Governo aumenta lista de remédios gratuitos - Saúde S/A

Governo aumenta lista de remédios gratuitos - Saúde S/A:

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Cleanroom Cleaning and Disinfection: Eight Steps for Succes

de timsandle@btinternet.com (Tim Sandle)

The correct use of detergents and disinfectants is important for contamination control. In view of this, Tim Sandle has written an article for Controlled Environments magazine.

“The object of cleaning and disinfection is to achieve appropriate microbiological cleanliness levels for the class of cleanroom for an appropriate period of time. Thus the cleaning and disinfection of cleanrooms is an important part of contamination control. This article examines the eight key steps to be followed, in relation to cleaning and disinfection, in helping to keep cleanrooms “clean.””

To read the full article on-line, go to Controlled Environments

No Estado do Paraná fabricante e consumidor serão responsáveis pelo destino de medicamentos em desuso — Descarte de Medicamentos

No Estado do Paraná fabricante e consumidor serão responsáveis pelo destino de medicamentos em desuso — Descarte de Medicamentos

USP Capitulo 62 - Microbiologia - Questões Frequentes

Bom auxilio para ajuda em questões relacionadas a USP, capitulo de Contagem de Microrganismos para Produtos Não Estéreis.

http://www.usp.org/support-home/frequently-asked-questions/frequently-asked-questions-usp-general-chapter-microbial-enumeration-nonsterile-product

GMP News: MHRA publishes GMP Deficiency Data Review April 2011 - March 2012

Recently, the UK MHRA published a review of the main GMP deficiencies for the period from April 2011 to March 2012.  They performed 303 relevant inspections with 26 critical observations and 644 major observations.

The Top 10 Deficiency Categories of these inspections are:

• Investigation of Anomalies
• Quality Management - Change Control
• Investigation of Anomalies - CAPA
• Complaints and Product Recall
• Quality Management
• Supplier and Contractor Audit
• Contamination, Chemical/Physical - Potential For
• Documentation-PSF/Procedures/Technical Agreements
• Documentation - Manufacturing
• Process Validation

As an example, the number one deficiency  "Investigation of anomalies" was documented in 97 cases, "Change Control" in 70 cases and "CAPA" in 63 cases.

Classical reasons of deficiencies are also found in many cases, e.g. the field of personnel training and hygiene are still represented with 57 cases or the investigation of OOS in 33 cases. Direct contaminations of  product were found 75 times, 44 of which were chemically/physically based and 31 microbial. This implicates, that "Contamination" is for the first time one of the "Top Ten".

For further details please see the presentation "Deficiency Data Review - April 2011 to March 2012".

Author
Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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Enhanced Sterility Assurance in Stopper Processing White Paper to Download from Sartorius - Pharmaceutical Technology

Enhanced Sterility Assurance in Stopper Processing White Paper to Download from Sartorius - Pharmaceutical Technology

FDA - Guia de Teste de Pirogenio e Teste de Endotoxinas - Perguntas e Respostas!

Esta disponível no site do FDA um guia com questões e respostas sobre o teste de Endotoxinas, vejam o link abaixo. Boa Leitura!


http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM310098.pdf




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