INTRODUCTION

 

Founded in 1984, Walthers & Associates (W&A) provides cGMP Validation Services to the pharmaceutical and related industries. Since that time, experience and in-depth involvement has led us to branching out into additional areas of this dynamic field. We provide services to the pharmaceutical, biotechnological and medical device industries in the following areas:

pillcool.jpg (1338 bytes)Compliance Audits

pillcool.jpg (1338 bytes)Validation Assessment Audits

pillcool.jpg (1338 bytes)Validation Master Plan Preparation

pillcool.jpg (1338 bytes)IQ/OQ/PQ Protocols and Testing

pillcool.jpg (1338 bytes)Computer System Validation

pillcool.jpg (1338 bytes)Standard Operating Procedure Development

pillcool.jpg (1338 bytes)Functional Specification Development

pillcool.jpg (1338 bytes)System Design Specifications Development

pillcool.jpg (1338 bytes)cGMP Training and Training Documentation

pillcool.jpg (1338 bytes)Project Management

The focus of these services is to assist the client with the increasing demands and complexity of FDA regulations. We have an excellent history of quality service and a track record of positive results with FDA compliance requirements and are committed to the principles of quality, integrity, service, and continual improvement.

COMPLIANCE AUDITS

W&A’s Compliance Audits focus on facilities, utilities, equipment, computer hardware, software, processes or all. Audits are specifically tailored to the need of the client to determine any gaps or potential areas of concern. They are to determine the client's compliance with regulations and the risk, if any, that may be encountered during an inspection or investigation.

VALIDATION MASTER PLANS

W&A’s Validation Master Plan process involves all the disciplines necessary for the successful completion of a validation project. By incorporating the vital aspects of design, engineering, and validation into your master plan you are provided with an effective tool to guide you, your contractor, and your validation team through the validation project.

Our Validation Master Plans include a detailed description, detailed testing requirements and specific acceptance criteria. Taking a detailed approach to the master plan is an effective and efficient way to assure a successful validation project. The client and all contractors have a clear understanding of what is to be validated, how it is to be validated, and together, they have established the information necessary to facilitate development of validation protocols.

DESIGN REVIEWS

The goal of any validation project is to achieve a validated facility and process. With this in mind, we recommend that W&A be a regular participant in design meetings to help accomplish this goal.

W&A personnel have significant experience in reviewing design packages, including component specifications, schematic and piping installation drawings, plus construction specifications and procedures. Our involvement in the design phase, working closely with your engineering firm, provides early identification of potential validation problems or errors that can lead to potential delays and/or difficulties in the qualification of a facility.

INSTALLATION AND OPERATIONAL QUALIFICATION

W&A provides thorough documentation and evaluation of the installation of your systems and equipment. The Installation Qualification protocol will include:

pillcool.jpg (1338 bytes)Description of the system/equipment

pillcool.jpg (1338 bytes)Utilities verification

pillcool.jpg (1338 bytes)Identification of component specifications

pillcool.jpg (1338 bytes)Identification and documentation of instruments

pillcool.jpg (1338 bytes)Identification and verification of documentation

pillcool.jpg (1338 bytes)Support documentation including applicable SOP’s

pillcool.jpg (1338 bytes)Any discrepancies observed

W&A provides thorough documentation and evaluation of the Operational Qualification protocol and will include tests designed and implemented to challenge systems and equipment in a manner appropriate to their design and use requirements. In both cases any discrepancies will be documented, the client notified, and a detailed plan devised to correct the discrepancy and re-test.

Our protocols are designed to be documents for use in compliance with FDA regulations, and as a potential tool for re-validation should the system/facility be modified.

COMPUTER SYSTEMS VALIDATION

W&A supports the life cycle approach as well as the GAMP guide to implementing and validating computer systems used in the manufacture of drug products. We develop and implement test protocols designed to test individual modules, and build up to testing the totally integrated system operation. W&A testing includes documenting all hardware associated with the system including the documentation of how the hardware is configured. When possible, W&A participates from the inception of the system through its implementation validation.

W&A has experience in the following:

pillcool.jpg (1338 bytes)Programmable Logic Controller (PLC) Control Systems

pillcool.jpg (1338 bytes)Distributed Control Systems (DCS)

pillcool.jpg (1338 bytes)Stand-Alone Microprocessor Based Controllers

pillcool.jpg (1338 bytes)Personnel Computer Based Control Systems

PERFORMANCE QUALIFICATION TESTING

W&A offers performance qualification services to provide the necessary documented evidence to establish the reproducability of processes and equipment performance. Each performance qualification protocol will address:

pillcool.jpg (1338 bytes)Purpose

pillcool.jpg (1338 bytes)Method

pillcool.jpg (1338 bytes)Equipment

pillcool.jpg (1338 bytes)Acceptance Criteria

pillcool.jpg (1338 bytes)Results

pillcool.jpg (1338 bytes)Conclusions and Recommendations.

Each PQ protocol is designed to include the appropriate challenge necessary for the design and application of the system or equipment.

FINAL REPORTS

Final reports are the end-product of any validation activity. Final reports are the most important aspect of demonstrating the credibility of the validation firm, and the compliance of the client company.

W&A uses a format for final reports that provides a clear and concise summary of test results versus acceptance criteria. During the course of extended validation testing projects, W&A provides periodic summary/progress reports to the client’s personnel. These summary/progress reports are intended to highlight any testing abnormalities or failures that may occur. These summary reports allow the client to correct any deviations in a timely manner.

Final reports are prepared for:

pillcool.jpg (1338 bytes)Installation Qualification

pillcool.jpg (1338 bytes)Operational Qualification

pillcool.jpg (1338 bytes)Computer System Validation

pillcool.jpg (1338 bytes)Performance Qualification

pillcool.jpg (1338 bytes)Compliance Audits

STANDARD OPERATING PROCEDURES

W&A writes Standard Operating Procedures which describe the proper methods for operation, maintenance, cleaning and calibration methods for the equipment according to manufacturer's recommendations.

These SOP’s will give the client a firm base from which to begin operations and will enable the client’s operators to use the equipment and expand on the SOP’s where needed.

VALIDATION REVIEW

W&A provides review services of validation packages written and executed by clients or other validation service-related firms. These reviews are thorough and provide the client with assurance that the validation and testing performed adequately challenge the operating limits of the equipment being tested and contain all areas defined in the functional and design specifications.

EXISTING SYSTEMS AND EQUIPMENT VALIDATION

W&A supports validation of systems and equipment already in place and in use. This validation is similar to that described in the preceding sections, but is limited to documentation of the systems and equipment on an "as found" basis. W&A testing includes documenting all hardware and software associated with the system including how it is configured. Systems and equipment qualifying for existing validation include systems or equipment that have not been validated and for which validation is required.

CONSTRUCTION QUALIFICATIONS

W&A can provide a validation team for your construction site that will remain on-site from the beginning of construction through implementation of the validated facility. We can be most effective if we are closely involved in the verification of construction/installation activities versus design requirements. W&A will also coordinate the control of documentation for construction , and, if necessary, will create a document control system which centralizes storage and controls access to the following:

W&A can be on-site to collect information such as:

pillcool.jpg (1338 bytes)Documentation to write Installation and Operational Qualification (IQ/OQ) protocols

pillcool.jpg (1338 bytes)Inspect incoming materials and equipment against current specifications

pillcool.jpg (1338 bytes)Produce a photographic record of the construction and/or installation of  validatable systems

pillcool.jpg (1338 bytes)Verify "as built" drawings for validatable systems

A written report that summarizes our findings versus design requirements is provided.

PROJECT MANAGEMENT

W&A Project Managers work closely with customers and contractors to develop a comprehensive validation project plan and schedule. A Project Manager can facilitate and coordinate the resources necessary to complete the validation project.