GMP Audit

GMP Audit – The Ultimate FAQ Guide

In this guide, you will find all information about GMP audit.

From basic, to advanced processes, while comparing GMP with other factory audit procedures in the industry.

By the end of this guide, you will be an expert in GMP Audit.

What is a GMP Audit?

GMP stands for Good Manufacturing Practices. It refers to safety practices put in place to ensure that production is of the highest quality standard.

GMP Certified

GMP certified stamp

A GMP audit is an independent third party inspection done on manufacturing companies.

The purpose of the audit is to identify the flaws within the factory’s manufacturing process.

GMP audit is used to advise production companies on acceptable quality standards and how to meet those standards.

It is essential to conduct GSM audits on your supplier’s manufacturing facility and processes to guarantee safe products.

Why is GMP so Important?

The increase in many suppliers causes a threat in terms of the quality of products supplied.

A GMP audit allows you to trust the products your supplier ships.

It also helps to guide suppliers on the acceptable quality levels.

A GMP audit is useful for both importers and exporters in the following ways:

Cut Losses and Maintain Profits

Suppliers produce goods to sell them at maximum possible returns.

Achieving this maximum return becomes problematic if the quality of the goods manufactured does not meet consumers’ demand.

Consumers tend to look for alternatives if the goods supplied are with defects.

Therefore, GMP helps a company by providing a system in which all aspects of the product is monitored before it reaches the market.

Boost Export Opportunities

GMP provides the surety that a company produces quality products that are fit for health and consumption.

Some governments have restrictions that limit the importation of products that do not meet GMP guidelines.

Therefore, many companies continue adopting GMP to sell their products beyond borders, eventually increasing their returns.

Reduce Complaints and Avoid Recalls

Before sourcing goods from particular suppliers, it is best to check if they have the requisite GMP certification.

By ensuring your supplier’s GMP compliance, you can rest easy knowing that you will receive products of acceptable quality, safety, and efficacy.

In this way, customers will rarely reject your products and will eventually gain trust in your brand.

On the manufactures’ side, ensuring GMP compliance in their facilities and manufacturing process reduces the frequency of complaints and goods recall after supply.

Prevent Health Damages

GMP is mostly used in the food and pharmaceutical industries.

These industries have a direct impact on health.

Nobody would want to purchase food or medicine from a company that is not GMP compliant.

Lack of GMP in these industries sometimes results in unintentional contamination of products.

Such goods that fail to adhere to GMP may not have the desired effect.

In worst cases, medicine with toxic contamination may cause harm to human and animal health.

Perfect Hygiene Protocols

GMP is not only applicable in the production process.

This practice is also essential in ensuring that all employees within the production chain are hygienic.

When the employees within the company handle themselves properly, instances of cross-contamination significantly reduces.

Additionally, GMP ensures that a factory’s storage, packaging, and transportation systems are appropriate and meet set standards.

Easy Scheduling of GMP Audit

When dealing with a company that has GMP, it is easy to schedule audits.

The company has an elaborate manufacturing process, and the employees are well trained.

Therefore, it becomes easy to conduct a GMP audit and even advise if there is a shortage in quality standards incorporated within the company.

Who should Consider a GMP Audit?

GMP standards are enforced to ensure close monitoring of the production process to manufacture only quality products.

Anybody dealing in consumables can initiate GMP.

Companies that seek to build a reputation overseas must have independent GMP audits.

This is to assure importers that they uphold higher manufacturing standards.

Importers can also request GMP audits on their supplier’s premises to verify the GMP standards’ compliance.

In the food and pharmaceutical industries, GMP is enforced to safeguard consumer health and wellbeing.

Importers should conduct a GMP audit on their manufacturers.

This will help to ascertain that they are receiving GMP-compliant goods that safe for consumption.

What is the Difference Between GMP and cGMP?

GMP refers to Good Manufacturing Practices.

It is the desired quality protocol that manufacturers have to adopt in their production.

cGMP, on the other hand, denotes Current Good Manufacturing Practices.

It is the most recent quality practice required in the manufacturing of products.

The difference between GMP and cGMP is only on the emphasis on the manufacturing process’s quality level.

cGMP means that the manufacturing process has to be top-notch and involves the most recent standards, technology, and practices

What is a GMP Audit Checklist?

A GMP audit checklist gives an outline used to verify if manufacturers conform to the accepted GMP standards.

Sample GMP audit checklist

Sample GMP Audit Checklist

It is basically a tool used by auditors to verify the manufacturing process’s quality and personnel.

What are the Features of a GMP Audit Checklist?

You want to ensure that your supplier meets all your demands before settling on them.

Therefore, your GMP audit checklist should be as comprehensive as possible.

Depending on your market, the following categories provide the basic guidelines for a GMP audit checklist.

Building and Facility

The buildings and facilities used by the supplier have a significant impact on the final products.

Also, the GMP for building and facility looks at the construction design and the layout.

In this case, facilities should be such that all manufacturing, packaging, and storage processes meet GPM standards.

The environment around the building should also be conducive to ensure adequate waste management and water source.

Important things under building to put in your checklist include;

  • Availability of clean toilets and washing points: the facility should have running water and soap for washing.
  • Adequate ventilation: The area used for manufacturing, packaging, storage, and offices should have proper ventilation.
  • Lighting: All rooms should be appropriately lit, and there should not be dark corners that can lead to accidents.

Organization and Personnel

Getting quality products entirely depends on the organization and the kind of personnel the supplier has.

Your GPM serves to identify the manufacturing process and factors in those who provide the workforce needed.

Here, the GMP audit checklist can include;

  • Number of employees: the supplier should have enough employees, each with an exact role.
  • The education level of employees: When dealing with pharmaceuticals, the supplier should have employees who have the required knowledge to guarantee the desired quality.
  • Availability of frequent training: for the supplier to guarantee GMP, the workforce must be trained on new manufacturing trends.

Production and Process Control

The supplier’s production methods should be precise and conform to GMP.

There should be proper methods that ensure only quality raw materials are delivered for manufacturing.

In assessing production and process control, the GMT checklist can include;

  • Methods of checking and validating raw materials
  • How the manufacturing process incorporates new trends

Packaging and Labeling

The information provided on the products affects how they are consumed.

Suppliers are required to include information on the ingredients used, product expiry date, and usage instructions.

Packaging and labeling are thus crucial and should be GMP compliant.

The GPM audit should check the following:

  • Description of the product
  • Quantity and weight of the product
  • The tracking number of the product: this can be in the form of a bar code

Storage and Distribution

The FDA states that GMP does not stop at manufacturing.

Until the goods are loaded for shipping, the supplier should practice GMP at all times.

With this in mind, the storage method used at the manufacturer’s warehouse and even outside should comply with GMP.

Also, the distribution channel should avoid situations that can lead to product contamination.

Here, the GPM checklist can include:

  • The type of storage facility used.
  • Method of quarantining the products.

Documentation and Record Control

Documentation and record control provide key evidence on how the supplier handles the manufacturing process.

The GMP audit will pay attention to the reliability of the manufacturer’s data storage methods.

Your GMP audit checklist should include;

  • The methods of data storage
  • Preparation of records
  • Approval and distribution of the records

How do you Prepare a GMP Audit?

Audit

Audit

Preparation is a necessary aspect of the GMP audit.

You want to have the best result from the audit.

Therefore, it would help if you prepare adequately before undertaking the audit.

Determine the Basis of the Audit

You don’t just wake up one day and decide to conduct an audit.

It would be best if you first started by defining the need to perform the factory audit.

You begin by knowing the objectives of the audit and the roles you will play in the audit.

Also, there should be a clear scope of what the GMP audit will cover.

The scope can be the number of facilities to be audited or the time allocated for the audit.

Finally, there should be clear standards to be used in evaluating the GMP of the company.

Determine the Feasibility of the Audit

Feasibility can involve looking at the probability of having a successful audit.

You can look at the availability of time and resources or sufficient information to carry out the audit.

Review Documents

Once your feasibility test proves that the GPM audit is fit to be done, review documents from the auditee and set standards to be used in the actual audit.

You can liaise with the auditee to provide other documents if the available records don’t meet your needs.

Where they fail to do so, you can decide to postpone the audit.

Prepare the Audit Plan

If everything works out well, the next thing is to prepare an audit plan.

The audit plan includes;

  • The objectives of the audit and the scope
  • The role of the audit team
  • The time, date, and venue of the audit

After preparing the audit plan, share it with your supplier and solve any disparities before rolling out an official GMP audit plan.

Communicate the Audit Plan to your Team

Inform your audit team of their roles and the time frames for the audit.

It would help if you also informed the specific personnel working within your supplier’s company and their role in the audit.

Finalize the Work Documents

When everything is ready, prepare the necessary audit documents such as questionnaires and forms to gather data.

What are the Steps of GMP Auditing?

As you already know, GMP is vital in assessing quality standards practiced by manufacturing companies.

Therefore, all aspects of the GMP should be outlined before the auditing to ensure no valuable detail is left out during the audit.

Use a Written SOP

The first step in carrying out a GMP audit is outlining the roadmap to the audit.

This involves having elaborate plans that are recorded. The audit should be systematic, and each part to be audited at the assigned appropriate time.

The audit team should also be aware of their roles to avoid making mistakes or misreporting feedback and observation.

Confidentiality of the Outcome

Regardless of the kind of audit you undertake, the results should be confidential.

Those working in the company you are auditing should not feel targeted.

Let them know that the audit’s purpose is to check if the manufacturing systems, technology, and processes comply with GMP regulations.

While conducting the audit, use a checklist that only targets the systems and facility and not the employees.

Using Checklist

GMP provides an essential checklist to be used during the audit.

You can customize it and only collect relevant data.

Ask employees clarification where the answer you seek is not clear and avoid jumping to conclusions.

Auditing from a Cooperative Angle

The GMP audit ensures quality standards of operations and does not reveal its harmful practices to customers.

Therefore, stick to the checklist and endeavor to create a harmonious relationship with the firm.

Do not approach the audit to reveal ills within the company.

Timing of Events

GMP audit does not stop after visiting the facility and gathering data.

You must prepare reports and submit them to the necessary parties.

Your plan should have an appropriate order of activities and proper timing.

You should do the reports within the shortest time and submit them while the audit is still fresh in the management’s mind.

This will provide room for swift implementation.

Plan Re-audits and Corrective Actions

After presenting the results of the audit, it doesn’t stop at that.

If there were unavoidable barriers that hindered carrying out audits in some parts of the company, you could plan for re-audits.

Essentially, a firm will not achieve all GMP practices once.

With frequent audits and advice, the company will improve its GMP.

What are the Main Components of Good GMP?

GMP practices help companies build strong market admiration because they deliver quality products to customers.

Often referred to as the 5-Ps, the components of a good GMP comprise all aspects of the company’s operation.

These are:

People

The personnel employed by the firm ensure all other operations are in order.

They provide a workforce and take part in all activities that cumulatively help achieve the firm’s objectives.

Company personnel should therefore have the necessary skills in their respective jurisdiction.

They should keep proper sanitation by observing appropriate dressing codes and follow laid down procedures.

Product

This is the primary purpose of the firm and should follow all protocols regarding GMP.

The product should be correctly packaged, labeled, and have stable testing methods.

Besides, the product should have clear guidelines regarding what the components of raw materials should constitute and channels for by-products.

Procedures

Procedures outline methods to be followed when dealing with either production or management of the firm.

The process should be well documented and made available to employees.

Firms should have proper methods of ensuring that procedures are followed to the latter.

Premises

Premises and equipment should be laid in a way that allows proper and unhindered cleaning and decontamination.

They should also have appropriate records on servicing and maintenance of the facility and equipment.

Processes

Processes define clear roadmaps to be followed when dealing with certain aspects of the business.

They can include stages in production or how information is to be relayed within the firm.

These should have proper documentation and control methods.

Further, they should highlight critical points to be observed within the business.

What is a GMP Inspection?

GMP inspections are quality checks done to enforce GMP compliance or give permission to manufacture certain types of goods.

This inspection is usually done in factories without GMP certification.

The inspection is therefore done to assess whether the company qualifies for GMP certification.

Or, as earlier mentioned, to provide authorization for the manufacturing of a particular product.

What are ICH q7 Guidelines?

ICH q7 provides guidelines to be applied in dealing with active pharmaceuticals.

It gives the standard qualities that manufacturers dealing in active pharmaceutical ingredients should follow.

How does GMP compare to ISO and QSR?

Quality Systems Regulations (QSR) is a subset of the GMP set by the FDA.

It provides the needed quality standards in the diagnostic industry.

ISO

ISO

International Organization for Standardization (ISO) provides globally accepted quality standards for managing a company.

Both QSR and ISO refer back to GMP, with ISO focusing majorly on its management aspect.

On the other hand, QSR is in charge of the systems used in the company.

Who Regulates GMP?

Depending on the country of operation, GMP is regulated by an appointed government body.

If the manufacturing company is operating in the US, the Food and Drug Administration (FDA) regulates the GMP.

What are the Types of GMP Audit Reports?

Audit reports vary depending on the findings and opinions given by the auditor.

There are four basic types of GPM audit reports that include:

Qualified Opinion

This report will be given when the auditor feels the manufacturer is hiding something due to restricting access to some areas during an audit.

A GMP auditor will give his opinion but with a note indicating their reason for deciding so.

Unqualified Opinion

This type of report scores the firm high in a position they can obtain their GPM certificate.

It usually results from closely adhering to GMP regulations.

Adverse Opinion

When the auditor feels some information has been hidden from them and the firm does not adhere to GMP, they can issue an adverse opinion report.

When this type of report is given, companies must analyze their GMP and be re-audited.

Disclaimer of Opinion

An auditor’s report may have a disclaimer of opinion.

Meaning, they did not have access to documents that could provide the information they needed.

What does a GMP Audit Report entail?

A GMP audit report is the most critical part of the whole process since it provides the answers sought for in the audit.

The information should give as much detail as possible about what was observed during the audit.

A standard GMP audit report should contain:

  • The name of the auditors
  • The date and how long the audit lasted
  • Details about the firm being audited (the name, address, owner)
  • The observations during the audit and obstacles faced, if any.
  • Areas that were included and those not included in the audit
  • The findings and conclusions from the audit
  • Recommendation to the firm on what to improve on as a result of the audit findings
  • List of all those who should receive the results of the audit reports.

The audit report is an essential reference that helps manufacturers, importers, distributors, and retailers decide.

Therefore, it would help if all necessary details from the audit are included in the final report.

What are GMP Documents?

The goal of conducting a GMP audit is to ensure the supplier meets the highest production standards.

GMP documents provide proof of how the supplier handles their affairs.

These documents provide a picture of the past and present ways in which the supplier handles manufacturing.

The GPM documents also offer information for planning purposes and predicting how the supplier will produce in the future.

Some GMP documents are:

  • Standard operating procedures (GOP)
  • Specification
  • Bath production records
  • Laboratory control records
  • Records for Raw materials, Intermediates, Labelling, and Packaging Materials
  • Bill of materials
  • Training assessment records
  • Work instructions
  • Protocol records

What is a GMP’ mock’Audit?

A GMP mock audit is a particular type of audit that is usually conducted before the official audit.

If a firm wants to apply for a GMP certificate, before having FDA conduct their audit on your firm, you can have a specialist do a mock audit.

A mock audit will highlight how they are doing in terms of GMP before the official auditing is conducted.

How do you Maintain GMP?

You want your company to be favored by consumers and expand your operations beyond your borders.

Then you have to consider practicing GMP and maintain it in the following ways:

  • Always maintain the cleanliness of the equipment and the facility to prevent contamination.
  • Following procedures laid down for manufacturing to the latter
  • Having an elaborate data management system for documentation of records for easy planning.
  • Having the right workforce assigned to handle what they are best at.
  • Conducting frequent audits to ascertain if your firm conforms to the set GMP
  • Integrating all aspects of product quality from sourcing raw materials, manufacturing, packaging, and even storage.

What is a GMP Certified Manufacturer?

GMP is about quality standards in manufacturing.

A GMP certified manufacturer is one whose processing system and management are proven to be in line with GMP regulations.

For a manufacturer to be GMP certified, they must complete an FDA GPM audit.

After this, they will be awarded a certificate indicating that they are compliant with GPM standards.

Who issues GMP Certificates?

Certified bodies issue GMP certificates upon the company’s Quality Assurance Manager or managing director’s request.

It is issued after a physical GMP audit has been done, and the result has proven to be satisfactory.

How Long does it Take to get GMP Certification?

The time taken to receive GMP certification varies from country to country.

It also depends on the industry in which your business is.

However, for pharmaceuticals in the USA and Canada, it takes 1-2 weeks.

What is the Relationship between GMP and SOP?

Standard Operating Procedures (SOP) are the routine procedures used in different departments within a firm.

They vary from one company to the other and provide the techniques that help conform to the accepted GMP.

SOP is internally documented to give employees proper directions on applicable standards within the company.

Which SOPs are required in GMP?

GMP is broader in coverage.

It usually employs several standard operating procedures to assess the manufacturing systems’ quality standards, technology, and processes.

The following SOPs are included in GMP:

  • Provisions for special testing requirement
  • Packaging methods, labeling, and distribution, and warehousing of the products
  • Cleaning, maintenance, and servicing of pieces of equipment
  • Methods for sampling and testing of in-house materials and products
  • Roles and responsibilities of the quality control team
  • Assessing and monitoring the quality of raw materials to be used for processing
  • Provision on accepted types of facilities and their locations

What is the Importance of GMP in the Food Industry?

Food is critical to the health of every living organism.

The safety standards required for processing and handling foods determine if the food is fit for human consumption.

GMP help ensures that the processing systems and those handling food uphold high-quality hygiene to reduce contamination.

What is the Role of Quality Control in Maintaining GMP?

Quality control incorporates GMP in it to ensure the products manufactured are of the highest possible standards.

Quality control ensures that:

  • Production and operations are well documented as per the GMP requirements.
  • Finished products are correctly checked and recorded as per the defined procedures.
  • Systems are designed for rectifying errors that may arise in the course of the production.
  • The responsibility of individuals is spelled out to reduces instances of employees handling what they are not good at
  • There is a proper arrangement to access quality raw materials and packaging materials following the appropriate standards.

What is the Coverage of GMP?

GMP covers nearly all aspects within the firm that directly or indirectly affects product quality and safety.

First, it covers the sourcing of raw materials all through to production, packaging, and storage.

Secondly, GMP covers the premise and facility used in production and administration.

It looks at the quality standard used in handling the machines and servicing them.

Finally, GMP covers the people, the premise, and the processes within the firm.

It regulates hygiene and proper training of employees to be competent in their operations.

What is the Difference Between HACCP and GMP?

HACCP is the short form for Hazard Analysis Critical Control Point.

It provides the guidelines for ensuring that the manufacturing unit is safe from hazards.

HACCP gives a preventive mechanism for monitoring and advising on ways in which such risk can be averted.

Both HACCP and GMP serve the same purpose of protecting consumers against manufacturing flaws.

Nevertheless, GMP is more comprehensive in its scope, covers preventive hazard measures, and focuses on general hygiene.

Unlike HACCP, GMP covers a broader spectrum of the firm’s manufacturing process.

It covers the production process, the environment, documentation process, employee welfare, and the factory’s location.

HACCP only covers the production processes and aims to prevent hazards.

What are the Basic Requirements of GMP?

GMP relies on having the best manufacturing standards that deliver quality goods to the consumers.

For a GMP compliant supplier, they should know what type of production system is termed quality.

GMP requires carefully designing your facilities to meet desired standards.

Your processes should be useful and practical.

Similarly, your employees should be well acquainted and trained frequently.

Lastly, GMP requires a proper record-keeping system and documentation that provides operations and store data procedures.

What Standards are used to Perform the GMP Audit?

The use of GMT audit gives an in-depth opinion on how manufacturers handle their business’s critical aspects associated with the final product.

The GMP Audit is subdivided into different parts of the production and should tick the following standards.

  • Process and controls; the standards, the reliability of the methods, and how flaws are controlled.
  • People; Here, the quality standard can include the employee dressing code and how information is relayed from one person to another.
  • Facility; Quality standards can include verifying the sanitation around the buildings, water sources, proper ventilation, and lighting.
  • Distribution and storage; under distribution and storage, quality standards can be sufficient records of products leaving and entering warehouses and proper storage.

How do you Choose a GMP Auditor?

Choosing a good auditor is never a walk in the pack.

It involves doing a background check on the auditor’s reputation and assessing if they have a past case related to auditing.

Generally, a good auditor should:

  • Be independent and have no relationship with either the firm or importer.
  • Have knowledge on the field to be audited. If it is a pharmaceutical company, the auditor should have experience in medical aspects.
  • Experience in auditing with no negative reputation on matters confidentiality of information
  • The budget of the auditor must be affordable as per your budget.

Essentially, the underlying goal should be on finding an auditor with experience in GMP.

This way, you increase the chances of getting accurate information on the firms manufacturing practices.

How do you Ensure the Confidentially of Information during a GMP Audit?

During GMP audits, the auditors have access to crucial production information of the firm.

Such information should not be revealed to the public or any other party unless approved by the firm.

To ensure the utmost confidentiality of the information, auditors should hire only honest and impartial audit assistants.

The information obtained from the audit should also be secured and stored in protected safes away from competitors.

Do you need to perform a GMP Audit in a GMP Certified Facility?

Production processes change, and a company would want to equip itself with new technologies.

In doing so, their quality of production changes and may be passed over to the ultimate product.

GMP audits are frequent and can be performed whenever deemed fit.

This is regardless of whether a firm has already acquired a GMP certificate.

Furthermore, the GMP certificates are only applicable after two months, and when being renewed, the firm must be re subjected to GMP audits.

Do EU and US FDA Regulators Accept GMP Third Party Audits?

3rd Party Inspection and Auditing Companies

3rd Party Inspection and Auditing Companies

Many firms seek to use GMP third-party audits to save on time and the enormous costs associated with official audits.

Both the EU and FDA regulators accept the GMP third-party audits used to verify supplier compliance status.

However, the auditors have to follow specifically prescribed procedures in auditing the suppliers.

What are the Requirements of the 3rd GMP Auditing Firms?

The FDA is strict when it comes to the use of third party GMP audits.

For the audits to be regarded as accurate and justifiable, they must have specific requirements that include:

  • There should be satisfactory evidence that the third party factory audit company is independent and show no conflict of interest.
  • There must be proper documentation of the findings and procedures. The audit reports should also be easily retrieved when needed by inspectors.
  • The auditor should have substantial experience and qualifications in the field.

GMP auditing avails essential information about the firm to local and overseas customers.

Therefore, every detail of the audit becomes crucial, and third party auditors should maintain professionalism.

What is a Shared 3rd Party GMP Audit?

A shared 3rd party GMP audit means that the audit is initiated by more than one qualified company.

The 3rd party audit should not be ordered by the same firm handling the processing.

How do you Address GMP Violations after Audit?

After the audit, you will receive reports on your firm’s status concerning GMP.

If you fail to meet the GMP standards, you will be required to present explanations on why you were unable to meet the GMP and how you plan on correcting the violations.

If your response to how you plan to mitigate the deficiencies is not substantive, the regulatory body will issue you with a warning letter.

How much does GMP Audit Cost?

No predetermined cost is set to be incurred in a GMP audit.

A lot of factors have to be understood before approximating the cost of the audit.

If the firm hires an independent third-party auditor to carry out the audit, they will have to agree on mutual costs with the auditor.

The cost of hiring such third-party auditors ranges from $1,500-$2,000 per day.

Therefore, the larger the facility, the longer the audit will last and the more you will pay.

Besides, getting a GMT certificate attracts an annual subscription fee of $1000 and a registration fee of $250.

The registration request and the costs are paid to the relevant authorities before the necessary audits are conducted and the certificate awarded on qualification.

At BanSar, we can help with all quality inspection procedures.

We have partnered with reputable companies to ensure your products meet the highest quality standards.

Contact us today for all your GMP audit requirements.

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