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What is Good Manufacturing Practices: GMP Guidelines and Processes

ISO 22716 GMP requirements
ISO 22716

What is Good Manufacturing Practices: GMP Guidelines and Processes

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Good Manufacturing Practices is a system for guaranteeing products are constantly developed according to quality standards. GMP also ensures products are controlled by conforming to guidelines.

 

It reduces the risks involved in the production that cannot be removed through the final product’s testing.
Good Manufacturing Practices are ensured through the effective use of a Quality Management System. QMS optimizes processes to help companies fulfill customer requirements and satisfaction.

 

In this article, QSE Academy explains the key aspects of GMP:

 

– What are the guidelines?
– What happens when a company does not apply GMP?
– What areas can a GMP address?

 

Understanding GMP Good Manufacturing Practices

 

GMP covers a system that ensures the production of goods complies with your country’s set of standards.
In effect, you can guarantee that the production conforms to guidelines that control the licensing and authorization of the manufacture and sale of goods.

 

Good Manufacturing Practices are applicable in dietary supplements, pharmaceuticals, food, beverages, cosmetics, and medical devices.

 

Know that manufacturers must implement GMP according to their respective country’s government.
For example, the United States has the US FDA to enforce GMP guidelines. The FDA covers a wide range of industries such as food, cosmetics, prescription drugs, and medical devices.

 

It also executes facility inspections to evaluate if a company follows GMP regulations. Hence, the FDA can recall products that made serious violations.

 

This is why it is important to follow Good Manufacturing Practices. Recalls can pose problems to a company’s operations, profit, and credibility.

 

Moreover, every country has GMP guidelines that regulate the production, validation, and verification of manufactured products.

 

In effect, manufacturers can make sure that their goods are safe and effective for market distribution.

 

Since GMP includes the most current standards, manufacturers must obtain updated systems and technologies.
Up-to-date equipment and systems can prevent errors, mix-ups, and contamination.

 

What Does GMP Address?

 

Good Manufacturing Processes regulations take action on:

 

 Personnel qualifications
 Equipment verification
 Process validation
 Materials
 Premises
 Sanitation
 Cleanliness
 Hygiene
 Record-keeping
 Complaint handling

 

Fortunately, Good Manufacturing Processes requirements are general and open-ended. Therefore, manufacturers can decide the best way to implement controls.

 

As a result, companies gain flexibility in interpreting the requirements that best fit their environments.

 

Manufacturers must develop detailed written procedures for each process. Know what processes impact the quality of the finished product.

 

 

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Basic GMP Good Manufacturing Practices Guidelines

 

As explained, GMP guidelines are principles that help implement an efficient manufacturing process. Countries have legislations that develop GMP principles and guidelines.

 

Even though the guidelines could be flexible, the outcome is that companies must produce quality services and goods.

 

The Good Manufacturing Practices guidelines could be taken from these basic concepts:
Quality Management

 

This guarantees that manufactured products follow Good Manufacturing Practices requirements. In this way, the goods become fit for their intended use. Subsequently, they will not harm consumers.

Achieve this by implementing:

 

– quality objectives
– quality control
– quality risk management

 

Personnel

 

Trained and qualified staff must implement GMP. They should obtain relevant tools, hygiene instructions, and training for the job.

 

Sanitation and hygiene

 

Impose proper hygiene and sanitation to avoid contamination on personnel, materials, equipment, containers, and equipment.

 

Raw Materials

 

Store materials according to appropriate conditions. Apply a proper stock management system for all incoming materials.

 

Equipment

 

Design, place, and maintain equipment to preserve functionality according to their purpose.
Besides, clean and store equipment according to procedures. If there are malfunctioning equipment, label them as defective before removing from premises.

 

Building and Premises/Facilities

 

The premises must be in an environment suitable for quality operations. The facilities should also be free from risks of contamination.
Likewise, manufacturers should design their buildings in a way that is easy to clean and maintain.

 

Validation and Qualification

 

Validate systems, equipment, and premises if they are qualified for their purpose. Likewise, evaluate whether procedures and processes can constantly produce high-quality products according to GMP.

 

Complaints

 

Manufacturers must have a well-designed GMP complaint system. They must also provide solutions and corrective actions.

 

Inspections and Audits

 

Conduct regular audits to ensure implementation and compliance with GMP. Document areas for improvement and corrective measures to be taken.
Moreover, use GMP audit checklists in performing site visual walkthroughs.

 

Documentation and recordkeeping

 

Documentation is a crucial part of conforming to GMP requirements.
Accurate recordkeeping help manufacturers monitor historical record of manufacturing procedures and corrective measures.

 

GMP in Goods Production

 

Manufacturers must follow a comprehensive set of guidelines for producing goods. These include key points to remember for materials, equipment, the health of staff, and safety training.

Only trained employees must perform and carry out manufacturing processes to ensure efficiency.

Next, companies must clean facilities. In this way, they can preserve high standards of quality and hygiene.

Staff can prevent cross-contamination using temperature and humidity-controlled environments. They can also restrict access or entry to authorized employees with proper working gear.

Manufacturers must develop a document called Standard Operating Procedures. The SOP details and records the processes.

 

The quality and amount of goods are other crucial things to record. Remember to be careful in distributing the goods to preserve quality and prevent damage. The distribution should also be recorded for traceability.

In the case of problems, investigate any complaints. Devise contingency plans for recalls or updates.
Finally, remember to record and investigate any deviation from the SOP.

 

What Happens When There’s No GMP?

 

As you can see, GMP regulations need a quality approach to manufacture products and goods. This enables manufacturers to remove or diminish cases of errors.

Therefore, the absence of Good Manufacturing Practices can cause ineffective, or worse, dangerous items.
Manufacturers that do not comply with GMP guidelines can pose hazardous or fatal consequences to customers. Consequently, harm the environment.

 

This may cover temperature control, poor hygiene, and cross-contamination.
In some countries, failure to follow GMP regulations can cause consequences such as hefty fines, product recall, seizure, legal cases, and imprisonment.

 

Are You Ready to Follow Good Manufacturing Practices?

 

Good Manufacturing Practices serve as flexible guidelines to protect customers by delivering effective and quality products.

Similarly, a GMP is beneficial in ensuring a finished product conforms to quality standards and is free from contamination.

Successful implementation of Good Manufacturing Practices will provide your company with quality products, improved operations, better processes, and satisfied clients.

For smooth compliance to GMP, let QSE Academy help you using our consultants and toolkits.

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ISO 22716 2017

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