Project Phase Validation4.1 The validation documentation and reports should cover the relevant steps of the life cycle. Manufacturers should be…
PrincipleThis annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system…
PrincipleLiquids, creams and ointments may be particularly susceptible to microbial and othercontamination during manufacture. Therefore special measures must be taken…
PrincipleSampling is an important operation in which only a small fraction of a batch is taken. Valid conclusions on the…
EU Guidelines For Outsourced Activities Any activity covered by the GMP Guide that is outsourced should be appropriately defined, agreed…
Change management system – Innovation, continual improvement, the outputs of process performance and product quality monitoring and CAPA drive change.…
MICROBIAL CONTAMINATION OF COMPRESSED AIR Compressed air systems can harbor the nutrients required for microbes to grow; namely water, oil,…
Shilpa Medicare Limited FDA Warning Letter 2020 Delivery Method:VIA UPSProduct:Drugs Recipient:Mr. Vishnukant Chaturbhuj BhutadaManaging DirectorShilpa Medicare Limited #12-6-214/A1 Hyderabad RoadRaichur 584135 KarnatakaIndiaIssuing…
Sterility Testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Sterility…
Antimicrobial Effectiveness testing is described in USP <51>. Previously this chapter was known as “Preservative Effectiveness Testing”. Detailed procedure for…