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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…

Basics of HVAC System and Its Components

Air conditioning has changed over the years, the HVAC system is used to control the environment in the manufacturing as well as the storage area of the pharmaceutical facility. Maintenance of area and air quality by filtration and temperature and humidity is controlled by using an HVAC system.  

Quality Management System (QMS)

Organizations engaged in the distribution, as well as the storage of materials along with products, should monitor, establish, maintain and implement the aspects of the quality management system that allows the delivery of resources, product and services, and materials with the requisite quality and safety.

Insight on Data Integrity in Chromatography

The core objective of any analytical work is to produce reliable and scientifically accurate data. When the process is compromised the analyst is bound to obtain inaccurate results. This, in turn, affects the integrity of the data. Data integrity in the chromatography analysis is a key area of concern in the pharmaceutical industry. Technicians have linked it to the ease of data manipulation when…

Criteria to Choose the Correct Swab for Cleaning Validation

In pharmaceutical manufacturing, the product must not be contaminated by previous product as well as it should not be contaminated with the cleaning agent used for equipment cleaning.

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.

Steps to Minimize the Data Integrity Risk

Data security and has become a hot issue in pharmaceuticals over the past few years because FDA and other regulatory agencies have issued many warning letters and import alerts due to lack of data integrity in records. Recently FDA has published a guideline in the form of question and answer for the compliance of data integrity in firms. These documents clarify the expectations of the FDA from ph…

Fungus in Pharmaceutical Cleanrooms: Types, Origins, and Decontamination

The presence of fungus in pharmaceutical cleanroom areas is considered a critical issue because it denotes a cleanliness issue. Fungus is very difficult to clean because it has spores that are resistant to most of the cleaning agents. In this article, you will find a detailed study on the fungus removal from the cleanroom.

Data Integrity - A Major Problem in Pharmaceuticals

It's a giant task to ensure that all your computer systems comply with data integrity regulations and guidelines. There are also costs involved. Conducting gap analysis, writing procedures, developing action plans, training staff, and changing IT systems require time, money, and resources. Even if a worst-case scenario occurs in which you need to get rid of the old and replace it with new IT …

5 Steps of FDA Approvals

Medicines are not food and those are taken by unhealthy individuals. Therefore, the safety and efficacy of the drug product are a primary requirement while producing the medicines. Drug approval by the FDA is a critical process and has to follow different steps before any drug product reaches to the market. The following steps are followed by any company to get approval from the FDA to produce an…

Why is Analytical Method Validation Required?

Analytical method validation is documented evidence that any analytical method used for the analysis of any product is suitable, reliable and produces consistent results. We can say that a validated analytical method produces reliable and authentic results.

Transport Validation for Pharmaceutical Products

In the past, it was not important to validate the transportation of the pharmaceutical products but now it is recommended by all major regulatory agencies. Storage conditions during transit of the pharmaceutical products should be validated because it may affect the product stability.

Regulatory Expectations from Cleaning Validation

Cleaning validation is an integral part of the pharmaceutical manufacturing process. A piece of equipment itself can contaminate the product if it is not cleaned properly. Improperly cleaned manufacturing equipment is a major source of cross-contamination. Regulatory agencies are more concerned about the cross-contamination of penicillin with non-penicillin products.

Top 10 Tips for FDA Inspection Preparation

FDA audits are very important and regular part of the pharmaceutical industry. Regulatory audits ensure the quality and safety of pharmaceutical products. But it is not easy to pass FDA audits and it needs proper planning. Here are some useful tips that will help pharmaceutical companies to pass the FDA audits successfully.

5 Challenges Facing Pharmaceutical Warehousing

The pharmaceutical industry is instrumental in the health and well-being of the global population. In the intricate web of this field lies the need for superb warehousing. It's an essential component of the supply chain that ensures efficient medication supply storage and distribution. This critical link experiences a fair share of hurdles but with solutions. Here are five challenges that eve…

Determination of Data Integrity Compliance in Pharmaceuticals

Data integrity is the principle of generating, maintaining and assuring the consistent accuracy and completeness of data in a company or manufacturing plant through the entire life cycle complying with the regulations set within the pharmaceutical industry by the Food and Drug Administration (FDA). Data integrity compliance is the key issue to be looked into especially in pharmaceuticals because …

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.

Key Preposes of Change Control in Pharmaceuticals

Change control is an important part of the pharmaceutical quality management system. It ensures that all changes are done in a controlled manner and changes made in the system do not have any adverse impact on the product quality. In this article, we will discuss the main purpose of the change control in pharmaceuticals.


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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