Pharmaceutical Guidelines : Total Pharmaceutical Solution

Pharmaceutical Guidelines

Mechanism of Drug Release from Oral Dosage Forms

Oral dosage has been a predominant form to provide Active Pharmaceutical Ingredients (APIs) to a patient. The disintegration of the drug through oral dosage forms has been a cause of major bioavailability problems in the past.Therefore, the mechanism is carefully controlled in pharmaceutical products. Oral dosage usually refers to the category of drugs administered to the patient in the form of tablets, capsules and other orally administered forms.

Biosimilars and their Significance in Pharmaceuticals

The pharmaceutical industry is important for human health for it discovers, produces and markets drugs which most of us use for medicinal purposes. However, they work under laws and regulations that govern them on how to perform their duties. The industry deals with a large number of drugs but this article will focus on biosimilar drugs. Everything about the drugs including their importance is explained below.

Best Weighing Practices in Pharmaceuticals

It has always been a great challenge for many people when it comes to adopting and using the best weighing practices in pharmaceutical industries. This is simply because electronic balances that are used may create the wrong impression sometimes that they are offering guaranteed measurement precision. That's why below, we have compiled the best practices to help you as an individual or organization to be able to use them to lower risks of incorrect measurement.

Requirement of Active and Passive Air Sampling in Controlled Areas

What would you say if I ask for the causes the most contamination of products during the manufacture of pharmaceuticals? If you’re like me, 'people' was the first thought that came to mind. You and I both are right, in fact; people, raw materials, and water are one of the main contaminants of products according to most microbiologists.

Preparation Process for Water for Injection (WFI) in Pharmaceuticals

There are basically two types of water preparation in pharmaceuticals.Water for Injection (WFI) preparation process and Purified Water preparation process. The analytical standards for the two water are almost very similar, the only difference is that Water for Injection (WFI) preparation process in pharmaceuticals has stricter bacterial control standards than purified water process and has to pass the bacterial endotoxin test. Preparation methods are very similar to a particular point, however, Water for Injection (WFI) preparation process in pharmaceuticals must include distillation or double pass reverse osmosis techniques.

Protective Gears used in Pharmaceutical Sterile Areas

In the health-related area, laboratories need to follow strict measures in order to keep everything flowing. Not only to protect the workers from possible hazards but to protect the patients from possible anomalies in the manipulated substances. In this article, we will tell you more about the laboratory protective gear in the pharmaceutical sterile area and how to use it.

21 CFR and Its Recommendations

The 21 CFR and its recommendations are very important in today's pharmaceutical industry. Title 21 of the CFR or the Code of Federal Regulations deals with governing of food and drugs in the United States for three of its governing bodies: The FDA (Food and Drug Administration), DEA (Drug Enforcement Agency) and ONDCP (Office of National Drug Control Policy). It consists of three chapters, each specializing in codes for these organizations.

Restricted Access Barrier System (RABS) in Pharmaceuticals

The goal of a barrier system is to segregate people from the product so that certain pharmaceuticals are not exposed to certain organisms. RABS process in an ISO 5 environment, similar to isolators. RABS manually performs bio-decontamination. If the doors are ever opened, the system must be sanitized correctly, a line clearance must be performed, and the intervention recorded. RABS allows for faster start-ups and easier and quicker changeover.

Fishbone Tool of Investigation in Pharmaceuticals

Fishbone diagrams, also known as Ishikawa diagrams, is a visual form of cause and effect diagram which can help analyze the root causes of a problem. It allows the audience to brainstorm the reasons which might otherwise be directly ignored. These causal diagrams have been in use since 1968 to find root-cause analysis of a specific event. The fishbone diagrams are a part of root cause analysis techniques which are used by pharmaceutical firms to analyze deviations and avoid series of near-misses. In addition to fishbone diagrams, the root cause analysis techniques also include brainstorming and “5 whys” which helps the firm or industry to dig deeper into a problem and then, find a practical solution.

Duct Designing in HVAC System

Designing an air conditioning duct system is crucial while installing HVAC system in the enclosure. An improper design of HVAC system may not give that satisfaction of the comfort level as well as it may lead to a negative impact on your energy bill.

Problems Associated with Pharmaceutical Cleanroom Areas

Pharmaceutical cleanroom areas are used to protect pharmaceutical products from pollutants that cause undesired contamination in pharmaceutical products to be produced. These contaminants can occur due to a number of reasons. Human being plays a significant role in producing this contamination through vital body organs such as the skin.

Sampling in Cleaning Validation in Pharmaceutical Industry

Sampling in cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections. The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). Such as, FDA inspectors now expect to see a functioning cleaning validation program with appropriate documentation in place during their inspections.

Possibilities of Contamination in Sterile Products

In pharmaceutical production, the term "sterile products" is usually used to describe parenteral preparations. These are products which are not meant to be administered via oral route or alimentary canal, so do not benefit from the protection of the immune system which the alimentary canal provides. Administration of these drugs is done directly to the blood stream or various body tissues.

ALCOA in Pharmaceuticals : A necessary tool for Quality

Any pharmaceutical product has to undergo a process before it can be used by the public. This process ensures that the product is safe for everyone. And if there are any side-effects of the product, the consumer can be warned about them beforehand. This helps to decide for whom the product would be suitable.

Controlled area in Sterile Pharmaceutical Manufacturing

A controlled (classified) area is an enclosed environment or room with a flawless control over particulate contamination. More specifically, the areas have a controlled contamination level, which is specified regarding the number of particles for every cubic meter, for a specified particle size. The restricted areas are constructed with impeccable humidity, temperature and pressure control to minimize the generation, introduction, and retention of particulate matter inside the rooms.

Basics of HVAC System

Air conditioning has changed over years, HVAC system is used to control the environment in the manufacturing as well as the storage area of the pharmaceutical facility. Heating, Ventilation and Air Conditioning is a system that is used to control the air temperature by controlling the air filtration and the moisture in the air. 

About the Author

Ankur Choudhary is experienced in pharmaceutical, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008.

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