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Validation

Validation involves the collection and evaluation of data — from the process design stage through commercial production — which establishes scientific evidence (proof) that a process is capable of consistently maintaining the necessary level of compliance. Here you will find content that discusses the qualification of systems and equipment.

Articles

ElevateBio earns ICMC certification for gene and cell therapy capabilities

The Waltham, Massachusetts facility met nine system criteria under the Initiative for Certification of Manufacturing Capabilities program, the company said.

Pharma’s hybrid inspection model

Four strategic steps to creating and executing a hybrid audit protocol

Pharma’s remote audits are here to stay

Distinctive strategies for doing remote audits successfully

Is it time to call the dogs off drug testing?

One group is putting pressure on the FDA and Congress to move pharma away from animal modeling in drug development

Taking it to the extreme

The importance of temperature, humidity and light testing for drug stability

SGS-LSS-Elemental-Impurities-EN-18-TABLE-1

Analyzing for Elemental Impurities

Understanding new guidance from the USP

EU FMD: The One-Year Countdown

Companies that manufacture, sell or dispense drugs in the European Union have until February 9, 2019 to comply. Where does the industry stand?

Validation & Qualification in Pharma Facilities

Validation, calibration and qualification are extremely critical in pharmaceutical processes. Understanding them is necessary in order to meet cGMP guidelines.

Why Are Paper Mountains Still Common in Validation?

Ending the up-hill battle of Paper-based validation document control

BRIEF: How Humidity and Temperature Mapping Differ

There are a few special considerations for mapping humidity: calibration and sensor density/placement.

Leveraging Third-Party Audits in Pharma/Biotech Industries

Finding ways to reduce complexities, eliminate redundancies and streamline operations while staying compliant

Management’s Role in Sustaining Continued Process Verification

A CPV approach based only on statistical tools addresses only the operational level of the system; management needs to be involved

Implementing Risk-Based Validation Team-by-Team

Solid, defensible execution of Risk-Based Validation requires strong collaboration between QA, PE and maintenance

Compliance Management

How and why Baxter International implemented an automated continued process verification program

A Case for Stage 3 Continued Process Verification

Reducing process related failures and quality costs; Continued Process Verification can improve control and lower failure rates