Sterile pharmaceutical manufacturing is the most demanding area in pharmaceutical industry. Injectable drug products and other formulations are produced in sterile area. These products must be free from microbial contamination, pyrogens and particulate matter. Any contamination in these products and life threatening because they are administered directly into the stream.
Gemba Walks and Its implementation in Pharmaceuticals
Compliance quality and efficacy are non-negotiable in pharmaceutical industry. It is required to implement management practices to improve compliance and continuous process improvement. One such practice is Gemba Walk, which is a concept taken from lean management. In which team goes to the actual place where work is being done and engages with the people doing it.
Effective Deviation Management in Pharmaceutical Manufacturing
Deviations in pharmaceutical manufacturing are not only manufacturing mistakes but they are threats to product quality, patient safety and regulatory compliance. They can arise from equipment failure, human error or raw material issues. If these deviations are not handled proactively they can lead to batch rejection, regulatory observations or damage to company’s reputation.
Cleaning Validation of Clean-in-Place (CIP) Systems
Cleaning of manufacturing equipment has great importance in the pharmaceutical and biotechnology industries. It is required to clean manufacturing equipment thoroughly between batches to prevent cross-contamination and ensure the product quality. Non disassembling systems and production equipment are cleaned using the clean-in-place method. It is an automated system that cleans the interior surfa…
How to Strengthen Microbiological Control of Non-Sterile Pharmaceuticals
Microbiological quality of pharmaceutical products is essential for patient safety and product stability. As we know, the sterile products are manufactured in a sterile environment, but non-sterile products like tablets, capsules and liquid pharmaceutical products are manufactured in non-sterile manufacturing area.
The importance of FDA Form 483s and Warning Letters in Pharmaceuticals
Compliance with good manufacturing practices is not optional in the pharmaceutical industry but is essential for public health and sustainability of business. The US Food and Drug Administration uses two important tools to ensure GMP compliance — Form FDA 483 and Warning Letters.
Importance of Data Integrity for Pharmaceutical Regulatory Agencies
In the pharmaceutical industry, data is everything because data is a proof of work. Batch manufacturing records and raw data ensure that pharmaceutical products are safe, effective and of high quality. Data integrity is the assurance that data is complete, consistent and accurate. Regulatory agencies found that data integrity issues are the most critical concerns in pharmaceutical industry.
Best Practices in Pharmaceutical Microbiology Laboratory
Microbiology lab in the pharmaceutical industry helps to identify microbial contamination in pharmaceutical products. Critical analysis like environmental monitoring in clean rooms, sterility testing, microbial limit test and endotoxin testing are important analysis done in microbiology laboratory. Testing of microbial load in pharmaceutical products safeguards the patient's health against mi…
Sterile Pharmaceutical Manufacturing Area (Cleanroom) Cleaning
Injectable products like ophthalmic solutions, vaccines and injectable drugs are manufactured in sterile cleanroom areas. Cleanroom area must be free from visible particulate matter and microorganisms. Therefore, the cleaning and sanitization of cleaning room area is not just a routine task but it is also a critical component of contamination control and regulatory requirements.
Understanding the Stability of Injectable Products
Stability of pharmaceutical products is important to make those stable, safe and effective for a long time. When it comes to antibiotics, vaccines or other injectables, these must remain chemically and physically stable from the manufacturing stage to administration. Unlike the oral dosage forms, injectables bypass the body’s natural filters; therefore, any degradation product can lead to serious…
Usages of Artificial Intelligence (AI) in Pharmaceutical Industry
Artificial intelligence is being used in every field these days. It has revolutionary effects on the pharmaceutical industry by speeding up drug discovery, the manufacturing process and ensuring patient-specific healthcare. The following are the key areas where Artificial Intelligence is making a significant impact.
Data Falsification in Pharmaceutical Industry
Falsification of analytical and manufacturing data is not rare these days. You may think only one or two such cases are found yearly but studies show that about 50% of data and pharmaceuticals are unreliable. In most of the cases, even companies don’t know about this data fabrication. In most cases, it is done by the personnel due to over workload or sometimes they produce backdated records.
Extraneous Peaks in Chromatographic Analysis
Apr 21, 2025
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Chromatography is a popular analytical technique that separates compounds on the basis of their properties and how they interact with stationary phase present in the column. This separation happens when a mixture of compounds passes through a chromatographic column and individual peaks of different compounds show in the form of chromatographic peaks.
Principle and Working of Gas Chromatography
Gas chromatography is one of the most useful analytical tools in pharmaceutical and chemical laboratories. Because of its reliability and accuracy, this technique has been used for decades to analyze chemical and pharmaceutical products.
10 Tips for Fresh Graduates Seeking Jobs in the Pharmaceutical Industry
In the real world of pharmaceutical carriers, it is challenging to find a dream job after graduation. For many fresh candidates, a question arises "From where I should start". With the growing competition, it is essential to build a strategy in the early days of your job search. Following are some actionable tips to help you find your first pharmaceutical job.
Regulatory Compliance: 8 Common Mistakes and How to Avoid Them
In the pharmaceutical industry, regulatory compliance is essential, not optional. Companies following regulatory guidelines not only protect customers' health but also gain the reputation and operational continuity of the company. Our study on FDA warning letters shows that more than half of warning letters are issued to pharmaceutical manufacturers due to compliance violations.
10 Step Guide to cGMP Certification
In the pharmaceutical industry, it is mandatory to get certified by regulatory agencies. GMP certification ensures the quality of pharmaceutical products. Compliance with regulatory requirements ensures the efficacy and safety of pharmaceutical products.
Resolving API Impurity Issues in Drug Development
Active pharmaceutical ingredients are the main part of every pharmaceutical product because these are the active content in any drug formulation. The presence of impurities in any active pharmaceutical ingredient during product development always remains a concern for product safety and regulatory compliance. Identification and control of these impurities are not only required for regulatory comp…
Investigation of OOS Results in Analytical Testing
It is important to maintain product quality in the pharmaceutical industry. Product quality, safety and efficacy are ensured by adherence to the regulatory standards and product specifications. Analytical testing by quality control laboratory is the key to ensure the desired quality of pharmaceutical products. Out-of-specification results are critical to deal with during analysis. OOS results are…
Strategies for Resolving Stability Issues in Drug Formulations
The stability of pharmaceutical products plays an important role in the effectiveness of drug products and patient safety. An unstable pharmaceutical product can degrade and produce toxic byproducts those can lead to fatal consequences.
Equipment Failure in Pharmaceutical Manufacturing
Pharmaceutical industry has great expectations and opportunities because medicines play an important role in everyone’s life. The pharmaceutical manufacturing process is complex and time taking. A lot of equipments are required to manufacture a batch of drug products.
Contamination Issues in Pharmaceutical Production and their Prevention
Contamination is one of the biggest problems in pharmaceutical industry, especially in sterile pharmaceutical manufacturing. It is very important to identify the source of contamination to manufacture safe pharmaceutical products.
Difference between Process Validation and Product Validation
Pharmaceutical products need to follow a set of standards as a means of assurance of quality. Such a standard is validation, whether process or product validation, it is well known that the validation is made as an essential building block of good manufacturing practices (GMP) process or a guideline for good management systems (GMS).
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.
Principle of HPLC | HPLC System Working Explained
High Performance liquid Chromatography also known as HPLC is a widely used instrument for analysis in pharmaceutical, chemical and food industries. It has powerful ability to identify and quantify the complex mixtures and this makes it an essential instrument for analytical laboratories. This article will provide detailed knowledge on major components, working and principle of HPLC.
Sampling and Testing in Exhibit and Process Validation Batches
A sample is a portion of a material collected according to a defined sampling procedure. The size of any sample should be sufficient to allow all anticipated test procedures to be carried out, including all repetitions and retention samples.
Performance Qualification (PQ) of Pharmaceutical Equipment
When you subscribe to a new internet plan, you tend to check the download speed by downloading something in order to verify if you are receiving the promised data rate. But are the data rates consistent throughout the day? Do you get the same speed if another device is also connected to the network? These are the kind of questions that are answered by performance qualification.
Operational Qualification (OQ) in Pharmaceuticals
Operational Qualification or OQ is an essential process during the development of equipment often used by pharmaceutical companies. OQ can simply be defined as a series of tests which ensure that equipment and its sub-systems will operate within their specified limits consistently and dependably.
Installation Qualification (IQ) in Pharmaceuticals
Installation Qualification (IQ) is ascertaining that all the important aspects of process equipment together with ancillary system installation follow the approved specification of a manufacturer and what the supplier recommends. An equipment has to be installed by trained personnel according to the drawings and specifications provided.
Design Qualification (DQ) of Equipment
Design qualification is defined as a verification process on the design to meet particular requirements relating to the quality of pharmaceuticals and manufacturing practices. However, the procedure for design qualification in pharmaceuticals is one reason as to why some products do not make it to the shelves in drugstores.
