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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.
SterRx.com Confidential – For Client Use Only
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
SterRx.comConfidential – For Client Use Only
* 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
SterRx.comConfidential – For Client Use Only
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
CU
RR
EN
T G
O
OD MANUFACTURING PR
OC
ESS
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: [email protected]
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