The U.S. Food and Drug Administration (FDA) is responsible for ensuring that pharmaceutical products are safe and effective. As part of this process, the FDA conducts regular inspections of pharmaceutical manufacturing facilities.
Tips for Effective Internal Audit System
An effective internal audit system is critical to the success of any pharmaceutical company. By ensuring compliance with cGMP regulations and keeping track of manufacturing quality, an internal audit system can help reduce risks and improve patient safety. In this article, we'll share 10 tips for setting up an effective internal audit system in your pharmaceutical company.
How Gowning Practices Provide Clues to cGMP Compliance in Pharmaceuticals
Pharmaceuticals are often subject to stringent regulations governing their manufacturing and packaging processes. One area of cGMP compliance that pharmaceutical companies must pay close attention to is gowning practices. This article provides a brief overview of how gowning practices can help you determine if your company is in compliance with cGMP regulations.
Tablet Defects in Pharmaceutical Manufacturing
Tablet defects are one of the most common manufacturing problems. They can occur in any stage of tablet production, from raw material procurement to final packaging and distribution. Defects can also be caused by human error, equipment malfunction, or environmental factors like humidity or temperature. In this article, we'll focus on defects that occur during pharmaceutical manufacturing - a …
Steps to Ensure CAPA Success in Pharmaceuticals
The Corrective Action and Preventative Action process, also known as CAPA, is a quality assurance system used by organizations to identify and correct issues that result in non-conformance with product or service requirements.CAPA is an important part of any quality management system, and its success depends on the effective implementation of several key steps.
How to Improve Microbiological Control of Non-Sterile Pharmaceuticals
Microorganisms are present everywhere in the environment and can contaminate pharmaceutical products during production. To ensure patient safety, it is important to have effective microbiological control measures in place during the manufacture of non-sterile pharmaceuticals. In this article, we will discuss some key tips on how to improve microbiological control within your facility.
Best Practices for Isolator Technology
Isolator technology is a critical part of protecting your data against cyber attacks. It's important to understand the best practices for using isolator technology and to apply them consistently across your organization. In this article, we'll outline the key steps you need to take to implement isolator technology successfully.
Air Handling Unit and Its Working Process
The process of handling air in pharmaceuticals is critical to ensuring the quality and safety of the products being manufactured. In this article, we'll take a look at how air handling units work in pharmaceuticals to ensure that the products being made meet the highest standards.
Role of Lubricants in Tablets
Lubricants are added to oral solid dosage forms such as tablets and capsules to prevent or minimize sticking of the material to punches, dies, and tablet-press during compression. Lubrication also facilitates the ejection of the tablets from the die cavity and prevents adhesion of the tablets to each other during packaging.
How does Granule Size Influence the Stability and Bioavailability of Tablets
The physical and chemical properties of drug substances have a great influence on the process and quality of the finished product. One of the most important aspects is particle size. Particle size distribution (PSD) is a term that refers to the range of sizes that particles present in a powder. The average particle size (APS) is a measure that indicates what-sized particles make up the majority o…
GMP Requirements in Pharmaceuticals
Pharmaceuticals are some of the most highly regulated products in the world. In order to meet all the safety and quality standards demanded by regulators, pharmaceutical companies must adhere to strict GMP (Good Manufacturing Practices) requirements. This article introduces you to GMP and its key requirements, so that you can better understand how pharmaceutical companies ensure their products ar…
GMP and Room Design in Pharmaceuticals
Good manufacturing practices (GMP) are guidelines that provide a system of controls for the manufacturing process to ensure consistent quality of pharmaceutical products. Room design is an important aspect of GMP as it can impact product quality. In this blog, we will introduce you to the basics of GMP and room design in pharmaceuticals.
Generic Drugs Manufacturing: Opportunities and Obstacles
The production of generic drugs has been on the rise in recent years, as more and more people look for cheaper alternatives to brand-name medications. However, this increase in production has not come without its challenges. In this article, we'll take a look at some of the opportunities and obstacles faced by generic drug manufacturers.
Event Tree Analysis (ETA) in Pharmaceuticals
Event tree analysis (ETA) is a top-down, quantitative risk assessment technique used in a variety of industries to identify the most likely sequence of events and associated outcomes that could result from the occurrence of a specified initiating event. In this article, we'll take a look at how ETA is being used by pharmaceutical companies to assess the risks associated with drug development.
Purified Water System: Biocontamination Control Techniques in Pharmaceuticals
Pharmaceutical companies use water in many different processes, from cleaning and sanitizing equipment to manufacturing finished products. As a result, it is critical that the water used in these processes is free of contaminants that could potentially cause harm to patients. In this article, we will discuss some of the techniques used to purify water and control biocontamination.
Investigational New Drug (IND) Application
The FDA requires several steps for the approval of new drugs. One of these steps is to apply for the Investigational New Drug (IND) status, which is an expedited process available for drugs that are not yet proven to be effective but seem promising enough. In this article, learn about the details of applying for IND status and how it may affect your application.
Risk Assessment for the Purified Water System in Pharmaceuticals
The risk assessment is a process that is used to identify and assess the potential hazards and risks associated with a project or activity. This is done in order to make informed decisions about whether or not the project should proceed.
Pharmaceutical Compliance and Product Quality
In order to remain compliant with regulations and produce quality products, pharmaceutical companies must have comprehensive quality control systems in place. However, these systems can be complex and difficult to manage. This article will discuss the different compliance requirements for pharmaceutical companies as well as how product quality is monitored.
Why is Analytical Method Validation Required?
Analytical method validation is a process used to ensure that an analytical method is fit for its intended purpose. This process involves testing the method under various conditions to assess its accuracy, precision, and repeatability.
New Drug Application (NDA)
When you file a new drug application with the US Food and Drug Administration (FDA), you are submitting a proposal to the government detailing your proposed product and how it will be used. This document can take many months or even years to be approved, so it is important that you submit the best possible NDA.
Temperature Sensors and Their Key Features
You've probably seen temperature sensors all around your house - they're those little black and white boxes that you see in the corner of most appliances, and they come in a variety of shapes and sizes. In this article, we'll be looking at the different types of temperature sensors, as well as discussing their key features.
Maintenance of Aseptic Conditions in Pharmaceutical Sterile Areas
Aseptic areas are used in the pharmaceutical industry for creating sterile and controlled environments. Clean rooms must be constantly maintained by following strict procedures, including daily cleaning and disinfecting.
Aseptic conditions are a crucial part of any sterile area, and keeping them up to date can be challenging. This article discusses the various aspects of Aseptic maintenance.
Aseptic conditions are a crucial part of any sterile area, and keeping them up to date can be challenging. This article discusses the various aspects of Aseptic maintenance.
What you should Inspect when Conducting Self-inspection in Pharmaceuticals
The self-inspection of a company is the process of ensuring compliance with regulatory requirements and product standards. It involves inspecting current processes, workflow, quality control and maintenance tasks to ensure that there are no gaps in the system that might lead to non-compliance.
Out of Specification Investigation in Pharmaceuticals
A recent report by the US Food and Drug Administration (FDA) showed a rise in investigations into out of specification products in the pharmaceutical industry. The FDA cited a deterioration in quality control as a leading cause of these problems.
The Importance of Personal Protective Equipment in Pharmaceuticals
As a pharmacist, it's your responsibility to ensure that the medication you're prescribing to your patients is safe and effective. But safety isn't just a concern when it comes to medications - it's also important when handling any hazardous materials in pharmaceutical industries.
Good Distribution Practices for Pharmaceutical Products
Pharmaceutical products are highly regulated and must meet stringent safety and efficacy standards. This means that the distribution process for these products is critical to ensure that they reach their intended recipients in a safe and effective manner. In this article, we will discuss some of the best distribution practices for pharmaceutical products, including how to identify potential bottl…
Spillage Management in Pharmaceutical Production Area
Pharmaceutical production is a highly complex and demanding process that requires careful management of resources. One of the key areas where effective spillage management is essential is in the pharmaceutical production area. In this article, we will explore the different types of spillages that can occur in this environment and discuss the best ways to manage them.
4 Steps to Effective Change Control in Pharmaceuticals
Pharmaceuticals are a key part of many people's lives, and as such, they can have a big impact on the world. But like any other type of business, pharmaceuticals can also be prone to errors and problems - which can lead to serious consequences for everyone involved. To help prevent this from happening, it's important to have good change control in place. In this article, we'll outline…
Tips for Hazardous Chemical Handling in Laboratory
Handling hazardous chemicals can be dangerous and require proper training and precautions. In this article, we'll provide you with tips on how to safely handle these substances, so you can stay safe while working in a lab.
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.
