In the pharmaceutical industry, validation is an essential part of quality control and quality assurance. Various regulatory authorities give particular emphasis on the validation of all the processes used in the industry. Validation is a formal and systematic way to demonstrate the suitability of the assay method to provide useful data to ensure that the process or the technique gives satisfacto…
Importance of Validation in Pharmaceuticals
Validation is a documented evidence of the consistency of any process or system. It was firstly appeared in 1978 in the United States by the Food and Drug Administration (FDA) to investigate the failure of the product in sterility and now it is a very common concept in the pharmaceutical industries throughout the world.
Detergents Used for Cleaning of Pharmaceutical Equipment
Cleaning is an important part of pharmaceutical manufacturing to manufacture contamination-free quality products. Facility cleaning and sanitization is an important part of GMP compliance. In this post, we will explore the importance and use of detergents used in the cleaning of pharmaceutical equipment used in manufacturing.
Components of GMP : GMP in Detail
GMP stands for Good Manufacturing Practices in pharmaceuticals, it means to follow the regulatory standards during manufacturing of pharmaceutical products. There are several guidelines for good manufacturing practices worldwide but GMP guidelines provided by WHO and FDA are followed worldwide. These guidelines have recommendations for almost all departments of pharmaceutical firms like manufactu…
Importance of Data Integrity in cGMP: Ensuring Drug Safety and Quality
In 2016 FDA published a guidance “Pharmaceutical Manufacturing/Quality Standards Data Integrity and Compliance with cGMP” to highlight the data integrity issues found during the FDA inspections in pharmaceutical companies. FDA emphasized data integrity and its importance to ensure the safety and quality of drugs to protect public health. Data integrity violations result in various regulatory acti…
New FDA Update on Glycerin, Propylene Glycol, Maltitol Solution and other Glycols
FDA recently published a guidance for manufacturers and suppliers of the glycols to spread awareness about the potential health risk. In early 2023 FDA received the reports on poisoning of liquid drug products those have glycerin and glycols as ingredients. These products were contaminated with diethylene glycol or ethylene glycol. The aim of this guidance is to aware the manufacturers to prevent…
Calculation for Capacity of Tablet Coating Machine
The quantity of tablets used for coating in coating pan plays a great role in getting good coating results. The capacity of the coating machine pan should be calculated to get a uniform coating. Inadequate quantity of tablets used for coating in the pan may cause different coating problems.
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.
Possible Causes of Out of Specification
Out of specification is the deviation of the product from the pre-determined specification. It means when a product is unable to meet the predefined limits for that particular product. There are various possibilities that may be responsible for these deviations.
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 of the pharmaceutical industry to ensure the efficacy, quality and safety of drugs, and at the same…
How Effectively Execute a Validation Protocol?
Proper execution of protocol is an important part of the validation process. Execution of validation protocol affects the validation results. There should be minimum deviations during the validation process.
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 …
Performance Qualification (PQ) of Pharmaceutical Equipment
When you subscribe to a new internet plan, you tend to check the download speed by downloading something in order to verify if you are receiving the promised data rate. But are the data rates consistent throughout the day? Do you get the same speed if another device is also connected to the network? These are the kind of questions that are answered by performance qualification.
Operational Qualification (OQ) in Pharmaceuticals
Operational Qualification, or OQ, is an essential process during the development of equipment often used by pharmaceutical companies. OQ can simply be defined as a series of tests which ensure that equipment and its sub-systems will operate within their specified limits consistently and dependably.
Installation Qualification (IQ) in Pharmaceuticals
Installation Qualification (IQ) is ascertaining that all the important aspects of process equipment together with ancillary system installation follow the approved specification of a manufacturer and what the supplier recommends. An equipment has to be installed by trained personnel according to the drawings and specifications provided.
Design Qualification (DQ) of Equipment
Design qualification is defined as a verification process on the design to meet particular requirements relating to the quality of pharmaceuticals and manufacturing practices. However, the procedure for design qualification in pharmaceuticals is one reason as to why some products do not make it to the shelves in drugstores.
Working Principle of pH Meter
A pH meter is used to determine the acidity or alkalinity of the solution. pH is the concentration of hydrogen ions in the solution. A solution containing more H+ ions remains acidic while the solution containing more OH- ions remains alkaline. pH value of solutions ranges from 1 to 14.
6 Ways to Reduce Human Errors in Pharmaceuticals
Human errors have critical effects on pharmaceutical product quality. About 80% of the product quality issues occur due to the human errors. Human errors are traced by the occurrence of the deviations in the process. Most of the root causes of deviations are human errors due to improper communication or failure to follow the written procedure.
Different Stages of Tablet Manufacturing Process
The tablet manufacturing process is a series of steps that are followed step by step to produce a quality product. All steps have their unique processing and testing to proceed to the next step.
Maintenance of Aseptic Conditions in Pharmaceutical Sterile Areas
Aseptic area is used to manufacture sterile products in pharmaceuticals. The aseptic area is maintained by following strict cleaning and disinfection procedures. Maintenance of aseptic conditions in the sterile area can be challenging. Various aspects of aseptic area maintenance are discussed in this article.
Air Handling Unit and Its Working Process
Air handling in pharmaceutical manufacturing is important to maintain the safety and quality of the products. In this article, we shall understand the working of air handling units in pharmaceuticals to produce safe and effective products.
GMP Violations at Indian Facilities
GMP violations are found in some pharmaceutical manufacturing facilities in India. These GMP violations mean these manufacturers do not follow the good manufacturing practices regulations and this may cause serious health problems to the patient consuming the drug products manufactured in these facilities.
GMP Requirements in Pharmaceuticals
The pharmaceutical industry is a highly regulated industry. To meet the regulatory requirements, a lot of good manufacturing practices guidelines are required to be followed. This article is an introduction to the key requirements of the GMP guidelines for a pharmaceutical company to produce better and quality products.
Writing Effective SOPs in Pharmaceuticals
Standard operating procedures are back bone of a pharmaceutical manufacturing company. These are essential to produce effective and quality products consistently. But writing an effective, easy to understand and meeting the regulatory requirements SOP is not an easy task.
How to respond to an FDA 483 observations?
FDA 483s are the observations found during the inspection of a pharmaceutical manufacturing facility. These observations are documented on a form known as form 483. After getting a notice from FDA on form 483 manufacturing facility has to respond to FDA about the actions taken on the observations. It is not a difficult task to respond to FDA if you have a plan.
Preparing for FDA Inspections: Best Practices for Compliance
The food and drug administration plays an important role in production of quality products because it regulates pharmaceutical manufacturing facilities. FDA inspect and evaluate the company’s status with the regulations and identify the issues those can affect the quality of products and harm the patients.
Out of Specification Investigation in Pharmaceuticals
A recent FDA report shows that out of specification product investigations in the pharmaceutical industry are rising. The FDA cited a deterioration in quality control as a leading cause of these problems.
Are You Ready for an FDA Inspection?
The FDA regulates many different industries, from food and beverages to cosmetics and pharmaceuticals. If your company falls under the FDA's jurisdiction, then you're likely familiar with the agency's inspections. But what happens if you're not prepared for one? In this article, we'll explore what FDA inspection is, why they're conducted, and what you can do to make sure y…
Importance of Cleaning Validation in Pharmaceutical Manufacturing
Pharmaceutical manufacturing is a process that requires a high degree of cleanliness and accuracy in order to ensure the safety of the products. Clean validation is one part of this process that helps make sure the equipment and processes are kept clean and free from any contaminants.
Impact of Culture and Behaviors on Data Integrity Compliance in Pharmaceuticals
Data integrity compliance in pharmaceuticals has been a hot topic recently, with the need for companies to be aware of how they store and transfer data. To help aid them in knowing these policies, culture and behaviors are key influencers when it comes to data integrity compliance. This article talks about the impact of culture and behaviors on data integrity compliance in pharmaceuticals.
