Validation

Computerized System Validation

What is it?
SIt means providing documented evidence that computerized systems with GxP impact comply with the purpose for which they were designed, assuring safety, traceability, and integrity of information, quality of finished product and customer safety.

Why validate?
To make sure that the functions of the system are consistent with user’s needs and process, to attest data safety, integrity, and traceability, to promote system and process improvement, for a better understanding on how the system works, which contributes to reduce deviations in compliance with national and international quality requirements.

When validate?
Validation must occur upon the purchase of a system that will be part of any process with GxP impact – Prospective Validation
When existing systems are considered to have impact on GxP – Concurrent Validation
When validated systems require updates and/or improvements – Maintenance of validated status

IT infrastructure

What is it?
It is the physical and technological part of a computerized system project, which allows communication, information safety, interfaces, use of wireless equipment, and others.

Where can we support?
• Formulation of IT Policies and Procedures;
• IT Infrastructure Qualification.

Process Validation

What is it?
Documented evidence attesting, with a high safety degree, that a certain process will manufacture a product in a consistent manner, complying with predefined specifications and quality features.

The Process Validation principle is to ensure the entire lifecycle of a product, from process design to its validation and continuous verification, up to product discontinuation.

In the case of new products, validation completion must occur before its marketing, as well as for new processes and current processes that had impacting changes.

What are the types?
Concurrent: Validation is performed during manufacturing routine of products intended for sale. Follow-up of manufactured batches

Prospective: Validation is performed during product development stage, based in a risk analysis of manufacture process, which is detailed into individual steps; these, on the other hand, are evaluated based on experiences to determine whether they may cause critical situations – Follow-up of pilot batches

Retrospective: Involves the evaluation of past manufacture experience, provided that composition, procedures and equipment remain unchanged – historic/statistical survey.

Why validate?
• Compliance
• Safety
• Efficacy
• Quality

When validate?
• New products
• New processes
• Significant change in an existing process

Cleaning Validation

What is it?
Documented evidence proving that the cleaning procedures remove residues at predetermined acceptance levels, taking into account factors such as: batch size, dosage, toxicological data, solubility, and contact area between the equipment and the product.

Why validate?
• Compliance
• Safety
• Efficacy
• Quality

When validate?
The validation of cleaning procedure involves only areas and surfaces with which the product or pharmaceutical active ingredient is in direct or eventual contact.

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