Validation in Pharmaceutical Industries

Pharmaceutical Industriesare expected to follow the requirements of existinggood manufacturing practices. To confirm that quality standards are being met, there has to be anorganized approach by which data is collected and studied to validatethat processesas intended. This organized approach is achieved by Validation.

Validation ensures a high level of assurance and serves to confirm that a given process has been developed correctly and that it operates within particular controls. This assures that quality products are produced and reduces the chances of rejection.

Validation is now considered as anessential part of good manufacturing practices. IfPharmaceutical industries want to get approval to manufacture drugs or to launch any new drug products into the market must obey with validation requirements as specified by authorized bodies.

What is Validation?

To prove that something is based on fact or is acceptable is known as validation.

Scope of Validation:

Pharmaceutical Industriesshould ensure that their validation processincludes all the significant areas of pharmaceutical processing. The significant areas are:

• Instrument validation
• Process validation
• Utility validation
• Cleaning validation
• Equipment calibration etc.

Benefits of Validation in Pharmaceutical Industry

• Validation helps to find errors in the process or system over a period time
• Validations make audits easy
• Validation reduces the difference in quality between 2 or more batches
• It reduces the wastage of materials during manufacturing processes
• Validation minimizes the failure of products at the final stage
• It reduces the cost of maintaining quality
• Due to validation, complaints and rejections get reduced
• Validation helps to find flaws (big or small) in the manufacturing process
• Validation helps to study the system and equipment thoroughly
• Validation process offers a significant cost reduction as compared to process running without validation
• It improves output production

Validation should be carried out for new equipment, utilities, systems, procedures, buildings and processes. Validationshould also be carried out when modificationis done in any of these.

Why choose HTA Instrumentation (P) Ltd?

• NABL Accredited Calibration Laboratory
• Validation done at a reasonable cost
• Vast experience in this field
• Well qualified &trainedpersonnel who are trained by reputed institutions
• Well organized effective tracking system for calibration/ validation services year by year
• On-site calibration facility available