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…
