Services - cGMP Validation LLC

Equipment

cGMP Validation provides Commissioning and Qualification services for a wide variety of process equipment, including, but not limited to, the types listed below.

cGMP Validation also provides Factory Acceptance Testing and Site Acceptance Testing support.

Utilities

cGMP Validation provides Commissioning and Qualification services for a wide variety of utility systems, including, but not limited to, the types listed below.

Chilled Water / Glycol Systems
Compressed Air Systems
USP / PW Water Generation and Distribution Systems
Compressed Gas Systems
WFI Generation and Distribution Systems
HVAC Systems

cGMP Validation also provides Factory Acceptance Testing and Site Acceptance Testing support. cGMP Validation also provides Commissioning and Qualification services for facilities, including those required to demonstrate compliance with an air quality or international standard, such as:

Cleanroom / Controlled area construction
HVAC Performance Qualification
Environmental Baseline studies
Preparation of SOPs for process flow

Laboratory Instruments

cGMP Validation provides Qualification services for a wide variety of utility systems, including, but not limited to, the types listed below.

Biorobotic Systems
GC, HPLC and Software
Weighing and Dispensing Systems
Microplate Readers
DNA and Peptide Sequencers
Laboratory Centrifuges
Laboratory Information Management Systems

Processes

cGMP Validation provides Validation services for many process, including, but not limited to, the types listed below.

cGMP Validation provides Validation services for Product Validation (Rx and OTC):

Auditing

cGMP Validation offers many services to aid clients in meeting regulatory and compliance expectations including, but not limited to, the following:

Auditing

cGMP Validation offers specialized auditing service of vendors, suppliers and contract laboratories. cGMP can assist you in building a vendor qualification program for raw materials or services.

Risk Assessments

cGMP Validation also provides internal auditing services and can provide a report based on quantitative evaluations of programs, procedures, policies, and practices at your site(s). Relative risk of each parameter or area reviewed will provide prioritization awareness needed to successfully remediate any situations not in compliance with agency, industry, or internal standards.

Regulatory Consulting

cGMP Validation helps clients develop and implement sound cGMP compliance strategies. cGMP Validation can assist your company with these and other compliance an regulatory activities.

Preparation for FDA inspections, particularly pre- and post-approval inspections
Evaluation of Quality Systems with quantitative evaluation reports
QA / QC documentation review
Development of Quality Systems
Plan Presentations to FDA
Development of Quality System SOPs
Design Reviews
Responses to FDA observations or action

Educational Training

cGMP Validation offers on-site training for client staff and management, as well as for your vendors and / or contractors. Common topics include:

Good Manufacturing Practices (21CFR 210, 211)
Validation protocol generation and execution
FDA Pre- and Post-Approval Inspections
Current Industry Trends
Client SOPs
Facility Design

cGMP Validation can develop a custom training program for you company’s internal procedures.

cGMP Validation will provide training course documentation suitable for your training records.

Computer Systems Validation

cGMP Validation has experience in all areas of computer and automation validation. cGMP Validation has led computer validation projects for the following representative systems:

Computerized Systems Validation, support documentation development
Computerized Systems Guidelines Development
Computerized Systems Configuration
Laboratory Management Systems (LIMS)
Software Quality Assurance and Quality Control
Building Management Systems (BMS)
Automation / Controls System Validation for temperature, humidity, access control, and similar functions

Supervisory Control and Data Acquisition Systems (SCADA)
Programmable Logic Computers / Controllers (PLC)
Data Migration Plan development
Bar code, material handling, inspection systems, and process monitoring systems
GMP / GAMP Compliance Assessment and Remediation
21CFR Part 11 Assessment and Remediation

21 CFR Part 11

cGMP Validation can help you understand and implement a risk-based approach to compliance with 21CFR Part 11, rooted in the Final Guidance for Scope and Application provided by FDA.

Our experience will help you determine the Part 11 relevance to your processes.

Our staff maintains certification and ongoing education to be able to provide advice in which you can be confident.

cGMP Validation can provide all phases of activities needed for compliance with this regulation from gap-analyses and remediation planning for existing systems to prospective assessments of new systems.

Other Services