Report CardQ2

SterRx, LLC141 Idaho AvenuePlattsburgh, NY 12903(844) 319-7799

Confidential – For Client Use Only

cGMP MANUFACTURER OF 503B COMPOUNDED DRUGS

April 1, 2019 through June 30, 2019

SETTING HIGH STANDARDS OF QUALITY AND RELIABILITY

At SterRx, it is our mission to provide you with a consistent supply of superior quality pharmaceutical product. Our industry-leading, aseptic, automated processes allow us to consistently deliver what you care about most — patient safety.

SterRx follows FDA requirements for 503B compounding, utilizing Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals — 21CFR Part 211. We use the same processes as those used for commercially available drugs, producing sterile compounds from non-sterile ingredients with minimal human intervention and no hood. This includes sourcing API from only FDA-approved manufacturers and the use of a 0.2-micron filter during drug sterilization.

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MANUFACTURING PROCESSES

STERILE MANUFACTURER OF 503B COMPOUNDED DRUGS

Manufacturing Processes Set the Quality StandardTo produce sterile preparations of high quality, SterRx follows FDA requirements for 503B compounding in accordance with Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals–21 CFR Part 211.

cGMP/503B Meets Details

Incoming Material Control √ • Materials quarantined until tested/examined and released by quality unit• Full testing until supplier’s results are validated

Vendor Qualification/API Testing √ • Product specific: filter validation and bioburden

Production Controls √

• Fully automated production; minimal manual intervention with BFS processes• Detailed batch records completed in real time• Fully qualified water system• In-process inspections and testing• Hold times established• Control of microbiological contamination• Comprehensive manufacturing investigation system

Packaging/Labeling Controls √• Line cleaning and clearance• Strict label controls• Product inspection

Licensed Pharmacist √ • Verification of critical operations

Training √

• Ongoing cGMP training• Proper combination of education and experience• Assessments where required• Detection of visible particles

Laboratory Controls √

• Equipment qualified• Product specific: sterility and test method validation• Reserve samples• Comprehensive laboratory investigations

Environmental Monitoring √

• Monitored surface and air quality• Personnel gowning qualification• Rigorous cleaning regimen with rotation of cleaning agents• Static and dynamic monitoring

Stability Program √ • Real-time stability monitoring• Accelerated studies, where appropriate

Validation Program √

• Media fills performed for each process to ensure proper aseptic technique• Equipment qualification (IQ, OQ and PQ)• Process validation• Packaging validation

Other Quality Systems √

• Change control• Corrective action/preventive action (CAPA)• Customer complaints• Annual product reviews (APRs)• Internal audits

Document Control √ • Standard operating procedures/forms/methods• Rigorous documentation practices

To produce sterile products of high quality, SterRx follows FDA requirements for 503B compounding in accordance with Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals–21 CFR Part 211.

SterRx.comConfidential – For Client Use Only

503B OUTSOURCED COMPOUNDING FACILITY

Quality Assurance

SOPs and Documentation

• SOPs in place for every process from receipt of incoming materials throughproduction, packaging and shipping to ensure consistency and conformity

• Master batch records detail and document preparation of each product• Licensed pharmacists verify critical operations• Experienced Quality Assurance professionals complete, collect, review and

store all documentation associated with every facet of operations

Environmental Control

• Validated, calibrated and certified equipment• Monitoring of clean room environments, differential pressure, surfaces and air quality• Rigorous cleaning program utilizing rotational disinfection• Clean rooms and fill zones are routinely certified to ensure ISO 14644 compliance

Personnel Control• Multi-level training program consists of procedural review, task-based training

and proficiency evaluation• Media fills performed for each process to ensure proper aseptic controls

Validation Program

• Equipment qualified (IQ, OQ, PQ) to ensure proper performance• Cleaning procedures verified• Manufacturing processes validated• Validation of critical utilities• Periodic media fills performed to ensure proper aseptic technique

Finished Product

• Rigorous stability program to ensure products meet specifications throughout the lifecycle of the products

• Multi-layered quality control verification process to ensure each unit is made correctlyand to the highest standards

• Final product verification to ensure all preparations meet specifications

Quality Systems

• Comprehensive investigation system• Customer complaints investigated• Rigorous change control program• Corrective and preventive actions based on in-depth root cause investigations to

ensure remediation of issues• Ongoing trending for key quality systems evaluate data from a broader perspective to

implement change from a strategic perspective

141 Idaho Avenue, Plattsburgh, New York 12903 Telephone: 518-324-7879

QUALITY ASSURANCE

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* https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities. Accessed September 3, 2019.

FDA INSPECTION RELATED TO COMPOUNDING*

Last Inspection Date: June 7, 2019

Inspection Results: No Form FDA-483 issued

503B OUTSOURCED COMPOUNDING FACILITY

Quality Assurance

SOPs and Documentation

• SOPs in place for every process from receipt of incoming materials throughproduction, packaging and shipping to ensure consistency and conformity

• Master batch records detail and document preparation of each product• Licensed pharmacists verify critical operations• Experienced Quality Assurance professionals complete, collect, review and

store all documentation associated with every facet of operations

Environmental Control

• Validated, calibrated and certified equipment• Monitoring of clean room environments, differential pressure, surfaces and air quality• Rigorous cleaning program utilizing rotational disinfection• Clean rooms and fill zones are routinely certified to ensure ISO 14644 compliance

Personnel Control• Multi-level training program consists of procedural review, task-based training

and proficiency evaluation• Media fills performed for each process to ensure proper aseptic controls

Validation Program

• Equipment qualified (IQ, OQ, PQ) to ensure proper performance• Cleaning procedures verified• Manufacturing processes validated• Validation of critical utilities• Periodic media fills performed to ensure proper aseptic technique

Finished Product

• Rigorous stability program to ensure products meet specifications throughout the lifecycle of the products

• Multi-layered quality control verification process to ensure each unit is made correctlyand to the highest standards

• Final product verification to ensure all preparations meet specifications

Quality Systems

• Comprehensive investigation system• Customer complaints investigated• Rigorous change control program• Corrective and preventive actions based on in-depth root cause investigations to

ensure remediation of issues• Ongoing trending for key quality systems evaluate data from a broader perspective to

implement change from a strategic perspective

141 Idaho Avenue, Plattsburgh, New York 12903 Telephone: 518-324-7879

503B OUTSOURCED COMPOUNDING FACILITY

Quality Assurance

SOPs and Documentation

• SOPs in place for every process from receipt of incoming materials throughproduction, packaging and shipping to ensure consistency and conformity

• Master batch records detail and document preparation of each product• Licensed pharmacists verify critical operations• Experienced Quality Assurance professionals complete, collect, review and

store all documentation associated with every facet of operations

Environmental Control

• Validated, calibrated and certified equipment• Monitoring of clean room environments, differential pressure, surfaces and air quality• Rigorous cleaning program utilizing rotational disinfection• Clean rooms and fill zones are routinely certified to ensure ISO 14644 compliance

Personnel Control• Multi-level training program consists of procedural review, task-based training

and proficiency evaluation• Media fills performed for each process to ensure proper aseptic controls

Validation Program

• Equipment qualified (IQ, OQ, PQ) to ensure proper performance• Cleaning procedures verified• Manufacturing processes validated• Validation of critical utilities• Periodic media fills performed to ensure proper aseptic technique

Finished Product

• Rigorous stability program to ensure products meet specifications throughout the lifecycle of the products

• Multi-layered quality control verification process to ensure each unit is made correctlyand to the highest standards

• Final product verification to ensure all preparations meet specifications

Quality Systems

• Comprehensive investigation system• Customer complaints investigated• Rigorous change control program• Corrective and preventive actions based on in-depth root cause investigations to

ensure remediation of issues• Ongoing trending for key quality systems evaluate data from a broader perspective to

implement change from a strategic perspective

141 Idaho Avenue, Plattsburgh, New York 12903 Telephone: 518-324-7879

503B OUTSOURCED COMPOUNDING FACILITY

Quality Assurance

SOPs and Documentation

• SOPs in place for every process from receipt of incoming materials throughproduction, packaging and shipping to ensure consistency and conformity

• Master batch records detail and document preparation of each product• Licensed pharmacists verify critical operations• Experienced Quality Assurance professionals complete, collect, review and

store all documentation associated with every facet of operations

Environmental Control

• Validated, calibrated and certified equipment• Monitoring of clean room environments, differential pressure, surfaces and air quality• Rigorous cleaning program utilizing rotational disinfection• Clean rooms and fill zones are routinely certified to ensure ISO 14644 compliance

Personnel Control• Multi-level training program consists of procedural review, task-based training

and proficiency evaluation• Media fills performed for each process to ensure proper aseptic controls

Validation Program

• Equipment qualified (IQ, OQ, PQ) to ensure proper performance• Cleaning procedures verified• Manufacturing processes validated• Validation of critical utilities• Periodic media fills performed to ensure proper aseptic technique

Finished Product

• Rigorous stability program to ensure products meet specifications throughout the lifecycle of the products

• Multi-layered quality control verification process to ensure each unit is made correctlyand to the highest standards

• Final product verification to ensure all preparations meet specifications

Quality Systems

• Comprehensive investigation system• Customer complaints investigated• Rigorous change control program• Corrective and preventive actions based on in-depth root cause investigations to

ensure remediation of issues• Ongoing trending for key quality systems evaluate data from a broader perspective to

implement change from a strategic perspective

141 Idaho Avenue, Plattsburgh, New York 12903 Telephone: 518-324-7879

503B OUTSOURCED COMPOUNDING FACILITY

Quality Assurance

SOPs and Documentation

• SOPs in place for every process from receipt of incoming materials throughproduction, packaging and shipping to ensure consistency and conformity

• Master batch records detail and document preparation of each product• Licensed pharmacists verify critical operations• Experienced Quality Assurance professionals complete, collect, review and

store all documentation associated with every facet of operations

Environmental Control

• Validated, calibrated and certified equipment• Monitoring of clean room environments, differential pressure, surfaces and air quality• Rigorous cleaning program utilizing rotational disinfection• Clean rooms and fill zones are routinely certified to ensure ISO 14644 compliance

Personnel Control• Multi-level training program consists of procedural review, task-based training

and proficiency evaluation• Media fills performed for each process to ensure proper aseptic controls

Validation Program

• Equipment qualified (IQ, OQ, PQ) to ensure proper performance• Cleaning procedures verified• Manufacturing processes validated• Validation of critical utilities• Periodic media fills performed to ensure proper aseptic technique

Finished Product

• Rigorous stability program to ensure products meet specifications throughout the lifecycle of the products

• Multi-layered quality control verification process to ensure each unit is made correctlyand to the highest standards

• Final product verification to ensure all preparations meet specifications

Quality Systems

• Comprehensive investigation system• Customer complaints investigated• Rigorous change control program• Corrective and preventive actions based on in-depth root cause investigations to

ensure remediation of issues• Ongoing trending for key quality systems evaluate data from a broader perspective to

implement change from a strategic perspective

141 Idaho Avenue, Plattsburgh, New York 12903 Telephone: 518-324-7879

503B OUTSOURCED COMPOUNDING FACILITY

Quality Assurance

SOPs and Documentation

• SOPs in place for every process from receipt of incoming materials throughproduction, packaging and shipping to ensure consistency and conformity

• Master batch records detail and document preparation of each product• Licensed pharmacists verify critical operations• Experienced Quality Assurance professionals complete, collect, review and

store all documentation associated with every facet of operations

Environmental Control

• Validated, calibrated and certified equipment• Monitoring of clean room environments, differential pressure, surfaces and air quality• Rigorous cleaning program utilizing rotational disinfection• Clean rooms and fill zones are routinely certified to ensure ISO 14644 compliance

Personnel Control• Multi-level training program consists of procedural review, task-based training

and proficiency evaluation• Media fills performed for each process to ensure proper aseptic controls

Validation Program

• Equipment qualified (IQ, OQ, PQ) to ensure proper performance• Cleaning procedures verified• Manufacturing processes validated• Validation of critical utilities• Periodic media fills performed to ensure proper aseptic technique

Finished Product

• Rigorous stability program to ensure products meet specifications throughout the lifecycle of the products

• Multi-layered quality control verification process to ensure each unit is made correctlyand to the highest standards

• Final product verification to ensure all preparations meet specifications

Quality Systems

• Comprehensive investigation system• Customer complaints investigated• Rigorous change control program• Corrective and preventive actions based on in-depth root cause investigations to

ensure remediation of issues• Ongoing trending for key quality systems evaluate data from a broader perspective to

implement change from a strategic perspective

141 Idaho Avenue, Plattsburgh, New York 12903 Telephone: 518-324-7879

Signatures and dates assigned at authorized release

CERTIFICATE OF ANALYSIS

SterRx.comConfidential – For Client Use Only

SterRx, Llc. 141 Idaho Avenue Plattsburgh, NY 12903 518-324-7879

EM Data 2nd Qtr 2019 (April, May, June)

Air Monitoring Area Limits Results ISO 5 NMT 1 CFU/m3 Satisfactory (n=360)

ISO 7 Alert=> 5 CFU Action=>10 CFU

Satisfactory (N=1030) Satisfactory upon investigation (n=16) Unsatisfactory upon investigation (n=9)

ISO 8 Alert=50 CFU Action=100 CFU

Satisfactory (n=490) Satisfactory upon investigation (n=2)

Particle Counts Area Limits Results ISO 5 0.5µm=<100/ft3

Satisfactory

(n=317) Satisfactory upon investigation (n=46)

ISO 7 0.5µm=100,000/ft3

Satisfactory (n=148)

ISO 8 0.5µm=100,000/ft3 Satisfactory (n=108)

Water For Injection (Daily) Testing Limits Results Membrane Filtration

Alert= > 5CFU/100mL Action= > 10CFU/100mL

Satisfactory (n=345)

Total Organic Carbon

<500 ppb Satisfactory (n=345) Satisfactory upon investigation (n=1)

Conductivity Conforms to USP

Satisfactory (n=345)

Bacterial Endotoxin

<0.25 EU/mL Satisfactory (n=345)

Surface Monitoring Area Limits Results ISO 5 NMT 1 CFU Satisfactory (n=776)

Satisfactory upon investigation (n=1)

ISO 7 Alert=> 13 CFU Action=>25 CFU

Satisfactory (n=5363) Satisfactory upon investigation (n=2) Unsatisfactory upon investigation (n=1)

ISO 8 Alert=>25 CFU Action=>50 CFU

Satisfactory (n=5576) Satisfactory upon investigation (n=1)

Compressed Air (Weekly) Area Testing Limit Results ISO 5 Viable NMT 1

CFU/1000L Satisfactory (n=102) Satisfactory upon investigation (n=2)

ISO 7 Viable ≤10 CFU/1000L

Satisfactory (n=13)

ISO 8 Viable ≤100 CFU/1000L

Satisfactory (n=26)

ISO 5 Particles 0.5µm=<100/ft3

Satisfactory (n=104) Satisfactory upon investigation (n=1)

ISO 7 Particles 0.5µm=<100/ft3

Satisfactory (n=13)

ISO 8 Particles 0.5µm=<100/ft3

Satisfactory (n=26)

----- Hydrocarbon No color change in the Drager tube

Satisfactory (n=39) Satisfactory upon investigation (n=1)

------ Dew Point <39°F(<3.88°C) Satisfactory (n=39) Satisfactory upon investigation (n=2)

Personnel Monitoring Area Limit Results ISO 7 Alert= < 5 CFU Satisfactory (n=322)

ENVIRONMENTAL MONITORING DATA

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Site Map Privacy Terms of Use ©2019 SterRx, LLC

STERILE MANUFACTURER OF 503B COMPOUNDED DRUGS

COMPANY WHY SterRx PRODUCTS RESOURCES CONTACT US

THE FUTURE OF COMPOUNDING IS NOW

1930s & 1940s

MEDICATIONS COMPOUNDED FOR SPECIFIC PATIENTS

LARGE-SCALE MEDICATION MANUFACTURING CAUSES COMPOUNDING DECLINE

1950s & 1960s

USP ESTABLISHES STERILE COMPOUNDING

GUIDELINES

2004

DRUG QUALITY & SECURITY ACT IMPLEMENTED

2013

cGMP STANDARDS ESTABLISHED

FOR 503B OUTSOURCING

FACILITIES

2013

MINIMAL HUMAN INTERVENTION

ENHANCED WITH AUTOMATED TECHNOLOGY

2016

THE DISTINCTION IS AUTOMATIONIn Sterile Manufacture of 503B, cGMP-compliant Compounded Drugs

USP<797> cGMP

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API-TO-STERILE PROCESSSterRx uses 0.2-micron pharmaceutical-grade microfilters, validated to produce a final sterile product. The API is sourced only from 510 FDA-registered suppliers.

cGMP-COMPLIANT. EVERY LOT. EVERY TIME.SterRx uses the same processes as those used for commercially available drugs, including sourcing API from FDA-approved manufacturers to formulate and produce aseptic products.

AUTOMATED FACILITYAutomated processes reduce errors,

increase production speed and capacity, and reduce the risk of contamination,

patient harm and costly litigation.

PACKAGING FLEXIBILITY & ASEPTIC MANUFACTURINGOur packaging process utilizes blow-fill-seal (BFS) and other automated technologies to produce sterile products in IV bags, prefilled syringes and vials, providing optimal choice and convenience for healthcare providers and pharmacists based on storage and patient needs.

BAR CODES AND NDCSWe provide an NDC and bar code for every

product we manufacture, to help end users receive and monitor drugs

efficiently in their hospitals.

EXPIRY DATINGUnlike many other compounders, we use expiry dating, a more precise statement

of product viability than beyond-use dating.

Sterile Manufacturer

of 503B compounded drugs.

ICONS CHANGE TO BLUE WHEN HOVER OVER

SterRx is a registered trademark of SterRx, LLC.

Contact your local SAGENT® representative for your 503B compounding needs.

EMAIL: customerservice@SterRx.com

CALL TOLL FREE: 1-844-319-7799

Thank you for your business!

cGMP MANUFACTURER OF 503B COMPOUNDED DRUGS

©2019 SterRx, LLC. SPM19-0026

STATE LICENSING

SterRx.comConfidential – For Client Use Only