Pharmaceutical Guidelines : Total Pharmaceutical Solution

Pharmaceutical Guidelines

Requirements of FDA for Training in Pharmaceuticals

The FDA compels every drug or medical devices manufacturer to train every employee starting with the regulated procedures to the CFR requirementsThe FDA training requirements in pharmaceuticals are defined in 21 CFR 211.25 and have three key aspects:

Causes and Remedies of Cracking in Tablet Manufacturing

Cracking is a situation in which small cracks are identified on the top and bottom central surfaces of tablets during the processing of the tablets or during their subsequent use. Hardly are the cracks identified on the sides of the tablets but mainly on the top and bottom surfaces.

Causes and Remedies of Lamination in Tablet Manufacturing

An ideal tablet should be free from any visual defects as well as the functional defects. Despite the advancements and innovations in the manufacturing of tablets, the problems that are often encountered in the production have not decreased but instead increased. And this is mainly due to the complexities of tablet presses as well as the high demand of quality.

Different Types of Dissolution Apparatus

Drug dissolution testing is usually used on a regular basis in the quality control department of any pharmaceutical company. This method is used to monitor the quality of the capsules and tablets that are produced. A drug can only go into the market if only it passes a dissolution test and is approved.

Difference Between Paddle and Basket Dissolution

When a drug is ingested orally, it takes some time to dissolve in the stomach and get absorbed by the body. The rate at which the drug dissolves inside the stomach affects the drug's concentration in the blood as it gets absorbed. If it dissolves too fast it may cause an over-dosage, and if it dissolves too slowly it may cause an under-dosage.

Causes and Remedies of Capping in Tablet Manufacturing

When the top of a tablet separates from rest of its body, it is called tablet capping. It happens when the air in the tablet is not being released properly. The following are some of the common factors which can cause tablet capping;
1. Formulation related
2. Excipient related
3. Machine related

Difference Between Dynamic and Static Pass Box

In pharmaceutical manufacturing industries, pass boxes are normally used to transfer a particular material between two areas generally of different cleanliness levels. The boxes can be said to transfer the materials from a high level of cleanliness to a lower level of cleanliness or vice-versa. The pass boxes while transferring the material, help to prevent air from flowing from one area to another. Pass boxes are made of stainless steel which is powder coated.

Environmental Risk from Microbial Waste

Microbial waste includes any product that emanates from or has been used in tampering with microbes. This includes discarded cultures of microorganisms and infectious agents i.e. bacilli, discarded microbial specimens from pharmaceutical laboratories, pathological or research institutes, live and attenuated vaccines that have been discarded are also considered as waste and lastly, disposable Petri-dishes and all other containers and bottles that have been used in storage and transportation of specimens. Microbial wastes from pharmaceutical premises can either be a solid waste or liquid effluents.

Different Types of Hand Disinfectants Used in Pharmaceuticals

There are different types of hand disinfectants used in pharmaceuticals. These differences can be attributed to the fact that each one varies in its mode of action and the level of activity. It is important to utilize different types of disinfectants in pharmaceuticals because the mode of action in each is needed to prevent the resistance of microbes.

Key Differences between LAF and Biological Safety Cabinet

From a basic point of view, both the Laminar Air Flow and the Biological Safety Cabinets are simply protection compartments but offering different levels of protection. Various aspects of protection offered are dependent on the sample, the environment and the user as well.

Self Inspection and Its Implementation in Pharmaceuticals

Self inspection is basically a very useful and powerful mechanism for detecting any shortcomings or faults operating within any system. It means one needs to redeem on their own policies and check for its conformity and compliance with the appropriate corrective measures. It is a sure-shot way to evaluate the whole operating system from every aspect to ensure and maintain the quality of products. It is not limited to finding the faults and follies, and infiltrators within the system but also finding and planning ways to overcome the problems effectively.

Alarm Challenge Test in Pharmaceuticals

The alarm challenge test in pharmaceuticals is very important as it ensures that everything is in working order, hence preventing accidents and other hazards. Safety concerns take the front seat in pharmaceuticals, in large part because the industry deals with the manufacture of medicines consumed by patients. The alarm challenge test in pharmaceuticals is intended to ensure that the systems and processes used to manufacture drugs are in optimal operating mode.

Different Types of Chemical Indicators for Sterilization

Chemical indicators have been around for a long time. Hydrangeas bloom blue used in acidic soil and bloom pink for use in basic soil, for example, are perfect indicators for soil conditions. Until 1940 to early 1950s, biological and chemical indicators were never used routinely to monitor sterilization processes. This is because earlier than 1940s; scientists believed that there was no single quality assurance method that would assure that an item is actually sterile and that it only assured that the conditions meant for sterilization have been met. However, this scientific statement is still taken as true today in many sterilization practices.

Role of RH and Temperature in Dry Powder Injection Manufacturing

Moisture remains to be a great risk to the pharmaceutical industry. Moisture is known to cause deterioration of hygroscopic substances, it activates reactions between containers and the pharmaceutical substances contained in them and it is also known to cause solidification of dry powder injection.

Safety Guards During Handling of Pharmaceutical Equipment

Working pharmaceutical manufacturing can be very dangerous especially if the right precautions are not followed or the working environment is not up to the standard. In every year, various workers in the pharmaceutical industry globally suffer varying forms of injuries that expose them to various risks and even death while handling pharmaceutical equipment. As such, this makes it very crucial to come up with safety guards in pharmaceutical equipment that will help prevent such injuries.

Bracketing and Matrixing in Pharmaceutical Stability

The practice of bracketing and matrixing in pharmaceutical stability has been comprehensively covered in various forums interested in the testing of new drug products in accordance with the standards and regulations guiding the industry.

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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