The process of manufacturing is characterized by a number of steps, checks, tests, audits as well as evaluations along with other elements of quality like validations and many others. All these components give confidence to the process or system that it is functioning as expected. While all these elements are critical, the final hurdle is to make sure that the product is successfully manufacture…
How to Eliminate Microbial Contamination from Classified Area
We are receiving a lot of queries from pharmaceutical professionals that they have a lot of contamination in the classified areas. Contamination exceeds grade limits and they have tried everything but unable to get rid of it. Here we shall discuss the effective ways to remove the contamination from the classified areas.
Importance of Microbiological Analysis in Cleaning Method Validation
Cleaning Method 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 processed in the same equipment.
Common Ways to Avoid the Most Frequent GMP Errors
Most of the 483s and warning letters are issued because of the common GMP errors. Below I have described common mistakes (and ways to avoid them) that I have seen and that many managers, supervisors, and executives have told me they have seen. Many common good manufacturing practice errors in pharmaceuticals can be easily avoided by following a few simple rules.
Difference Between Aseptic and Sterile Conditions
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 pharmaceutical context, it is very important to know which is which and what they represent medically. They soun…
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 data. Though protecting the pharmaceutical microbial data against vulnerability is much more importan…
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.
Code of Federal Regulations (CFR)
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations (sometimes called administrative law) distributed in the Federal Register by the executive departments, leader offices, and agencies of the Federal Government of the United States. The Office of the Federal Register, also known as the agency of the National Archives and Records Administrat…
Generic Pharmaceutical Drugs
When a drug company first invents a drug, only that company is allowed to make that drug in the same country for a certain number of years and known as an innovator drug. The same drug can be manufactured by other companies after a certain period of time. These drugs are called generic drugs. FDA estimates that innovator firms manufactured over 50% of generic products.
Pharmaceutical Labeling Requirements
The label plays an important role which allows the customer to have complete information regarding the product which includes ingredients of the product, its usage, and caution in use, precautions to be taken while using it, manufacturing date, batch number etc. Drug labeling refers to all the information printed which includes instructions, ingredients, and a lot more information that accompanie…
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It is only possible to get the therapeutic effects of any drug when the drug can be absorbed by the body, so bioavailability is the key to making an enhancement that delivers proven benefits. Bioavailability of drugs indicates the percentage, amount or concentration of drug that reaches into the systemic circulation and is available at the site of action. When the drug is administered into the bo…
Transdermal Patches and Their Working
Having a powerful attitude, prolific mindset, and put under a magnifying glass test-and-adapt approach is the definitive way to stay firmly in front of any racing – and it’s a sure bet against becoming complacent. This dynamic mindset and out-of-the-box thinking made researchers develop something new, not the conventional one and this leads to the development of “Transdermal Patches.
Novel Drug Delivery System
Before we comprehend the idea of a Novel Drug Delivery System (NDDS), or before we gain some insight into what made researchers develop such a new, advanced and innovative drug delivery system i.e, NDDS, let us first understand the concept of “Drug delivery”. What is drug delivery? In simple terms, it can be understood as a method or a process of administering or delivering a pharmaceutical compo…
Requirements and Implementation of Continuous Training in Pharmaceuticals
Training in pharma industry is crucial in almost every field. In the pharmaceutical industry, it is of great importance as a slight difference in the composition of a drug can cause huge effects on a person or even cause death. It takes years of hard work to develop a drug formula. Getting the drug approved by FDA and another decision-making committee is not an easy job.
Why pH Value is Measured between 0 and 14?
Curiosity is the first and foremost trait of a science student. Remember when your chemistry teacher in high school taught you about the pH scale? Remember how you were told pH value is measured between 0 and 14? Well, if you are reading this, you're probably a science enthusiast and probably do have the basic traits of a science student. So if you did wonder why pH is measured only on a scal…