What is the FDA status of your facility?
PPI is a fully  cGMP compliant facility.  PPI is current and compliant with FDA Drug cGMP and Device QSIT regulations.  The FDA has performed inspection.  Also, PPI is registered with the State of California food and drug branch. 

Is PPI ISO Certified?
PPI is ISO Certified by the British Standard Institute.  All registrations are current.

In what areas does PPI specialize?
PPI specializes in small (clinical batch supplies in quantities as low as 5O vials) to medium (multiple thousands per shift) volume productions runs.  Our core expertise and experience include the following product categories:      

• Drugs:
  • Injectables
  • Lyophilized Delivery
  • Aseptic Fill
  • Gels
    
• Devices:
  • Manufacturing & Assembly

What type of package presentations can PPI perform?

Vial, Stopper, Seal	1mL to 250mL
Glass ampules and vials	Various Sizes
Plastic bottle, tip and cap	5mL to 360mL
Pre-filled syringes	Various Sizes
Lyophilization Vials	1mL to 25mL
Kit Assembly	Diagnostic and Medical Device

 

How long has PPI been in business?
PPI was formed in 1992. Our management team came from extensive career experience with fortune 100 pharmaceutical and medical device companies.  Our vision was to fill the niche contract manufacturing needs of pharmaceutical and medical device organizations with the highest standards and quality manufacturing processes.

Our business proposition is simple, we strive to meet or exceed the quality standards our clients would expect from their own organizations, yet we provide flexibility to meet demanding and accelerated timelines.   PPI has enjoyed steady and increasing growth for over 14 years. Since our inception, we have expanded our client base to also include cosmetic companies, OSHA safety products companies and the US Government.

Does PPI have formulation capabilities?
PPI has full formulation capabilities and can assist clients in formulation development and optimization.  We also offer manufacturing process development expertise and assistance.

Does PPI do lyophilization cycle development?
PPI has extensive experience in developing lyophilization cycles and processes

Can PPI perform aseptic fills?
PPI has strong capabilities and long experience in this area.  Within our sterile core, we have three class 100 rooms. One room with automated vial filling and stoppering.    Another Class 100 clean room contains a 24 cubic ft. hall lyophilizer.  All aseptic processes are confirmed on a periodic basis by media fill testing.

Can PPI do sterility release testing?
PPI has validated test facilities to perform sterility testing as per USP standards. 

Can PPI perform endotoxin testing?
PPI is qualified and certified to perform endotoxin testing as per USP LAL methodology.

Does PPI have analytical chemistry capabilities?
PPI has the capability to perform most laboratory wet chemistry and UV visible spectrum photometry, viscosity, osmlality and particulate count.   PPI also has a strong network of trusted contract analytical laboratories for HPLC, GC, mass spec and other required testing.

How large is PPI?
PPI currently has 35 full-time employees dedicated to your contract manufacturing needs.  We are housed in 22,000 square ft. facility.  PPI will soon be expanding to a larger facility with state of the art facilities. 

Can we be assured our products will be in compliance with FDA and cGMP requirements?

A full 1/3 of all employees at PPI are employed in the QA/QC staff.    We welcome and encourage client audits.

IS PPI open & available for customer cGMP audits?
PPI welcomes and encourages customer audits.  Please contact Peter Martin, Manager QA to schedule your visit.

What value-added capabilities and services does PPI bring to its clients?
Our management team brings over 150 yrs combined experience in product development, optimization and manufacturing to the table with every client.  We have extensive liquid, gel, suspensions and lyophiliztion experience.  Our systems & procedures are in place to assure regulatory compliance.  We have a vast wealth of experience working with FDA & notified bodies to facilitate product approvals.  Our management team comes to the table with a strong background and extensive tenures with fortune 100 companies in the pharmaceutical and medical device markets.  We also have a strong network of long-term associations with equipment suppliers, packaging providers, analytical labs and business consultants in pharmaceutical and medical device products around the world.

How long will it take to the start of cGMP manufacturing?
This will depend on the type and complexity of the process.  Typically, 60-90 days is a normal timeline for projects. Typically, the following milestones are accomplished within this timeframe:

Project Agreement

Devleopment & Qualification

Documentation

Scale-up (Engineering Batch)

Production

Labeling & Release