VALIDATION SERVICES

What Is validation?

Topics addressed

Areas of validation expertise

Why use our outside validation services?

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What is validation?

This is "the documented act of demonstrating that any of your critical procedures, processes, equipment, materials, activities, or systems will consistently lead to expected results."

This can be further broken down into the following categories:

• Concurrent validations:

where current batches are used to monitor processing parameters;

• Retrospective validations:

for products already being marketed, and based on extensive data accumulated over several lots and over time;

• Prospective validations:

conducted prior to the distribution of either a new product or a product made under a modified process, where the modifications are significant;

• Installation qualification:

to demonstrate that production equipment and ancillary systems are appropriately selected and correctly installed;

• Operational qualification:

to demonstrate that production equipment and ancillary systems operate consistently in accordance with established specifications; and

• Process qualification:

developing sampling and testing procedures for various stages of the manufacturing process to ensure that product specifications are met.

Topics addressed

Our Validation Master Plan, states how the validation will be conducted, including:

• who will conduct the various tasks;


• defining the testing parameters;


• sampling plan;


• testing methods and specifications;


• product characteristics;


• equipment to be used;


• number of batches to be used;


• defining acceptance criteria; and


• specify who will sign / approve / disapprove the conclusions derived from the study.

Absence of the Validation Master Plan and supporting documentation will result in a non-compliance rating.

Areas of validation expertise

• Analytical methods such as: chromatography, spectroscopy, spectrophotometry, colourimetry, and most other modern laboratory techniques;


• Laboratory instrumentation such as: HPLC, GC, MS, AA, ICP, etc;


• Pharmaceutical production equipment such as: mixers, blenders, encapsulating / tableting machines, container fillers, cappers, shrink-wrappers / heat tunnels, labelling machines, weigh scales / load cells, etc;


• Process validation such as: % yields, contamination, homogeneity, accuracy, precision, Paredo analyses, etc.;


• Cleaning validation such as: microbial, product residues, cleaning agent residues, etc.;


• Utilities such as: HEPA systems (for air quality) and Purified Water systems (i.e. RO units, conductivity / resistivity monitors, UV sterilization, and microbiology); and


• Software and hardware (generation of batch orders, product counters, etc.).

Why use our outside validation services?

• Allows full-time staff to concentrate on revenue-generating activities;


• No need to hire additional staff, then lay them off after the validation projects have been completed;


• Allows you to bring in our areas of expertise that your company may not have. This will speed up the validation project; and


• aids in scheduling.

Our Summary Report of the Validation Studies can then be made available as an easy reference for your clients to review and approve.