A Validation program estab-lishes documented evidence that provides a high degree of assur-ance that a specific process, method, protocol, computer system or unit of physical equipment will consistently produce a product or output that meets pre-determined speci-fications and quality attributes. Validation Protocols: validation is performed using protocols that are pre-approved by key stakeholders (one of these being the Quality Assur-ance Unit). The protocols will typically contain ra-tionale for the study, sam-ple plans, acceptance crite-ria based upon regulatory requirements, risk assess-ments, quality standards, and scientific rationale.

Validation Training: Any personnel that creates protocols, executes proto-cols, documents testing, or creates summary reports must be trained on the applicable cGMP’s, appli-cable protocols, test meth-ods, data recording stan-dards, and standard oper-ating procedures. Validation Testing: While the protocol is exe-cuted, results and observa-tions are documented for evaluation against the ac-ceptance criteria. Validation Summary Reports:

A report that summarizes the key elements of the protocol, testing, observa-

tions, deviations, and ra-tionale for any acceptance of data that deviates from expectations is typically required to conclude a validation study. Validation Document Management:

Validation protocols, test data, and summary reports must be retained and maintained for review by regulatory entities.

The Validation System System Description and Overview of Key Requirements:

CGMP Compliance Checklists for:

• CGMP Trainers

• Quality Assurance and Compliance Professionals

• Pharmaceutical Managers and System Owners

• Pharmaceutical Executives w

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GMP Validation References:

FDA CGMP Compliance Checklists - CGMP Compliance in Everyday Language

Current Good Manufacturing Practices, Title 21 CFR 211.100

Current Good Manufacturing Practices, Title 21 CFR 211.180

Current Good Manufacturing Practices, Title 21 CFR 820

ICH Q7A, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, 10 November 2000

WHO, Good practices for the Manufacture and Quality Control of Drugs

CPG Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharma-ceutical Ingredients Subject to Pre-Market Approval

Medical Device Quality Systems Manual, Section 4

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The validation system ensures that new equipment, products, methods, and computer systems are tested before being intro-duced into CGMP Production.

The validation system ensures that cleaning procedures re-move product and other manufacturing residues from new and existing equipment.

Quality systems such as change control are in place that as-sure the validated state is maintained.

The validation program is involved in the complete system lifecycle from planning, design/build, testing, to production.

Written plans exist that provide a rationale for the validation strategy and list affected systems and protocols.

The extent of validation testing is based upon a documented risk control strategy.

Protocols are pre-approved by project stakeholders including the quality unit.

Deviations from protocols follow a written validation devia-tion procedure.

A change control system is in place to protect the validated state of each validated system.

Validation documentation is retained in an organized manner. Employees are systematically trained and qualified before un-

dertaking validation responsibilities. The company's overall policy, intentions, and approach to

validation, including the validation of production processes, cleaning procedures, analytical methods, in-process control test procedures, computerized systems, and persons responsi-ble for design, review, approval and documentation of each validation phase, are documented.

Systems and processes are periodically evaluated to verify that they are still operating in a valid manner.

For cleaning validation, the sampling methods used are capa-ble of quantitatively measuring levels of residues remaining on the equipment surfaces after cleaning.

Attributes of a Healthy Validation System:

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Definitions:

Change Control System: a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated man-ner. Concurrent Validation: Validation that is con-ducted during routine processing, manufacturing, or engineering. Prospective Validation: Prospective validation is conducted before a new product is released for distribution or, where the revisions may affect the product's characteristics, before a product made under a revised manufacturing process is released for distribution. Retrospective Validation: Retrospective valida-tion is the validation of a process based on accu-mulated historical production, testing, control, and other information for a product already in produc-tion and distribution. This type of validation makes use of historical data and information which may be found in batch records, production log books, lot records, control charts, test and inspection re-sults, customer complaints or lack of complaints, field failure reports, service reports, and audit re-ports. Validation: confirmation by examination and provision of objective evidence that the particular requirement for a specific intended use can be con-sistently fulfilled. Validation Protocol: a written plan stating how validation will be conducted, including test parame-ters, product characteristics, production equip-ment, and decision points on what constitutes ac-ceptable test results.