Courses and Conferences on Validation and Qualification

Installations qualification and processes validation are basic requirements in the pharmaceutical industry.

EU GMP Guide Annex 1 states that: „It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation.“

In Europe, qualification should be documented at the following stages:

• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

The US-American Food and Drug Administration (FDA), on the contrary, pursues a new approach. Through FDA Guidance for Industry on Process Validation, a separation of qualification into the stages named above isn’t required anymore. The FDA rather expects extensive development studies and the evidence of stable operating processes. The magic 3 batches for validation aren’t required anymore.

It is essential that pharmaceutical companies have enough qualified personnel to plan, carry out, and document those tasks. Moreover, a validation manager for each area should be appointed. Companies which plan pharmaceutical manufacturing plants should also employ trained validation managers.

The importance of validation becomes obvious when one considers and assesses FDA`s inspection reports and FDA Warning Letters. Every year, the topic “Qualification and Validation” gets in the top 5 hit list of deviations.

The following courses and conferences regularly take place:

• Cleaning Validation
• SPC in the Pharmaceutical Industry
• The Validation Manager
• Validation of Isolators
• The new FDA/EU Approach to Process Validation

Read more here about the Validation Manager Certification Programme