“Kellerman Consulting acted like a trainer for our new QC employ the service of, so we benefited from that in addition to the profitable planning for the SQF audit. We acquired a 98% to the audit. That should discuss for by itself.
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We assist thousands of firms, including seventeen of the very best 25 global pharmaceutical, biotech, and health-related system companies, hook up While using the professionals they want throughout the best workforce product.
Doing the job through the Original improvement activity stage, prospect choice, through scale up and specialized transfer in to the factory network, our knowledge in validation and microbial evaluation from the manufacturing method, chance assessments and medical demo layouts is usually invaluable when applied to your portfolio.
“We understood if we needed to get where by we desired to go together with our business enterprise and securing a few of those big buyers, that we necessary to have SQF certification. Once i 1st started out talking to Kellerman Consulting, I understood they ended up industry experts.
Supplier Qualification The nice production follow environment requires qualification of suppliers to be certain drug high quality and security
Commissioning, Qualification & Validation We get the job done with our clients to acquire scalable source ideas to assistance validation efforts throughout the job lifecycle. Whether it is drafting protocols to execution and compilation of data packs, our means Have you ever coated.
Operating collaboratively, our regulatory specialists coordinate all areas of your demo’s document selection and submissions, such as:
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Our final results-driven staff will generate and put into practice your GMP program, teach you and stick with you until eventually you pass your GMP certification audit.
Study our developments report from a get more info couple of years again to overview essential click here pharma criteria that remain at play in the field.
Talent Management Really helps to create a human useful resource base which can fulfill the technical and managerial need of increasing business enterprise plans.
Very good Manufacturing Techniques (GMPs) also are called prerequisite packages, or food stuff protection and excellent fundamentals. These are typically the positioning and firm certain principles and everyday things to do set into location to retain goods Protected. GMPs may very well be penned down or communicated verbally and they are frequently enforced by way of Excellent Assurance or management staff.
This includes as an example, qualification, validation and deviation or adjust administration. The Hole Assessment is an Energetic comparison of the established present state Using the demands specified by regional or Worldwide GMP rules.