WHY HIRE SPS?
Have you ever found yourself in one of these situations?
Spending Many $’s for a New or Upgraded Water System
Spending Many $’s on Water System Validation
Suspect You Have Water System Micro Problems
Manufacturing Has Been Shut Down by Water System Problems
Concerned That Your Water System May Not Pass Inspection
Received Water System Regulatory Citations
- Spending Many $’s for a New or Upgraded Water System: You’re about to spend many thousands of dollars to build a new water system or upgraded an existing one based on the advice and designs from one firm (possibly the lowest bidder). You are staking the regulatory acceptability and profitability of your site on their capabilities! Are you really sure they know what they are talking about? Do you need an expert unbiased second opinion about those designs and the associated planned maintenance?
- Spending Many $’s on Water System Validation: You’re about to enter into or are in the midst of an expensive water system validation program, either contracted out (possibly to the lowest bidder) or by in-house staff. Are you certain of the regulatory acceptability and scope of the protocol being used? Is the location, type, and duration of testing adequate or perhaps even overboard? You are staking the regulatory acceptability and profitability of your site on it! Would you feel more comfortable with an expert unbiased second opinion about that protocol?
- Suspect You Have Water System Micro Problems: You’ve been having sporadic high microbial counts from your water system, but the vast majority of data is very good. However, you’ve noticed the incidence of Alert or Action Levels or OOS’s steadily increasing over the past few months. The usual corrective actions don’t seem to last like they used to. If you’re not sure what to do to reliably restore control, do you want an expert consultant who can find the root cause of your problems and recommend workable solutions?
- Manufacturing Shut Down by Water System Problems: You’ve just been informed by the labs that the most recent microbial monitoring of the water system serving your manufacturing area has revealed a serious problem! QA just called and told you that the water is unfit to use, so production is at a standstill!. Every day of lost production is costing over a million dollars and you know that the laboratory staff are competent but are just not water experts. Time is money and you need a resolution to whatever the problem is NOW. Do you need a water system expert who can identify and correct this problem in the shortest possible time?
- Concerned That Your Water System May Not Pass Inspection: Your site has just submitted its first NDA and you know that a PAI will be performed in several months. This new drug is VERY important to your company’s financial success and you cannot afford to fail the PAI. One of your concerns is the water system which was validated many years ago. Are you concerned that your water system will pass muster against FDA’s current thinking regarding validation, sampling, chemical and micro testing, alert/action levels, etc.? If so, do you need an expert who can assess your system’s regulatory liability and propose solutions if needed?
- Received Water System Regulatory Citations: You’ve just received one or more 483’s or a Warning Letter mentioning your water system. None of your staff truly knows enough about regulatory expectations and water systems to fix the deficiencies and craft an acceptable reply – and the clock is ticking on that response deadline. Do you need a water expert known and respected by FDA to help you write that response and execute a remediation plan that resolves the root cause of the deficiencies?
If You Answered “Yes”, You Need SPS back to top
These and many other scenarios* are real-world examples of decisions you may have to make. If you answered “yes” to the final question in any of these scenarios, you need the help of Dr. T. C. Soli of Soli Pharma Solutions, Inc.
As Principal Consultant with SPS, Dr. Soli (a Ph.D. microbiologist whose credentials you may review in detail here if you like) brings a level of expertise, formal education, and unique ability to track down root causes to resolve your problems.
He prefers to work WITH his clients to understand their needs, propose and negotiate workable solutions, and then help them implement those solutions, rather than just work in isolation and leave a long “to do” list on the way out the door.
He has the communication and teaching skills to explain the “whats” and “whys” of your problems and proposed solutions that you will understand, and the project management skills to help you effectively implement those solutions.
* Dr. Soli’s expertise extends to other microbiological disciplines as well, including sterilization and aseptic processes, contamination control in non-aseptic processes, and laboratories, plus all associated regulatory compliance and validation issues. His teaching skills come from a long history of giving presentations and workshops, and moderating roundtable discussions and whole conferences on water and utility validation. His knowledge of compendial and regulatory requirements and expectations come from a 26-year career -long involvement in industry working committees associated with pharmaceutical water. He has been a paid consultant since 1995, but his years as an unpaid consultant in those capacities extend back another 13 years.
