and became operational in January 1997. Despite having no uniform legal framework for implementation, it was largely adhered to within the European Community (EC) as a set of 13 internationally recognised principles for conducting clinical trials, founded in the bioethical principles that were established in the Declaration of Helsinki. But, its adoption as a regulatory standard was neither complete nor uniform.

SOP Europe

Does the Clinical Trials Directive Require SOPs?

In 2001, Directive 2001/20/EC – legislation known as the Clinical Trials Directive – eventually provided a common legal framework across Member States for monitoring and enforcing GCP standards applicable to clinical research implementation. However, Directives have to be transposed into national law, in each Member State (within three years of their publication). This created scope for differing interpretations of the intended regulatory requirements, somewhat at odds with the goal of harmonisation. Even so, ICH GCP is the cornerstone standard within both the Clinical Trial Directive (Article 1 (3)), and the GCP Directive (Directive 2005/28/EC: Introduction, points 1 and 8; Chapter 1, Article 1 (1a)). So, far from receiving less emphasis, its principles have been adopted in both Directives, where it provides a basic standard for the conduct of clinical trials in a “set of internationally recognised ethical and scientific quality requirements, which must be observed for designing, recording and reporting trials that involve the participation of human subjects”.

This then brings me to the question about requirements for SOPs. Even if this requirement isn’t explicitly stated in European legislation, the burden to satisfy it exists nonetheless, particularly for sponsors because, according to ICH GCP 5.1.1, they’re responsible for “QA and QC systems with written SOPs to ensure that trials are conducted in compliance with the protocol, GCP, and the applicable regulatory requirement(s)”. Likewise, IRBs or IECs – as they’re better known across Europe – also need to have SOPs for their functions (ICH GCP 3.2.2).

Europe SOPs require?

Requirements for EU
Member States

As it turns out, in the GCP Directive, the requirement for SOPs is emphasised less for sponsors, and more for Member States, since their inspectors need appropriate tools for verifying GCP compliance (Chapter 6, Inspection Procedures, Article 26: “Member States shall establish the relevant procedures for verification of good clinical practice compliance. The procedures shall include the modalities for examining both the study management procedures and the conditions under which clinical trials are planned, performed, monitored and recorded, as well as follow-up measures”.

So there you have it: SOPs are required tools for sponsors to ensure GCP compliance; and, for inspectors they’re required tools for verifying compliance. As an all-encompassing requirement in the GCP Directive it often seems to escape everyone’s notice, perhaps because it appears understated. But, it’s there in Chapter 2, entitled Good Clinical Practice for the design, conduct, recording and reporting of clinical trials in Section 1, Article 2 (4): “The necessary procedures to secure the quality of every aspect of the trials shall be complied with.” I don’t know about you, but I think that’s all about SOPs. What do you think?

Links to the Clinical Trials Directive, GCP Directive and the ICH GCP guideline can all be found on the European Medicines Agency website on the link below.

European Medicines Agency (EMA)

EMA GCP Inspections

Marie’s Blog on the Difference between ICH and WHO GCPs

Carl’s Guest Post on Marie’s Blog on Differences Between FDA & EMA Sponsor/CRO Requirements

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You can help out GxP Perspectives! Please let your colleagues and friends know about GxP Perspectives. I also encourage you to get an email subscription (on the sidebar to your right) or join the LinkedIn group (below).

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On the Blogroll: New from the UK: Assero UK
“Working to connect your data…”

And, an interesting development:

PharmTech Talk on EU Transparency Initiative

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A new service: Please check out the Services page at the top of the Blog to learn more about GxP Services.

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There are some important new FDA Warning Letters:

Warning Letter on Fraud at Clinical Site


Warning Letter for GMPs at Clinical Supplies Facility

Which brings us to a new feature from FDAzilla on FDA 483s

Read the Press Release on 483s

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For more information about Europe you can read:

Applied Clinical Trials, View From Brussels by Peter O’Donnell
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Jobs in Clinical Research? The April issue of the Journal of Clinical Research Best Practices just arrived on my doorstep (actually my email inbox) with a review by editor Norm Goldfarb on a new book, “Careers Opportunities in Clinical Drug Research” by Rebecca J. Anderson. At $59.00 it is a bit pricey but reading Norm’s journal always gives you a spectrum of information on clinical trials. You should consider an introductory Free Subscription to the Journal.
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