An Ultimate Guide on GMP Audits For Product Quality And Compliance
Manufacturing industries, including pharmaceuticals, cosmetics, and food and beverage, depend on GMP audits. They evaluate the compliance of production processes with quality standards.
In this article, we’ll look at the five major components of?GMP audits, their benefits, the best ways to conduct them, and how the UrAudits?inspection app?can help you prepare.
What are GMP Audits?
A GMP audit determines whether a production system is compliant with Good Manufacturing Practices (GMP) policies. These regulations guarantee that the manufacturing processes of products adhere to the highest quality standards. The audit involves the following steps: preparing, scheduling a meeting, collecting information from interviews and documents, conducting an in-person inspection, and compiling a report on previous discoveries.
There are two categories of GMP audits:
????????? Audits conducted by third parties
????????? Audits conducted internally
Is it essential to conduct GMP audits?
Industries that are overseen by health authorities, such as the FDA, are required to undergo GMP audits. Product recalls, fines, and reputational damage can result from noncompliance with GMP constraints.
Duration and Frequency of GMP Audit
The inspection scope and the building length determine the duration of a GMP audit. It may remain for a few days or weeks.
Nevertheless, companies conduct rigorous internal GMP audits annually, which can differ depending on the rules, the complexity of the activities, and the deficiencies identified during previous audits. The external audits are conducted less frequently by external entities, typically every two to three years or as mandated by certification or standards.
It is advisable to conduct minor internal inspections more frequently to guarantee that GMP guidelines are adhered to daily.
GMP Audits Units
The following are factors that are inspected during a GMP audit:
????????? Validation of essential production procedures that have been verified.
????????? The effectiveness of quality control actions.
????????? Analyzing the methods of document and record preservation.
????????? Addressing the concerns and product recalls.
????????? The qualification of the equipment and personnel is being verified.
5 GMP Pillars
1.????? People
2.????? Processes
3.????? Procedures
4.????? Products
5.????? Premises
GMP Audits’ Nine Parts
The five Ps of GMP audits are responsible for managing the primary areas that are essential for the quality and safety of manufacturing:
·???????? Personnel
·???????? Warehousing and Distribution
·???????? Processes and Controls
·???????? Sanitary Operations
·???????? Sanitary Buildings and Control
·???????? Equipment and Utensils
·???????? Defect Action Levels
·???????? Plant and Grounds
·???????? Handling of By-Products
Practices for Making a GMP Audit with UrAudits
Here’s a how to prepare for a GMP audit with the UrAudits?inspector app.
·???????? Initial Steps and Team Preparation
·???????? Document Preparation and Accessibility
·???????? Creating SOPs and Audit plan
·???????? Conducting Internal Audits
·???????? Implementing Changes and Continuous Improvement
UrAudits?auditing app or inspector app for Android?or iOS?is easy to use! Sign up for a free 14-day trial.
GMP Audits Benefits
GMP (Good Manufacturing Practice) audits comes with major advantages:
·???????? Improved Product Quality
·???????? Enhanced Compliance
·???????? Improved Efficiency and Cost Savings
·???????? Customer Confidence
·???????? Employee Awareness and Training
What Is the Difference Between GMP and CGMP?
Production standards are established by both GMP and CGMP. The distinction is that the term "current" is included in the CGMP, which implies that producers must implement state-of-the-art technologies and procedures to guarantee the safety and quality of their products. The CGMP regulations are adaptable, enabling businesses to implement the most effective methods that are compatible with their unique processes.
Summary
The UrAudits inspection app is a digital solution that can assist you in adequately preparing for GMP audits. It streamlines the process of conducting internal GMP audits and managing remedial actions, enhances document management, and provides faster access to information.
UrAudits??inspection app for iOS?or inspection app for Android? also exists for tablets. Your team captures each part of the information quickly, fastening the audit process.
Also, besides food standards, we provide to many other sectors as we exist as an?audit app for home care, healthcare, construction, and automotive.