Deprecated: Return type of Ai1wm_Recursive_Directory_Iterator::rewind() should either be compatible with FilesystemIterator::rewind(): void, or the #[\ReturnTypeWillChange] attribute should be used to temporarily suppress the notice in /home/biotech/public_html/wp-content/plugins/all-in-one-wp-migration/lib/vendor/servmask/iterator/class-ai1wm-recursive-directory-iterator.php on line 37

Deprecated: Return type of Ai1wm_Recursive_Directory_Iterator::next() should either be compatible with DirectoryIterator::next(): void, or the #[\ReturnTypeWillChange] attribute should be used to temporarily suppress the notice in /home/biotech/public_html/wp-content/plugins/all-in-one-wp-migration/lib/vendor/servmask/iterator/class-ai1wm-recursive-directory-iterator.php on line 44

Deprecated: Return type of Ai1wm_Extension_Filter::accept() should either be compatible with FilterIterator::accept(): bool, or the #[\ReturnTypeWillChange] attribute should be used to temporarily suppress the notice in /home/biotech/public_html/wp-content/plugins/all-in-one-wp-migration/lib/vendor/servmask/filter/class-ai1wm-extension-filter.php on line 37

Deprecated: Return type of Ai1wm_Recursive_Exclude_Filter::getChildren() should either be compatible with RecursiveFilterIterator::getChildren(): ?RecursiveFilterIterator, or the #[\ReturnTypeWillChange] attribute should be used to temporarily suppress the notice in /home/biotech/public_html/wp-content/plugins/all-in-one-wp-migration/lib/vendor/servmask/filter/class-ai1wm-recursive-exclude-filter.php on line 41

Deprecated: Return type of Ai1wm_Recursive_Exclude_Filter::accept() should either be compatible with FilterIterator::accept(): bool, or the #[\ReturnTypeWillChange] attribute should be used to temporarily suppress the notice in /home/biotech/public_html/wp-content/plugins/all-in-one-wp-migration/lib/vendor/servmask/filter/class-ai1wm-recursive-exclude-filter.php on line 37
Quality Assurance Archives – Page 2 of 2 – PSC Biotech- Life Science Services and Solutions Provider
Regulatory Agency Inspection Preparation & Quality Oversight

Regulatory Agency Inspection Preparation & Quality Oversight

Regulatory Agency Inspection preparation & Quality Oversight

  • Area: Canada, Saskatchewan
  • Project Type: QA

About this Project

OBJECTIVE

 Preparation for regulatory agency inspection services 

SERVICES

Our client, a research foundation in Saskatchewan, brought PSC Biotech on for Quality Assurance services. The client was seeking GLP lab accreditation to aid in their therapeutic development programs. PSC Biotech was able to oversee, arrange, conduct, and report on audits of cGMP facilities, nonclinical systems.

 

PSC Biotech is responsible for overseeing the implementation of a  pharmaceutical quality program to support the client’s agency inspection preparation. This process involved: reviewing: reviewing procedures and systems, checking for consistency with appropriate practices, assisting in the preparing/revising SOPs. 

 

 

Project Success

The project continues to progress successfully.

Related Projects

20 Years & Counting of CQV Services

Commissioning, Qualification, Validation and Engineering services for the clients  facility since its inception.

Cleaning Validation & Decommissioning Project

PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.

Sterile Fill/Finish Laboratory Facilities CQV Project

The operations performed included: Filling, Parts Preparation, Formulation, Filling, Process Support Systems and Cleaning.

How Can We Help You?

[ninja_form id=6]

Quality Assurance | New Product Development Projects

Quality Assurance | New Product Development Projects

Quality Assurance | Product Development

 

New Product Development Projects
  • Area: Greater Greater Richmond Area & Greater Salt Lake City Area
  • Project Type: Quality Assurance

About this Project

OBJECTIVE

New Product Development of Medical Devices

SERVICES

PSC did multiple projects with this client for their new product development. This included:

  • Design Control work including:
    • Creation of design control templates to be executed by R&D team.
    • Design Control Matrix review and implementation.
    • Design Verification & Validation document review.
    • Creation & Implementation of Design Change Control Program.
    • Creation & Implementation of Design Risk Assessment Program.
    • Creation of incoming good specification sheets.
  • Creation & execution of equipment qualification protocols.
  • Creation of process validation protocols.
  • GxP auditing of manufacturing facilities to various regulations and standards.
  • Quality Assurance staff augmentation at various facilities.
  • Creation & implementation of process sampling program ensuring the manufacturing facilities are adhering to ANSI Z1.4.
  • Rental of calibrated equipment including particle counters and temperature data loggers.
  • Creation and execution of shipping validation protocols.
  • Documentation GAP assessment to determine what procedures and work instructions need to be created to ensure the manufacturing facility was compliant.
“I am writing this letter to recommend the services of PSC Biotech. During the past year, our company has been working with PSC on various activities within the development and implementation of a new medical device product. PSC offers high quality services, and we can say that we have always been satisfied by their work.”

Read Full Letter of Recommendation Here

EQUIPMENT USED

  • Fridges
  • Freezers
  • Thermal Cycler
  • Heat Cabinet
  • Incubator
  • Cleanroom

PROJECT SUCCESS

The client has been very happy with PSC’s work on the project ensuring all Toll Gate Activities were achieved on time and that the product transfer to manufacturing was successful.

Related Projects

Temp/Humidity Circular Chart Recorder

LCD display used at a controlled warehouse company facility.

Kaye Validator 2000, SIMs, TC and Drywell

Calibration support for validation equipment.

Metrology Field & Lab Calibrations

Temperature, Humidity, Pressure, Mass and Dimensional.

How Can We Help You?

[ninja_form id=6]

Commissioning and Qualification Projects

Commissioning and Qualification Projects

Commissioning and Qualification Projects

Equipment Qualification, Computerized Systems Validation, IT, QA, Systems Assurance, EDMS, Administration Business Analysis

  • Area: Greater Los Angeles Area
  • Project Type: CSV

About this Project

OBJECTIVE

Commissioning and Qualification, Equipment Qualification, Computerized Systems Validation, IT, QA, Systems Assurance, EDMS, Administration Business Analysis

SERVICES

Equipment Qualification, Computerized Systems Validation, IT, QA, Systems Assurance, EDMS, Administration Business Analysis

EQUIPMENT USED

  • Kaye Validator
  • Additional SIM for Kaye 2000
  • iRTD-400 Probe
  • LTR-140 Bath
  • HTR-400 Bath
  • Data Loggers
  • Kaye Feed Thru Device
  • Pressure Transducer
  • CLiMET (laser particle counter)
  • Low Pressure Gas Flowmeter
  • CLiMET (Microbial Sampler)
  • Shortridge Air Data MultiMeter
  • Druck Pressure Testing
  • Gas Flowmeter
  • SVMS Steam Quality
  • Thermocouples
  • Scissor Lift
  • Specialized PPE
  • Specialized Tools

PROJECT SUCCESS

Needs content 

Related Projects

20 Years & Counting of CQV Services

Commissioning, Qualification, and Validation (CQV) services for one of the clients plants since the mid 1990’s to the present.

Cleaning Validation & Decommissioning Project

PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.

Sterile Fill/Finish Laboratory Facilities CQV Project

The operations performed included: Filling, Parts Preparation, Formulation, Filling, Process Support Systems and Cleaning.

How Can We Help You?

[ninja_form id=6]

Greenville Facility Buildout

Greenville Facility Buildout

Greenfield Facility Buildout  |  CQV & Engineering Projects

PSC® provided Commissioning, Qualification, Validation (CQV) and Engineering Services for the Clients Sterile Fill/Finish Manufacturing Facility Since its Inception.
  • Area: Greater Los Angeles
  • Project Type: CQV, Engineering,  Manufacturing, Technical Writing, and Quality Assurance

About this Project

OBJECTIVE

CQV, Engineering,  Manufacturing, Technical Writing, and Quality Assurance on Facility

SERVICES

PSC® served as the key consultants for the entire facility and covered engineering and validation in various functional areas. After the facility reached the operational phase, PSC® continues to provide Engineering Managed Services to Facility Engineering, PMO and automation groups. Additionally, PSC® continues to provide consulting services in Validation, Quality Assurance and Manufacturing.

EQUIPMENT USED

  • Kaye Validator
  • Additional SIM for Kaye 2000
  • iRTD-400 Probe
  • LTR-140 Bath
  • HTR-400 Bath
  • Data Loggers
  • Kaye Feed Thru Device
  • Pressure Transducer
  • CLiMET (laser particle counter)
  • Low Pressure Gas Flowmeter
  • CLiMET (Microbial Sampler)
  • Shortridge Air Data MultiMeter
  • Druck Pressure Testing
  • Gas Flowmeter
  • SVMS Steam Quality
  • Thermocouples
  • Scissor Lift
  • Specialized PPE
  • Specialized Tools

PROJECT SUCCESS

The clients commissioning project was a guaranteed maximum lump sump project. PSC® was able to accurately manage the scope of work and performance to meet the companies satisfaction. PSC’s team played a major role in the FDA approval of the clients site in late November 2019. The success of PSC® at the site led to ongoing consulting services expanding into other functional areas with the company, and has kept many of the team members who began their services this client since the inception of the facility. We are still currently supporting them through their validation engineering.

 

Related Projects

20 Years & Counting of CQV Services

Commissioning, Qualification, and Validation (CQV) services for one of the clients plants since the mid 1990’s to the present.

Cleaning Validation & Decommissioning Project

PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.

Sterile Fill/Finish Laboratory Facilities CQV Project

The operations performed included: Filling, Parts Preparation, Formulation, Filling, Process Support Systems and Cleaning.

How Can We Help You?

[ninja_form id=6]