commissioning, qualification, & validation (CQV)

+3,500

Projects Executed

+650

Clients Supported

17 years

Average Staff Experience

+40%

Clients we've supported for over a decade

Validation Program Development

We partner with organizations to develop and implement continuously reliable and compliant validation programs that help clients successfully bring products to market. ProPharma utilizes a scalable/flexible approach to ensure the validation program is right-sized based on clients’ industry, clinical/commercial stage and size.

Gap
Assessments

Our gap assessment process utilizes a planning, execution, and reporting format focused on identifying program gaps and recommended corrective action/remediation.

Facility, Equipment, & Utility Qualifications

Projects ranging in size from small system qualifications to full greenfield/brownfield facility buildouts are routine. Our in-house project managers and SMEs have vast industry experience, transferring knowledge and expertise to the project team to ensure a seamless and efficient approach. Whether it is a single project or a portfolio of CapEx / OpEx projects at a single site, we are built to execute successfully.

Cleaning & Sterilization Validation

Our sterilization services include the physical (IQ and OQ) and microbiological inactivation (PQ) testing aspects for steam sterilization, dry heat, and vaporized hydrogen peroxide.

Our cleaning services involve a defined clustering approach of products, protocols, defined assays and limits, protocol writing, in-test lab selection support, execution of testing support, and reporting that results in effective controls for limiting the bioburden.

Process Validation

ProPharma’s product lifecycle approach towards process validation in pharmaceuticals and biotech helps you deliver optimal product quality by identifying the presence and degree of process variation and the impact variation has on process efficiency and product quality. Minimizing the variation reduces risks and ensures a robust process that reliably produces quality product.

Project Management

Through its internal project management process, ProPharma provides full oversight for validation services or capital project management outsourcing.  ProPharma has successfully executed thousands of C&Q projects over the last 20+ years providing various levels of project management focused on schedule, cost, communication, and conflict management.

Staff Support & Outsourcing

At ProPharma, our network of 1,000+ CQV professionals can augment your internal capabilities to ensure project timelines are met utilizing experienced professionals. Our team acts as an extension of your engineering/quality/validation department, while our management team provides you with a direct line of communication for any operational assistance related to the resources deployed.

FDA & ISO Experience

We have in-depth knowledge of 21CFR Parts 210, 211, 11, & 820 and ISO13485.

Industry Standards & Best Practices

Flexible Approach

Right-Sized Solutions

We provide tailored CQV-related policies and procedures to clients at the level of equipment usage and related regulatory and business risk they need.