The pharmaceutical industry is highly regulated, and audits are essential to ensure compliance, maintain product quality, and protect patient safety. In this blog, we’ll explore the key differences between internal and external audits, why they matter, and the regulations that mandate them. Why Audits are Mandatory Audits are crucial in pharmaceutical quality management, helping to…
Inspection and audit are two distinct processes used to assess compliance with various guidelines and standards, including ISO 9001, FDA, EMA, and others. Here’s a breakdown of the key differences between inspection and audit based on these guidelines: Purpose: – Inspection: Inspections verify compliance with specific regulations or guidelines, focusing on identifying non-compliance issues…
Put together an Inspection Team that will be responsible for dealing with the inspection when the FDA is on the premises. The inspection team should consist of: Responsible Person — Select a high-level officer or manager, someone with ultimate responsibility for the company’s compliance. This person could be as high level as the CEO…
1. Pre-inspection planning This involves determining the scope and objectives of the inspection, identifying the specific areas to be inspected, and gathering relevant information about the foreign facility. 2. Notification The regulatory authority or agency conducting the inspection notifies the foreign facility about the upcoming inspection, providing details such as the date, time, and…
If you are a manufacturer or a processor of FDA-regulated products, sooner or later, you can expect a visit from FDA. The purpose of this visit is to verify compliance with all relevant regulations — most commonly referred to as an “FDA inspection.” But not all inspections are created equal. FDA Inspections The four…
As a life science sector audit and inspection are common terms in pharmaceutical industry. Here we going to mention a list of criteria of maintaining audit and inspection readiness at all times in pharma industry. 1. Clear Communication Channel Manufacturing and quality teams should establish clear communication channels. Regular meetings and discussions enable both…
