Installation Qualification
The installation qualification (IQ) is a protocol meant to ensure that a system is properly installed and configured. It ensures that all the necessary procedures are accurately adhered to. The pharmaceutical industry has specific requirements for equipment used in production of pharmaceuticals. Before these firms purchase the equipment, they will want to make sure that they are designed and produced to function in a standard way. Basically, these protocols are documented. Installation qualification in pharmaceuticals is broken down to the following protocols:
Design Qualification (DQ), Mechanical Installation Qualification (MIQ), Automated Installation Qualification (AIQ), Operational Qualification (OQ), Process Validation (PV), Cleaning Qualification (CQ).
As mentioned earlier, the pharmaceutical industry has some set standards for production of any equipment to be used in production. The set standards are referred to as continued Good Manufacturing Procedures (cGMPs). Installation qualification in pharmaceuticals (IQ) involves two procedural protocols; the current Good Manufacturing Procedures (cGMPs) and the Factory Acceptance Testing (FAT). Pharmaceutical firms begin with cGMPs before embarking on FAT protocols.
CURRENT GOOD MANUFACTURING PRACTICES (cGMPs)
Pharmaceutical production is a very sensitive area. Keep in mind that any slight mistake in the production of any pharmaceutical product can lead to health complications or even death. To avoid this, the food and drug administration (FDA) regulates the quality of pharmaceuticals very carefully. This body has enforced the following standards:
All pharmaceutical firms must have a strong and quality management systems They ought to obtain quality raw materials. Here, the body recommends the standard materials to use. The body has also established robust operating procedures. The body investigates to detect any product quality deviation. Finally, to ensure quality production, the body have enacted laws to maintain reliable testing laboratories.
The good thing about the cGMPs requirements is that FDA made them flexible. This was to allow each manufacturer to solely decide on ways to implement the set standards; provided they used scientific, processing and testing measures acceptable by the body. Bear in mind that cGMPs are minimum requirements. A number of pharmaceutical firms are actually implementing comprehensive measure which exceeds the set standards.
FACTORY ACCEPTANCE TESTING
Upon completion of the first installation protocol, the manufacturers now embark on FAT. This protocol entails both FAT and SAT. SAT is basically the Site Acceptance Testing. With reference to the user requirement specification document that which comes with the equipment, all functional specifications are evaluated to ensure that they all function as required. Both FAT and SAT are documents used to proof that the equipment meets the expected standards. Although SAT is a slightly less onerous document, it can still be used to validate the equipment qualification.
Factory acceptance test protocol has a very significant role in securing the quality of pharmaceutical products. This stage is very significant and actually calls for quite a number of parties to be present. The client (who actually owns the pharmaceutical firm), the equipment designer along with members from the designer’s firm should be present. Upon successively taking both the FAT and SAT, the equipment is delivered and installed.
