Good Manufacturing Practices for Pharmaceuticals

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Table of Contents

Total Quality Control
Packaging and Labeling Approaches
Biochemical Analyses
3D Printing Technology
Conclusion
References

Creating conditions for the safe production of pharmaceuticals is a practice that has evolved significantly due to the introduction of modern approaches to the manufacturing process. As effective measures aimed to establish control in this industry, various measures are promoted to ensure the operation of pharmacological enterprises. These practices include both external aspects of manufacturing, for instance, packaging, and internal ones, which involve tracking production technology. This work aims to present such useful techniques as quality control, packaging and labeling, biochemical analyses, and 3D printing as approaches to the safe manufacturing of pharmaceuticals.

Total Quality Control

For manufacturers of pharmaceuticals to supply quality products to the market, appropriate control mechanisms are engaged. According to Deidda et al. (2018), in some countries, there are both government agencies involved in monitoring the quality of manufactured drugs and companies testing these products for compliance with national safety standards. Although it is in the interests of manufacturers to supply quality pharmaceuticals to the market so as not to lose their licenses, cases of errors and production flaws are possible. Therefore, the relevance of quality control practices applied at different levels is objective.

The principles of quality control may vary depending on the methods used by agencies involved. Deidda et al. (2018) cite the experience of different countries and note that one of the most common practices is the testing of raw materials used for the production of pharmaceuticals. In some cases, as the authors remark, additional analytical mechanisms are utilized, which are implemented through the comparison of finished products with reference

samples (Deidda et al., 2018). To implement these tasks effectively, special error prediction mechanisms are applied to track any cases of the non-compliance of pharmaceuticals quality with production standards. In addition, screening metrics obtained through testing may be used as a rationale for reorganizing manufacturing algorithms. In the context of pharmaceutical companies broad market activities, these total quality control measures are valuable and important approaches to ensuring the safe production of drugs.

Packaging and Labeling Approaches

One of the criteria for the safe production of pharmaceuticals is the use of convenient and demanded packaging formats. Prescribing drugs, principles of their administration, and other aspects are taken into account. As Lorenzini et al. (2018) argue, pharmaceutical packaging is a key facilitator for delivering patient-friendly medication (p. 363). Due to the variety of forms of drugs, modern manufacturers use various methods of delivering pharmaceuticals to the market, starting from such criteria as the target audience, dosages, the proportion of active substances, and other factors. Lorenzini et al. (2018) note that policymakers control packaging principles carefully to provide more patient-centered terms of sale. Thus, from a practical standpoint, proper packaging approaches are essential techniques for maintaining quality pharmaceutical manufacturing.

One should also take into account additional aspects of packaging that determine trends, in particular, marketing goals. According to Lorenzini et al. (2018), today, drug manufacturers go to different tricks to win the recognition of the target audience and draw attention to their products. At the same time, safety standards dictate specific rules that are crucial to adhere to in order to distribute pharmaceuticals based on the existing legal regulations. Today, there are requirements for manufacturers, for instance, the rule to display the active substances of drugs on their packaging. Raju et al. (2016) mention environmental sustainability principles that are to promote green production for medication packaging. These control measures contribute to maintaining good manufacturing practices for pharmaceuticals are an important aspect of patient safety.

The fight against counterfeit products is one of the hot topics in the pharmaceutical market. In this regard, Zhang et al. (2020) offer to pay attention to special labeling techniques that are designed to protect drugs from counterfeiting and promote patient safety. In particular, the researchers give an example of the use of nanomaterials in the labeling of pharmaceuticals and note that utilizing such a technology can have a positive impact on reducing fake drugs (Zhang et al., 2020). Unique labels, codes, and other designations on packaging oblige manufacturers to monitor the quality of their products and create barriers to counterfeit goods from entering the market. Moreover, medicines coming from abroad, as a rule, are also subject to mandatory checks and certification, which is indicated on them. Therefore, special labeling practices are valuable manufacturing approaches to drug safety.

Biochemical Analyses

One of the most accurate practices for promoting the safe production of pharmaceuticals is biochemical testing. According to Kumar et al. (2018), today, laboratories are involved in testing drugs not only for the presence of active substances but also for hazardous components that can harm patients. As working methods in this direction, the authors note special analyses for the identification of such elements in the composition of drugs as carbohydrates, metal ions, inorganic anions, and other microparticles (Kumar et al., 2018). These tests serve as valuable drivers for ensuring the safety of drugs that enter domestic and foreign markets and eliminating the likelihood of manufacturing errors. In addition, due to such control algorithms, consumers can ensure that the products they purchase meet the existing production standards and can be used as intended without fear. Thus, biochemical testing is a good practice to maintain the quality of pharmaceuticals.

3D Printing Technology

To improve the quality of pharmaceuticals production, today, the practice of 3D printing is applied. Jose and GV (2018) consider this technique in terms of a method that can play a significant role in multiple active ingredient dosage forms (p. 46). The principle of this approach is to create a streaming system for the manufacturing of drugs for patients needs by combining individual doses into common ones to maintain a higher quality of therapeutic interventions. At the same time, Jose and GV (2018) emphasize that this modern technology is not applied randomly and requires regulation by the responsible agencies, which increases the safety of this practice. Patients can benefit from this technique since the combination of doses into a single form unit makes it possible to create highly effective drug complexes with strong effects. As a result, the 3D printing technology is a good manufacturing practice for pharmaceuticals, and its expansion in the medication market demonstrates the demand and benefits of such a technique.

Conclusion

As good manufacturing practices for pharmaceuticals, one should highlight such approaches as proper packaging and labeling, total quality control, biochemical analyses, and 3D printing. The considered approaches to ensuring production safety make it possible to monitor compliance with all the existing standards and, at the same time, expand the range of potentially positive effects on patient health. The use of these techniques in the general practice of manufacturing pharmaceuticals is a step towards preventing the penetration of counterfeit products into the drug market and contributes to successful quality control.

References

Deidda, R., Orlandini, S., Hubert, P., & Hubert, C. (2018). Risk-based approach for method development in pharmaceutical quality control context: A critical review. Journal of Pharmaceutical and Biomedical Analysis, 161, 110-121. Web.

Jose, P. A., & GV, P. C. (2018). 3D printing of pharmaceuticals A potential technology in developing personalized medicine. Asian Journal of Pharmaceutical Research and Development, 6(3), 46-54. Web.

Kumar, M., Bhatia, R., & Rawal, R. K. (2018). Applications of various analytical techniques in quality control of pharmaceutical excipients. Journal of Pharmaceutical and Biomedical Analysis, 157, 122-136. Web.

Lorenzini, G. C., Mostaghel, R., & Hellström, D. (2018). Drivers of pharmaceutical packaging innovation: A customer-supplier relationship case study. Journal of Business Research, 88, 363-370. Web.

Raju, G., Sarkar, P., Singla, E., Singh, H., & Sharma, R. K. (2016). Comparison of environmental sustainability of pharmaceutical packaging. Perspectives in Science, 8, 683-685.

Zhang, H., Hua, D., Huang, C., Samal, S. K., Xiong, R., Sauvage, F., Braekmans, K., Remaut, K., & De Smedt, S. C. (2020). Materials and technologies to combat counterfeiting of pharmaceuticals: Current and future problem tackling. Advanced Materials, 32(11), 1905486.

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Good Manufacturing Practices for Pharmaceuticals

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