Introduction: Lean Six Sigma (LSS) is a combination of two processes that were initially applied separately to improve business efficiency and effectiveness. In a nutshell, the lean methodology is aimed at reducing or totally eliminating steps that do not add value in a manufacturing process and si…
CAPA and Its Proper Implementation
When we are sick, we always trust the medical product believing that they will certainly provide relief. We get assured that the medical care we receive is not faulty. It is so fortunate that failure is not frequently experienced in medical devices and healthcare. Oftenly failure can occur, and th…
Data Integrity as per 21 CFR Rules
Meaning of Data Integrity
If you have been in the pharmaceutical industry for some time, you may have realized that protection of data from accidental/intentional modification, distortion, or deletion is the key to maintaining reliable health records which comply with the laid down regulations.
How Does Quality Cost Less in Long Term?
Have you ever wondered why high-quality products or goods last longer than the low-quality ones? Do you know the reason why the rich buy quality products and still remain rich? Have you ever thought of internalizing the saying "cheap is expensive"? Well, in this article you will be able t…
Why does HEPA Filters have 0.3 Micron Pore Size?
HEPA or High-Efficiency Particle Air filters are an essential part of the pharmaceutical and healthcare industries, where sterile environments are mandatory. Particles that cannot be seen by the naked human eye fill the air. These minute particles can cause the development of problems when working …
Why do We Expose Media Plates for 4 Hours in Cleanroom Areas?
A media plate, also known as a settle plate is basically a Petri dish that contains agar medium which acts as a growth medium for microorganisms. It is commonly used in Pharmaceutical companies to assess the level of microorganisms in their clean rooms in order to maintain a clean environment.
Difference Between Disinfectants and Antiseptics
Disinfectant and antiseptics are widely used for cleaning in both health care settings and also in homes. These products contain various chemical components, a majority of which have been used as cleaning agents for ages. It's a fact that they are both used for destroying disease-causing microo…
What Does Quality Really Mean for Pharmaceuticals?
Pharmaceutical companies are an important part of the medical field. They play a significant role for everyone involved, such as the producer, the doctor who prescribes and the consumer who is the patient. The pharmaceutical industry has been in existence for several years now and is considered to …
Manufacturing of Tablets by Direct Compression Method
In the past years, processing of drugs was mostly achieved through wet granulation or related unit operations. Progressively, other methods emerged that revolutionalized and gradually replaced the old tablet manufacturing methods. Amongst the new techniques, the direct compression method uses the m…
Importance of Visual Inspection in Pharmaceutical Manufacturing
Pharmaceutical manufacturing industries are the most precise and quality improving industries in the world. Their main aim is to manufacture the high-quality medicine products which are closely related to the health of people to heel them. But the most important in pharmaceutical manufacturing indu…
Importance of Microbiological Analysis in Cleaning Validation
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…
