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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…

Working of a HVAC System and Its Functions

Heating, ventilation and air conditioning (HVAC) is the key to ensuring that the pharmaceutical products manufactured by an industry are of good quality. It ensures that there are all the necessary favorable conditions for successful manufacturing.

FDA Warning Letters for Cleaning Validation

Cleaning of equipment was first published in the Code of Feral Regulations (CFR) as 21CFR211.67 Equipment Cleaning and Maintenance in 1978. After that a lot of document guidelines are published on cleaning validation and nowadays cleaning validation is the main focus area of FDA GMP inspections.

10 Tips for HPLC Analysis In Pharmaceuticals

HPLC, also known as High-Performance Liquid Chromatography system, is one of the most crucial analytical methods in pharmaceuticals. The purpose of HPLC is the separation of each compound that make up a mixture.

It passes pressurized liquid solvent with the use of pumps which holds the sample mixture via a column full of solid adsorbent substance. There is a difference in the flow rates for each …

Computerized System Validation Planning and Execution

Computer validation planning consists of a Computer Validation Plan (approach), specific activities required to carry out the plan, and a Computer Validation Report as documented assurance that all activities required to validate the computerized system have been successfully completed.

7 Steps for Monitoring Compliance in Pharmaceuticals

Pharmaceutical manufacturing industry is a highly regulated industry that is regulated by different regulatory agencies from drug development to manufacturing and marketing. To ensure the compliance with all regulatory norms, pharmaceutical company needs to have a well-established monitoring system. In this article we understand the key step to monitor the compliance.

Role of Lubricants in Tablets

Lubricants are added to solid tablets and capsules to prevent the sticking of material to the punch, dies and compression machine during manufacturing. It allows the tablet to remove easily from the dies. Lubricants also stop the tablets from sticking to each other when stored in bulk form.

Difference between FDA 483 and Warning Letters

FDA inspects pharmaceutical manufacturing facilities to find cGMP violations. The observations are documented in form 483. If these observations are not fixed within the given timeframe by the company, the FDA may send them a warning letter.

Trends in GMP Violations in Pharmaceuticals

All pharmaceutical companies have established strict guidelines and regulations according to current good manufacturing (cGMP) guidelines. These guidelines help the manufacturers to ensure the quality of manufactured pharmaceutical products. Despite these efforts by the companies, there are a lot of issues found during regulatory inspections. This article will explore some of the most common GMP …

Guidelines for Drug Master File Submission

1. Meaning of a Drug Master File
DMF stands for Drug Master File which is a voluntarily submission at the holder’s discretion to help the customers.

Tips for a Successful FDA Inspection in Pharmaceuticals

It is the responsibility of the FDA to ensure that pharmaceutical products are safe and effective. To ensure this, the FDA inspects the pharmaceutical manufacturing facilities. This inspection of pharmaceutical manufacturing facilities is known as regulatory inspection. There are some important things to remember in the preparation of FDA inspection. In this article, we will share the same tips t…

Indian Govt releases guidelines on Pharmaceutical Marketing

Indian government published the latest guidelines to prevent unethical pharmaceutical industry practices that can influence healthcare professionals. Foreign tours in the name of medical education workshops and grants for research are not allowed now. This will help to gain transparency in the medical field.

Risk Assessment for the Purified Water System in Pharmaceuticals

The risk assessment is the process that helps to identify the risks associated with the process or system. Risk assessment is important for all pharmaceutical systems to know the potential risks for the product and the patients. In this article, we will discuss the risk assessment process for purified water system in pharmaceutical industry.

4 Steps to Effective Change Control in Pharmaceuticals

The pharmaceutical industry is the most impactful industry for human beings because it has direct impact on people’s lives. But the pharmaceutical industry is also a business and the personnel working in pharmaceutical industry can make errors like any other industries. These human errors can lead to serious consequences for patients and workers. To prevent these problems from happening, a good c…

Event Tree Analysis (ETA) in Pharmaceuticals

Event tree analysis (ETA) is a risk assessment technique that is used to sequence of events in a variety of industries. In pharmaceutical industry ETA is widely used to determine the root cause of any event. In this article, we will understand the uses of event tree analysis in pharmaceutical industry.

Tablet Defects in Pharmaceutical Manufacturing

Defected tablets are the most common problem in pharmaceutical manufacturing. These defects may occur in any stage of manufacturing from raw material to final product packaging. The defects may occur due to any human error, equipment malfunction or any environmental factor. In this article, we will focus on tablet defects that occur during manufacturing.

The Stratified Sampling Approach in Process Validation

Pharmaceutical manufacturing is a perfectly systematic process that primarily relies on quality control to produce quality products. The goal of quality control is to reduce batch failures and defects during manufacturing by taking steps at every manufacturing stage. Therefore, the sampling of the intermediate and final products is very important. One more considerable approach to validate the ma…

Contamination Control Strategies for Manufacturing Area

Contamination is a very serious issue in pharmaceutical manufacturing especially in sterile manufacturing. It is important to control the contamination in the pharmaceutical manufacturing area to protect the product. There are many ways of contamination so there are different strategies to control it. This article provides some strategies to control contamination in pharmaceutical production.

New Drug Application (NDA)

New Drug Application (NDA) are the documents about the product you want to manufacture and those are submitted to the government to detail the product and its usage. This document may take months to years to be approved, so it is important to submit the correct NDA for approval.

Case Studies: Troubleshooting Purified Water System Failures

Purified water in the pharmaceutical industry is a critical component because it is used at various stages of pharmaceutical manufacturing. There are many cases of water system failure in pharmaceutical industries that can be a cause of quality-compromised products. In this article, we shall discuss two different case studies of water system failures in the pharmaceutical industry.

Cleaning Validation of Clean-in-Place (CIP) Systems

The clean-in-place cleaning method is used to clean equipment that can not be disassembled or displaced like pipelines, tanks and large vessels. Cleaning validation ensures that our cleaning method is capable of removing the residues and contaminants from the equipment or vessel. Cleaning validation of such equipment as great importance because we can not move them for proper cleaning and some pa…

Regulatory Requirements and Guidelines for Cleaning Validation

Cleaning validation is an important part of pharmaceutical manufacturing and regulatory agencies take it very seriously. FDA issues many warning letters due to improper cleaning of facilities and equipment in various pharmaceutical manufacturing firms every year. Cleaning validation helps to ensure cleanliness to prevent cross-contamination to maintain product quality.

Enhancing Efficiency and Quality: Implementing Lean Manufacturing Principles in Pharmaceutical Manufacturing

In pharmaceutical manufacturing product quality, efficiency and regulatory compliance have important roles. To maintain product quality and use manpower efficiently, lean manufacturing principles play an important role. Lean manufacturing principles can help to optimize manufacturing operations, reduce manufacturing costs and improve product quality while maintaining regulatory compliance. In thi…

Common Challenges in Pharmaceutical Manufacturing and How to Overcome Them

The pharmaceutical manufacturing process is a highly regulated process that has different challenges related to manufacturing, quality and compliance. A small error can cause a big financial loss as well as to company's reputation. It requires different compliances like WHO, FDA and EMA etc. to run the firm smoothly. In this article, we will discuss these challenges and their overcome strateg…

Buffer Area and Its Maintenance in Sterile Facility

The buffer area is the sterile zone in pharmaceutical manufacturing. Generally compounding area in sterile pharmaceutical preparation facility is known as the buffer area. The buffer area is always ISO 7 area (class 10,000) or better air quality.

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.

Implementation of Six Sigma in the Pharmaceutical Industry

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…

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.

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…

Tablet Manufacturing Process: An Overview

In the tablet manufacturing process, powders are blended and then compressed into tablets. The powders must be of uniform size and weight so that they can be accurately measured. Next, the powder is placed on a die, which is a tool that gives the tablet its shape. Then, the die is placed in a punch, which presses the powder into the desired shape. Finally, the tablet is ejected from the punch and…


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

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