Cleaning validation is the process in which documentation of how the cleaning process of manufacturing equipment is done. Most times during manufacturing and processing of pharmaceutical products, active residues are left on the equipment and it may cause contamination of the next product to be pro…
Root Cause Analysis with Examples
Root Cause Analysis is the most important factor in determining the quality of each organization including the pharmaceutical industry, it is a methodology of knowing the first action that leads to the sequence which in turn leads to the problem and finds a way to solve this problem.
Effect of Humidity Level on Tablet Stability
The level of humidity greatly affects the stability of tablets. Tablets and capsules are protected for moisture by their packing. Degradation of tablets and capsules starts when they get a high moisture content and this also appears in their physical appearance too. There are different ways through…
Smoke Study in Cleanroom Areas
The smoke study also known as dynamic air visualization study is the key qualification, maintenance and monitoring of facility to ensure the final product is free from contamination in a processing company. The smoke study in cleanroom area is conducted to visually confirm unidirectional airflow ex…
Data Integrity in Microbial Analysis
Data integrity in microbial analysis refers to the maintaining and assuring the accuracy of the data that is being obtained from the raw information. Microbiological laboratories handle a lot of important data. In most of the occasions, those are the mix of quantitative as well as the qualitative d…
Importance of Data Integrity in Pharmaceuticals
These days, pharmaceuticals have started relying on computers and automated systems to a great extent, whether in terms of manufacturing, laboratory release testing or many other tasks involved. Due to this, a renewed focus has been brought to the concept of data integrity. It is the responsibility…
Principle and Working of Autoclave
Sterilization is critical within the pharmaceutical and medical industries. From direct patient care to laboratory work, huge numbers of instruments, containers, and equipment are used each day. With each new surface comes the risk of contamination by spores, bacteria, viruses, or other dangerous m…
Don’t Know an Answer during Interview? 8 Powerful Tips to Tackle the Situation
The word ‘Interview’ comes from a Middle French phrase “s'entrevoir” which means "to see each other, visit each other briefly, have a glimpse of," and that is exactly what interviews are about. The interviewer wants to have a brief look at your capabilities and hence, tests you mental…
Aseptic Processing Area and Its Maintenance
Good manufacturing practices and regulations are critical areas for having good practices for the pharmaceutical industry. Much care should be taken especially when manufacturing sterile drugs and other biological products using aseptic processing. A critical area is where sterilized drugs, contain…
Difference between Injection and Infusion
Both injection and infusion are medical terminologies. They are both ways of administering medicine to a patient and important in health and life-saving. The medicine is usually in liquid form. Many people are usually confused and do not know their differences.
Basics of Cleaning Validation
Cleaning of pharmaceutical instruments after a product has been manufactured is critical to ensure that the subsequent products to be manufactured are not contaminated. The removal of the residues of the previous products from manufacturing equipment is known as cleaning. If the whole process of cl…
Causes and Remedies of Chipping in Tablet Manufacturing
Innovations in tablet manufacturing have seen the dawn of machine operations in the manufacture of tablets. While it would have been thought that the machines would produce perfect tablets, but that is far from the truth. Chipping is the breaking of the edges of the tablet during the manufacturing …
Airlocks and Change Rooms in GMP Facility
A pharmaceutical GMP (Good Manufacturing Practices) facility has to be designed to minimize the risks involved in the pharmaceutical production those cannot be avoided through testing the final product. There is a protocol to follow the GMP system which ensures that the products are consistently pr…
Sterilization of Parenteral Products by Radiation
There are many different routes through which pharmaceutical products i.e drugs, medicinal chemical, fluids etc. are administered into the body. The different ways through which drugs and other pharmaceutical products are administered into the body can be classified broadly into two simple categori…
Periodic Review and Compliance in the Pharmaceutical Industry
Compliance in the pharmaceuticals is key to success, not only because it is required by law, but because the pharmaceuticals industry is considered one that doesn't allow mistakes. That is, if you make a faulty cell phone, your customers will ultimately get angry at you, but nobody gets hurt. W…
Prevention of Microbial Contamination in Manufacturing
The quality and safety of pharmaceutical products should be a key concern to any manufacturer in order to take care of clients consuming the product as well as maintaining their brand name in the market. Therefore to prevent microbial contamination in pharmaceutical products, there are some key mea…
