Validation Survival Kit

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Master Planning for Validation: Doing it Right!

The Validation Master Plan (VMP) is a scope document aimed at outlining the approach of validating the healthcare product production facility and process. Its intent is to define and enumerate critical systems to be validated and outlines the approach to validate such systems. The VMP’s main objective is to outline in sufficient detail the approach to be taken by an organization to develop documented evidence that the process used to manufacture the Pharmaceutical, Biopharmaceutical or device, will result in a product which meets its predetermined quality attributes. This presentation will discuss a pragmatic way of getting it done.

This seminar presents a recommended validation approach and will define the contents of a typical validation master plan. This seminar will also present real life examples to illustrate the points being made. Additionally, the presentation will provide ideas as to what should be included into the various sections of the VMP. Finally, we will discuss steps to be taken to ensure the VMP is developed on a timely basis and earn the buy-in and commitment from all stakeholders within the organization. Following this approach would result in increasing the probability that the VMP will be approved and successfully implemented.

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Master Planning for Validation: Doing it Right!

Part I - Validation and Master Planning

• Defining validation
• Defining how validation is conducted
• Determining the need for a validation master plan
• The basic contents of a master plan
• Identifying what each section should contain
• Identifying which systems require validation
• How to schedule validation activities
• What it takes to develop an effective Master Plan
• How to get your Master Plan approved

Validation Protocol Development and Acceptance Criteria

The validation protocol is the road map, which guides the qualification effort for a given piece of equipment or system. It not only describes in detail what experiments would be conducted but also serves as a repository of the data collected during the execution of the document. The validation protocol also defines the objective results to be met by the testing; these are usually referred to as predetermined acceptance criteria. This seminar will show you how to define the acceptance criteria and develop a successful protocol.

This seminar begins by describing the industry standard for using protocols to complete the validation effort. It then proceeds by defining what each protocol’s objective is. Next is defining the contents of a typical validation protocol and real life examples to illustrate the points being made. We will discuss protocols for utility systems, process equipment and cleaning validation. Additionally, the presentation will provide ideas as to what should be included into the various sections of the protocol. Finally, we will discuss steps to be taken to ensure the protocol is developed and approved easily and on a timely basis. These suggested steps would result in increasing the probability that the protocols will be developed and executed with a minimum number of rewrites and deviations.

Validation Protocol Development and Acceptance Criteria

Part I - Validation Protocol Development and Acceptance Criteria

• Defining validation
• Determining the need for protocols
• Determining how validation is conducted
• Defining the various types of protocols
• Determining acceptance criteria and how to define them for use in protocols
• The basic contents of validation protocols
• What the protocols should accomplish
• What it takes to develop an effective protocol and getting it approved

Validation Protocol Execution and Addressing Deviations

This seminar presents an overview of a proposed methodology to execute validation protocols. We will review the requirements to be fulfilled to facilitate protocol execution. The seminar will define who is to execute the protocols, the need for calibrated instruments and validated analytical methods. The discussion will also define validation protocol deviations and how to address them. This will be accomplished by proposing a systematic approach to addressing the deviations and provide a logic tree, which when followed will result in resolving such deviations. Finally we will review how to prepare a final report summarizing protocol execution, which should be easily approved. This discussion will provide the validation professional with ways to expedite the validation effort and avoid protocol execution deviations related delays during the execution of the validation program.

A new facility for drug processing has been built; a Validation master Plan (VMP) was developed and approved. All necessary documents associated with the process and facility have been collected and the proper protocols have been developed and approved. Protocol execution begins once the equipment is installed and becomes operational. The personnel required is defined and begins the execution. They need the proper instruments and the appropriate laboratory support. Invariably deviations and non-conformances will be encountered. These deviations must be addressed and resolved prior to completing the validation effort and summarizing the results. The final step of summarizing the result and confirming the process is validated and acceptable for use is the culmination of this effort and hence a critical step in the effort.

Validation Protocol Execution and Addressing Deviations

Part I - Validation Protocol Execution

• Defining validation
• Identifying the protocols required to complete the validation effort
• Determining when the protocol execution takes place during the validation effort
• Determining who executes the protocols
• Determining what is needed for ensure successful execution
• Information to be gathered for each protocol
• Identifying what is needed for successful execution of validation protocols

Part II - Addressing Deviations

• Defining deviations/non-conformances and how to address them
• What to do when you encounter a nonconformance or deviation during protocol execution
• How to resolve these non-conformances or deviations
• How to close the protocol

Validation and Change Control: The Validation Life Cycle

This seminar presents an overview of validation and change control as they pertain to pharmaceuticals manufacturing.  Dr. Amer will review the general validation approach, define what is meant by a validated state, and identify the need for having a change control system and procedure in place. He will define what a change control system entails and propose an outline of a robust change control procedure. The concept of validation life-cycle will also be introduced and its meaning discussed at length. The importance of change control in maintaining the validated state and closing the validation cycle will be discussed.

Managing changes in pharmaceuticals manufacturing through implementing a change control procedure is a regulatory requirement. Manufacturers of drug products are required to maintain the operations in a validated state and to have a change control system in place. This seminar is aimed at introducing the concept of a validated state and managing change within the validation life cycle. Dr. Amer will draw on his vast experience in the pharmaceutical industry to explain the concepts and provide many real life examples to support these concepts.

Validation and Change Control: The Validation Life Cycle

Part I - Validation and Change Control

• What is meant by validation and its confirmatory nature
• How validation is conducted
• The validated states and the importance of maintaining them
• The Validation Life Cycle
• The types of change and their potential impact on the validated state
• What a change control system entails and its importance
• What a robust change control system and procedure may look like and entail

Gamal Amer, Ph.D.

Gamal Amer, Ph. D. is Principal at Premier Compliance Services, Inc.; Management Consultants for compliance and manufacturing operations performance in the life sciences industry. He holds a Ph. D. in Chemical Engineering and has over two decades experience in the Pharmaceutical and related industries. He has held positions of increased responsibility with leading pharmaceutical, consumer product and engineering consulting firms over the years. His experience includes comprehensive process design in bulk pharmaceutical manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations.

Dr. Amer is a recognized expert in GMP compliance and validation. He has consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers. He has lectured extensively in the US, Europe, Asia and the Middle East, taught many courses, and authored many papers which were published in peer reviewed publication. He is a member of ISPE, PDA, ACS and AIChE.