Cleaning of pharmaceutical instruments after a product has been manufactured is critical to ensure that the subsequent products to be manufactured are not contaminated. The removal of the residues of the previous products from manufacturing equipment is known as cleaning. If the whole process of cleaning has been documented, it is referred to as cleaning method validation.
Understanding the US FDA Drug Approval Process
It is a multi-step journey to ensure safety, efficacy and quality to bring a new drug in the market in the United States. This journal is conducted by US Food and Drug Administration that is a federal agency responsible for protecting public health and regulates pharmaceuticals, biologics and medical devices. It is required to understand the FDA drug approval process for manufacturers as well as …
How to Submit a DMF (Drug Master File)
During document submission to regulatory agencies, the Drug Master File (DMF) plays an important role in pharmaceuticals in protecting confidential information. If your company is a manufacturer of active pharmaceutical ingredients (APIs), intermediate products, excipients, or packaging material then it is required to know that how to properly prepare and submit a drug master file to regulatory a…
FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities
Recently US FDA announced the expansion of unannounced inspections of foreign manufacturing facilities that produce medicines and medical products and supply them in the United States. The aim of this decision is to align the foreign manufacturing facilities with the domestic ones.
CAPA Documentation: Common Mistakes to Avoid
Corrective and preventive action (CAPA) is an essential aspect of the pharmaceutical industry's quality system required by agencies such as USFDA, EMA, and WHO. Well-documented CAPAs ensure that organizations can address problems correctly and prevent recurrence by identifying and addressing their root causes. However, many companies face challenges with CAPA documentation, often making mista…
Top 4 Problems in Sterile Pharmaceutical Manufacturing
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.
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.
Determination of Hot and Cold Spot in Stability Chamber
Everything from pharmaceutical products to personal consumer products is tested in stability chambers to get an accurate reading of conditions to be stored in. This process is absolutely foremost to be considered for FDA approval, the FDA requires proper testing and evidence of tests performed to monitor how products react, taking temperature, humidity and various other conditions into account.
Requirements for Good Documentation Practice (GDP)
Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of documents.
Site Acceptance Test (SAT)
Site Acceptance Test can determine whether or not systems are meeting the desired and required specifications. The main purpose of site acceptance testing is to give an overall evaluation of a system's compliance and to ensure this compliance meets the requirements of the business involved. Site acceptance testing can be useful in relation to criteria testing for optimum results of systems.
Working of an Effluent Treatment Plant
Water is an essential part of manufacturing industry processes and domestic use. Water is used as a coolant, solvent or in many other chemical based reactions in companies.
After the manufacturing process is completed, wastewater is produced as a byproduct. This wastewater is then called effluent. It contains both toxic and non-toxic materials. Effluent cannot just be disposed to the environment …
After the manufacturing process is completed, wastewater is produced as a byproduct. This wastewater is then called effluent. It contains both toxic and non-toxic materials. Effluent cannot just be disposed to the environment …
Self Inspection and Its Implementation in Pharmaceuticals
Self inspection is basically a very useful and powerful mechanism for detecting any shortcomings or faults operating within any system. It means one needs to redeem on their own policies and check for its conformity and compliance with the appropriate corrective measures. It is a sure-shot way to evaluate the whole operating system from every aspect to ensure and maintain the quality of products.…
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.
Relative Response Factor (RRF) and its Calculation in HPLC Analysis
During the manufacturing process of active pharmaceutical ingredients, some unwanted substances are produced those are known as impurities. Some impurities are raised due to the degradation of the actual drug.
ALCOA Principles of Data Integrity
Data integrity is highly important in any industry, but especially so in the pharmaceutical industry where any data error could mean serious consequences. Data integrity is defined as maintenance and assurance of data consistency and accuracy throughout its life-cycle. Keeping data consistent (unchanged from the very start to the end) is also a matter of data security and even though data integri…
Purified Water Storage and Distribution System
The purified water is prepared by purified water generation system (Reverse Osmosis System) and collected in purified water storage tank of required capacity and distributed by a centrifugal pump for loop recirculation.
Steps for HPLC Method Development
Analytical method development is considered as a critical process in pharmaceuticals. Availability of the different types of columns, operating parameters, mobile phase composition, diluent and pH values make it critical to develop an analytical method. A good analytical method should be simple, used column, mobile phase and buffer should be common. It can be done easily step by step.
Steps for Analytical Method Development
Analytical methods in chemistry context entail how chemical components in natural materials or synthetic materials are identified, separated and then quantified. Analytical method development is a process whose main purpose is to prove if any analytical method in the pharmaceutical industry is suitable to be used in the measurement of API.
Importance of Microbiological Analysis in Cleaning Method Validation
Cleaning Method validation is the process in which documentation of how the cleaning process of manufacturing equipment is done. Most times during manufacturing and processing of pharmaceutical products, active residues are left on the equipment and it may cause contamination of the next product to be processed in the same equipment.
Process Validation in Pharmaceutical Manufacturing
1. IntroductionProcess validation is an essential part of good manufacturing practices (GMP). It is, therefore, an element of the quality assurance program associated with a particular product or process. The basic principles of quality assurance have as their goal the production of products that are fit for their intended use. These principles are as follows: • Quality, safety and efficacy must b…
User Requirement Specification (URS) of Equipments
User Requirement Specification (URS) is a list of all requirements of buyer regarding the equipment to be purchased. URS is prepared by the equipment user department. It is sent to equipment manufacturer to make it as desired criteria.
Why Cold Chain Logistics are Required in Pharmaceuticals?
Over the years the pharmaceutical industry has used non-temperature specific drugs as pills for most of its purposes. Cold chain pharmaceutical logistics, however, for much of the decades, has been associated heavily with the food industry and less with the pharmaceutics. The introduction of new types of medicines, time and temperature dependent, has seen the adoption and wide consumption of cold…
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.
Mode of Action of Disinfectant Solutions
A lot of disinfectants are used for sanitization and disinfection in pharmaceutical industries. These have different antimicrobial properties based on their mode of action. Disinfectants having a different mode of actions are helpful to prevent the development of the resistance in microbes.
Validation of Compressed Air
Compressed air is used in the different areas of the pharmaceutical manufacturing facility. Compressed air may contain contaminants those may cause contamination in the pharmaceutical products. Therefore validation of compressed air is necessary to produce quality products.
Three Consecutive Batches for Validation in Pharmaceuticals
This is a common concept to validate three consecutive batches in pharmaceuticals. In process validation, initial three batches are taken for validation. This is a basic question that concentrates everyone’s mind that why three batches are taken for validation?
Qualification Procedure for Vial Washing Machine
Sterile pharmaceutical preparations as injections are filled in glass vials. These vials should be cleaned properly before filling. Automatic vial washing machines are used to clean but the process of cleaning of the vials should be validated. The efficiency of these machines is verified by following tests.
HPLC System Software Validation Plan
Introduction
Softwares are used to operate and interpret the analysis results in HPLC systems. There are many softwares those are used in different HPLC systems. All softwares are required to validate to ensure the accuracy of the produced data.
Software Validation is a requirement of GxP system. This software validation is intended to provide details of activities carried out and results therei…
Software Validation is a requirement of GxP system. This software validation is intended to provide details of activities carried out and results therei…
NOEL and MACO Calculations in Cleaning Validation
NOEL is “No Observed Effect Level” of any pharmaceutical drug. It is determined
to calculate the MACO (Maximum Allowable Carry Over) in cleaning validation. NOEL
is the amount of drug in mg that does not have any effect on the human health.
Purpose of Process Validation in Pharmaceuticals
The kind of effort expended for Process Validation is largely determined by organizational structure. Whether Process Validation is managed by a department, a consultant, or a committee, the criteria for the program are still the same. These criteria will be examined by the responsible individuals so that the program will be tailored to the character of the process under study. The following ques…
Recovery Factor Determination in Cleaning Validation
It is necessary to use recovery factor for accurate results in cleaning validation of pharmaceutical manufacturing equipment. Recovery factor is the recovery of swabbed material from the equipment to the solution.
Sampling in Cleaning Validation in Pharmaceutical Industry
Sampling in cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections. The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). Such as, FDA inspectors now expe…
