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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.

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APC Ltd

AlbyPharma

Ash Stevens, Inc.

Biovian

Boston Analytical

Cambrex Corporation

Cebiphar

Curida AS

Dannalab B.V

Delorbis Pharmaceuticals LTD

GRAM Laboratory Inc

LabConnect

Merck Millipore

Nanjing Dorra Pharmaceutical Technology Co.,Ltd

Novick Biosciences

Nutrasource

PHYTOPHARM KLEKA S.A

Polfa Tarchomin S.A

Progenerics Pharma Pvt Ltd

QUINTA-ANALYTICA s.r.o

Quotient Sciences

Ropack Inc

Shijiazhuang Rainbowlabs Pharmaceutical Technology Co.Ltd

Tepnel Pharma Services

Unique Biotech Limited

ZCL CHEMICALS LTD

mKnal Global Solutions

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Virtual Booth Quinta-Analytica, a leading Central European one-stop-shop CRO located in Czech Republic. Providing end-to-end solution to its partners

Nordic Life Science Days

Analytical Support of Manufacturing Process V...

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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.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Virtual Booth 100% Export Oriented R&D Center & cGMP facility// Broad range of advance fine chemical intermediates & APIs

Pharma ChemOutsourcing

Lab Equipment

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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.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Virtual Booth Transforming Drug Development with Science & Innovation.

American DDF Summit

Finished Product Purity Testing

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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.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Permeability Studies

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

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Solubility Determination

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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.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Routine CoA Testing

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

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Raw Materials Testing

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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.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Melting Point

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- Service Details

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.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Raw Material Testing

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Tepnel offers a comprehensive raw material testing, pharmacopoeial testing and microbiology testing of pharmaceutical excipients and ingredients service. Our raw material testing supports formulation development within research and development, release of excipients and APIs.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Refractive Index

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- Service Details

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.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Project Management

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A highly experienced lead Project Manager (PM) will be assigned to lead your study. Your PM will serve as your primary contact and will be responsible for the execution of all laboratory related aspects of your trial.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Viscosity

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- Service Details

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.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Rotational Viscosity Test

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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.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Analytical Services

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UBL offers private labeling services enabling you save years of research and development activities before you enter the market.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Life Science Research Services

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As a leader life science industry, Merck’s new technologies and workflow solutions enable life science researchers in pharmaceuticals, biotechnology, and academia to engage in critical research.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Small Angle X-Ray Scattering to Characterize ...

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An advantage of this method is that it permits the observation of objects that have not been stained or fixed, showing them in their native aqueous environment (in contrast to X-ray crystallography, which generally requires placing the samples in non-physiological environments).

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Iodine value determination

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- Service Details

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.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Specification Development & Material Testing

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Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Reference Standard Qualification

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- Service Details

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.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Characterization of Nanoparticles with SAXS

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At Dannalab we offer a range of analytical services devoted to the identification and characterization of nanoparticles - both in solid and liquid matrices.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Analytical Testing Services

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In addition, DELORBIS offers many analytical testing services in compliance with GMP requirements and in accordance with the corresponding pharmacopeia (Eur. Ph., USP).

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

True Anisidine Value (TAV) Test

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The True Anisidine Value (TAV) test, a proprietary analytical method developed by Nutrasource scientists, solves a common issue faced by the omega-3 industry: false-positive rancidity readings in coloured and flavoured marine oils.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Specific Rotation

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- Service Details

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.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

pH Testing

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- Service Details

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.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Molecular Diagnostics

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- Service Details

LabConnect's test menu includes specialized oncology assays, biomarker analysis, pharmacokinetic analysis and method development services. Scientific expertise your tests require along with the project management and client service tools.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Nitrogen Determination Method (Volumetry)

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- Service Details

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.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Analytical Methods for In-Process Control

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Biovian provides an extensive set of analytical methods for in-process control and end product analysis.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Pharmacogenomics

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- Service Details

LabConnect's test menu includes specialized oncology assays, biomarker analysis, pharmacokinetic analysis and method development services. Scientific expertise your tests require along with the project management and client service tools.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Ion Exchange Chromatography

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- Service Details

Equipped with the advanced instruments HPLC, GC-HS, Particle size analyzer, UV, IR, Digital polarimeter, Multinuclear NMR (400MHz), we are expert in various techniques, for instance, Chiral chemistry (Classical racemate resolution, Resolution by entrainment), Second-order asymmetric transformation..

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Chemical Analytical Testing

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Our services include the development & validation of analytical methods. We identify by-products and determine polymorphic product forms's broad portfolio of analytical methods includes HPLC(-MS), CE, GC(-MS), FT-IR, NMR, particle size determination etc.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

pH-Solubility-Stability Profile

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- Service Details

GRAM Laboratories offers services for conduct of preformulation studies. These studies are physical and chemical characteristics of the active ingredient of pH-solubility-stability profile, evaluation of solubility in various matrices and moisture uptake studies-hygroscopicity.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Analytical Testing & Release

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We provide full range of analytical services, State-of-the-art instruments, cutting-edge technologies, and experienced scientific staff ensure efficient, high-quality and cost-effective services.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Determination of Bioburden & Endotoxin Conten...

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- Service Details

Our services include the development & validation of analytical methods. We identify by-products and determine polymorphic product forms's broad portfolio of analytical methods includes HPLC(-MS), CE, GC(-MS), FT-IR, NMR, particle size determination etc.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Testing of- API/FDF/Packaging Materials/Medic...

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- Service Details

Curida provides the professional expertise and regulatory qualifications necessary to perform analytical testing of raw materials, APIs, finished products, packaging material and medical devices.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Differential Scanning Calorimetery Analysis

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- Service Details

GRAM Laboratories offers services for conduct of preformulation studies. These studies are performed to gather in-depth knowledge about the physical and chemical characteristics of the active ingredient and eventually aid in the development and optimization.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Thermo Gravimetric Analysis

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- Service Details

GRAM Laboratories offers services for conduct of preformulation studies. These studies are performed to gather in-depth knowledge about the physical and chemical characteristics of the active ingredient and eventually aid in the development and optimization.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Freezing Characteristics

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- Service Details

GRAM Laboratories offers services for conduct of preformulation studies. These studies are performed to gather in-depth knowledge about the physical and chemical characteristics of the active ingredient and eventually aid in the development and optimization.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

X-­ray Single Crystal Diffractometer

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- Service Details

Equipped with the advanced instruments HPLC, GC-HS, Particle size analyzer, UV, IR, Digital polarimeter, Multinuclear NMR (400MHz), we are expert in various techniques, for instance, Chiral chemistry (Classical racemate resolution, Resolution by entrainment), Second-order asymmetric transformation..

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Eutectic Point Determination

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- Service Details

GRAM Laboratories offers services for conduct of preformulation studies. These studies are performed to gather in-depth knowledge about the physical and chemical characteristics of the active ingredient and eventually aid in the development and optimization.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

XRD-­6000 Diffractometer

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- Service Details

Equipped with the advanced instruments HPLC, GC-HS, Particle size analyzer, UV, IR, Digital polarimeter, Multinuclear NMR (400MHz), we are expert in various techniques, for instance, Chiral chemistry (Classical racemate resolution, Resolution by entrainment), Second-order asymmetric transformation..

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Esquire 6000 Ion Trap Mass Spectrometer

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- Service Details

Equipped with the advanced instruments HPLC, GC-HS, Particle size analyzer, UV, IR, Digital polarimeter, Multinuclear NMR (400MHz), we are expert in various techniques, for instance, Chiral chemistry (Classical racemate resolution, Resolution by entrainment), Second-order asymmetric transformation..

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Compatibility with Manufacturing Components

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- Service Details

GRAM Laboratories offers development of a clinically relevant and more stable formulation. This is made possible because of the knowledge gained from preformulation evaluation. Formulation studies are customized to achieve the most appropriate formulation in a timely and cost efficient manner.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Admixture Compatibility Studies

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- Service Details

GRAM Laboratories offers development of a clinically relevant and more stable formulation. This is made possible because of the knowledge gained from preformulation evaluation. Formulation studies are customized to achieve the most appropriate formulation in a timely and cost efficient manner.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Advanced Process Analytical Technology (PAT)

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- Service Details

Dedicated laboratory and infrastructure addressing the needs of clients with highly potent synthetic molecules including containment solutions for beta-lactams.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Analytical Release Testing

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- Service Details

We can support your product through its lifecycle from pre-IND to commercial product, including routine analysis such as CTM release and stability testing.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Thermal Cycling

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- Service Details

ICH-compliant stability storage temperatures and, where applicable, humidity control, with many intermediate options available.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Raw Material Testing

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- Service Details

Raw material, intermediate testing, finished product testing, stability testing and validation testing laboratory.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Intermediate Testing

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- Service Details

Raw material, intermediate testing, finished product testing, stability testing and validation testing laboratory.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Finished Product Testing

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- Service Details

Raw material, intermediate testing, finished product testing, stability testing and validation testing laboratory.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Determination of Content Consistency

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Determination of consistency of content of the active ingredient in antibiotic medicinal products.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

UV-Spectrophotometer, Auto Titrator, Moisture...

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- Service Details

Novick Biosciences offers comprehensive range of analytical services using state-of-the art facilities and efficient analytical team to support discovery and development teams.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Phytochemistry Laboratory Services

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Phytopharm conducts analyses of herb materials and medicinal products using pharmacopoeial and own methods.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

Analytical Testing Services / Overview

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- Service Details

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.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Overview

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.

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