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Analytical Support of Manufacturing Process Validation

Analytical >> Analytical Testing Services >> Overview

Manufacturing validation of the finished dosage form is the one of the most important processes in the GMP production. Manufacturing process has to be validated under GMP.

Lab Equipment

Analytical >> Analytical Testing Services >> Overview

Well-equipped laboratories performing comprehensive tests for the finished products, WIP, raw materials, equipment cleaning in compliance to ICH guidelines using Pharmacopoeial methods, In-house test methods and customer's requirements.

Analytical Testing Services / Overview

Analytical >> Analytical Testing Services >> Overview, Overview

Cebiphar offers analytical testing of raw materials, APIs, excipients and FDFs. Testing is performed in accordance with Eur Ph, USP, or client specific methods. We regularly acquire new equipment to meet new regulatory requirements and clients’ needs.

Reference Standard Qualification

Analytical >> Analytical Testing Services >> Overview

Cambrex’s analytical services are based on detailed Standard Operating Procedures (SOPs) and stringent quality assurance practices to comply with cGMP standards. Whether your analytical requirements are big or small, let our expertise in research and compliance meet your needs.

Finished Product Purity Testing

Analytical >> Analytical Testing Services >> Overview

At Quotient Sciences, we pride ourselves on providing the best analytical support, delivering candidate screening, drug product analysis and phase-appropriate method development and validation.

Permeability Studies

Analytical >> Analytical Testing Services >> Overview

Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.

Solubility Determination

Analytical >> Analytical Testing Services >> Overview

Shijiazhuang Rainbowlabs pharmaceutical Technology Co. Ltd (Rainbowlabs) is a FDA-inspected laboratory set up to provide high quality laboratory testing and services to pharmaceutical companies throughout the world.

Raw Materials & Excipient Testing

Analytical >> Analytical Testing Services >> Overview

Eurofins BioPharma Product Testing has the wide range of chemistry expertise and state-of-the-art instruments required to perform all types of raw materials testing, including qualification of compendial methods, as well as development, qualification and validation of new methods.

Routine CoA Testing

Analytical >> Analytical Testing Services >> Overview

At Nutrasource, we offer a variety of testing services to provide your firm with the necessary qualifications for a CoA for your product.

Raw Materials Testing

Analytical >> Analytical Testing Services >> Overview

Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract anlytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Recently, the International Conference on Harmonisation (ICH) regulatory guideline QIA was revised (R2) when QIF “Stability Data Package for Registration Applications in Climatic Zones III and IV” was incorporated. The main changes included: Adjustment of intermediate storage conditions (previously 30°C ± 2°/60% RH ± 5%); acceptable relative humidity was changed to 65% ± 5% for drug substances, drug products and drug products packaged in semi-permeable containers, 30°C ± 2°/65% RH ± 5% can be used for long-term storage instead of 25°C ± 2°/60% RH ± 5% for drug substances and products, 30°C ± 2°/35% RH ± 5% can be used for long-term storage instead of 25°C ± 2°/40% RH ± 5% for drug products packaged in semi-permeable containers. Stability testing is required for all biopharmaceutical drug products to detect all changes in identity, purity, and potency as a result of a number of environmental and processing factors. Whether testing is conducted in-house or through contact laboratories, it involves the development and performance of comprehensive and specific stability protocols for all stages of a product’s life cycle. Testing product stability in-house requires significant time and resources, and carries challenges associated with commercialization market, time, and capacity. Stability assay methods should be specific enough to differentiate between analytes and possible degradation products. The overall quality of drug-substance and drug-product batches placed on formal stability studies should represent the quality of materials used in clinical studies and of the quality of materials to be made at manufacturing scale. Supporting stability data can be provided using stability data generated from batches of drug substances and drug products made on a laboratory scale. Stability studies also should be conducted on material stored in a container–closure system that is the same as (or simulates) packaging proposed for real storage and distribution. GMP Stability Services include cGMP registration stability programs, Design, storage and management, Development and validation of stability indicating methods, Stability testing for APIs, Clinical Trial Materials, formulated products, Tailored reporting (timepoint and final reports), All ICH conditions storage, Photostability (ICH Q1B Options 1 & 2), Temperature cycling, freeze-thaw and shipping studies, Bespoke or specialised conditions,Stability contingency and disaster recovery storage etc. Depending upon the aim and steps followed, stability testing procedures have been categorized into the following four types: Real-Time stability testing, Accelerated stability testing, Retained sample stability testing and Retained sample stability testing. Stability Studies are performed to understand the compounds/formulation in development: Physical & Chemical properties of API and drug product, Drug and excipient compatibility, Impact of manufacturing process steps, Interactions with packaging materials, Assignment of shelf life etc.