Featured Pharma Online Editorial
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Establishing An Effective Calibration Program
3/15/2021
Calibration is the comparison of inspection, measuring, and test equipment against a traceable reference device to determine if accuracy and precision limits are met. It is one of the fundamental, yet often neglected requirements for GMP. Several international standards, regulations, and guidances provide requirements for an effective calibration program.
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Applying QbD To Incorporate Excipients Into Drug Lifecycle Management
3/10/2021
This article is the third in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design, published by the International Pharmaceutical Excipients Council Federation (IPEC Federation). In addition to life cycle management, the article delves into continued monitoring, multivariate analysis, continued product verification, and more.
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Integrating Excipients Into QbD For Drug Development: Understanding Drift & Critical Material Attributes
3/3/2021
This article is the second in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design, published by the International Pharmaceutical Excipients Council Federation (IPEC Federation). Learn about product, process, and excipient drift, as well as critical material attributes.
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Important cGMP Considerations For Implementing Electronic Batch Records
2/26/2021
Mistakes in batch records can have considerable consequences for the release of medicines in terms of delays and rejections. Errors can be minimized through the implementation of electronic batch records. However, with any electronic system within the pharmaceutical industry, the requirements of current good manufacturing practice (cGMP), including those of data integrity, need to be met.
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Incorporating Excipients Into QbD Studies For Drug Development — An Introduction
2/24/2021
This article is the first in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design, published by the International Pharmaceutical Excipients Council Federation. Topics covered include measuring the impact of excipient variability on finished product quality and more!
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7 Rules For Properly Interpreting Control Charts
2/15/2021
It is time to consider augmenting your validated production processes, including processing, packaging, and labeling, with continuous process monitoring using control charts to ensure continued compliance with established specifications and requirements.
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9 Rules For Cleaning Verification & Validation Of Multipurpose API Plants
2/12/2021
Cleaning validation continues to be a hot topic during regulatory inspections and industry discussions. The cleaning required in an active pharmaceutical ingredient (API) plant between one manufacturing process and the next can present a huge challenge, particularly when multipurpose plants are used.
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Do These Recent Drug GMP Warning Letters Signal A Shift In FDA Enforcement Focus?
2/10/2021
The FDA posted two unique warning letters that all pharmaceutical and API firms, regardless of their product category, should consider and evaluate. These first-of-a-kind warning letters represent a renewed emphasis on both alternatives to on-site inspections and the importance of purchasing controls and supplier management.
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Quality Management Review — Benchmarking Quantitatively!
1/29/2021
Typically, when the cost of quality is depicted, it is split into “cost of control” and “cost of failure of control.” At the next level of detail, the costs of prevention and appraisal appear on one side and the costs of internal failure and external failure on the other side. How to interpret and implement these buckets at the tactical level is often left to personal imagination.
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When Biopharma Automation Projects Fail: Averting Disaster
1/25/2021
Automation does not always result in success, and poor automation can be as damaging to the pharmaceutical organization as no automation at all. This article addresses what happens when automation goes wrong and how mistakes can be avoided by adopting a risk-centric approach.