Pharmaceutical manufacturers have varied main processing stages depending upon their actual products. The sector has extremely high validation regulations and continuous improvement opportunities are limited. The industry’s challenge is to take the results of its R&D and to productise a new medication to obtain competitive advantage, this has to be done ‘right first time’ and be capable of being validated and re-validated. Production data is archived for long periods, new product types can be of various medical and biological complexity
One of the main problems in Pharmaceutical production is managing the (usual) FDA validation and processes which align with GAMP. Production types are typically process driven at the front and discrete in packaging stages. ‘Post assembly’ stages require correct retail labelling, correct product marking (best before etc.), trade packing, trade pack labelling, palletisation and routing to the warehouse. Cost of getting new products to market has meant that the production & packaging process needs optimisation with Lean 6 Sigma being widely used.
Proven Solutions -
Pharmaceutical manufacture utilises GAMP and other techniques to obtain validation (both locally and to FDA). Audit trails of who, what, when etc. are the norm, particular forms of manufacture may have OEE applied, always through a validated interface with the focus being on any mechanical components which may wear and thus take the process out of specification (and validation). FDA 21 CFRPt11 applies to electronic systems especially such as batch management. Batch Management which is FDA validated, security and high levels of automation.
The EmsPT Difference -
EmsPT has a detailed understanding of the technologies and techniques that can be put into effect in a phased and controlled manner that will deliver measurable business benefits. The EmsPT DRIVE programme shows our working methodology and how this could be deployed to your benefit.
EmsPT Solutions -
EmsPT DRIVE programme
MES (Manufacturing Execution Systems)
Product Track and Trace (Traceability and Compliance)
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