Regulatory compliance

What is Regulatory compliance? and what kind of audit for regulatory compliance issue

Continued from previous page…

There is no alternative to meeting regulatory compliance requirements by pharmaceutical, medical devices and healthcare companies.
Given the nature of regulatory compliance, the importance of regulatory compliance to pharmaceutical, medical devices and healthcare becomes clear. All these three industries have much in common, but the most important commonality is that they all play a critical role in ensuring health and wellbeing of people.

This is where the importance of regulatory compliance to pharmaceutical, medical devices and healthcare needs to be understood, because no other means ensure the wellbeing and health of people than regulatory compliance. We have just examined how regulatory compliance is essential and indispensable to make sure that the processes and products in these industries meet quality standards. When the products in these industries comply with regulatory requirements, it ensures that they are of high quality standards, which in turn is the sole means to seeing to it that human wellbeing is ensured. It is in this context that the importance of regulatory compliance to pharmaceutical, medical devices and healthcare needs to be understood.

Therefore, the audit of pharmaceutical facilities (Manufacturing, Packing, Storage, Transportation, Pharmacy shops etc.) conducted by the Regulatory authorities, such as CDSCO (DCGI) for India, USFDA (USA), EMA (Europe), TGA (Australia), SAHPRA (South Africa), ANVISA (Brazil), Health Canada (Canada) assess level of GMP Compliance is known as “Compliance Audit (Compliance Inspection)”.

There are different types of inspections conducted by the Drug Regulatory authorities depending upon objective of the inspection such as,

  • Routine GMP compliance assessment
  • For new facility (before grant of licence)
  • For any serious non-compliance (GMP)
  • For cause audit (For any serious product complaints such as deaths, Serious adverse reaction of drug etc.)
  • For exporting drug to different countries
  • For any major changes in the facility
  • Any other valid reason(s)

Similarly, other types of inspections are also conducted by the Drug Regulatory Authorities such as assessment of Clinical Trials on human volunteers for new drugs (GCP inspections), Toxicology studies on animals for new drugs (GLP inspections) etc.

1 Like

Enhances Customer and Investor Confidence
No product is likely to gain the trust from everyone who matters, right from the customers, stakeholders, employees and investors alike, unless it has met regulatory compliance requirements. Complying with regulatory requirements is the highest and surest guarantee and safeguard for the efficiency and efficacy of a product. When a pharmaceutical, medical device or healthcare company gains the trust of these vital players, it can be said to be valued company.

Saves Costs
Yet another benefit compliance with regulatory requirements brings for companies in the pharmaceutical, medical device and healthcare industry is that it helps to save costs throughout the lifecycle of the product. High costs are associated with ensuring compliance, but the cost of noncompliance is multifold higher. If an organization discovers that it has failed to meet regulatory requirements at any particular stage; it is usually impossible to abandon work at that stage and start afresh. The cost is astronomical in such an exercise.

1 Like