Validation Services- Sterile and Non-sterile Operation


When it comes to validation services, proGamma Science brings a vast experience to the table. Our primary area of service is fulfilling validation, regulatory and compliance. Our Validation, Regulatory, and Compliance division offers a full range of validation services for Sterile and non-sterile operations, including the following:


Validation Master Plan Development

The Validation Master Plan is the top level document which identifies the scope and depth of validation required delineated system by system. It is a living document, which is constantly updated and amended during the course of the project. It describes the tests to be performed and it identifies the systems, computer systems and processes to be validated. It also defines the responsibilities of the various groups (QC, engineering) during the validation of the equipment or facility. It is a critical part of a successful project and the usual starting point.

Installation Qualification Protocol (IQ)

IQs represent verification in the field that the equipment has been installed properly in accordance with design specifications and manufacturer’s recommendations. IQs also verify that utility connections conform to manufacturer’s specifications and confirm the existence of equipment SOPs, preventive maintenance programs, sanitization programs, and operator training programs.

Operational Qualification Protocol (OQ)

OQs verify by actual testing that the equipment is capable of operating in accordance with specifications and requirements. Equipment capability and operating ranges are established separately for each machine and not as part of a process or system. The document includes data recording, filing reference, testing SOPs, and operating parameters (speed, temperature, etc.)

Performance Qualification (PQ)

PQ's verify by actual testing that the equipment is performing to manufacturer’s specifications and your requirements. PQ's verify that the equipment is operating correctly and will not cause product loss during manufacturing and packaging.


SOP Development - Sterile and Nonsterile Operations

proGamma Science can provide services to write your facility's SOPs. SOPs are standard operating procedures that describe how to perform basic operations in the facility. SOPs will be written to be easily understandable and logically organized.
The following list includes a sampling of the SOPs required for plant-wide certification:
· General SOP procedures to generate, review, and approve SOPs
· Equipment SOPs
Cleaning (sanitization), Sterilization, Maintenance, Operation, Calibration
· Personnel SOPs
Job description (general), Personnel practices & cleanliness, Personnel training (general)
· Control SOPs
Receipts (raw material), Stability and quality testing, Rotation of stock, Product sampling, Labeling, Product distribution
· Facilities
Physical facilities, Cleaning (sanitizing), Plant maintenance, Environmental control, Safety, Housekeeping

Cleaning Validation - Sterile and Nonsterile Operations

Development of cleaning programs in general is a rigorous, time consuming and often frustrating experience. The objective of cleaning validation is to ensure that a specific cleaning process will consistently clean to predetermined limits so as to prevent contaminants (product or cleaning process related) from leaving residues that will adulterate and adversely affect the safety and quality of the next product manufactured. Cleaning validation is documented proof that one can consistently and effectively cleanse a system or equipment item. proGamma Science Corp has extensive experience in developing meaningful acceptance criteria and ensuring the execution is conducted in an orderly manner. Our experienced staff can provide services in Cleaning validation. Our highly skilled individuals can ensure that equipment-cleaning procedures are removing residues to predetermined levels of acceptability. These individuals are trained to:
· Understand regulatory (FDA) requirements, guidelines and expectations
· Select and evaluate effective cleaning methods and processes
· Establish residue limits and calculate sample acceptance criteria
· Select sampling and analytical methods
· Simplify the cleaning validation program.


Computer Validation - Sterile and Nonsterile Operations

The purpose of the Computer Validation (CV) is to verify that all aspects of a system specific to an automated control system and application specific source code are satisfactorily tested, and meet defined acceptance criteria. proGamma provides validation services for all types of standard and custom computer systems, including automated and semi-automated processes controlled by a DCS (Distributed Control System), PLC (Programmable Logic Controller), and similar computer systems. With the FDA's new Part 11 ruling, it is critically important to insure your system has been properly validated.
We also carry out vendor audits of developers of software to determine compliance to the GMP, GLP, GCP, 510(K), GAMP and international standards such as ISO 9000, IEEE, and ANSI. An integral part of the overall validation effort involves qualification studies for the computer hardware/software controlling and/or monitoring utility systems and process equipment as well as information systems. We have a specialized Computer Validation Team to meet your system, network and workstation validation needs.
When you install a new computerized system we will supervise the installation of the computer system and prepare the installation, operational and performance qualification protocols, as specified in the Validation Master Plan. Our process consists of validating the equipment, hardware, and software as one unit. We can assist with project planning, system design requirement analysis, configuration, data issues and system retirement.
For higher level systems such as client-server systems, we will develop IQ, OQ, and PQ protocols, and ensure compliance to 21CFR Part 11. We will tailor our solutions to your individual validation needs with today's rapidly evolving technology.


Process Validation - Sterile and Nonsterile Operations

A process is the controlled interaction of components, equipment, environment, software and personnel to produce a product or achieve an acceptable outcome. proGamma Science Corporation provides the consulting expertise to demonstrate through appropriate testing that the finished product produced by a specified process meets all release requirements for quality. The process validation protocol describes a plan that demonstrates consistency and reliability in processing and confirms that all component, processing and product specifications are appropriate and attainable under ideal and challenged conditions. The Process Validation effort typically occurs after the Installation Qualification (IQ), Operational Qualification (OQ), and (when required) a Performance Qualification (PQ) have been satisfactorily completed. Successful process validation requires thorough process development, identification of controlled and critical parameters and in-process and final product specifications. Typically at a minimum three (3) consecutive lots of product meeting the established quality specifications are necessary for process validation. These three consecutive are completed at the boundaries of critical parameters.

Equipment Qualification -

- The FDA guideline states that "it is important that equipment qualification simulate actual production conditions, including those which are 'worst case' situations," and that "tests and challenges should be repeated a sufficient number of times to assure reliable and meaningful results." proGamma Science Corporation ensures that multiple tests are performed to simulate actual operating ranges and to establish consistency of operation.
-proGamma Science’ Installation Qualification Protocols include data forms for the equipment. The consultants use pre-approved Operational Qualification Protocols for testing equipment operation. proGamma Science will work with you to combine the commissioning of new equipment with the Installation Qualification to avoid duplication of information. Analytical Laboratory equipment qualification and validation of LIMS is offered by experienced consultants.For sterile operation we offer various services of commioning such as qualification of clean room , evaluation and verification.






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