Validation Policy in Pharmaceuticals | Purpose, Scope and Benefits

Validation is one of the main aspects of pharmaceutical quality assurance. It establishes documented proof that facilities, utilities, equipment, processes, cleaning procedures, analytical methods and computerized systems operate in the required way. Validation policies prescribe how the validation process will be managed in the facility while validation reports are applicable to particular systems.

Companies that have a good validation policy are always more effective in dealing with validation tasks and have fewer problems with compliance inspections. Validation policies maintain consistency among departments and take scientific evidence into account while making decisions concerning validation.

A validation policy does not present validation procedures itself but specifies needs and responsibilities regarding validation activities.

What is a Validation Policy?

Simply put, a validation policy is an important document that describes the philosophy and commitment of a company regarding validation. A validation policy includes the process of validating an activity and how the validation activities will be planned, conducted, reported, reviewed, authorized and controlled to ensure compliance with the relevant Good Manufacturing Practices (GMP).

The validation policy covers all those processes where validation is critical for compliance with GMP. Validation policies should not be confused with Standard Operating Procedures (SOPs) and Validation Master Plans (VMPs). SOPs detail specific activities, while VMPs summarize the summary on overall validation projects. Instead, validation policy provides the overall concept of validation in the organization.

Objectives of a Validation Policy

A validation policy needs to support the pharmaceutical quality system by ensuring consistent, risk-based and science-grounded validation efforts undertaken throughout the organization. The main purpose of ensuring validation policies is:

• To have a uniform validation policy across the organization
• To comply with regulations
• To define roles and responsibilities
• To encourage lifecycle validation
• To help quality risk management

Through these objectives, the fact of validation being part of daily pharmaceutical activities becomes evident.

Scope of the Validation Policy

The policy must make it clear which systems are subject to validation or qualification. Commonly included are:

• Manufacturing operations
• Equipment qualification
• Utilities systems
• HVAC systems
• Water systems
• Validation of cleaning procedures
• Sterilization process
• Computerized systems
• Validation of analytical methods
• Laboratory apparatus
• Packaging operations
• Transportation and cold chain management

The limitations in question should be in line with the products produced in the plant, processes adopted for manufacturing and provisions provided by regulations.

Key Elements of a Validation Policy

Although different organizations may present the validation policy in forms which may be different from one another, in order to make the validation policy effective it should contain different important elements.

1. Validation Philosophy

The validation policy should say that validation measures will be performed via a lifecycle/systematic approach following the scientific principles and the quality risk management principles which ensure the stable performance of the processes.

2. Roles and Responsibilities

The policy should outline the roles and responsibilities of the essential departments, such as:

• Quality Assurance
• Validation
• Manufacturing
• Engineering
• Quality Control
• Information Technology (as to computerized systems)

Clear responsibilities ensure better coordination and accountability.

3. Risk-Based Validation

The validation measures should be performed based on the priority of their importance for product quality and patient safety. High-risk systems usually need more thorough validation procedures compared to low-risk systems.

4. Documentation Requirements

The policy also indicates the necessity to document validation processes through valid protocols, reports, deviation records and other necessary supporting documents. Proper documentation is vital for demonstrating compliance during inspections.

5. Change Control

Additionally, the policy is to indicate that any change which influences validated processes must be assessed via change control procedure. The necessity for further qualification and revalidation depends on the impact of such change.

6. Periodic Review

Eventually, the validated systems are to be verified from time to time in order to make sure that they keep operating according to the approved limits.

Relationship Between Validation Policy and Validation Master Plan

Although the Validation Policy relates to the Validation Master Plan (VMP), each serves distinct purposes. The Validation Policy indicates the principles and rules applied for validation.

On the other hand, the Validation Master Plan explains how the principles laid out in the policy can be applied at a site choosing which systems need validation, when, who will carry out the validation, what documents are required, how quickly the process can be completed and so on.

In other words, while the policy indicates the thoughts of the company, the VMP reveals how these thoughts would be brought to life at the site.

Benefits of a Well-Defined Validation Policy

A good validation policy has many administrative and regulatory benefits.
Some of them are as follows:

• Standardization of validation practices in various departments
• Improved compliance with GMP requirements
• Increased efficiency in teamwork between departments
• Decrease in discrepancies between validation practices
• Improved change management
• Improved readiness for inspections
• Better management of the product lifecycle
• Confidence in product quality

According to my experience, companies with an established validation policy manage to dedicate less time to solving validation issues.

Common Weaknesses Found During Audits

Frequent inspections sometimes reveal problems linked to governance of validations.
Common observations are:

• No validation policy
• Outdated policies
• Unclear responsibilities
• Weak connections with change control
• No lifecycle validation principles
• Bad document control
• Validation activities not consistent with the policy

These issues tell one that weaknesses exist in the pharmaceutical quality system rather than indicating isolated validation problems.

Best Practices for Successful Validation Policy

In order to create a successful validation policy, pharmaceutical manufacturers should implement the following best practices:

• Make sure that the policy is in compliance with the current good manufacturing practices (GMP) regulations and with the company’s quality objectives.
• Establish the scope of systems to be validated.
• Specify who is responsible for approving, executing and reviewing the process.
• Utilize principles of quality risk management.
• Make connections between the policy and the Validation Master Plan and the systems of change control.
• Review the policy periodically so as to update it according to the requirements of the authorities, as well as operating improvements.
• Train the personnel involved in implementation of the policy.
• Get support from top management.

A validation policy sets forth guidance for all validation procedures in a company. It provides a unified framework for the implementation and maintenance of validations during the operation of GMP systems. The policy performs the role of the cornerstone of a strong validation system through assignment of responsibilities to various parties, establishment of the principles of risk-based decision-making and the association of validation processes with change control and quality management activities.

From my own experience, organizations with well-laid-out and implemented validation policies are the ones that successfully fulfill all the regulatory requirements and improve their productivity and product quality. It must be noted that, although the validation policy is a general document, it has a far-reaching impact on all activities that take place in a company.

Regulatory References

1. FDA Process Validation: General Principles and Practices
https://www.fda.gov/media/71021/download
2. ICH Q9(R1): Quality Risk Management
https://database.ich.org/sites/default/files/Q9%28R1%29_Guideline.pdf
3. ICH Q10: Pharmaceutical Quality System
https://database.ich.org/sites/default/files/Q10_Guideline.pdf

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