8 part interactive series.

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Data Integrity in Action

Now that you have a better understanding of the basics of Data Integrity, let’s take a look at what Data Integrity actually looks like in the real world and at most pharmaceutical companies.

Data Integrity applies to all elements of the Quality Management System (or Q.M.S.) and to data created, edited, and maintained in both electronic and paper-based systems.

Examples of Data Integrity activities in everyday business operations would include:

• Compiling and reviewing quality metrics and performance indicators on a regular basis through Quality Management Reviews.
• The physical and cyber security measures in place at your organization, including requirements you may need to comply with such as locking your computer when leaving your workstation or not sharing passwords.
• The access and configuration controls set up within computerized system.

Trainings like this one that make team members aware of the importance of Data Integrity and how it can impact product quality and patient safety,

Even a company making sure printers are set up throughout a building so that they are close to the people and places printed documents will be used is an example of practices ensuring Data Integrity.

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Why is Data Integrity Compliance Important?

Data quality determines the possibility for companies to guarantee the quality of their products. Data records are the only proof that our G.x.P. processes are performed according to the quality standards.

By ensuring the integrity of data and records, not only do you help to protect the patients who use our products, but you also contribute to safeguarding our company as a whole and the people who work here.  By contributing to Data Integrity, you are helping to ensure the quality of the product released by the company.

While some data integrity breaches are intentional, most data integrity failures are accidents that might have been prevented if team members were more aware of the possible, unintended consequences of failure to maintain data integrity.

Unwanted Outcomes

It’s important to remember there are many unwanted outcomes that might happen as a result of data integrity issues.  These consequences can be extremely damaging to a company’s reputation and commercial success.  In addition to company impacts, intentionally falsifying data could be grounds for immediate dismissal of the colleague(s) involved from the company.

Product recalls and/or market withdrawals can create shortages and reduce patient access, as well as have a serious financial impact on the company.

One thing to note is that industries that focus on data integrity are typically unique in that their customers, who are often patients, can’t determine the quality or safety of the products simply by looking at them on the surface.

Patients can’t look at certain products, such as medicine or medical devices, and evaluate the quality of the product the way they can with other products, such as food, clothes, or furniture.

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The five key organizations that play a major collaborative role in the legal framework of Pharmacovigilance globally are:

• The European Union (or E.U.)
• The United States Food and Drug Administration (or U.S. F.D.A.)
• Health Canada
• The World Health Organization (or W.H.O.)
• And The International Council for Harmonization (or I.C.H.)

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Remote Inspections

All GVP inspections in 2020/21 were conducted remotely due to the ongoing COVID-19 pandemic. Routine inspections were prioritized based on areas of highest risk to patients and public health. In addition, most of the routine inspections were focused on core PV activities (i.e., collection of safety information, management and reporting of adverse drug reactions (ADRs), aggregate reporting, and signal management).

According to the MHRA, remote inspections were made possible by using online platforms that facilitated document sharing and video conferences, which both inspectors and inspected organizations could securely access.

Approaches for Remote Inspections

Several different remote inspection approaches were piloted to determine the most suitable approach. These approaches included inspections consisting entirely of document review, with no interviews with company staff, and inspections spread over several weeks. However, in the end, the preferred inspection mode was a hybrid approach which consisted of targeted interviews conducted remotely and review of data and documents.

“The experience and learnings from the remote inspections completed during the pandemic will likely shape alternative inspection approaches in the future”, says the agency.

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Pharmacovigilance Inspection Report

The MHRA GVP inspectorate recently published the pharmacovigilance inspection report for the period from April 2020 to March 2021. Pharmacovigilance inspection metrics have been published since 2009 and are based on PV inspections carried out annually.

The reports include information on:

• The number and type of marketing authorization holders (or M.A.H.s) inspected
• The areas associated with common inspection findings
• The number of critical, major, and minor findings

Following Brexit, the UK entered a transition period where European Union law continued to apply and therefore inspections continued to be conducted following EU regulations (until 31 December 2020).

Since the end of the transition period, inspections have been conducted following the Human Medicines Regulations 2012 (or H.M.R.) and GVP Module III, as modified by the “Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the licensing authority”.

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Good Documentation Practices in Action

So, what do Good Documentation Practices actually look like in the real world and at most pharmaceutical companies?

Good Documentation Practices apply to a wide range of activities across an organization; from documenting the cleaning of manufacturing equipment to documenting that you’ve read and understood the S.O.P.s that  apply to your work. All Product (R&D, Production, Post-Market Surveillance / Vigilance), Process, and Quality related documents and records are in scope.

Examples:

Examples of Good Documentation Practices in everyday business operations would include:

• The creation of training records to document attendance of an in-person training or completion of an online eLearning course, like this one.
• Production batch records that are created and maintained to document how a product batch was made, by whom, and following what processes.
• All of the records and reports that are generated from carrying out internal audits
• Documentation of customer complaints regarding any element of a product

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Procedures

One of the top citations in FDA 483’s and warning letters every year is companies failing to follow their own procedures.

As an industry, we tend to write long procedures (sometimes 20, 30 pages or more) consisting primarily of black-and-white text, often in paragraph form.

Yet, numerous studies have shown that the brain processes visual information – colors, pictures, and symbols – exponentially faster than black and white text.

GMP Habits

Creating strong everyday GMP habits starts with procedures that are clear, concise, visual, and user-friendly  – and following them precisely every day.

This also means involving the end user in the SOP creation and revision process, as the author, or at least a reviewer. Why? Because the end users are the ONLY audience that really counts for written procedures. They are the people that follow the procedures. They need to be involved in creating them.

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Importance of Inspections

Why are inspections so important? As stated previously, they are a critical mechanism for helping to ensure safe and effective, high quality medicines for patients, which is the ultimate goal shared by medicine manufacturers and health authorities, such as FDA.

Manufacturers must take inspections extremely seriously. Failure to prepare for inspections and create strong cGMP habits every day could result in poor inspection results, including observations (or 483’s, noted on FDA’s Form 483), warning letters. In the case of severe or repeat violations could result in injunctions, consent decrees, seizure of product or facilities, and even criminal prosecution. If violations are found during pre-approval inspections, inspectors may recommend that the FDA NOT approve a product for commercial manufacturing.

Poor Inspection History= More Inspections

Firms with a poor inspection history also incur more inspections, as they are considered higher risk by health authorities, who use a risk-based approach in determining their inspection schedule. Additionally, a firm’s reputation will be adversely impacted by warning letters and other regulatory consequences, which are a matter of public record. All of this can have major financial consequences, as well as the potential to not be able to make products for patients in need.

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Quality Risk Management

As you know, Quality Risk Management is:

A systematic, risk-based approach to quality management, composed of the assessment, control, communication, and review of quality risks in the development and manufacture of medicinal products.

Regulatory bodies expect pharmaceutical manufacturers to assess these risks by implementing a robust Quality Risk Management System.

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