Particularly ridiculous is this situation where our State Institute for Drug Control (SIDC) in cont

Thursday 12.VII.2012 sent U.S. FDA (U.S. Food and Drug Administration = by the Food and Drug Administration in the USA by the Slovak State Institute for Drug Control trs (SIDC)) vaccine manufacturer Sanofi Pasteur warning letter, in which he draws attention to a number of serious missteps against the requirements of cGMP (current Good Manufacturing Practice = current Good Manufacturing Practices). These are: the inability to demonstrate the accuracy, sensitivity, specificity and reproducibility of test methods employed by this company, failure to ensure adequate system for monitoring environmental conditions (eg, has not been established sterility safety glasses worn by operators of production), trs failure to ensure adequate cleaning and disinfection of premises and tools necessary to prevent trs bacterial contamination (the effectiveness of disinfectants has not been sufficiently tested, at least 58x isolated fungus trs in the production of BCG, which definitely should not be), the inability to accept and comply with the directive to effectively prevent microbiological contamination trs of products that should be sterile (ie without live bacteria, fungi or spores), failure to adopt and maintain a program for stability testing of pharmaceutical products trs (eg potency of diphtheria and tetanus toxoid vaccine Pentacel , which Shelf life is 2 and a half years, were tested after a year and a half since production), trs inability to implement laboratory controls which ensure that the identity, purity, quality and strength additives, substances used in the manufacturing process trs and the resulting pharmaceutical products shall conform to appropriate standards, failure to notify the FDA of any change in the product, trs production process, quality controls , production facilities or product label (eg a change in the manufacturing process tetanus toxoid), standard operating guidelines are not subject to duties to be assessed on the quality control department, significant differences between the training and the actual manufacturing practice, insufficiency of training (eg, do not include detailed instructions on how to verify "completeness"), non-compliance with the guidelines trs for the movement of people, production equipment and materials, lack of documentation on control alarms for monitoring the pressure difference, technical defects in buildings (eg nesting birds in the air inlet for air conditioning), non-compliance with the guidelines for the control of production and production processes, the inability to verify trs the outcomes of those manufacturing processes that may be responsible for the variability characteristics of the production of semi-finished (eg inactivation trs of polio virus), breach of aseptic processing in the manufacture of products to be sterile (eg BCG-IT), failure to ascertain the effectiveness of disinfectants under the current conditions in the building where they are grown live polio virus, missing guidelines for the decontamination process of production tools used in the manufacture of live viruses, lack of guidelines for the practice of personnel in aseptic processing (for BCG), non-compliance with the directive to control production diaries ( it was found that the production diaries are sometimes not re-evaluated), the lack of guidelines for procedures and control subcontractor employees who are replacing dirty brushes for clean, non-compliance trs with guidelines for archiving reference vaccine trs for testing purposes, unapproved modification in the manufacturing process of tetanus toxoid, insufficient investigation failures production batch or any of its components (eg, the investigation failed test, which was to verify whether a vaccine polio virus completely trs inactivated).
Particularly noteworthy is that the inactivated polio vaccine (which should be the only polio infection, incapable of attacking the cells of vaccinated persons) pursuant to this inspection may still contain live viruses to cause disease.
Me personally, the whole thing extremely puzzling that, despite such incidents (qualitative deficiency in the production of vaccines) whether trs Sanofi Pasteur or a few months previously at Merck (see "FDA reveals weaknesses in the factory for the production of vaccines Merck: small pieces of burnt plastic in vials of vaccines ") still has the audacity to anybody gush about it, what is a super-safe vaccine production and control their quality.
Particularly ridiculous is this situation where our State Institute for Drug Control (SIDC) in contrast to the U.S. FDA, in fact, the vaccine does not at all, not even think to inspect factory-style FDA. The only thing that checks the papers supplied by the manufacturer trs of the vaccine. trs However, natural trs or vaccine really correspond to the supplied paper to Slovakia or deer unaware.
'Before each batch of vaccine produced in the Slovak market maker has yet to bring forward trs the State Institute for Drug Control production and control documentation even if issued by the European Certificate. Upon validation of the SIDC approve putting the vaccine to the