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GMP Auditing

How about making good-quality a mission? Consumers deserve the best services and products which is why GMP audit is important. But what does it mean?

So, a GMP audit is a procedure through which an internal member or a third party verifies that the manufacturer is following all the good manufacturing practices. That’s GMP for you.

You cannot be physically present in these situations at all times, so GMP audits ensure adherence to all the quality control guidelines. Customers expect the best quality which is why this GMP auditing service is relevant.
The question is – why is it important? Let’s find out through this quick post.

The Goal of GMP Audit

GMP audit ensures that the product is safe for usage else the manufacturer will make errors in the process.
During GMP auditing and inspections, the official checks and assesses the production process, materials used, equipment being used, packaging, labelling, and laboratory controls.

There are legit GMP audit companies so you need not worry about going to the manufacturing site yourself.
Businesses go down the drain if they get defective and poor products from the manufacturer. But with the GMP audit, businesses are breathing in peace.

What’s The Process like?

The time taken for a GMP auditing service depends on the complexity of the job. The officials may have to pre-inspect the space before the manufacturing begins.

The official may walk in and do a GMP audit pharmaceutical. There are some set standards that the manufacturer has to adhere to.

Once the audit is complete, the manufacturers will get GMP audit reports that state all the findings. Since there is a proper report, everything is mentioned in detail.

Why is a GMP audit so important?

GMP audits will help identify all the deficiencies in the manufacturing process. Everything cannot be perfect, but as a business person, you cannot afford to get shoddy quality products.
GMP audits are essential for too many reasons. This process will help manufacturers rectify the mistakes, and offer the best products to businesses. Nobody wants a non-compliance or warning letter which is why the GMP is recommended.

The officials go to the manufacturing unit, and they check if the personnel is following all personal hygiene practices. Besides this, they also check if the products are in proper storage in sanitary conditions.
The equipment has to be functional and clean. Moreover, the equipment needs an update.
The officials also ensure that pest control is necessary because products that rodents touch are dangerous and unhygienic for human beings. Officials will check everything before they make a final judgment.

Concluding thoughts

You could hire a third-party GMP service provider or have an internal team member do it. Although, we suggest having some expert on board to avoid any glitches.

The professional team knows what all guidelines are there for manufacturers to adhere to, so consider doing some research about the best GMP audit provider.

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    Audit Report Package

    Our Audit Report Package is very thorough and includes all of the following which is sufficient enough to qualify the supplier:

    • Full Audit Report.
    • Auditor’s CV.
    • Auditor’s non-conflict of interest declaration.
    • CAPA plan with evidence, as applicable.
    • Audit closure signed by Lead Auditor, with CAPA review confirmation.
    • Attachments including lists, certificates, licenses, layout etc.
    • Additional documents such as SMF, SOP index, Site presentation etc. as available.