Regulatory compliance simply means adhering to the legislation and regulations that apply to a company’s b... View more
Regulatory compliance simply means adhering to the legislation and regulations that apply to a company’s business. For a pharmaceutical manufacturer, this means complying with applicable laws enacted by a governing body and rules set forth by a regulating agency.
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Good Practice (GxP) in the Pharmaceutical Industry
Good Practice (GxP) in the Pharmaceutical Industry
What is GxP?
GxP are the quality standards and regulations for a specific field or activity. GxP revolves around two main regulatory pillars: accountability and traceability. Accountability refers to the ability to demonstrate what each person has contributed to a product or project and when they contributed it. Traceability means that there needs to be a way to reconstruct the entire history of a product or project’s creation. To be compliant, organizations need to document and log every action made by every employee in the development or production of a product or project.
The ‘x’ stands for the particular field, whether that’s manufacturing (GMP), distribution (GDP), laboratory (GLP), and so on. They aim to ensure that businesses working in regulated industries manufacture products that are safe and fit for use, meeting strict quality standards throughout the entire process of production. The guidelines are generally similar from country to country, and each country has its own regulator. But for many manufacturers, the FDA’s requirements are king – the US market is the world’s biggest, and so the most profitable.
The 5 Ps of GxP
GxP is no different to any other quality benchmark in that it’s complex to interpret and difficult to put into practice.
What’s the purpose of GxP?
First and foremost, GxP exists to protect consumers like you and me. The guidelines are created and enforced by national or international regulatory agencies, like the United States’ Food and Drug Administration (FDA) or the global International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), to ensure that products, research, and projects are done safely and that the end products are safe to use.
The guidelines themselves are the minimum requirements that an organization needs to meet to ensure that the quality of their goods or services is consistently high. Generally, the guidelines cover products or projects that could put peoples’ safety at risk. That’s why GxP compliance is essential for food, pharmaceutical, medical device, and life sciences organizations as well as for any other companies who work within regulated industries.
Concept of GxP in Pharmaceuticals
One of the biggest concerns that the pharmaceutical industry constantly attempts to address is the safety of its products. GxP is a collection of regulations that aim to resolve this matter in a systematic and wholesome manner. The concept of GxP requirements in Pharmaceuticals was established by the United States Food and Drug Administration. The term itself encircles many different regulations in many different fields.
As we mentioned earlier, there are tons of different guidelines out there. These guidelines also vary by country and region. So, if you wanted to cover them all, you’d probably have to block out a few days in your calendar. In the interest of time, we’ll quickly go over some of the regulations of one of the most important and far-reaching iterations of GxP, Good Manufacturing Practices (GMP).
List of GxP in Pharma:
Though there are several GxPs, few of them are highly important for the life cycle of any product:
- Good Manufacturing Practices (GMP)
GMP are the guidelines recommended by agencies for the authorization and control of manufacturing of products such as drugs, medical devices, active pharmaceutical ingredients (APIs) etc. Adhering to these guidelines assure the agencies about the quality of the products and that the manufacturers have taken every possible measure to ensure the safety of the product.
- Good Clinical Practices (GCP)
GCP are international quality standards defined by the International Conference on Harmonization (ICH) that state the clinical trial regulations for the products that require testing on human subjects. The standards outline the requirements of a clinical trial and the roles and responsibilities of the officials involved in it. It ensures that no human experiments are performed just for the sake of medical advancement.
- Good Laboratory Practices (GLP)
These are the standards set by the FDA for non-clinical laboratory tests and studies conducted for assessing the safety and efficacy of the product. GLPs are a set of standards which define the framework for a non-clinical study and states how they should be performed, evaluated, reported etc.What is GxP compliance?GxP is a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution.
What is GxP compliance?
GxP is a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution.
Manufacturing must occur in a controlled environment that prevents cross-contamination. Software used in a GxP environment must be CFR21 Part 11 compliant. Software requirements for Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Clinical Practice (GCP) require the following:
– An audit trail at the point in time when a record is first saved to durable media
– The audit trail must contain the date and time stamp of the change, the description of the change, the reason for the change and the name of the person making that change.
– The audit trail must not obscure previous values—so both the old value and the new value for a given parameter must be recorded.
– Specific user accounts
– Forward compatibility of all files generated by the software
– All records, including audit trail records, must be protected from tampering.
Software must meet GxP requirements if it is to be used in a GxP compliant environment or connected to GxP validated instrumentation, as may be the case for pharmaceutical development and manufacturing. Your customers will tell you if their labs are GxP validated —chances are if you sell into discovery or don’t know, then it’s not a concern for you. CFR21 Part 11 compliance is necessary if results from the software are sent directly, electronically to the FDA or regulatory bodies as part of submissions.
What is GMP and cGMP?
Good Manufacturing Practices (GMPs) and Current Good Manufacturing Practices (cGMPs) are quality standards and guidelines that companies involved in food, cosmetics, medical device, and pharmaceutical manufacturing need to adhere to. These regulations are meant to ensure that manufacturers consistently produce high-quality products that are safe for people to use or eat. Generally speaking, GMP regulations provide rules on manufacturing, testing, and quality assurance.
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