Fundamentals of Validation SOP

Purpose: The goal of establishing Fundamentals of Validation SOPs is to help the parent business, affiliates, and contract manufacturers understand and maintain the validation program in order to meet GMP regulations.

Responsibility: The quality assurance manager is responsible for developing and maintaining the validation program. Compliance with SOPs is the responsibility of departmental managers and contrac­tors.


1. Purpose and Scope of Fundamentals of Validation

The quality assurance department is responsible for helping the parent business, affiliates, and contract manufacturers understand and maintain the validation program in order to meet GMP regulations. Validation SOPs (Fundamentals of Validation) are needed to give step-by-step guidance in achieving validation.

2. Definitions of Validation

  • Proving that any procedure, process, equipment, material, activity, or system truly leads to the expected result in accordance with the principles of the good manufacturing practice.
  • Evidence that a specific procedure will consistently produce a product that meets its set specifications and quality attributes and properties.

3. Justification of Validation

Validation is basically good business practice. The objective is to achieve success in the first production of a new product.

  • Government regulations: However cGMP regulation was established by the government, but basically it only provides guidelines, but it does not provide the path or steps to achieve validation results. The validation master plan (VMP) and related SOPs, on the other hand, clearly define roles: who, when, where, and how much is enough to demonstrate.
  • Assurance of product quality: Because the over-quality of a given process cannot be confirmed due to the small sample quantity, validation offers assurance in the quality of manufactured items. Validation reduces the amount of troubleshooting during daily manufacturing. As a result, the frequency of customer complaints and drug recalls is reduced.
  • Cost reduction: Because of reinspection, retesting, rework, and rejection, processes working at marginal levels frequently increase expenses. Validation contributes to the improvement of processes and the reduction of costs.

4. Background of Validation

4.1 History:

History of Validation and its Importance.

4.2 Legal requirements:

GMP regulations are recognized as official law in several major countries, and noncompliance is punishable. Legally, further compliance policies, manuals, and guidelines are not required. The pharmaceutical industry, on the other hand, adheres to them as a matter of good management and business practice.

4.3 Market requirements:

Customers (governance, doctors, pharmacists, patients, and health insurance companies) are more concerned than ever about product safety, efficacy, and potency, and they are soliciting more value for their money.

The quality of pharmaceutical items must be uniform and meet all applicable health and regulatory standards. To be in conformity with Good Manufacturing Practice criteria, the pharmaceutical sector must validate GMP to their process.

4.4 Validation philosophy:

All reputable businesses understand the need for validation and have procedures in place to support it in their quality assurance manuals.

5. The Basic Concept of Process Validation

  1. Requalification or revalidation
  2. Calibration, verification, and maintenance of process equipment
  3.  Establishing specifications and performance characteristics
  4.  Selection of methods, processes, and equipment to ensure the product meets specifications
  5.  Qualification or validation of process and equipment
  6.  Testing the final product, using validated analytical methods, in order to meet specifications
  7. Challenging, auditing, monitoring, or sampling the recognized critical and key steps of the process

6. The Basic Concept of Equipment Validation

Equipment validation includes installation qualification (IQ), operational qual­ification (OP), and performance qualification (PQ). The purpose is to indicate that the equipment is suitable for processing.

7. The Basic Concept of Area and Facility Validation

The goal of the area and facility qualification is to show that the area and facility meet the design requirements for temperature, humidity, viable, and nonviable count.

8. Validation of Utilities: A Basic Concept

This validation shows that the utilities needed to support the process meet the quality requirements.

9. Cleaning Validation: The Basic Concept

The cleaning validation is required to demonstrate that, after cleaning, the equipment To avoid cross-contamination, cleaning validation is required to verify that the equipment and surfaces are fundamentally free of product residues and traces of cleaning chemicals after washing.

10. The Basic Concept of Computerized System Validation

Computer systems are used worldwide in the pharmaceutical industry and have a direct bearing on product quality. The purpose of validation is to demonstrate that in the pharmaceutical sector, computer systems are used all over the world and have a direct impact on product quality. The goal of validation is to show that the planned product, which is made, packed, or distributed via a computerized controlled system, will meet the specific monograph’s safety, effectiveness, and potency standards.

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