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Pharmaceutical Industry Audit: Best Practices for GMP Compliance


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Pharmaceutical Industry Audit: Best Practices for GMP Compliance

GMP stands for Good Manufacturing Practice regulations, which is a set of guidelines enforced by relevant agencies. These guidelines provide the foundation for determining if companies take proactive steps to ensure their products are safe, pure, and effective.

For example, the World Health Organization (WHO) version of GMP comes with instructions regarding the production, quality control, and development of pharmaceutical products. In the United States, GMPs are enforced by the U.S. Food and Drug Administration (FDA).

Conducting a GMP audit is crucial for keeping you and your company secure. Otherwise, you cannot guarantee your facility meets all regulatory requirements. It is a critical step in protecting your business from far-reaching consequences, such as fines, recall, seizure, and jail time.

Many factors come into play in carrying out a comprehensive and well-executed GMP audit. Here are the best practices to ensure your company passes the upcoming one with flying colors:

Educate Your Employees

One of the first things you should do is educate your personnel on the requirements your company has to meet. This way, you can keep everyone on the same page, increasing your chances of avoiding hiccups down the road.

Besides hiring people with a deep understanding of the rules and regulations applicable to your industry, you also must provide them with opportunities to grow their knowledge. For instance, you could purchase a course about regulatory compliance, gaining access to online certified training for pharmaceutical professionals.

Another vital component is training your employees to carry out and document various procedures. Machine operators and other employees participating in the manufacturing process need to understand the potential risks associated with the machinery they use and the products they create.

On top of that, you could consider organizing random evaluations to test your staff’s level of comprehension of necessary directives. It will make your workplace much safer and help you fulfill quality assurance needs at every stage of product development.

While the regulations keep getting more robust, human failure remains a frequent cause of crises. Constantly assessing your employees’ familiarity with GMP expectations will help ensure it does not happen to you.

Evaluate Your Workflow

Speaking of product development stages, you must carefully inspect those before an audit. Review each phase of the process to locate and eliminate any issues before they grow out of hand.

Elements subject to an assessment during a GMP audit include:

  • sanitation,
  • cleanliness,
  • personnel qualifications,
  • equipment verification,
  • process validation,
  • record keeping,
  • complaint handling.

For instance, you may examine if complaints about marketed products are handled correctly. Workers responsible for this task should investigate the causes of quality defects and take appropriate measures to prevent a recurrence.

At the same time, you cannot forget about preparing and storing records that demonstrate you took all the steps required by the defined procedures and instructions. Without them, you have nothing to back up your claims.

Other than that, think about improving the coordination of the five subsystems, which are essential for every pharmaceutical company. These are facilities and equipment, production, materials, packaging and labeling, and laboratory controls.

Although most GMP requirements are general and open-ended, implementing the necessary standard operating procedures (SOPs) and controls is paramount for passing the inspection successfully.

Get Your Documentation in Order

Last but not least, it would be wise to go over critical documents and records.

Every GMP audit includes auditors collecting necessary information on-site by speaking with employees and getting acquainted with the documentation. Consequently, you should prepare a list of all the documents subject to assessment during the audit and review them beforehand. Thanks to it, you might localize and fix hidden problems, saving yourself a lot of trouble.

An excellent place to start is reviewing past audit and FDA inspection results. This way, you can quickly pinpoint which areas of your manufacturing process require more attention.

One of the basic principles for all GMP guidelines is that every manufacturing process must be clearly defined and controlled. Because of that, you should also validate your processes. Not only will it help with your GMP compliance, but it will also allow you to keep everything in order.

Bear in mind that all the instructions and procedures have to be written in clear, unambiguous language. Whenever in doubt, refer to good documentation practices (GDocP) to determine if they are up to par with the industry standards.

The Bottom Line

Preparing for a GMP audit can be stressful. After all, there are many things to consider and address. However, it does not have to be such a nerve-wracking affair. You just need to follow a few guidelines to stay on the right side of things.

For example, educating your employees about the compliance requirements can help ensure everything goes smoothly. Once your staff knows what they can expect, ensuring high-quality product research and manufacturing will become much more manageable.

Similarly, reevaluating all the critical processes and getting your documentation in order can be an enormous step in the right direction. Doing so is a straightforward way to meet quality standards and safety requirements and help your business become the industry leader.

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