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Wednesday, October 04, 2023
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Is Training Required for Employees Working in a GMP Regulated Environment?

Yes, training is required for employees working in a Good Manufacturing Practice (GMP) regulated environment. In fact, training is a critical component of GMP and is required by regulatory agencies such as the US Food and Drug Administration (FDA) to ensure that all employees are knowledgeable and competent in their roles and responsibilities.

Who working in a GMP environment should be trained on quality control?

In a Good Manufacturing Practice (GMP) environment, it is important for all personnel to be trained on quality control principles and practices. This includes not only the quality control department, but also all employees who are involved in the manufacturing, testing, packaging, labeling, storage, and distribution of products.

Should companies extracting components from cannabis plants follow GMP guidelines?

Yes, companies that extract components from cannabis plants for use in pharmaceutical or medical products should follow Good Manufacturing Practice (GMP) guidelines.

What is the difference between WHO, FDA, and other regulatory agencies?

The World Health Organization (WHO) and the US Food and Drug Administration (FDA) are both regulatory agencies that play important roles in ensuring the safety, efficacy, and quality of medical and pharmaceutical products. While there are similarities in their missions and functions, there are also some key differences between these and other regulatory agencies.

What are the Advantages and Disadvantages of Employee Training?

Training is a process of enhancing the skills and knowledge of employees for performing a specific job. Training has many advantages for both employees and employers. Follow the link to learn more.

Are Custom Made Information Systems Worth It?

Information systems are critical to any pharmaceutical research and development efforts since they provide an easy way to collect, store, analyze and share information.

Do Medical Devices Need To Undergo Rigorous Clinical Trials?

Medical devices are becoming more important in healthcare, and this is why many pharmaceutical firms are now focusing on developing some of them.

How Are Lab Standard Operating Procedures Developed?

Standard operating procedures are important in any lab where quality output is expected.

How Do You Maintain The Highest Standards In Laboratory Practices?

Pharmaceutical companies heavily depend on laboratories when developing new drugs or doing research. For the sake of accuracy and better results, high standards need to be maintained in such a lab at all times.

How Do You Prevent Leakage Of Medical Device Prototypes To The Competition?

In the biopharmaceutical industry, medical devices are all the rage since they are increasingly becoming more critical in the treatment of various illnesses.

How Do You Reliably Back Up Biopharma Electronic Records?

Biopharma records are important tools for any pharmaceutical firms, which is why most of them go to great lengths to ensure that they keep them safe.

How Is Data Collected For Pharmacovigilance Purposes?

Pharmacovigilance is an important process for pharmaceutical firms and other regulatory bodies since it allows them to monitor the safety of a drug.

Is Pharmacovigilance Only Important During Clinical Trials?

Clinical trials are important steps needed to capture the nature of newly developed drugs, particularly when it comes to significant side effects.

What Are Some Of The Consequences Of Faulty Computer System Validation?

The use of computers has become an integral part of pharmaceutical research and development.

What Are Some Of The Special Requirements For Drug Warehousing?

In the pharmaceutical industry, drug warehousing is an important step in the chain of drug distribution.

What Are The Common Safety Protocols For Electronic Records?

We live in an age where information is one of the most important commodities in all industries, including in the biopharmaceutical industry.

What Are The General Phases Of Clinical Research?

Clinical trials are an important part of developing drugs and medical devices for use by the public.

What Are The General Steps Involved In Applying For Patents For Newly Developed Pharmaceuticals?

One of the critical steps involved in the development of new pharmaceuticals is application for patents to the drugs.

What Are The Main Principles Of Good Laboratory Practice?

In any pharmaceutical or chemical development company, one of the most important aspects of drug development is good laboratory practice.

What Is The Difference Between Drug Patents And Drug Exclusivity?

When a new treatment modality is developed, the originator of the new treatment has the right to file a patent for the treatment.

What Is The Difference Between Single Blind And Double Blind Clinical Trials?

When undertaking a clinical trial, the two major models that one can use are the single blind and double blind trials.

What Is The Minimum Information Needed For Clinical Trial Registration?

Clinical trials are sensitive procedures, primarily due to the fact that they involve human beings.

What Is The Role Of IT In Pharmaceutical Research And Development?

Research and development in the pharmaceutical industry is usually labor and capital intensive.

What Is The Role Of Pharmacovigilance In Pharmaceutical Research And Development?

Pharmaceutical firms have an important role to collect data for pharmacovigilance purposes for all the drugs they are responsible for.

Why Is Pharmaceutical Validation Critical To Medicinal Product Development?

Pharmaceutical validation is a key element of drug research and development. In a nutshell, pharmaceutical validation is a process where all the elements of drug production are regularly inspected and tested to make sure that they conform to a particular standard.