Validation & Qualification

Gxp Cellators is well-known for its quality, professionalism, performance, and solutions and is a favored partner to many businesses in the pharmaceutical, biotechnology, API, veterinary, and natural health product industries worldwide.

Our success is a result of our commitment to providing high-quality, individualized service and to your projects' success. While offering the best level of service while maintaining the strictest level of anonymity, you receive a cost-effective validation strategy.

For your organization to continue to be competitive, and dynamic, and reach a new level of confidence, your validation needs must be met. Our highly experienced validation associates for New Instrument Setup and Qualification Consultants in Canada have the skills and dedication to deliver the superior service necessary to meet all of your needs. Aseptic systems (autoclaves, depyrogenation ovens, tunnels, cleanrooms, vial washers), Biotech systems (bioreactors and fermenters, cell harvest), APIs (reactors, mills, centrifuges), and Solid and Liquid Dosage Products are just a few of the facilities, systems, and equipment they have experience with (blenders, tablet presses, solution prep, liquid fill machines).

We may ease short-term workloads that may exceed your available resources by offering hands-on validation support, qualification templates, and the creation and execution of validation and compliance papers.

We provide a wide range of services, such as New Instrument Setup and Qualification Consultants in Canada, Facility Qualification, Equipment Qualification, Temperature Mapping, Cleaning Validation, Process Validation, Computer Validation, and many more.

For the most cutting-edge solutions for your new or existing facilities, our team of New Instrument Setup and Qualification Consultants in Canada brings a wealth of knowledge to the table. We offer the following services:

Qualification of Facilities, Critical Utilities, and Equipment

• Purified by USP
• Deionized Water, Reverse Osmosis, and Water-for-Injection (WFI)
• Fresh Steam
• Clean-in-Place/Steam-in-Place
• Constricted Gasses
• HVAC
• Qualified Air Handling Unit (AHU)
• Filter Integrity of HEPA
• Airflow Research
• A tidy room
• Class 100
• Grade 10K
• Type 100K
• Planning for Manufacturing Requirements (MRP)
• Management Systems for Buildings (BMS)
• Airlocks, restrooms, washrooms, and technical rooms inside production areas must all be qualified.

Method Validation

• Chemicals in bulk and APIs
• stable dosage
• cycles of sterilization
• Systematic sterilization
• Biotechnology
• Vaccine Producers
  

A process will consistently generate a product that satisfies its predetermined quality attributes, according to the recorded proof provided by process validation, which is done with a high degree of certainty. Process Validation normally happens following the successful completion of the Installation Qualification (IQ), Operational Qualification (OQ), and (if necessary) Performance Qualification (PQ). A thorough process development, the identification of controllable and crucial parameters, and in-process and finished product specifications are necessary for successful process validation. For process validation, typically three consecutive lots of products must meet the stated quality specifications. These three lots in a row are finished on the edges of crucial criteria.

Validation of Cleaning

Cleaning validation is evidence that a system or piece of equipment can be cleaned consistently and effectively. The goal of cleaning validation, according to New Instrument Setup and Qualification Consultants in Canada, is to guarantee that a particular cleaning process will consistently clean to predetermined limits to prevent contaminants (related to either the product or the cleaning process) from leaving residues that will adulterate and negatively affect the safety and quality of the following product manufactured.

• Plans for cleaning validation
• Cycle Formation
• Design-of-Experiments (DOE) (DOE)
• Choosing efficient grouping techniques
• Choosing sampling techniques
• Development and Application of Protocols
• Recovery studies with swab and rinse
• Method Development and Validation for Analytical Tests
• establishing sample acceptance standards and residual limits

Validation of Computer Systems and Software

Computerized systems that carry out legally required tasks need to be certified or validated. Computer validation calls for a cross-functional skill set that includes business insight, software modeling, IT experience, and a practical understanding of QA (including GXP procedures and computer validation).

In Conclusion  -  

 The validation team for Gxp Cellators Services is familiar with GAMP and the software development lifecycle approach. Our staff provides a full variety of services for your computer validation needs and new instrument setup and qualification consultants in Canada thanks to their specialized skill sets. At TrackWise, Delta V, SAP, and custom software validations, we excel! For software implementation and validation projects, we provide full-service outsourced quality assurance services!