Irvine - Clinical Drugs

PROJECT OUTLINE

Irvine- clinical drugs

Commercial- referring to real manufacturing such as Waco, Texas.  

1. Recognition of need for ingredients

1. Forecasting – 1-2 years in advance – Irvine facility “makes a million things once, and commercially (Waco) makes one thing a million times”.  

Make to stock (Irvine)

1. Inventory control management- use SAP system.  (Irvine)

1. If they worry about recalls on bad batches, they go back and check the process from those days even prior to the batch that is bad.  
2. All in one door.
3. Labeled, scanned into SAP ststem.  
4. Quarantined raw materials only have 3-4 employees that have access. Tested at least one of the lot.  
5. Placed in inventory.  
6. Packaged/manufactured- put through a small door with triple sealed products to ensure sterility.  

1. Demand

1. (Irvine) Goes back to how accurate forecasting is?

1. Description of need- (Irvine) Will have a 9 month stability run, and may need more product when they find that the drug is stable past that stage.  

(Irvine) Innovative process.  Needs to possibly change parts of machinery to adjust to new products.  

1. Unique specifications
2. Technology
3. Substitutions and availability

1. Batch manufacturing or compounding

1. Suppliers- use first approvable vendor.  There is an approved supplier list.  

1. Used for h20, buffers, bottles, tips, caps, labels.  

1. Who? List of suppliers.
2. How they are chosen- Selection…all based of SAFETY.  Use ISO 9000, determine if they are a GMP follower, and are good upon inspections.  

Test their technical capabilities- have them send samples of the product.  

Can they handle their workload?

(Commercial) Always has a plan B supplier.  

1. Location
2. Cost-

1. (Irvine) uses a supply agreement.  Manufacturing support group in place.  Bundle products together with suppliers to get a better price.  

1. Reliable

1. Uses a quality agreement- separates legal issues between parties.  

1. Placement of Purchase Order
2. Standard costs of materials

1. Cost of materials
2. Cost of labor
3. Cost of overhead

1. Process problems with suppliers
2. Maintaining relationships with suppliers
3. Available substitutions

1. Have several suppliers available for competition- Yes and to drive prices down.  

1. Manufacturing of ingredients

1. (Irvine) uses ISO 5..how sterile the environment is.  
2. Use fully Bunny suits, static/ hepa filters everywhere.  
3. Sterilizing the H2o- Use WFI processing station.  Begins with city water  ** Is so clean, it will eat through stainless steel if left to sit.  

1. Steps involved

1. Cost of self manufacturing vs outside suppliers

1. For clinical trials, creates a very controlled environment before released for sale.  

1. Cost of materials, labor, and overhead.

1. Keeping the solutions sterile

1. Precautions taken- Keeping solutions sterile!! Main factor.  Prevents infections (RELATE TO BAXTER CASE)

1. Shipping agents  Check risk over everything.  

1. Delivery process- (Commercial) uses distribution centers such as Louisville, TX.
2. Transportation/Location-

1. On time
2. Responsible
3. Meet expectations

1. Quality control testing and inspections

1. AGN’s specs after receiving the product from the supplier

1. Tests chemicals, sample each shipment once received in warehouse. (Commercial) check random every 6 maybe, unless if on lot 5 there is something wrong, then they will go back and recheck lots prior.  

1. FDA requirements-

1. Also gets approvals from EMA.  Subject to rules and regulations.  Problem with Japan’s market and how they were over analyzing the product…wanted transparent bottles rather than opaque.  
2. Present in over 130 countries creates many concerns.  Any tiny change may create a ripple effect in the product.  Ex adhesive ink on labels seeping through plastic.  EX. Latisse in single dosage, started attaching to the plastic and wasn’t as effective.  

1. Packaging

1. Individual or bundled
2. Inspection of packaging-

1. These are just as important.  

1. Quality Issues

Always making sure to uphold the FDCA and make sure the product is always branded correctly, and not adulterating the product.