Acceptable Quality Level in Pharmaceuticals
The acceptable quality level is the worst ratio or percentage that can be tolerated in a product which is still considered acceptable. Pharmaceutical products are materials in dosage form manufactured for human or veterinary use. These are usually under legislation of the importing and or the exporting states. Inspection of these materials must be done regardless of place of origin by qualified inspectors. The production of these materials involves all the processes such as material acquisition, packaging, labeling, relabeling to formation of the final product.
Inspectors ensure quality is maintained by taking random samples. These act as representatives of the whole batch produced. Some of these are also normally retained for testing in the future. The sample must in all cases be sufficient to allow for all tests that have to done. If not adequate, the inspector should take note and document the limitations of the inadequate sample.
Many methods of sampling are available each with a different procedure depending with the purpose. This could be for verifying identity, controls for either the finished or intermediate products or for other specific tests. These are usually specific to the material being tested. Once sampling is done, it is mandatory to describe the material sampled and indicate the batch number, date and method used and have notes of any anomaly experienced. The material sampled should be uniform.
The sampling facilities should prevent contamination of the sample and the individual carrying out the tests. The contamination could either be from external sources such as dust or it could be cross. It is also always wise to study the safety information and health consideration for the environment and the operator. Protective gear such as respiratory equipment should not be an option. Lighting and ventilation of the facility are also paramount. Tools necessary for the acceptable quality level must always be availed. These include pliers, seals and other handling equipment. WHO Certification Scheme ensures that all these are adhered to.
Many regulatory guidelines exist for sampling. Each method has its own risks and consequences associated with inherent errors during decision making. Starting product have different guidelines as outlined by the World Health Organization in the Good Manufacturing practices and Pharmaceutical Preparations (WHO 2005). It is stipulated that any inspection and WHO Expert Committee on Specifications for sample that is not labelled should be rejected. In addition, damaged sample containers should also be checked for. It is also not wise to open all product containers at once due to the risk of contamination and oxygen deterioration.
When random sampling is necessary for pharmaceuticals, tables should be employed. These are usually based on statistics sampling schemes. These tables should also dictate the required number of random samples. The n, p and r sampling schemes are examples of these schemes. The n plan is based on the formula n = 1+square root of N where N is the number of consigning units in the whole batch. The p plan is based on the formula p = 0.4 * square root of N whereas the r plan is based on r = 1.5 * square root of N. Standards for sampling final products such as the BS 6001-1, ANSI/ASQCZ1.4-1993 and ISO 2859 are also available.
