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 opt for production methods that can allow them to come up with the best quality medications that are p…
Insight on Data Integrity in Chromatography
The core objective of any analytical work is to produce reliable and scientifically accurate data. When the process is compromised the analyst is bound to obtain inaccurate results. This, in turn, affects the integrity of the data. Data integrity in the chromatography analysis is a key area of concern in the pharmaceutical industry. Technicians have linked it to the ease of data manipulation when…
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, manufacturing process validation has to be done. It is the essential element in ensuring that a drug product is pure, efficient, save and that its quality …
Types of Purified Water Systems in Pharmaceuticals
One of the most pronounced ingredients in any pharmaceutical engineering is water. Water serves as a solvent and ingredient for formulation in many pharmaceutical procedures. Special care and attention must, therefore, be taken to ensure that the water used, meets the standard quality for purified water. Water is purified to remove impurities and prevent microbes which might cause contamination o…
Regulatory Requirements for Market Complaints
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…
Bioavailability of Drugs
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…
