CONFIDENTIAL AUDIT REPORT JUMBO PHARMACEUTICALS AUDIT DATE: APRIL 20-22, 2009

29-April-2009 Dr. Subash Vinsinsola Chief Operating Officer Jumbo Pharmaceuticals Ltd Plot No. 22, SIPCOT I Krishnabuddy Highway Mumbunga 737 707, (T.N.) India Dear Dr. Vinsinsola: On behalf of Acme LLC, Global GMP Consulting, Inc. has performed a GMP compliance audit and mock inspection of the sterile drug manufacturing facility located in the SIPCOT business park in Mumbunga. Thank you for your kind hospitality during my visit; please forward my thanks on to all your professional staff as well. In summary, I found the SDRL physical plant in generally good condition, staff well trained and qualified for operations, and through our conversations, a management team who leads by example in constantly seeking to understand and apply best GMP practices as practicable throughout the facility; focused on achieving quality, consistency, and control through the pragmatic application of reasonable risk mitigation measures. From my direct observation, I believe the plant is currently in a good state of control, that work performed in the facility is of a high standard, and products generated from that work can be relied upon to be safe, pure and healthful. In consideration of the US FDA Drug GMPs, EU GMPs, and related guidance and annexes, operations have been observed to be generally in compliance with the letter and spirit of the regulations and associated guidance. However, some GMP compliance observations and recommendations are noted here for consideration. OBSERVATIONS 1. Poor aseptic technique was observed in vial fill area during the production of Dxxx, Lot #xxx036. a) Many interventions made into the Grade A area without spraying hands with secondary disinfectant. b) Many rapid movements were observed while the operator worked within Grade A area. c) Operator observed to reach over filling line to remove tipped vials. d) Attempts to remove stuck vials caused vial breakage with resultant broken glass flying around filled and unfilled vials. e) Filling operations continued during period when operators attempted to remove stuck and broken vials. 2. No continuous measurement system is utilized for the monitoring of particle concentration in the Grade A zone. a) Continuous monitoring of total particulates at the filling area is expected (EU GMP Annex 1, and FDA Guideline: Sterile Drug Products Produced by Aseptic Processing). b) Smoke studies need to be conducted to demonstrate laminarity of air flow at the filling area, and to define locations for monitoring probes. c) Viable particulate monitoring methods and locations (settling plates at return air ducts) also requires additional attention. 3. Deficient GMP documentation practices were observed in several areas, and in a variety of records. a) Independently-made handwritten changes were made to several approved master documents (SOPs, Forms, Protocols) b) Several controlled forms were not well designed for good documentation practices

~ CONFIDENTIAL ~

CONFIDENTIAL AUDIT REPORT JUMBO PHARMACEUTICALS AUDIT DATE: APRIL 20-22, 2009

4.

5.

6. 7. 8. 9. 10. 11. 12.

13. 14. 15.

c) A person performing a production operation (de-cartoning) was not the person who signed the batch documentation for the operation; the supervisor signed for this person d) Black ink observed (blue ink was specified in the SOP) on several documents e) Weekly log sheet dates filled out prior to actual date of documentation f) Checked by signatures missing on "Antiseptic Preparation Log" Several aspects of building/facility maintenance need immediate attention; at a minimum, a detailed, approved work order project plan should be available to describe known items requiring attention, expected completion dates, and risk mitigation controls during the maintenance period. a) Several air interlocks were inoperable b) Several walls required patching c) Excess condensate observed on ceiling in wash area d) A piece of cove molding was missing in the refrigerated materials storage area IQ Protocol for filling machine contained several errors/omissions. a) Observed values recorded were significantly different from expected values, however no remarks were made and no exception log was included to document and/or explain exceptions to protocol; IQ was executed in 2007 b) IQ protocol was not completely signed off prior to execution c) Cleaning and maintenance SOPs were not listed in the IQ protocol Sterile gowned operators in Grade A & B zones did not cover the eye area; goggles are expected. WFI storage tank vent filter is not integrity tested post-use to ensure the continued integrity of the filter at the time of replacement. Chart recordings used to support production activities are not signed as reviewed/approved. Several released materials in refrigerated storage were found with lids ajar; all materials need to be properly stored to ensure performance throughout their expiry period. A calibrated plant utility gauge was found in a rusty condition. Illegible documents and calibration stickers were found in several locations; operators passed by/used these items frequently, but did not initiate request for legible replacements. Instrument recording temperature readings in refrigerated storage was not in the calibration program, and was found to be approximately 2 hours, 4 minutes slow; all gauges monitoring facility conditions must be calibrated. Trash, which had remained longer than 30 days, was observed in 2 locations on the exterior premises; trash and organic waste matter must be disposed of in a timely manner. Gowning room for packaging area requires a mirror so operators can ensure proper gowning. Two SDLR labeled reagents in lab had expiry dates which exceeded the manufacturer's expiry dates, and water hardness testing reagents in utility area were not controlled.

As with any audit, this list of particular observations is not intended to be exhaustive, but representative of the things we discussed during the audit and closing meeting. RECOMMENDATIONS Also noted during the audit, several additional items may require consideration, including: 1. Ensure consistency in use of forms; ensure forms are designed for intended use. 2. Logbooks and binders should be stored in a designated location. 3. Consider alternate methods for affixing calibration tags in environments were tags could fall off or become illegible. 4. Avoid use of paper signage; if a non-temporary, non-process indicating sign is important enough to post, it should be made of a durable material. 5. Any gauge not requiring calibration should receive a "DO NOT CALIBRATE" or "NO CALIBRATION REQUIRED" sticker to indicate a clear decision to exclude that gauge from the calibration program; otherwise it's hard to explain during an audit. 6. Sampled material observed in quarantine for 3 months awaiting analytical method from supplier; QC lab should ensure samples being tested are truly representative.

~ CONFIDENTIAL ~

CONFIDENTIAL AUDIT REPORT JUMBO PHARMACEUTICALS AUDIT DATE: APRIL 20-22, 2009

7. Ensure that a study protocol is established for the use of any parallel system. Specifically in this case, a computerized inventory system was observed to be under evaluation while the official inventory system was paper-based. 8. Consider replacing DOP as a challenge particle for HEPA filter integrity testing with a different particle; a good alternative would be Emery 3004. 9. Operators should be trained to be alert and take initiative in pointing out potential GMP/Quality improvement opportunities. 10. Incorrect responses to training examinations should be accompanied by correct answers in the operators own hand to confirm the operator does know the correct response. 11. Training examinations should include a practical examination prior to independent task performance; exams should be criterion referenced and time-realistic for the operation. 12. Frequently used graduated cylinders and tubing should not be kept in proximity with true spare parts, and broken glassware should be discarded immediately. 13. Review gowning practices for sterile areas; minimize the removal of gowning material prior to gowning for the sterile area. 14. Re-examine WFI system maintenance procedures to ensure all routine and unexpected maintenance steps are adequate for long-term system operation. 15. Re-examine all validation protocols pertaining to filling/sterilizing equipment used for processing InnnoPharma product, and take corrective action to address any deficiencies. 16. Clean laboratory refrigerators on a regular basis 17. Consider harmonizing content of aseptic gowning practices SOPs for the lab and production areas. 18. Include load patterns as an attachment to laboratory autoclave and oven SOPs. 19. Replace all newsprint found in the lab with parchment paper 20. Ensure incoming rolled labeling material is examined for splices, and where found, splices are marked with red ink (or similar) to draw attention to the splice for further examination. 21. Monitor temperature and humidity in the labeling storage area. 22. Use the ANSI/ASQ Z1.4 2003 standard for sampling (instead of n + 1); a switch to ANSI could actually reduce sampling, and SDRL was observed to already use AQL nomenclature 23. Continue to enhance core quality systems (Nonconformance, Deviation, Audit, Complaints) and assess all potential triggers for an Investigation. 24. Track all investigations and uniquely number investigations for easy reference/cross-reference 25. Harmonize CAPA terminology with ISO standards (Correction, Corrective Action, Preventive Action) to free up potential corrective action overload of CAPA system These recommendations are representative of what we discussed during the audit, and are provided for your consideration as you make changes to address the observations. If you require any further detail regarding the listed observations and/or recommendations, please do not hesitate to ask. In conclusion, while several improvement opportunities have been noted here, I would attest that Jumbo Pharmaceuticals Ltd is presently operating in compliance with US FDA Drug GMP expectations, and presently has the capacity to address all noted observations. Please provide a written response to the noted observations within 30 days to: Dr. Narinder Wolski, Presiden Acme LLC 11 Sunset Park Drive, Suite 205 Laguna Beach, CA 92678 USA Sincerely,

Thomas G. Nimmer, President & CEO Global GMP Consulting, Inc.

~ CONFIDENTIAL ~