2. A Realistic Approach to Creating an Effective Process Control System www.comply2000.comPharmaceutical Consulting Services, LLC

3. www.comply2000.comPharmaceutical Consulting Services, LLC * The FDA is not going away. * The GMPs are not going away. * More regulations will come. * Raw material manufacturers * Raw material suppliers * FDA will visit your facility. * You will comply to the GMP regulations.

4. www.comply2000.comPharmaceutical Consulting Services, LLC * Many companies believe they are compliant when they are not. Why? * Many companies believe that third-party certification renders them safe. * Many companies believe that the FDA will never visit them because they are too small. * Many companies believe they have figured out the GMPs on their own and don’t need experienced help.

5. www.comply2000.comPharmaceutical Consulting Services, LLC * Some companies are in denial of the facts. * The FDA will eventually visit your company. * You may believe that you are ready for the FDA because you have a third-party certification. * You may believe that you have a well-established process control system, yet it may not meet the FDA’s GMP requirements. * You may believe that your automated computerization of some requirements is an asset, but it may not meet the requirements of 21 CFR Part 11.

6. www.comply2000.comPharmaceutical Consulting Services, LLC * Industry recognized organizations have created their own version of the GMPs that do not reflect the FDA’s GMP requirements. * Some companies have created process control systems on their own without the input from others such as regulatory professionals and pharmaceutical companies. * Some companies rely on new employees who have years of experience, yet not on the regulatory side.

7. www.comply2000.comPharmaceutical Consulting Services, LLC * We’re certified by ABC or XYZ organization. * We’re too small. The FDA will never visit us. * We’ve been doing this for ?? years, and the FDA has never had a problem with us. * We haven’t had a problem with the FDA yet. * I think we have a great GMP system.

8. www.comply2000.comPharmaceutical Consulting Services, LLC * Follow the model set by Pharmaceutical Manufacturing Companies. * Organize your company using similar standards. * Create an organizational chart. * Show separation of the QC Unit from Operations. * Departmentalize Operations. * Create realistic specifications for materials, components, and labels, etc. * Create written procedures that meet FDA requirements. * Create documentation that proves the GMPs and procedures are being followed.

9. www.comply2000.comPharmaceutical Consulting Services, LLC * Hire someone with lots of regulatory compliance experience in the pharmaceutical manufacturing industry. * Must have… * Knowledge of FDA regulations * 10+ years of experience in regulatory * Very good organization skills * Knowledge of manufacturing operations * Warehouse, shipping and receiving * Weighing and blending * Unit dose operations * Packaging operations * Quality Control and Quality Assurance

10. www.comply2000.comPharmaceutical Consulting Services, LLC * Finding an employee with all of these qualification will not be cheap. * What do you think the salary requirements might be? * $80K * $120K * $180K * $220+K * Keep in mind that once the job is done, you still have a highly paid employee.

11. www.comply2000.comPharmaceutical Consulting Services, LLC *F*F inding an employee with all of these qualification will not be cheap. *W*W hat do you think the salary requirements might be? *$*$ 80K *$*$ 120K *$*$ 180K *$*$ 220+K *K*K eep in mind that once the job is done, you still have a highly paid employee.

12. www.comply2000.comPharmaceutical Consulting Services, LLC * Yes, but not by hiring someone for less! * Hiring someone for less will produce less than acceptable results. * Hiring someone for less will take longer than most companies can afford. * Hiring someone for less may put the company at risk when the FDA pays you a visit.

13. www.comply2000.comPharmaceutical Consulting Services, LLC * Look to Pharmaceutical Consulting Services for your GMP Compliance. * PCS can… * Organize your company to pharmaceutical standards * Create an organizational chart * Departmentalize Operations * Create hands-on practical procedures * Create templates for specifications, tests, master manufacturing records, etc. * Create documentation to prove GMP compliance * All in an integrated Process Control System

14. www.comply2000.comPharmaceutical Consulting Services, LLC * Factors that effect the cost… * Size of the company * Number of employees * Services or products the company offers * Types of and number of production equipment * Items found during our FREE audit * All of these are considered when proposals are prepared.

15. www.comply2000.comPharmaceutical Consulting Services, LLC * Again, cost are determined individually for each client. * On average… * Small to medium sized companies * $20,000 to $30,000 * Medium to large sized companies * $25,000 to $35,000 * Larger companies * $35,000 +

16. www.comply2000.comPharmaceutical Consulting Services, LLC * Down Payment * A down payment is required to get started. This, generally, pays for the set-up and initiation of the creation of your process control system. * Monthly Payments * Monthly payments are spread out through the duration of your program. The amount of the monthly payment is far less than what you would pay monthly to an employee hired to complete the work.

17. www.comply2000.comPharmaceutical Consulting Services, LLC * On average, the program last four months. * After the initial down payment, the balance is spread out over the duration with the last payment due at the beginning of the last month of the program.

18. www.comply2000.comPharmaceutical Consulting Services, LLC * Much lower cost than hiring an experienced employee. * Implementation is quicker than a company can accomplish on their own. * All essential SOPs are provided. * All essential documents are provided. * All employees receive training. * Program enhances quality and efficiency.

19. www.comply2000.comPharmaceutical Consulting Services, LLC * The program establishes individual responsibilities. * The program establishes a Document Control System. * SOPs are integrated to form a complete Process Control System. * Templates allow ease when creating specifications, documents, and new SOPs.

20. www.comply2000.comPharmaceutical Consulting Services, LLC * On average, our clients gain 30 percent higher output from their production departments. * Some clients found additional revenues through the implementation of this program, and after a very short time increased their revenues by over 400 percent. * This program is the most effective tool your company will ever invest in.

21. www.comply2000.comPharmaceutical Consulting Services, LLC * Contact Pharmaceutical Consulting Services, LLC for a FREE GMP audit. * Our audits are conducted in accordance with FDA regulations and the IOM. We also give recommendations for improvements during the audit. * Your company will receive an audit report, compliance plan, and our proposal along with samples of what we provide. All FREE! * Travel cost are extra.

22. www.comply2000.comPharmaceutical Consulting Services, LLC 23 Los Coyotes Drive Phillips Ranch, CA 91766 PH – 909-622-1415 FAX – 909-622-1935 E-mail – info@comply2000.cominfo@comply2000.com Web – www.comply2000.comwww.comply2000.com