Preparing for Validation

Our standards have been utilized throughout the industry and are kept up-to-date with the FDA's and EMEA's latest Regulations and Guidelines, along with supporting agencies publications and Industry practices.

The Compliance Group can support you in the many areas of validation:

Equipment and Utility Validation
Cleaning Validation
Computerized Systems Validation
Sterilization and Sanitization Validation
Process Validation



Validation Master Plan

A properly validated system starts with the introduction of the Validation Life Cycle described in our Validation Master Plan...

Our Standard Validation Master Plans are structured,

to clearly define proper Validation/Qualification path for GXP relevant areas in a clear format
to identify the background, facility, process, boundaries and critical systems
minimum requirements to assure a validated process
to define the specific test functions and acceptance criteria
and to define support systems and procedures to assure continued compliance throughout the systems
validation lifecycle.

Many Validation Master Plans have been developed by our compliance consultants and are available to apply to your process:

Validation Master Plan - Facility & Equipment, Process
Computerized Systems Validation (CSV) Master Plans
Cleaning Validation Master Plan



Validation Procedures

Our standard package of procedures includes basic procedures to assure compliance during the qualification. These procedures are:

Validation Overview
Good Documentation Practices
Protocol Review and Approvals
Preparing Qualification Protocols
Executing Qualification Protocols
Comments and Deviations
Preparing Summary Reports

Our compliance consultants have developed magnitudes of procedures for all processes, which are available for your review. Also see our Quality Systems Section - Policies, Programs and Procedures.



Equipment / Utilities

Our validation engineers have developed and executed protocols for equipment and utility systems and completed projects in all areas and all type of products in the primary and secondary manufacturing. We are qualified to validate all types of Utility Systems and Equipment. Some of these areas are listed below:

Water System Qualification, System Walk Down Ultrasonic Flow Monitoring, Water Sampling - TOC, Bioburden,
etc.
Room Qualification Particle and Viable Monitoring, Touch Plates, Air Flow
Temperature Mapping Autoclaves, Warm and Cold Rooms, Freezers
Solid Dosage Equipment Fluid Bed Dryers, Capsulation Machines & Tablet Presses, Blistering Machines
Fermentation and Cell Cultures Sanitization and Sterilization, Tanks and Process Piping, Cell Mates and Puma
Robotic Systems, Chromatography & Ultra-filtration
Filling, and Packaging Depyrogenation Tunnel Liquid and Parenteral Filling Equipment, Visual Inspection Systems, Packaging Equipment