The difference between "aseptic" and "sterile" is not always properly understood. These terms, which can be obviously used in a medical setting, also apply to the safekeeping of food and other perishable goods that can be attacked by bacteria, fungi or viruses. In a pharmaceutic…
Difference between Recall and Mock Recall
Any product which is manufactured on a large scale sometimes has to go through the process of recall and mock recall. To some people, these two terms seem to be really confusing or some people don't even know the meanings of them.
Basic Requirements for Process Validation Exercise
Every pharmaceutical plant has got a prime objective of manufacturing products of required attributes and quality in a consistent manner, at the lowest possible cost. In order to maintain the quality of a drug product and to ensure its safety, process validation has to be done. It is the essential …
Implementation of Six Sigma in the Pharmaceutical Industry
Pharmaceutical companies are facing many challenges in the market where increased competition and rising cost of materials eat into their profit margins. The industry is also very competitive and each player is looking to develop the most effective product in the market. As a result, the players op…
Lean Six Sigma Concept
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 six sigma is a d…
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 do 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 high-quality medicine products which are closely related to the health of people to heel them. But the most important in pharmaceutical manufacturing industri…
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.
