Pharmaguideline : Total Pharmaceutical Solution -->

Pharmaguideline

Editable Pharmaceutical Documents in MS-Word Format

View

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.

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.

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 …

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.

Contamination Control Strategies for Manufacturing Area

Contamination Control for Pharmaceutical Manufacturing is an essential factor in the overall success of a pharmaceutical product. This article reviews some contamination control strategies for controlling microbial growth, including environmental control, personnel protection, and medical waste management.

Fungus in Pharmaceutical Cleanrooms: Types, Origins, and Decontamination

The article discusses the different types of fungus that can be found in pharmaceutical manufacturing facilities. It goes over how these microorganisms grow and spread, explaining how fungicide use impacts the prevalence of certain types of fungus. The article also covers the importance of implementing a plan for cleaning up any contaminated surfaces before they become a source for further contam…

Steps of FDA Approvals

FDA is the United States Food and Drug Administration, and it is responsible for regulating products that come into contact with the food chain. The FDA works with manufacturers to create safe products, and they also work with doctors to ensure that the medications that are prescribed to patients are effective and safe.

What is the Best Career Option after B.Pharmacy?

Pharmacy is one of the most popular careers that you can go into in India. But, what if you want to choose a different career after completing your B.Pharmacy degree? What are some good career opportunities in the medical field?


About the Author




Ankur Choudhary is experienced in pharmaceutical, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008.
Email: info@pharmaguideline.com

Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy

CURRENT JOBS

Show All ❭❭Jobs by PharmaJobs

Follow Pharmaguideline


DOCUMENTS

PHARMACEUTICAL DOCUMENTS




Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

View


adsbypg



GET APP FOR NEWS UPDATES

Pharmaceutical Updates




✔ Worldwide Regulatory Updates
✔ Pharmaceutical News Updates
✔ Interview Questions and Answers
✔ All Guidelines in One Place

Install




 
regulatory