Good Clinical, Laboratory and Manufacturing Practices (GxP)

About GxP

GxP means good practice. x represents a certain field. There are several fields, including Good Clinical Practice GCP), Good Distribution Practice(GDP), Good Manufacturing Practice(GMP), Good Agriculture Practice (GAP), and Good Laboratory (GLP). GxP guidelines and regulations are listed in the US Food and Drug Administration (FDA) and the European Union (EU). These regulations are established so that manufacturing companies produce products that are safe for use and can’t harm consumers. GxP processes that use computerized systems must meet the GxP requirements to fulfill them.

Microsoft and GxP

Companies that deal with the manufacturing and distribution of life sciences products rely on Microsoft. It also helps to ensure that their services meet the requirements of Good Clinical, Laboratory, and Manufacturing (GxP). These regulations are found in the US FDA under CFR Title 21 Part 11 that electronic records of computer systems can be trusted and relied on. Again, Annex 11, LudraLex, and Volume 4 are part of the EU that recognized computer systems’ guidelines.

Though cloud providers lack GxP certification, there are important things about Microsoft;

• Microsoft recognizes good practices for qualification such as Good Automated Manufacturing Practices (GAMP), Good Practices for Computerized Systems in Regulated GxP Environments, and Good Practices Guides from ISPE.
• Several independent audits have been incorporated in Microsoft Office 365 and Microsoft Azure to ensure quality management and secure information. They include ISO/IEC 27001 (ISMS) and ISO 90001 (QMS).

Though cloud providers ensure confidentiality of data in Microsoft cloud services, they don’t comply with GxP. However, they ensure that computerized systems have the best practices. Thus, cloud service providers are at peace because they can maintain integrity in their users’ various services.

Qualification Guidelines in GxP allow Microsoft customers to control GxP computerized systems. Again, GxP life science ensures that firms enjoy cloud’s efficiencies. Also, the patients are safe, high-quality products are manufactured, and data is secure. Clients also have the advantage of data privacy from operational and compliance policies and government technologies.

Microsoft in-scope Cloud Services

There are three in-scope cloud services, including;

• Microsoft 365
• Microsoft Dynamics 365
• Azure

How to Implement

• Microsoft Dynamics 365 GxP Guidelines: it’s a whitepaper where one can use Microsoft Dynamics 365, but GxP practices and regulations are met.
• Microsoft 365 GxP Guidelines: it’s a whitepaper, and the user can control Microsoft 365 yet adhere to GxP best practices and regulations.
• Azure GxP Guidelines: A complete toolset where a customer can use Azure but adhere to GxP best practices and regulations.
• Using Azure with GxP Systems: Using these guidelines, life science organizations can develop a strategy needed to build GxP applications.
• FDA CFR Title 21 Part 11 Guides: These guidelines can help one get help and establish a Microsoft 365 Office and an Azure qualification strategy that meets the FDA guidelines for computerized systems.

Frequently Asked Questions on GxP Cloud Compliance

With the increased use of cloud technology in life sciences, Quality groups and enterprises are determined to ensure that the cloud complies with the set regulations. Though there are improvements to incorporate cloud in life sciences, organizations are asked several questions frequently. Most clients are eager to know more about GxP cloud compliance and know its merits and demerits.

• Have any Clients who use Azure for GxP applications been assessed by the FDA?
• Where is the Azure Qualification pack found?
• How is data built for testing if infrastructure changes are made?
• Does Microsoft accept it when a Life Science company makes an on-site audit?
• What is the requirement for one to have the HIPAA BAA coverage from Azure?

Concept of GxP in Pharmaceuticals

Pharmaceutical companies must ensure that their products are safe. GxP regulations ensure that those in pharmaceuticals manufacture and distribute products that can’t harm their users. There are several GxP regulations, including;

Good Clinical Practice (GCP)

Good Clinical Practice ensures that the experiments done on humans are safe. It also ensures that research is done effectively and experiments on human subjects have more benefits than risks. Again, these human subjects must be made aware of what to expect during the experiment. If they aren’t aware, then it’s a violation of GCP guidelines.

Good Manufacturing Practice (GMP)

During manufacturing, products are exposed to many risks. Good Manufacturing Practice ensures that these risks are eliminated throughout the manufacturing process. After the drugs are manufactured, many hazards in them can cause extensive harm to the end-users. Thus, GMP ensures that the products meet quality standards, whether on a small or large scale.

Good Laboratory Practice (GLP)

Good Laboratory Practice ensures that animals are safe during their trials in the laboratory. Laboratory animals and samples must be thoroughly documented before the trials begin. GLP guidelines state that animals should be handled humanely. Dead animals shouldn’t be used to carry out laboratory trials.

Good Distribution Practice (GDP)

Good Distribution Practice ensures that the wholesale distributor must ensure that the supply chain quality products. A manufacturer who complies with GDP ensures that;

• The storage of medicine is done the right way from storage to distribution until they reach the end-users
• The supply chain of all medicine follows the European Union legislation.
• There’s no contamination of any products.
• The required products reach the right person at the right time.

If faulty products reach the end-user, the impact can be harmful and irreversible. Hence, distributors put tracking systems on their products so that faulty products can be recalled effectively. GDP also ensures that pharmaceutical ingredients are safe from the source, storage, and transportation before they are used to manufacture drugs.

Good Review Practice (GRP), Good Documentation Practice (GDP), Good Auditing Practice (GAP and Good Engineering Practice (GEP) don’t have a significant impact in the pharmaceutical industry. Hence, experts rarely talk about them. GxP plays a great role in the pharmaceutical industry, globally. Thus, it remains a quality standard in the manufacturing of drugs.

Companies producing various products must follow the FDA and EU regulations and guidelines. This ensures that the products are safe from manufacturing, storage, transportation, and distribution. If the risks are higher than the benefits, the product should be eliminated and shouldn’t be manufactured. The above guide explains GxP, how GxP and Microsoft works, and GxP in pharmaceuticals.

Paul Petersen