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Regulatory Affairs | Serialization
Serialization Validation: Right Fitting Your Strategy With a CMO
There are three key factors for manufacturers to evaluate as they define and refine their validation and testing approach.Linda Kristoffersen and David Colombo, KPMG Life Science Advisors 09.01.17
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Excipients | Process Development | Process Validation | Regulatory Affairs | Risk Management | Validation
Process Validation
Has it changed since the issuance of the FDA and EMA guidances?Peter H. Calcott , Calcott Consulting LLC 10.07.15
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Aseptic Processing | Process Development | Process Validation | Risk Management | Validation
Implementing Process Validation Guidances
Complying with FDA and EU for small and mid-sized companiesPeter H. Calcott, Ph.D., President, Calcott Consulting LLC 03.06.13
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Analytical Services | Bioanalytical Services | Bioassay Development | Cleaning Validation | Drug Development | Extractables and Leachables | Facilities | GMPs/GCPs | Methods Development | Process Development | QA/QC | R&D | Toxicology | Validation
A Novel Tool for Cleaning Validation
Light Induced Fluorescence TechnologyMakarand (Mak) Jawadekar, Contributing Editor 05.30.12
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Process Validation | Validation
Process Validation
Establishing, through documented evidence, a high degree of assurance that a specific process will consistently yield a product that meets predetermined specifications and quality characteristics.…02.27.12
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Validation
Validation
The establishment of documented evidence (for example, data derived from rigorous testing) that provides a high degree of assurance that a specific process or system will consistently yield a product meeting predetermined specifications and quality a…02.27.12
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Validation
Validation batches
Validation batches are commercial scale batches that are manufactured consecutively in order to validate a process according to a validation protocol that was developed and authorized.…02.27.12
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Process Validation | Validation
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Bioassay Development | Capsules | Drug Development | Extractables and Leachables | Facilities | Fill/Finish | Formulation Development | GMPs/GCPs | Inspections | Lyophilization | Methods Development | Process Development | Process Validation | Scale-up/Technology Transfer | Solid Dosage/Semi-solids | Toxicology | Validation
System Validation Requirements
21CFR11 enables use of electronic records and signatures, but it requires a comprehensive validation programKevin Lloyd 08.22.05
