Quality control and regulatory compliancesare essential for ensuring that drug products are marketed safely and effectively. From drug development and manufacturing through finished product, Qualitek Labs routinely performs QC analysis according to cGMP quality standards for Active Pharmaceutical Ingredients (APIs), formulations, bulk drugs, intermediates, excipients, finished products and packaging components.
We support customers at various stages of the development/validation process, full development and validation studies, optimization of existing research methods and transfer of previously validated methods.
The lab is equipped with modern sophisticated instrument with 21CFR Part 11 compliance data handling software to ensure integrity and reliability of results for our customer. We have the capability to conduct all sort of tests as per IP, BP, USNF, EP, or laboratory developed tests methods. Whether you need expert testing consultation, method development or validation protocol design, Qualitek Labs offers the widest range of product testing services in the industry, including:
Pharmaceutical Ingredients also known as “Raw Material”; may be chemical synthesis compound or biological derived product, which are used in formulation of different kind of doses. The Ingredient which have therapeutic value are called Active pharmaceutical Ingredient, (API) & Ingredient which are used to formulate a dose form with some purpose are called Excipients.
All Ingredients used in formulation are routinely analyzed to ascertain the quality of finished product.
Formulation drug testing pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The drug form varies by the route of administration, classified as below.
A “cosmetic product” shall mean any substance or mixture intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.
Microbiological contamination of pharmaceuticals is an everlasting worldwide problem. It can result in the spoilage of the formula by breaking down active ingredients and excipients, affecting the potency, stability and efficacy of the drug. Furthermore the presence of high numbers of pathogens poses a serious health threat to the consumers. So microbiological testing of drug and cosmetics is an important step to check the microbial contamination before reaching the products in market.
As per FDA,Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. The analytical procedure refers to the way of performing the analysis. It describe in detail steps for necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the calibration curve, use of the formulae for the calculation, etc. By help of deferent analytical tool we developed to new method and which is much accurate and presised.Qualitek Lab support customers at various stages of the development and validation process. Qualitek Lab have competent team who are expertise in optimization of existing research methods, full development and validation studies, and transfer of previously validated methods, we offer the best expertise in our field to support your needs.
The conditions under which drug substance and drug products are manufactured, transported and stored can influence their efficacy. Stability studies in the pharmaceutical industry help to estimate the impact of transportation and storage on drug performance by stressing materials under exaggerated environmental conditions. Throughout the world, there are 5 different ICH Stability Zones:
Drug product packaging must be able to withstand the effects of manufacturing, storage, transportation and distribution from the point of manufacture/packaging to the end user. A robust design preserves the package integrity, protects the primary product, preserves critical labeling and patient information and can function easily for the end user. We provide various testing for container and packaging properties, including container specific testing such as ID, moisture permeability and integrity. We can provide accelerated temperature storage to challenge the containers or packaging in order to meet USP guidelines and ensure product safety throughout the product’s shelf life.Additionally we offer a full service for Extractable and Leachable studies which are commonly performed to evaluate the potential for various chemicals to migrate from container closure or manufacturing systems into pharmaceutical products.
EXTRACTABLE:
Chemical species that can be released from a pharmaceutical packaging/delivery system, packaging component, or packaging material of construction under laboratory conditions including extraction solvent, technique, stoichiometry, temperature and duration. On the other hand, Extractables themselves, and/or substances derived from extractables, have the potential to leach into a drug product formulation under normal conditions of storage and use.
LEACHABLE:
Chemical species that migrate from a packaging/delivery system, packaging component, or packaging material of construction into an associated drug product formulation under normal conditions of use or during accelerated drug product stability studies. Leachables are typically a subset of extractables or are derived from extractables.
Our team of experts employs state- of-the-art and comprehensive analytical techniques, providing qualitative and quantitative analysis of extractable and leachable compounds which could impact pharmaceutical products, medical devices and related packaging. A qualitative risk-based approach not only allows for the identification of extractable and leachable, but also provides a determination of the potential risk they pose to patients. E&L studies are customized to a particular product and/or packaging and are tailored to your specific needs. Our process involves a four step E&L investigation designed to examine every aspect of product and packaging in order to have the necessary information to carry out a thorough E&L study:
HPLC with UV/ RID, UV –Vis Spectrophotometer, GC with FID, GC MS, GC-FID – HS, LC-MSMS, GC-MSMS, Potentiometer/Karlfisher Autotitrator, Polari meter, Pay of test apparatus, Break Load apparatus, Scratch Test Apparatus, Fome High apparatus, Viscometer, Penetrometer, AAS, ICP-OES, Ion Chromatography, Malvern mastersizer 2000/3000
Pharmaceutical training helps you to understand the curriculum of a theoretical education and the practical demands of adhering to pharmaceutical regulatory compliance and pharmaceutical validation processes. Qualitek provide hands-on professional training in pharmaceutical process, GLP, GDP and Sophisticated instrument, which help candidate to learn and grow as per Industrial need. Our trainer are well qualified and expertise in there relevant field. We will provide your staff with effective training. Our courses will be tailored to your exact requirements and can be held at your premises or externally.Additionally, we offer web-based training, enabling students to take the courses at a pace and time to suit them
