Regulatory Affairs (RA) play a pivotal role in ensuring drug products’ safety, efficacy, and quality in the dynamic pharmaceutical landscape. Chemistry, Manufacturing, and Controls (CMC) RA is essential for compliance. It aims to safeguard patient health and promote public confidence in pharmaceutical products by ensuring consistency and quality throughout the drug manufacturing process.
Validation protocol is defined as a documented plan for testing a medical device to confirm that the production process used to manufacture the product meets the specific user, technical, and Regulatory requirements. This includes a review of process variables and operational limitations and the analysis of test results under actual use conditions.
The validation process involves several tangible actions. The steps are elucidated as follows:
Post-market surveillance (PMS) is a system through which surveillance of adverse events and malfunctions of health products in the post-market phase are carried out, aimed at recommending the adoption of measures to ensure the protection and promotion of public health.
Regulatory inspections are crucial for ensuring compliance and quality in the pharmaceutical industry. Adequate preparation can significantly improve the efficiency and effectiveness of the process. Pharmaceutical companies must streamline their inspection process, demonstrate their commitment to compliance, and maintain a positive relationship with the Regulatory authorities.
From October 2023 onwards, the mandatory registration of Class C and D medical devices in India will require conformance with the Quality Management System (QMS) requirements, as per the Indian Medical Device Rules (IMDR) 2017. Thus, medical device manufacturers will have to implement a QMS that meets the requirements of Schedule V of the IMDR 2017. It is mandatory for manufacturers to be compliant with these requirements for the successful registration of their Class C and D devices.
Medical devices play a vital role in improving patient health, but non-conformities in the devices can occur even with the best quality control systems in place. Non-conformities refer to instances where a product or a process fails to meet Regulatory requirements, quality standards, or the approved in-house procedures. Effective non-conformance management is important for ensuring patient safety, Regulatory compliance, and the reputation of medical device manufacturers.
In Indonesia, the Good Method for the Distribution of Medical Devices, locally known as the Cara Distribusi Alat Kesahatan yang Baik (CDAKB), is a set of guidelines used in a series of distribution and quality control activities aimed at ensuring that the distributed medical device products meet the requirements for their intended use.
Labeling is an integral part of marketing medical devices. The label is a piece of information affixed with the device and/or packaging in a human-readable format. The main purpose of labeling is to provide safety information to users who can be healthcare professionals, consumers, or any other relevant person.
Determining and setting up a quality system is a challenging task for medical devices manufacturers. A robust quality system covers the aspects like the medical device design, manufacturing, supplier management, product labeling, storage & distribution, clinical data, risk management and complaint handling. The US FDA maintains a Quality System Regulation (QSR), which ensures that all the medical devices sold in the USA are safe, quality-oriented and effective for their intended use.