quality update - sca pharma · sca has a quality unit that has functional reporting relationships...

QUALITY UPDATE

Q1 2018

2 SCA Pharmaceuticals

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 email to [email protected].

Grace Breen - SVP, Head of Quality

Sincerely,

QUALITY LEADERSHIP

GRACE BREENGrace Breen SVP, Head of Quality

3SCA Pharmaceuticals

TABLE OF CONTENTS

4 Commitment to Quality

5 Quality and Operational Updates

6-8 Environmental Monitoring Data

9 End-Product Testing


COMMITMENT TO QUALITYSCA’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 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.

DEFECTS

100% visual inspection for

defects.

STERILITY

SCAN RDI (Rapid Microbiological Technology) enables quick

turnaround time and enables the longest usable dating to ensure

patients receive medications when they need them.

ENDOTOXIN

In-house equipment has undergone extensive validation

and fulfills requirements for endotoxin (pyrogen) testing per USP <85> and cGMP guidelines.

ENVIRONMENTAL MONITORING

Comprehensive environmental monitoring performed during compounding per USP <1116>

and <797>.

SCA’s standard for product release is that specifications must be met for the following product-related attributes, for every batch:


Q1 2018 QUALITY AND OPERATIONAL UPDATESSeth 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 2018.

Our Little Rock, AR facility hosted one client site visit in the first quarter of 2018.


ENVIRONMENTAL MONITORINGSCA 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 2018.


EM DATA - Q1 2018 LITTLE ROCK, ARThe 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 limits1 100% 99.9% 99.88% 99.92% 99.92%

Gloved Fingertip samples taken 1,051 996 1,205 1,084 3,252

Within specified limits 1,051 995 1,205 1,083 3,251

% of total samples within limits1 100% 99.9% 100% 99.97% 99.97%

Particle counts measured (non-viable) 895 824 994 904 2,713

Within specified limits 895 824 994 904 2,713

% of total samples within limits1 100% 100% 100% 100% 100%

Viable Air Samples Taken 899 824 1,016 913 2,739

Within specified limits 898 823 1,016 912 2,737

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.

% of total samples within limits1 99.89% 99.88% 100% 99.93% 99.93%


EM DATA - Q1 2018 WINDSOR, CTThe 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


% of total samples within limits1 99.96% 100% 100% 99.99% 99.99%

Gloved Fingertip samples taken 852 852 1,820 1,175 3,524

Within specified limits 852 852 1,820 1,175 3,524

% of total samples within limits1 100% 100% 100% 100% 100%

Particle counts measured (non-viable) 1,027 1,008 1,124 1,053 3,159


% of total samples within limits1 99.32% 99.90% 99.47% 99.56% 99.56%

Viable Air Samples Taken 1,447 1,339 2,260 1,702 5,106


% of total samples within limits1 99.86% 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.


END-PRODUCT TESTING

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

quality update - sca pharma · sca has a quality unit that has functional reporting relationships...

Documents