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This Month On IVT Network
Management Oversight of the Pharmaceutical Quality System: Obstacles and Opportunities
… compliance to current good manufacturing practice (cGMP) regulations is, in fact, a part of normal pharmaceutical business that requires diligent management oversight. Read More
LATEST JVT JOURNAL ARTICLES
Biopharmaceutical Cleaning Validation: Acceptance Limits for Inactivated Product Based on Gelatin as a Reference Impurity
Biopharmaceutical cleaning and sterilization processes denature and degrade the active pharmaceutical ingredient (API) into fragments that are pharmacologically inactive.
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cGMPS for Combination Products: 21 CFR Part 4—Final Rule
The US Food and Drug Administration released its Code of Federal Regulations Title 21 Part 4, Current Good Manufacturing Practice Requirements for Combination Products, on January 22, 2013.
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Establishing a Complete Set of Target, Alert, and Action Limits for Microbial Counts in Purified Water
Purified water (PW) is probably the only raw material essentially produced for internal use by pharmaceutical and other healthcare companies. Read More
Electronic Versus Paper Change Management System–Advantages and Disadvantages
Change is always around. This is especially true in the current globalized economic landscape wherein companies are facing changes on daily basis.
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LATEST GXP JOURNAL ARTICLES
Integration of Risk Management Principles into the Quality System: Risk-based Impact Assessment
As the principles of quality risk management have become increasingly pervasive in the biopharmaceutical and medical device industries, a point of saturation has been reached with respect to the risk toolkit. Read More
The Risk Mitigation Continuum and GMP Compliance
This paper presents the case that good manufacturing practice (GMP) compliance is basically the continuous mitigation of risk to the consistent quality of the drug product throughout the manufacturing lifecycle. Read More
Foreign Companies Beware–FDA is on a Regulatory "Warpath"
Over the past year or so, you can see that US Food and Drug Administration has been taking a very "proactive" inspectional approach. Read More
   
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