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
No comments
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.
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.
How to Write a Validation Protocol?
A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report and approval.
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.
Concept of Revalidation in Pharmaceuticals
The revalidation process is essential to maintain the validated status of the plant, equipment, manufacturing processes, and computer systems. It should be as important as calibration and maintenance.
Possible reasons for starting the revalidation process include: 1. The transfer of a product from one plant to another.
2. Changes to the product, the plant, the manufacturing process, the cleaning p…
Possible reasons for starting the revalidation process include: 1. The transfer of a product from one plant to another.
2. Changes to the product, the plant, the manufacturing process, the cleaning p…
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.
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.
Cleaning Validation of Pharmaceutical Equipment
The Cleaning validation is performed to demonstrate the effectiveness of procedures for cleaning to remove the residue of the previous product. After the process, equipment used for manufacturing of the product shall be cleaned as mentioned in respective SOPs for cleaning.
Different Types of Temperature Sensors
Temperature sensors are used in different processes in pharmaceuticals. Different types of temperature sensors are used in different processes according to their accuracy needs.
Preparation of Batch Packaging Record (BPR)
This Quality Standard describes the requirements for the preparation, generation and approval of new or revised Packaging Masters and Batch Packaging Orders.
A. Preparation and Approval of a Packaging Master 1. A unique identifier using an approved coding system shall be assigned to each proposed finished packaged product to distinguish, at a minimum, differences in testing, specifications, expir…
A. Preparation and Approval of a Packaging Master 1. A unique identifier using an approved coding system shall be assigned to each proposed finished packaged product to distinguish, at a minimum, differences in testing, specifications, expir…
Build a Quality Culture in Pharmaceuticals
Quality of pharmaceutical products is a major concern in the pharmaceutical industry. Quality of product indicates the seriousness of the manufacturer towards the safety of the patients. It means defects in product quality may harm the user of the product.
Preparation of Master Formula Record (MFR)
Master formula record (MFR) is a master document for any pharmaceutical product. It contains all information about the manufacturing process for the product. MFR is prepared by the research and development team of the company and all other documents like BMR and BPR are prepared using MFR by the manufacturing units.
