Abstract
The circulation of poor quality medicines, especially in the developing countries, is a public health concern. Compliance with good manufacturing practices (GMP) is essential to ensure the quality, efficacy, and safety of medicines. This study evaluated the outcomes of the Brazilian Health Regulatory Agency’s (ANVISA) international inspections of two years (2015 and 2016) and compared these to those of other regulatory authorities. The information from 255 inspection reports was analyzed, and the type and extent of deficiencies were collected. In the period evaluated, 62.75% of ANVISA-inspected companies were classified as GMP “satisfactory,” 24.71% were classified as having “on demand” status, and 12.55% of inspections concluded that the company did not comply with Brazilian GMP regulations (“unsatisfactory”). The most common areas of deficiency were documentation (28.63%) and premises (26.27%). The pattern of deficiencies was similar to the findings of other regulatory agencies. However, ANVISA detected a more significant number of non-compliance results than other authorities, which may be caused by differences in classifications adopted by each Agency. Furthermore, manufacturers inspected by ANVISA may follow different standards and practices for products manufactured for the Brazilian market. Disclosure of main GMP deficiencies found can be useful for encouraging the industry to comply with GMP, and additional guidelines in the specific areas where deficiencies are often identified may be useful to industry to improve GMP compliance. Harmonization of GMP guidelines and inspection procedures are the key steps to avoid duplicate work, but regulatory authorities also need to work together to enforce the proper level of GMP compliance by pharmaceutical manufacturers, assuring high quality and safe medicines supply.
Highlights
The most common areas of deficiencies reported by ANVISA during international Good manufacturing practices (GMP) inspections of medicines were related to documentation and premises, similar to the findings of stringent regulatory agencies such as the U.S FDA and Pharmaceutical Inspection Co-Operation Scheme (PIC/S) members, showing that similar inspection procedures are applied
Considering the compliance rate, ANVISA found a higher number of non-compliance results than other authorities, which may be caused by different types of decision adopted by each jurisdiction or the standards applied for manufacturing products to Brazilian market may not be the same as used in those markets
Our findings emphasize the need to promote the use of medicines manufactured under GMP conditions to prevent substandard medicine circulation, especially in developing countries
Summary
The primary objective of GMP is to manage and minimize the inherent risks in pharmaceutical manufacture to guarantee the quality, safety, and efficacy of products [1,2,3], assuring the highest standards of efficacy, quality, and safety in any process that involves the manufacture of health products [6]. Poor compliance with GMP standards can lead to substandard medicine production, lack of sterility, and product mix-ups, which may happen accidentally (such as through human error) or as a result of insufficient resources (e.g., expertise, appropriate manufacturing infrastructure, or human and financial resources). Reliable data on the prevalence of substandard medicines are lacking, but emerging economies and developing countries are likely to face significant problems with substandard medications because of poor drug regulation and poor pharmaceutical industry compliance with GMP [9,10]
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