PAControl.com - Pharmaceutical Validation

Pharmaceutical Validation is the implementation of a quality system approved by the FDA.

It is designed to ensure that every part of a pharmaceutical installation meets the standards during every stage of its lifecycle (design, construction, startup, production, maintenance and decomissioning). Keywords are "Good practices" and "Traceability". It is a very large field and some parts of it may not require much technical knowledge. However, if you have to prove that a certain program in a controller will act in certain ways, it may be useful to at least know how these things work in order to design a testing procedure to prove (validate) that this is true.

Pharmaceutical Validation is always teamwork. Mechanical, electrical, automation, control, process and software engineers each have to assist the validation officer with all the necessary documentation and testing. The only person that is not really a technical specialist is the validation officer. However to be successful, he must have a broad knowledge of technical stuff without real specialized knowledge in a specific field. His main job task is the interfacing between the technical staff and the FDA and therefore he is responsible for the final FDA approval of the entire project.

Check out the 21-CFR-Part 11 regulations (Electronic Records, Electronic Signatures), which has become the standard for the pharmaceutical industry.

>>> What is 21-CFR-Part 11?

ANSI/ISA S88 design concepts make validation easier. A modular S88 design will allow one to validate (and revalidate) procedures and equipment separately. With well-written equipment phases, for example, once Phase A is validated, modifying other phases will not upset Phase A's validated state.

Also, validating a recipe procedure is easier once the phases are validated. Since recipe procedure code is decoupled from equipment phase code, the need to revalidate a recipe procedure does not necessarily require that all phases be revalidated. Theoretically, one can validate new additions to a process or revalidate changes to a process faster. Moreover, the S88 modular design approach helps minimize the risk that a change to one part of the process will affect another. Validating new additions to a process or revalidating changes to a process faster, results in the product making it to the market quicker.

IQ / OQ / PQ

Installation Qualification, Operational Qualification, and Performance Verification of equipment and instruments is a vital link in the quality chain. One of the major areas of focus for both FDA (or any other regulatory body) and client audits. All equipment and instruments must meet manufacturer's or preset standards for operation and performance.

Installation Qualification does not just apply to a brand new piece of equipment or instrument. A used instrument or piece of equipment that is new to the site must also undergo installation qualification. Movement of equipment or instruments requires re-Installation Qualification to ensure proper operation. Many new pieces of equipment and instruments include either instructions for IQ or options for the manufacturer to perform IQ for you.

Operation Qualification and Performance Verification must be perform at least annually for every piece of equipment or instrument. Most manufacturers have provisions for performing these services, at a cost. This can be confusing, time consuming and costly to allow the manufacturer to perform.

Performance Verification is also necessary for movement of equipment and instruments to prove the operation prior to and after the movement of said equipment and instruments.