Fault Tree Analysis (FTA) Description: Fault tree analysis is a deductive technique that assumes failure of the functionality of a product or process. From the failure of the functionality, the process looks at possible causes and links them down (in the form of a tree of fault modes) to the desired ...

In all stages of the product lifecycle, good project management and good archiving that capture scientific knowledge will make the process validation program more effective and efficient. The following practices should ensure uniform collection and assessment of information about the process and enhance ...

The manufacturing of compressed solids is a complex process, requiring several steps to render powders compressible, yet easily dispersed, and with the active ingredient dissolved when placed at the site of administration. As a result, the formulations that deliver the drugs to the site of action, ...

Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. Although there are some examples of the use of quality risk management in the ...

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The discipline of cleaning validation is as individual as process validation, but the methods, techniques, and risks are almost identical in all kinds of pharmaceutical manufacture. Process understanding is the magic term when assessing what must be done and the effort to be put into the documentation ...

This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, ...

The subject of cleaning validation in active pharmaceutical ingredient manufacturing plants has continued to receive a large amount of attention from regulators, companies and customers alike. This guidance document has been updated by the APIC Cleaning Validation Task Force on behalf of the Active Pharmaceutical ...

Total quality management may be a system to satisfy the merchandise client. TQM results in continuous development in quality of the product by the involvement of the staff and management. Total Quality Management may be a social control approach utilized by pharmaceutical makers in making certain pharmaceutical ...

Data integrity is protection of information from unauthorized and unaccountable changes. ALCOA is that the thought to implement the information security and integrity in pharmaceutical industries. Data integrity is very necessary in any trade, however particularly therefore within the pharmaceutical ...