The shift from domestic sources to overseas sources deserves due process to prevent the change that occurs when drugs are manufactured, or sourced, from a different locality. The process of validation is dependent on the locality and the nature of materials used in the process. The process of validation involves the process design, process qualification and continued process verification. This process, as stipulated under Act 21 U.S.C section 501(a)(2)(B), determines whether a drug makes it to the market or not. It states that, a drug shall be considered to be contaminated should the methods put in use, or the facilities or controls used for its production do not meet the FDA standards of manufacture and processing. The facility, and product, must meet the quality and purity, which it claims to possess (U.S. Department of Health and Human Services, 2011).
Process analytical technology (PAT) aims at continuously improving the processes involved in drug manufacture. Its purpose, therefore, is to improve the quality of data that is taken from the manufacture and distribution of drugs and medicines. Most of the tools used are analytical and aim at control and monitoring of the conditions and factors that are involved in the process.
Protein biological products are used by a large percentage of the population; therefore, the importance of validation cannot be overemphasized. The objective of validation is to prevent addition of unnecessary ingredients or the removal of essential chemicals. A few areas that necessitate validation include the water systems, manufacturing processes and the frequency at which the equipment is cleaned. This is because the level of sterility of the equipment can shift the entire balance of the drug being manufactured.
The validation process is necessary in ensuring that the drug remains functional even after it leaves the manufacturing base. The major difference between verification and validation is that verification determines conformance of a product to the specified standards, while validation involves confirmation of the presence of requirements in a particular product. Process validation is a better choice over process verification for various reasons. Since quality assurance demands that the drug has to be produced as fit for what it is intended, process validation has to be effective.
Stage 1 is the process design. It involves understanding how the drug will work. Scientific methods and principles are applied at this stage and a risk analysis is carried out. Experiments are carried out to determine effectiveness and levels of toxicity. Next, a strategy is put in place to control the entire process. The FDA recommends that monitoring should be done throughout the entire process. All activities at this point have to be documented, for future reference. In the event that a change is made at the start of the process, it is necessary to indicate what was added or removed, and towards what end.
Stage 2 involves the assessment of the drug to ensure that it can be produced in bulk, should the need arise. It is at this point that it can be determined if the drug would pose any severe threats. The application of process performance qualification (PPQ) is the second aspect of this stage. The quality of machinery is a determining factor, as well as additional testing. PPQ protocol demands that data be collected and evaluated. This data can be put to use to define if the tests carried out included all the components. A sampling plan has to be created to cater for each stage of the process to ensure statistical confidence. There has to be provisions that are made to cater for unexpected changes and unforeseen reactions. This documentation has to be approved by the relevant departments involved in the process and the quality assurance unit. After review of protocol, all data is analyzed, summarized, discussed and cross-referenced with other available information on the same.
Stage 3 is the last stage, and it involves a continued verification of the process. The data that was gathered during the process has to be approved by trained personnel. This data must include all the components of the drug, any effects anticipated, and what changes had to be made at which stage. Continued monitoring of the procedures and machinery is essential in creating a variation if need be.
When the stages are completed, it is important to carry out a monitoring and evaluation procedure. Monitoring, however, starts from the moment the proposal is set up. It allows for changes to be made and mistakes to be rectified. On- site monitoring allows structural changes to be carried out during the process. Technical staff who is qualified can undertake this mandate. In the case of a shift in the supply of human protein supplement, it is significant to make sure that the new company is legit and possess a current permit. Conversely, it is essential to reach out to those that are in charge of centralized monitoring to determine the viability of the new drugs to be imported. A crosschecking of the data helps prevent legal battles. The acquired data must be verified. In addition, it is necessary to acquire information from on-site personnel to determine if due diligence was followed.
Since most of the drug tests are carried out by volunteers, it is important to establish whether these volunteers were coerced, and if not, was their consent informed. There have been cases whereby individuals have been lured into participating in drug tests on the promise of monetary gain or threats against their persons. Some countries out of the regular locality have been known to use minors in their drug tests, mostly without their consent.
The results of the entire process are communicated to the FDA to prevent lawsuits and to further encourage testing of the drug. Introduction of the drug into the market with FDA certification is likely to incur a ban. If the drug is introduced (without authorization from the FDA) and it causes negative effects on the consumers, an entire operation could be shut down. In this case, changing the supplier of human drugs is much more likely to attract the scrutiny of the FDA. Counterfeit drugs are banned and the importation of the same attracts a penalty of a fine, imprisonment, or both (U.S. Department of Health and Human Services, 2011).
The Code of Federal Regulations has stiff penalties that are linked to the disregarding of the law concerning imports and exports, especially for human drugs. Clinical investigators are expected to be the link between the importer and the manufacturer. The investigator relays data and other useful information about the drug. Drugs that are intended for human uses have to be verified to prevent poisoning or production of counterfeit material (Liang, 2006). The FDA, CFR and the importer all serve their functions in this entire process.
Liang, B. A. (2006). Fade to black: importation and counterfeit drugs. Am. JL & Med. 32, 279.
U.S. Department of Health and Human Services. (2011). Guidance for Industry Process Validation: General Principles and Practices. Biotechnology, 3-17.
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