Laura with Kellerman Consulting is simply terrific. She is quite valuable, quick to work with and obtained us by way of our GMP audit with a significantly better score than we anticipated. Also, the organization of all the paperwork Kellerman Consulting furnished us with is superb.
Technique of drinking water: There need to be a validated system for treating h2o drawn from just one's individual or some other resource to make it potable in compliance with prerequisites established because of the Bureau of Indian Criteria or even the area government, as the matter can be, so that you can make Purified H2o that satisfies Pharmacopoeial specifications.
Kellerman Consulting workforce members are kept up to date on each task, to ensure that Anyone of our consultants can easily stage in at any second to give you the reliability and responsiveness your venture warrants.
Use our dedicated group for help with approach validation and regulatory affairs, to help your reagent transition from initial submission to market authorization. We’ll offer complete documentation just about every step of that way.
"Strengthening human health necessitates brave thinkers who are ready to explore new ideas and Make on successes. Unleash your prospective with us.
Regulatory Compliance Associates High quality consulting incorporates assessments, method, implementations, employees augmentations, and identification of excellent metrics to make sure ongoing enhancement. click here Our pharma consultants understand the strategic wondering necessary to align your enterprise requires and targets.
The education supplied was very comprehensive plus the material was related to our field. Can think that the coach did planning and analysis about our sector before the schooling to provide more coaching illustrations.
Having an auditor come across non-compliances on your web site can be quite a incredibly expensive way to discover that you don’t hold the depth of get more info data or expertise in-house to manage GMP compliance.
I'd arrive at Shelby Foods just four months prior to the Original BRCGS audit and had little or no thought what was necessary for BRCGS. Brian labored with me and patiently answered all my questions until eventually I recognized everything.
cGMP is really a stage-up from GMP benchmarks and is needed for dietary health supplement suppliers. cGMP means Recent Good Manufacturing Apply. cGMP rules need more item tests and even more extensive excellent management techniques in position.
As your partners, we can easily negotiate the likely minefield of regulatory compliance and regulatory due diligence with Perception, hindsight, and also the distinct benefit of our exclusive knowledge and practical experience.
Whether you are ranging from scratch, otherwise you’d like us to include your existing courses, we’ll generate the program you have to get Accredited.
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