QUALITY UPDATE Q1 2018

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Alban Hawkins
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1 QUALITY UPDATE Q1 2018

activities at SCA. In February, our Windsor Connecticut facility was inspected by the FDA and in March, by the California State Board of Pharmacy.

2 QUALITY LEADERSHIP Dear Valued Customer, At SCA Pharmaceuticals, Quality is the cornerstone of our business. I am pleased to provide you with our first Quality Report of 2018 which includes our key environmental monitoring data for the first quarter of 2018 together with an update on key operational activities at SCA. In February, our Windsor Connecticut facility was inspected by the FDA and in March, by the California State Board of Pharmacy. Both were successful inspections and represent a welcome and critical step in the expansion of our capabilities at our newest manufacturing facility. As you ve heard, my mission is to enable our commitment to Quality, delight our customers and truly serve the priorities of our partners and their patients. Accordingly, I hope this Quality Report helps you better understand SCA s Quality standard for each drug product released to market and as such, meets your needs and expectations. I invite your feedback via to marketing@scausa.net. Sincerely, GRACE BREEN Grace Breen SVP, Head of Quality Grace Breen - SVP, Head of Quality 2 SCA Pharmaceuticals

3 TABLE OF CONTENTS 4 Commitment to Quality 5 Quality and Operational Updates 6-8 Environmental Monitoring Data 9 End-Product Testing SCA Pharmaceuticals 3

4 COMMITMENT TO QUALITY SCA s quality culture is such that every member of the organization owns Quality. SCA has a Quality Unit that has functional reporting relationships and responsibilities that are aligned with FDA s cgmp requirements. The Quality Unit s role spans Quality Assurance and Quality Control activities, including environmental monitoring. SCA performs sterility and endotoxin testing on 100% of our finished batches. Specific certificates of conformance (C of C) are available for every drug-product batch produced. SCA s standard for product release is that specifications must be met for the following product-related attributes, for every batch: DEFECTS 100% visual inspection for defects. ENDOTOXIN In-house equipment has undergone extensive validation STERILITY SCAN RDI (Rapid Microbiological Technology) enables quick ENVIRONMENTAL MONITORING Comprehensive environmental and fulfills requirements for turnaround time and enables the monitoring performed during endotoxin (pyrogen) testing per longest usable dating to ensure compounding per USP <1116> USP <85> and cgmp guidelines. patients receive medications when and <797>. they need them. SCA is committed to a comprehensive training and personnel qualification program to ensure compliance with regulatory requirements and to enable our commitment for Quality to our customers and their patients. 4 SCA Pharmaceuticals

Q1 2018 QUALITY AND OPERATIONAL UPDATES Seth Traub joined SCA Pharmaceuticals as Senior Vice President, Operations.

He has introduced and implemented Lean Principles and Techniques, and Six Sigma manufacturing to a number of industries, and has a wealth of 503B Pharmaceutical industry experience.

5 Q QUALITY AND OPERATIONAL UPDATES Seth Traub joined SCA Pharmaceuticals as Senior Vice President, Operations. Seth has dedicated his career to producing quality products at the right price, and providing unparalleled customer service and on-time delivery. He has introduced and implemented Lean Principles and Techniques, and Six Sigma manufacturing to a number of industries, and has a wealth of 503B Pharmaceutical industry experience. As the SVP of Operations, Seth is helping to shape SCA Pharmaceuticals into an innovative, efficient 503B organization. Our Windsor, CT Facility was successfully inspected by the FDA as well as the State of California Board of Pharmacy. SCA has updated all product labels to ensure compliance with FDA 503B labeling requirements as well as with USP <7>, ISMP, pharmacy regulations and the expectations of our customers. It is critical to standardize labeling across both locations to provide consistency and continuity for you. These label updates include serialization for all labels allowing us to better track both labels and their corresponding products through their entire lifecycle. Our Windsor, CT facility hosted five client site visits in the first quarter of 2018 from a total of 12 hospital systems with several more planned in the second quarter of Our Little Rock, AR facility hosted one client site visit in the first quarter of SCA Pharmaceuticals 5

ENVIRONMENTAL MONITORING SCA has established an extensive environmental monitoring program for the cleanroom areas to ensure preparations are compounded in the cleanest environment possible.

6 ENVIRONMENTAL MONITORING SCA has established an extensive environmental monitoring program for the cleanroom areas to ensure preparations are compounded in the cleanest environment possible. SCA employs a full-time microbiology team of experts in cgmp regulations and processes. This team works in conjunction with our operational team to oversee the collection of samples and interpretation of results. To ensure patient safety and FDA compliance, SCA takes EM samples during dynamic operations to include: Gloved fingertip testing of compounding personnel. Cleanroom surfaces and viable air sampling. SCA will not release any product until EM data is reviewed and it meets specifications. SCA s cleanrooms and laminar airflow hoods are certified for operational efficiency every 6 months by an independent certification agency. The last certification of hoods in our Arkansas location was performed in Jan 2018 and the last certification of hoods in our Connecticut location was performed in March SCA Pharmaceuticals

7 EM DATA - Q LITTLE ROCK, AR The environmental quality of sterile compounding preparation areas is monitored by measuring the viable and non-viable loading found within the clean room. January- 18 February-18 March-18 Average Year to Date Total Total Surface samples taken 2,057 1,961 2,470 2,163 6,488 Within specified limits 2,057 1,959 2,467 2,161 6,483 % of total samples within limits 1 100% 99.9% 99.88% 99.92% 99.92% Gloved Fingertip samples taken 1, ,205 1,084 3,252 Within specified limits 1, ,205 1,083 3,251 % of total samples within limits 1 100% 99.9% 100% 99.97% 99.97% Particle counts measured (non-viable) ,713 Within specified limits ,713 % of total samples within limits 1 100% 100% 100% 100% 100% Viable Air Samples Taken , ,739 Within specified limits , ,737 % of total samples within limits % 99.88% 100% 99.93% 99.93% 1. The acceptable excursion percentage at SCA is <1% of all samples tested. The data above indicates that the aseptic processing areas are in a state of environmental control. SCA Pharmaceuticals 7

8 EM DATA - Q WINDSOR, CT The environmental quality of sterile compounding preparation areas is monitored by measuring the viable and non-viable loading found within the clean room. January-18 February-18 March-18 Average Year to Date Total Total Surface samples taken 2,357 2,339 3,492 2,729 8,188 Within specified limits 2,356 2,339 3,492 2,728 8,187 % of total samples within limits % 100% 100% 99.99% 99.99% Gloved Fingertip samples taken ,820 1,175 3,524 Within specified limits ,820 1,175 3,524 % of total samples within limits 1 100% 100% 100% 100% 100% Particle counts measured (non-viable) 1,027 1,008 1,124 1,053 3,159 Within specified limits 1,020 1,007 1,118 1,048 3,145 % of total samples within limits % 99.90% 99.47% 99.56% 99.56% Viable Air Samples Taken 1,447 1,339 2,260 1,702 5,106 Within specified limits 1,445 1,339 2,260 1,701 5,104 % of total samples within limits % 100% 100% 99.96% 99.96% 1. The acceptable excursion percentage at SCA is <1% of all samples tested. The data above indicates that the aseptic processing areas are in a state of environmental control. 8 SCA Pharmaceuticals

END-PRODUCT TESTING SCA performs end-product testing according to USP <797>, <71>, <1223>, <85>, and 21 CFR 310.509 guidelines.

9 END-PRODUCT TESTING SCA performs end-product testing according to USP <797>, <71>, <1223>, <85>, and 21 CFR guidelines. Finished products remain in quarantine until testing results are reviewed and released by the Quality Unit. The validation protocol for our SCAN RDI was designed to meet the requirements of USP <1223> for Alternative Test Methods. Lot-specific certificates of conformance (C of C) are available upon request. Rapid sterility testing is offered for most aqueous solutions using SCAN RDI. This technology utilizes fluorescent labeling and laser scanning to detect viable microorganisms. Our validation protocol demonstrates SCAN RDI is equal to or better than the traditional 14 day sterility method, especially when recovering low counts of CFU (1-5). SCA takes pride in our sterility and endotoxin sampling of every lot of sterile admixtures we produce. The benefit of this quality procedure is something every patient deserves. SCA Pharmaceuticals 9

Where Quality Meets Flexibility

Where Quality Meets Flexibility is an industry leading 503B Outsourcing Facility providing sterile and non-sterile compounding services to hospitals, surgery centers, clinics, researchers & patients nationwide.