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.
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.
The Impact of Training Management on Quality Issues
Training programs are key to success in any industry. Professional training programs support employees, improve products, and serve as a great source of information. However, healthcare quality issues can arise when training is not adequately managed. In order to prevent such issues, let's first explore how effective training management can help you.
Tips for a Successful FDA Inspection in Pharmaceuticals
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.
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…
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.
