Pharmacy

Apr 23 2018

Equipment Validation Explained – IQ, OQ, PQ Process, pharmaceutical process validation.#Pharmaceutical #process #validation

pharmaceutical process validation Equipment Validation Explained Equipment validation is a term used to describe a set of independent procedures that are used to check if a product meets the specifications and requirements of its intended purposes. Regulatory agencies around the world have strict requirements for quality, procedures, performance testing, safety checks and the like, for a wide range of products. The Importance of Equipment Validation In precision instruments, lab equipment or specialized machinery, even minor inaccuracies can cause problems and lead to inaccurate or incomplete results. Equipment validation ensures your product will consistently perform within a given range. Most consumers …

Apr 7 2018

Ellab Thermal Validation Solutions, pharmaceutical validation jobs.#Pharmaceutical #validation #jobs

Thermal Validation Solutions Ellab offers Wireless Data Loggers and Thermocouple Systems for thermal validation processes. Our solutions are used in Pharmaceutical, Medical and Food industries, and provide industry leading accuracy. The ValSuite data collecting software is compliant with FDA 21 CFR part 11 and developed according to GAMP principles. An app is available for the ValSuite software that is used to survey data in real time and view validation reports. The data loggers and thermocouples can be used simultaneously in the same validation study, while our range of customized accessories solves the need for accurate positioning, even within the most …

Mar 14 2018

Pharmaceutical Particle Size, Shape, Surface Area and Stability, pharmaceutical validation.#Pharmaceutical #validation

pharmaceutical validation in the Pharmaceutical Industry The particle size distribution of active ingredients and excipients is an important physical characteristic of the materials used to create pharmaceutical products. The size, distribution and shape of the particles can affect bulk properties, product performance, processability, stability and appearance of the end product. The link between particle size and product performance is well documented with regards to dissolution, absorption rates and content uniformity. Reducing particle size can aid the formulation of NCE’s with poor water solubility. Proper matching of active ingredient and excipient particle size is important for several process steps. Particle size …

Mar 1 2018

HPLC Analytical Method Development and Validation, pharma validation.#Pharma #validation

HPLC Analytical Method Development and Validation Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability samples, testing of reference materials and to provide data to support specifications. This course provides a comprehensive coverage of the method development and validation requirements that are essential to progress a pharmaceutical compound, at each stage of product development. Upon completion of this course, delegates will have learned what is necessary to develop and validate methods for drug substance and drug product to comply with …

Mar 1 2018

Paperless Validation Software for Life Sciences Companies, pharma validation.#Pharma #validation

pharma validation Years in the Validated Cloud Years Paperless Validation and Quality Processes Customers in Life Sciences ValGenesis VLMS Most Advanced Paperless validation solution has become essential to the life sciences industries ValGenesis ALM Benefits of ValGenesis Application Lifecycle Management (ALM) ValGenesis Cloud The ValGenesis cloud Platform was designed to manage the life sciences industry’s Computer System Validation Enable risk based CSV manage requirements with paperless Equipment Validation 100% Paperless equipment validation lifecycle with real time validation status Cleaning Validation Provides real-time cleaning validation status through a KPI dashboard Process Validation Paperless approach to 3 stages with seamless data flow. …

Feb 16 2018

Life Science Services and Solutions, PSC Biotech, pharmaceutical process validation.#Pharmaceutical #process #validation

Welcome to PSC Biotech News: We are pleased to announce the launch of PSC Partners equipment! PSC Partners is a GMP equipment manufacturer’s representative for: Climet Particle Counters Microbial Air Handlers Esco Isolators, RABS, Downflow Booths, Custom Containment Farrar Chillers Controlled-Rate Blast Freezers with Thaw Capabilities Garvey Rapid Tray Loader, Accumulators, Conveyors, and our revolutionary new Vial Dryer which reduces drying time to under 5 minutes, slashing the time spent out of cold chain. This is the fastest out-feed rate in the industry and this entire process is completed in less than 15 minutes. The Automatic Vial Dryer utilizes a …

Jan 22 2018

Pharmaceutical Particle Size, Shape, Surface Area and Stability, pharmaceutical validation.#Pharmaceutical #validation

pharmaceutical validation in the Pharmaceutical Industry The particle size distribution of active ingredients and excipients is an important physical characteristic of the materials used to create pharmaceutical products. The size, distribution and shape of the particles can affect bulk properties, product performance, processability, stability and appearance of the end product. The link between particle size and product performance is well documented with regards to dissolution, absorption rates and content uniformity. Reducing particle size can aid the formulation of NCE’s with poor water solubility. Proper matching of active ingredient and excipient particle size is important for several process steps. Particle size …

Jan 15 2018

APPCO Pharma LLC, pharma validation.#Pharma #validation

About Company Appco Pharma LLC endeavors to be one of the leading pharmaceutical companies in the US by introducing high quality and affordable drug products. The Company was incorporated in Apr ‘2012 with its key business location at 120 Belmont Dr., Somerset NJ. This site hosts the Unit I manufacturing and development area and is inspected and approved United States Food and Drug Administration (USFDA). The Company also operates another manufacturing facility Unit II located at 262 Old New Brunswick Road Suite “N” Piscataway, NJ. The Unit II is also inspected and approved by USFDA. Between Unit I and Unit …

Jan 10 2018

Life-cycle Documentation – Computer Systems Validation, pharmaceutical process validation.#Pharmaceutical #process #validation

pharmaceutical process validation At this stage of the project an initial risk assessment should be performed. This is a high level assessment based on the overall risk to Product Quality, Patient Safety and Data Integrity. The output of the assessment should support the selction of the system and the validation requirements and be documented within the Computer Systems Validation Plan. Supplier Audit Regulations require that software is designed to a quality system (EU Annex 11). “The software is a critical component of a computerised system. The user of such software should take all reasonable steps to ensure that it has …

Jan 10 2018

Non-sterile Process Validation in Pharmaceuticals: Pharmaceutical Guidelines, pharmaceutical process validation.#Pharmaceutical #process #validation

Non-sterile Process Validation in Pharmaceuticals 1.2 The principles of planning, organizing and performing process validation are similar to those for qualification. It should be done in accordance with process validation protocols; data should be collected and reviewed against predetermined acceptance criteria, and reflected in process validation reports. 2.2 Normally process validation should cover at least the critical steps and parameters (e.g. those that may have an impact on the quality of the product) in the process of manufacturing a pharmaceutical product. 3.2 Process validation should normally begin only once qualification of support systems and equipment is completed. In some cases …

Apr 30 2017

Medical Product Compliance, Regulatory, Validation #pharma #dictionary

#pharma tech # FRESH THINKING, BETTER OUTCOMES Your products touch lives. At Pharmatech Associates, we help life science companies bring these products to market worldwide. Navigating the complex and interconnected regulatory processes require technical expertise in compliance, product and process development, validation, and regulatory affairs. We call this the Pharmatech Ecosystem. And that means better outcomes for our clients’ patients. VALUE IN OUR PROCESS Our Subject Matter Experts have fully integrated development knowledge, hands on experience, and the ability to respond rapidly with pragmatic solutions, by applying proven and effective systems and practices. Our diligence in managing budget and timeline …

Apr 21 2017

Medical Product Compliance, Regulatory, Validation #ucb #pharma #careers

#pharma tech # FRESH THINKING, BETTER OUTCOMES Your products touch lives. At Pharmatech Associates, we help life science companies bring these products to market worldwide. Navigating the complex and interconnected regulatory processes require technical expertise in compliance, product and process development, validation, and regulatory affairs. We call this the Pharmatech Ecosystem. And that means better outcomes for our clients’ patients. VALUE IN OUR PROCESS Our Subject Matter Experts have fully integrated development knowledge, hands on experience, and the ability to respond rapidly with pragmatic solutions, by applying proven and effective systems and practices. Our diligence in managing budget and timeline …

Mar 23 2017

Medical Product Compliance, Regulatory, Validation #pharmaceutical #companies

#pharma tech # FRESH THINKING, BETTER OUTCOMES Your products touch lives. At Pharmatech Associates, we help life science companies bring these products to market worldwide. Navigating the complex and interconnected regulatory processes require technical expertise in compliance, product and process development, validation, and regulatory affairs. We call this the Pharmatech Ecosystem. And that means better outcomes for our clients’ patients. VALUE IN OUR PROCESS Our Subject Matter Experts have fully integrated development knowledge, hands on experience, and the ability to respond rapidly with pragmatic solutions, by applying proven and effective systems and practices. Our diligence in managing budget and timeline …

Dec 20 2016

Medical Product Compliance, Regulatory, Validation #pharma #gmp

#pharma tech # FRESH THINKING, BETTER OUTCOMES Your products touch lives. At Pharmatech Associates, we help life science companies bring these products to market worldwide. Navigating the complex and interconnected regulatory processes require technical expertise in compliance, product and process development, validation, and regulatory affairs. We call this the Pharmatech Ecosystem. And that means better outcomes for our clients’ patients. VALUE IN OUR PROCESS Our Subject Matter Experts have fully integrated development knowledge, hands on experience, and the ability to respond rapidly with pragmatic solutions, by applying proven and effective systems and practices. Our diligence in managing budget and timeline …