CGMP Compliance Checklists for: CGMP Trainers Quality Assurance and Compliance Professionals Pharmaceutical Managers and System

tem Owners Pharmaceutical Executives

The Validation System

System Description and Overview of Key Requirements: A Validation program establishes documented evidence that provides a high degree of assurance that a specific process, method, protocol, computer system or unit of physical equipment will consistently produce a product or output that meets pre-determined specifications and quality attributes. Validation Protocols: validation is performed using protocols that are pre-approved by key stakeholders (one of these being the Quality Assurance Unit). The protocols will typically contain rationale for the study, sample plans, acceptance criteria based upon regulatory requirements, risk assessments, quality standards, and scientific rationale. Validation Training: Any personnel that creates protocols, executes protocols, documents testing, or creates summary reports must be trained on the applicable cGMPs, applicable protocols, test methods, data recording standards, and standard operating procedures. Validation Testing: While the protocol is executed, results and observations are documented for evaluation against the acceptance criteria. Validation Summary Reports: A report that summarizes the key elements of the protocol, testing, observations, deviations, and rationale 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.

www.fdacgmp.com

CGMP COMPLIANCE CHECKLISTS

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 Pharmaceutical Ingredients Subject to Pre-Market Approval Medical Device Quality Systems Manual, Section 4

2011 FDA CGMP Compliance Checklists (www.FDACGMP.com), All Rights Reserved

Attributes of a Healthy Validation System:

The validation system ensures that new equipment, products, methods, and computer systems are tested before being introduced into CGMP Production. The validation system ensures that cleaning procedures remove product and other manufacturing residues from new and existing equipment. Quality systems such as change control are in place that assure 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 deviation 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 undertaking 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 responsible 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 capable of quantitatively measuring levels of residues remaining on the equipment surfaces after cleaning.

Definitions:
Change Control System: a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. Concurrent Validation: Validation that is conducted 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 validation is the validation of a process based on accumulated historical production, testing, control, and other information for a product already in production 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 results, customer complaints or lack of complaints, field failure reports, service reports, and audit reports. Validation: confirmation by examination and provision of objective evidence that the particular requirement for a specific intended use can be consistently fulfilled. Validation Protocol: a written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results.

2011 FDA CGMP Compliance Checklists (www.FDACGMP.com), All Rights Reserved