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Our QMS and Validation Process

Validated to meet your requirements

Our Quality Management System is designed by industry-trained experts to enable us to manufacture custom reagents quickly without compromising quality. We implement rigorous training and documentation practices, qualify our equipment, and use a bracketed approach to validate our manufacturing processes so we can work with speed and flexibility. 

 

 

 

 

A Quality Management System
you can count on

Our Quality Management System (QMS) approach is built on ISO 13485:2016 certification standards. It includes an integrated electronic QMS (eQMS), change management, document control, Non-Conformance Reports (NCRs), Deviation Management (DEV), Corrective and Preventive Actions (CAPAs), raw material testing, and in-process and finished goods testing.

Industry expertise

 

Our facilities and QMS are designed by our team of quality experts who have decades of experience working in leadership positions across the global pharmaceutical industry.

Bracketed validation

To enable flexibility and burst capacity, our experts have designed a bracketed validation approach for our facilities, manufacturing processes, and container formats.

Continuous monitoring

Our QMS is continuously monitored and improved, with feedback from trends, CAPAs, complaints, customers, industry best practices, and user interface improvements.

We know how to keep cleanrooms clean

Everyone on our production team completes an in-depth aseptic training process module where they learn about microbiology and behaviors, how cleanrooms work, and how you can impact the environment. This training includes hands-on practical demonstrations as well as extensive practice gowning and moving within cleanrooms to prevent the introduction of contaminants.

 

Our validated gowning process includes the type of PPE to be worn, the gowning and degowning process, and the length of time an operator can be in a cleanroom. We keep a detailed data log to provide objective evidence that this validated process is adhered to at all times.

Optimized for high-volume production

We have validated our cleanrooms for large volumes to enable us to efficiently support our customers' commercial production. Using a bracketed approach, we have validated simultaneous media fills and ensured that the operation of parallel teams does not cause cross-contamination.

 

Our validated parameters cover a “worst-case" scenario, which we simulate by slowing down the media fill during our validation process—for example, by performing a process that usually takes 4 hours over a 10-hour period.

An integrated eQMS

Our eQMS offers seamless integration, giving you transparency into how we manage and document product development, quality, and compliance across our organization. It includes training, document control, complaints, and Quality Event Management: NCRs, DEV, and CAPAs.
 

Additional QMS capabilities include:

  • Asset management platform and software
  • Out-of-specification (OOS) process and management
  • A material review board (MRB)
  • Internal audits

Our validated processes and equipment

To ensure everyone on our team understands and adheres to our rigorous quality standards, each employee participates in ongoing, in-depth training specific to their role.

Training is required for all our employees, who follow training plans tailored for their specific roles and work areas. This includes production, sterility assurance, cleaning, maintenance, and other support personnel, as well as any other individuals who enter or perform work in our facilities. Our training process includes, but is not limited to:

 

  • New hire training and orientation program
  • Aseptic techniques, behaviors, and hygiene
  • Basic microbiology
  • Change management
  • Cleaning and disinfection
  • Code of business conduct and ethics
  • Complaint handling
  • Contamination control principles
  • Employee hygiene
  • Environmental monitoring techniques
  • Good documentation practices (GDP)
  • Gowning qualification
  • Hazardous determination
  • Injury and illness
  • ISO training
  • Media fill training (including interventions)
  • Root cause analysis

 

Documentation:

All completed trainings are documented and logged into our QMS.

 

Access:

Only trained personnel are granted badge access to aseptic areas.

 

Monitoring:

Trained personnel are subject to routine observations that may be performed at random or predetermined times. Anyone who exhibits behaviors that could potentially compromise the integrity of the aseptic environment will have their access to aseptic areas revoked.

 

Retraining:

All employees participate in general refresher training on a recurring basis. Those who routinely access aseptic areas also undergo ongoing assessments that include annual Aseptic Practices refresher training.

 

Our facilities are rigorously monitored to maintain an optimal manufacturing environment. Equipment and machinery are strategically placed for airflow and validated for our specific processes.

Our new, state-of-the-art ISO 7 and 8 cleanrooms are designed for improved contamination control with a unidirectional flow of materials and technicians. In addition, mobile vessels that employ single-use equipment ensure there's no product cross-contamination. Our validation process for these cleanrooms includes:

 

  • Aseptic Process Simulations (media fills)
  • Rigorous sanitization program and routine monitoring of cleanroom conditions
  • Smoke studies
  • Classification in accordance with ISO 14644
  • Environmental Monitoring Performance Qualification

To validate both single and simultaneous media fills, we run an Aseptic Process Simulation (APS) that simulates the entire aseptic process. We substitute a microbiological growth medium for the sterile product, which we then incubate for two weeks to ensure there's no growth.

 

This process provides a means to evaluate the aseptic technique of the operators running the process and includes the validation of autoclave hold times, the filling of different containers using the filling equipment, and the length of time an operator can be in a cleanroom.

To further mitigate risk, we design our media fill simulations based on “worst-case" scenarios. This includes performing two types of simulated interventions: inherent, to account for occurences that are part of the process, and corrective, to account for occurences outside of the process, for example, a potential breakage.

We have qualified a wide range of equipment to ensure every step of the manufacturing process adheres to our rigorous quality standards, from the intake of raw materials to the production and release of finished goods to the storage of retention samples.

  • Anaerobic environments for sample preparation
  • Balance-ventilated enclosure for raw material sampling
  • Biosafety cabinets for bacteriophage testing
  • Biosafety cabinets for raw material sampling
  • Fume hoods for titration and weighing
  • Laminar flow hoods

 

  • Freezers
  • Incubators for liquid performance testing
  • Incubators for USP <71> sterility testing and environmental monitoring
  • Incubators for solid media performance
  • Incubators for liquid performance testing
  • Refrigerators

  • Absorption and UV spectroscopy equipment
  • Bioanalyzer autosampler with bath
  • Centrifuge
  • Colony counter for visual confirmation of solid media
  • Density meters for manual and automated density testing
  • Equipment for atomic absorption spectrometry, identity, and concentration analysis for Ca, Cu, Fe, K, Na, Mg, Ag, Au, and Zn
  • Equipment for the fluorescent detection of DNA, RNA, and protein
  • Equipment for Fourier Transform Infrared Spectroscopy (FTIR) and Infrared Spectroscopy (IR) for raw material identity testing
  • High-performance liquid chromatography (HPLC) system
  • Liquid chromatography-mass spectrometry (LC-MS) system
  • Microfluidic PCR and qPCR system
  • Nitrogen generator for mass spectrometer
  • Osmometer for osmolality testing
  • pH and conductivity meters with Redox capability
  • Potentiometric titration for raw material identity and purity testing
  • Thermal cycler for bacterial, fungal, PCR, yeast, and tryptone performance testing
  • Titration equipment for raw material identity and purity testing
  • Total organic carbon analyzer for the calculation of organic and inorganic carbon

 

We have validated a wide range of container formats using a bracketed approach to enable us to efficiently manufacture your product in the format that best fits your needs. Our custom-built automated manufacturing platform accommodates 1 L bottles and single-use bags spanning from 1 L to 200 L, and we can manually fill formats ranging from 125 mL bottles to 20 L carboys. Our team can also validate custom container formats to meet your requirements.

Our products come in all shapes and sizes

We're here to help you find the ideal format that will fit seamlessly into your workflow. We can customize container size and type, as well as fill volume, documentation, and labeling.

Designed by industry experts

 

Meet the team

Rakesh Ahuja 

Vice President, Quality and Regulatory

 

Rakesh Ahuja has been serving as the Vice President of Quality and Regulatory at Teknova since March 2022. With nearly 30 years of experience in the pharmaceutical, medical device, and biotech industries, Rakesh brings substantial global expertise in quality management. Prior to joining Teknova, he held a dual role at Sun Pharma as Regional Quality Head of North America and Site Quality Head at Ohm Laboratories. In these roles, he was responsible for regional quality oversight, contract manufacturing organizations, and various production sites.

 

Before Sun Pharma, Rakesh held multiple leadership positions at Pfizer, including Senior Director and Associate Vice President, Quality. His extensive career also includes leadership roles at Edwards Lifesciences, Alere, Janssen Healthcare Innovation (a subsidiary of Johnson & Johnson), McNeil, Covidien, and Endologix. Rakesh has led teams in the US, Europe, Asia, and Australia, focusing on global quality systems, cGMP compliance, and various aspects of quality management. He is seasoned in health authority inspections and knowledgeable about the regulations of several countries and regions, including the FDA, MHRA, EMA, Health Canada, and Anvisa.

 

Rakesh holds a bachelor's degree in Computer Science from Gannon University and an MBA in Operational Management from CMJ University, India.

Meet the team

Nicky Young

Senior Director, Sterility Assurance

Nicky's career focus has been in sterility assurance and aseptic pharmaceutical manufacturing, with 27 years of experience ranging from CSL Behring and Baxter International to Patheon (Thermo Fisher) and GE Healthcare.

 

She has worked at large CDMOs where she was responsible for 15 manufacturing lines across two different sites, averaging 15 audits a week, and has overseen the quality of the manufacture of a variety of products, ranging from vaccines to sterile eyedrops to injectables and wound dressings.


As the Global Head of Sterility Assurance at Baxter International, she was responsible for 23 sites, including inspections from the FDA, MHRA, and TGA, among other international regulatory institutions.

Meet the team

Gordon Tommy

Director, Quality Control

With extensive pharmaceutical experience at Abbott and Baxter International, Gordon specializes in product development and lifecycle management, as well as risk management. He has over twenty years of hands-on knowledge of various analytical instruments, risk management tools, test method development, and validation protocols. He is an ASQ CQE and CMQ/OE with expertise in handling complaints, CAPA investigations, change control, risk management, and audits per the FDA CFR, ICH, and ISO standards.

 

Gordon has honed his knowledge of the quality management process in various roles throughout his career, including quality assurance, quality control, quality systems, research and development quality, and manufacturing quality. He holds both a bachelor’s and a master’s degree in Chemistry.

Meet the team

William Cummings

Senior Manager, Quality Operations

William Cummings’s career focus has been in the pharmaceutical and medical device industries. His extensive experience includes his roles as Production Manager and Quality Supervisor at Abbott where he worked from 2019 to 2023. 


William joined the Teknova family in 2023. He holds a MBA and bachelor’s degree from Olivet Nazarene University.

Meet the team

Yuliana Ortiz

Senior Manager, Quality Systems and Compliance

Yuliana Ortiz joined Teknova in April 2022 as the Manager of Quality Systems. She was promoted to Senior Manager of Quality Systems and Compliance in March 2023 after she successfully rebuilt and redeveloped the quality management system in under a year. With over 10 years of cross-functional quality experience across diverse regulated industries, she has worked for small and global companies as well as CMOs and CDMOs in the biotechnology, food, beverage, nutraceuticals, and third-party testing industries.

 

Yuliana has a robust quality background with extensive experience in ISO 13485, ISO 17025, ISO 22000, ISO 9001, 21 CFR 111, 113, 114, 117, 120, and 820. Her areas of expertise encompass QMS creation, establishment, development, and redevelopment, as well as eQMS implementation, training, document control, change management, supplier management and qualification, audit management, continuous improvement, auditing, and cross-functional team leadership.

 

Yuliana obtained a Bachelor of Science in Microbiology and a minor in Education with an emphasis in Mathematics and Science from the University of California Davis. She holds certificates in lead auditing, internal auditing, HACCP, and better process control (BPCS). She is currently working on obtaining her green belt and ASQ CQA certification.

We're here to help

Add our expertise to your team

Whether you need custom products or help planning your process development as you prepare for clinical trials, our team has the expertise to ensure you get the right reagents every step of the way. Consult with our experts today to find your solution.