The recent news from SEBI is that SEBI issued a warning notice to Aurobindopharma on June 27, 2022, about the USFDA audit. In 2019, USFDA audits peaked at 239 numbers. The evolving standards in manufacturing and pharmaceutical companies demand the USFDA audit. The database of USFDA states that there is a shortage of more than 164 drugs in the US market. In 2020, inspections were suspended due to the covid-19 outbreak. The pharmaceutical industry creates more than 2.7 million jobs in India. In 2030, the compound annual growth rate is predicted to rise to 90 billion dollars. By creating a supply chain with the US market, Indian pharmaceuticals could become the global biggest supplier. The Universal healthcare systems demand low-priced drugs. Pharmaceutical companies develop trade activities with other countries. India faces an unstable domestic pricing environment. Infrastructure improvement is essential for structural development. The Indian infrastructure work as a hurdle to innovation and investments. There is a lack of research support in India. The Indian manpower has the skills to do advance level research activities. In Uttar Pradesh and Andhra Pradesh, there are plans to build pharma parks. The blog revolves around the need for standards in the pharmaceutical industry to win over the USFDA audit.
What is an internal audit?
The following points elucidate the internal audit process and quality standards in the pharmaceutical sector. USFDA audit points/ observations educate the document and data requirement.
• Internal audits are helpful to identify the risk and problems in the current processes.
• Checking the previous audit reports is helpful to arrange the documents required.
• Check the documents during the internal audit.
• Train the personnel about the recent changes during the internal audit.
• The management team must check the internal audit report and implement the findings with the production processes.
• FDA conducts emerging technology programs to examine the current new technologies used for production. 3D printing, continuous manufacturing, process analytical technology, artificial intelligence, and distributed manufacturing are the recent hypes in drug manufacturing technology.
• FDA is a member of ICH. The international council work toward quality standards. FDA is in association with the ICMRA forum that unites 28 regulatory bodies around the world.
• High-quality products are beneficial to the producer and consumer.
• Raw materials, production process, trained resources, research and development and technology are essential checkpoints to promoting quality products.
• EU, ICH, FDA, and WHO guidelines provide the academic details for quality standards of drug production.
• The design features of the code of federal regulations state that the manufacturing units must have suitable size and location to support cleaning, maintenance and operations. Indian pharmaceuticals are lacking in the clean zone.
• The Indian pharmaceutical companies lack data integration. This is the second disadvantage. The personnel in manufacturing and quality control record false data. This activity ends with the inaccuracy of production data.
How do pharmaceutical companies do data collection for internal audits?
Data analytics and digital transformation are changing all sectors. The manufacturing sector is exposed to multiple sensor-activated primary data collection. The production batches update the data every ten seconds. The data analysis help in managing time, reducing the cost of production and improving quality. The following points explain the data collection process in the pharma industry.
• The sensors educate about the raw materials, process, intermediate by-products, and final product quality.
• The raw materials, intermediate product, and the finished product undergo the technical process with sensors, servers and databases.
• The final product undergoes the checking process with the sample product.
• Regularly, the product testing and quality standards are checked before the sales.
• The trained professionals periodically tes the seasonal changes, unusual events and equipment variabilities.
• The time series of production also varies as per the production process.
• The pharmaceutical industry has three types of products during the processes. The data collected during the production process are primary and secondary.
What are the documents required for the USFDA audit?
The USFDA checklist goes a quality manual, organisational charts, training records, quality system, and device listings, building structure, risk monitoring system, product compliant details, and required corrections with the documents to make it the current document. Instrumentation engineering also helps in maintaining the equipment in the proper place. The four types of audits from the FDA are pre-approval audit, routine inspection, for-cause inspection and compliance follow-up audit. FDA audits go for two to three days. In some cases, it goes to six weeks also. FDA is the agency within the USA working for the department of health and human services. USFDA and FDA are the appellation names of the agency located in the USA. Both the names mean the same agency.
Inspections and audits improve quality. Pharmaceutical quality control labs in India are trained for the surprise US FDA inspections. Sun pharmaceutical industries, Cipla Ltd, Divis laboratories Ltd, Dr Reddys Laboratories Ltd., Torrent Pharmaceuticals Ltd., Appollo Hospitals Enterprise Ltd., Gland Pharma Ltd., Abbott India Ltd., Piramal Enterprises Ltd., ZydusLifesciences Ltd., Biocon Ltd are the top ten Pharmaceutical Companies in India. The disability-adjusted life has declined since 1990. The DALY percentage has gone down to 36 per cent. The healthy life is going down, and diseases are increasing. India is the export partner to more than 200 countries for drugs. The manufacturing structure, research, human resource management and technological advancement are the points that differ in India and global countries. Periodic training, workshops and internal forums improve the practical knowledge to the Indian minds about the international expectation. Transformation in the Pharmaceutical Industry ends with the improvement of the supply chain and trade operations. The auditing process is not only about the financial figures, but it deals with the manufacturing structure, guidelines of regulators, data collection methodologies and human resource training. USFDA audit standards insist on the product quality and accuracy of data.