Authors
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Evaluating Impurities in Drugs (Part II of III)In Part II of a three-part article, the authors examine impurities from chiral molecules, polymorphic contaminants, and genotoxic impurities.
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Evaluating Impurities in Drugs (Part II of III)In Part II of a three-part article, the authors examine impurities from chiral molecules, polymorphic contaminants, and genotoxic impurities.
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The Digital Supply Chain: Seizing Pharma’s Untapped OpportunityCurrently, pharmaceutical manufacturers are said to waste $25 billion on supply chain inefficiencies. Technology offers a way to achieve transparency and results.
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GMP/GDP Inspections: Challenges and Opportunities Revealed by the COVID-19 PandemicAn annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.
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GMPs for Method Validation in Early Development: An Industry Perspective (Part II)IQ Consortium representatives explore industry approaches for applying GMPs in early development.
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Pharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and CommercializationA two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
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GMPs for Method Validation in Early Development: An Industry Perspective (Part II)IQ Consortium representatives explore industry approaches for applying GMPs in early development.
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Collaborative Efforts Address Key Data Integrity ChallengesMaintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
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Head in the CloudsWe interview Subhro Mallik from IT firm Infosys about how pharma is responding to the cloud computing phenomenon and what more can be done to realise business benefits.
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Pharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and CommercializationA two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
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Keys to Managing Growth of Your Quality OrganizationOptimal marketing potential begins with designing a strong quality organization and managing the rapid growth within QA/QC groups.
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GMPs for Method Validation in Early Development: An Industry Perspective (Part II)IQ Consortium representatives explore industry approaches for applying GMPs in early development.
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GMPs for Method Validation in Early Development: An Industry Perspective (Part II)IQ Consortium representatives explore industry approaches for applying GMPs in early development.
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Single-Use Systems: Enabling the Future of Biologics ManufacturingSingle-use technologies, which started off as a tool for small-volume solution storage and transport has now become the central, enabling technology around which manufacturing processes and facilities are being designed.
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Ethyl Cellulose as a Matrix Former: The Influence of Particle Size on Tabletting and Drug Release BehaviourThe aim of this work was to investigate the compactibility, compressibility and drug release behaviour of different fractions of a commercially available ethyl cellulose.
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Part VII GMPs for Small Molecule Drugs in Early Development Workshop SummaryThe authors explore and define common industry approaches and practices when applying GMPs in early development.
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Key parameters to be optimized in the development and manufacturing of oral solid-dosage formsAnil Kane, executive director, Global Head of Formulation Sciences, Pharmaceutical Development Services at Patheon discusses key parameters in the development and manufacturing of oral solid-dosage forms.
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Building Robust Specifications Using Powder TestingAdvanced powder testing is a useful tool to differentiate materials and optimize the supply chain.
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GMPs for Method Validation in Early Development: An Industry Perspective (Part II)IQ Consortium representatives explore industry approaches for applying GMPs in early development.
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Validation Changes to the USP Assay Method for Ibuprofen TabletsThis study investigated the effectiveness of the direct extraction of tablets and shaking time on the disintegration of tablets, solubilization, and recovery of ibuprofen from tablets of various formulations, strengths, and spiked placebo.
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Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
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Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
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Evaluating Impurities in Drugs (Part II of III)In Part II of a three-part article, the authors examine impurities from chiral molecules, polymorphic contaminants, and genotoxic impurities.
Latest:
GMPs for Method Validation in Early Development: An Industry Perspective (Part II)IQ Consortium representatives explore industry approaches for applying GMPs in early development.
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Implications and Opportunities of Applying QbD Principles to Analytical MeasurementThe authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.
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Improving Dose Content Uniformity Testing for MDIs and DPIsIt has been demonstrated that the existing FDA dose content uniformity test has very poor statistical relevance, which has resulted in the acceptance of poor quality batches and the rejection of good quality batches. By using Bayesian Inference, a much improved test has been produced that allows the quality of a batch of drug product to be determined accurately, using a suitable number of samples for the quality of the batch.
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The Biosimilars Market Today And TomorrowLast year, the global market for biological products exceeded $125 billion, accounting for 17% of the total market for pharma/biopharma products.
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The Effect Of The Financial Crisis On OutsourcingThe economic crisis has affected outsourcing providers in several ways.
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Quality management systems for small organizations: Reducing the headacheMany small pharma/biopharma companies do not understand what a QMS is and the benefits offered by such a system. To be effective, there are several key strategic elements and systems that a QMS must incorporate.
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Control of Quality Records in the Pharmaceutical IndustryThe security of documents in the pharmaceutical industry has become a critical issue since the advent of electronic data transfer. Companies in Europe must comply with 21 CFR Part 11 if they sell in the US. The regulations also require that secure, computer-generated, time-stamped audit trails are used to record the date and time of operator entries and actions that create, modify or delete electronic records. In particular, the record change must not obscure previously recorded information.
