The following are typical of the projects undertaken by PharmaConsult Us.
Science Based Risk Assessment for Shared and Multipurpose Facilities
Indian Generic Company supplying European and US markets with observations from both EMA and FDA
Completely overhauled the quality systems to meet regulatory expectation
Conducted sampling plans to show the efficiency of the installed systems and identified areas of concern
Conducted inspection awareness training
As a result no observations were made by both regulatory bodies during 2012 inspections
Similar projects for a diverse range of CMO’s and Generic manufacturers.
Major Generic manufacturer
Science based risk assessment of all sites supplying the US market for a major Generic company in response to a warning letter and 483 observations.
Sites in the US, Europe and the Middle East, extended later to cover India and Japan for over 20 sites to meet a regulatory deadline
Used PharmaConsult Us Excel tools
PharmaConsult Us provided training, tools, procedures, SOP’s, support, review and sign off.
We have provided similar services for companies in US, Europe and Asia, CMO’s, Generics and Pharma for Oral Solid Dose, Liquids and Creams and Parenteral
Risk Control Systems for Patient and Occupational safety
We design systems to meet the challenges identified by scientific means. API’s with identical OELs and ADE’s, the same processes and similar weights of API per batch will not show the same emission, driven by a wide range of variables, great effort and cost may well be expended on an API that does not need extraordinary methods to control it.
Flexible Film Containment Systems
These isolators are used where the process will only be undertaken a few times and were they are cheaper than cleaning a rigid isolator. The use varies for API and OSD they tend to be used for operator protection, in the Aseptic arena they are used with product contact disposables so that formulation or pre formulation can be used and then disposed of preventing cross contamination and cleaning. We help design and procure such systems.
Flexible Film Isolator for Demontration Batches
Enabled a small fluid bed dryer, a high shear granulator and a fitz mill to granulate dry and mill a highly hazardous compound in an single use disposable isolator with lead time of 6 weeks.
These are isolators that have adaptable plates into which a wide range of equipment can be attached. The examples here are all based around oral solid dosage, all the adapted equipment was provided with removable baffle plates so the equipment can be dismounted from the plate for conventional use.
These isolators are made up of panels and frames and can be configured quickly to suit the processes required in the is case the client has 4 frames that can be assembled as a four wide single sided isolator or as a back to back and a two wide single sided isolator. Where the answer in the past has been to buy an isolator for every process here the isolator is configured to suit each requirement.
Modular airlocks Many facilities do not have airlocks and our data shows that in many cases they add no value. However there are instances where airlocks are required. This example is used to service two existing rooms and incorporates de-gowning stations.
Modular de-gowning systems.
As a result of the data we have collected on how facilities perform in terms of cross contamination has led us to the conclusion that gowning is a major risk of cross contamination when in the dosage form. The reason is that there is no longer any chance of uniform distribution during blending or mixing to uniformity We have found that soiled gowns in the corridor can lead to cross contamination. For this reason we require gowning to be removed in the room at the point and time of exit. This simple unit only requires electrical power and does not affect the existing air system.
Integrated Systems API Manufacturing
High Hazard API manufacturing involving repeated cycles of filtration and wet cake dig-out, the process was modified so that wet cake was placed into a vessel that was then conveyed into the appropriate dryer. This allowed the operator to be protected against the API and the solvent, the isolators run inert. On the final cycle the Nutsche filters are docked to the convection ovens
This project was for the manufacture of an API using a specially designed filter dryer the isolator also included the precipitation vessel In fact the entire precipitation drying and packing into a purpose designed transfer system was incorporated in an 0.001 mcg/m3/8hrs.
This project in India for a major generic manufacturer was undertaken before the demonstration batches were made. The process had innumerable steps. Since the material handled is a human hormone the need for containment was essential. The use of V blenders was not negotiable as was the need for intensifier bars in the blenders. A geometric blend was also required.
Regulatory expectation for science and risk based assessments
Implementing science and risk based assessments
Implementing quality systems
Inspectional readiness training