Quality  >  GMP Quality

GMP Quality

Good Manufacturing Practice (GMP) deals with quality measures for both production and quality control as part of quality assurance. GMP also ensures that processes should be clearly defined, approved, revised, and recorded for production and testing.

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gmp quality
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What is GMP?

GMP refers to the Good Manufacturing Practices that consist of processes, procedures, and documentation. It can help to avoid recalls and fines and also reduce losses and waste. GMP addresses problems around cleanliness, handling complaints, valid process usage, sanitation and hygiene, record keeping, and employee qualifications.
It also ensures the safety, purity, and effectiveness of its products by taking proactive measures. Manufacturers can understand how to implement GMP quality in their specific environments by following Good Manufacturing Practices guidelines. GMP regulation and guideline consider the following areas:

  • Quality management and complaints
  • Building and facilities
  • Equipment and raw materials
  • Qualification and validation
  • Recordkeeping and documentation
  • Inspections & quality audit
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GMP Relation with Quality Standards

GMP is a set of processes, documentation and procedures that ensure that products are produced and controlled as per quality standards to mitigate risks. GMP practices are required to conform to guidelines and regulations as they cover all aspects of production, including premises, equipment, materials, training, and personal hygiene of workers. Implementing effective GMP can help manufacturers to save cost by reducing the cost of failures such as cost of recall, scrap and waste.

gmp quality standards
gmp quality and cgmp difference

How is GMP Different from cGMP?

The Good Manufacturing practices guidelines ensure that the entire process from record keeping to packaging is done correctly and precisely. There is some difference between GMP and cGMP even though both GMP and cGMP assure quality. The “c” is added to cGMP to assure systems have accurate design, tracking, and control of manufacturing processes and facilities. A manufacturer assures the identity, strength, quality, and purity of drug products through controlled manufacturing operations by adhering to cGMP compliance regulations.

Implemented by the US Food and Drug Administration (FDA), Good Manufacturing Practices (GMP) ensures that their products are safe and effective while the cGMP ensures continuous improvement to product quality. It commits to the greatest quality standards using upgraded systems and technologies.

cGMP is more expensive than regular GMP as it mostly uses new, innovative technology available at the time of production.

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Important Components of Good Manufacturing Practice

To ensure consistent quality and safety of products, it is important to regulate GMP quality in the workplace. The following components of Good Manufacturing Practice (5 Ps) comply with standards across the complete production process.

5ps of gmp quality
gmp quality people
People

Every organization should follow manufacturing processes and regulations. All employees should take GMP training to assess their performance and to understand their roles and responsibilities. Therefore, an organization can boost its productivity and competency effectively.

gmp quality products
Products

All products should be tested and quality assurance performed before distributing to consumers. Manufacturers should ensure that raw materials including ingredients, processing aids, and packaging materials must have clear specifications at the time of production.

gmp quality processes
Processes

Processes should be documented, uniform, precise, and circulated to all employees. The current processes and required standards of the organization should be complied by all employees.

gmp quality procedure
Procedure

A procedure is a set of guidelines and rules to follow in the business to achieve a consistent result for undertaking a critical process. It outlines the journey of your products from end to end with step-by-step instructions.

gmp quality premises
Premises

Premises should be cleaned to eliminate fatalities, cross-contamination, and accidents. All equipment should be calibrated and maintained regularly to make sure they are in good working condition to avoid the risk of equipment breakdown.



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Top 10 Principles of GMP

principles of gmp quality

Here are the 10 GMP principles:

  • Establish controlled and consistent performance by defining operating procedures and work instructions:

    • Work instructions and Standard Operating Procedures (SOPs) are maintained within the integrated document management system.

  • Conforming to written procedures and instructions:

    • SOPs and work instructions can be provided based on the visual workflows and user tasks. Users can carry out tasks relevant to their function by determining access rights and managing competency records.

  • Better compliance and traceability through proper work documentation:

    • Once users complete workflow tasks or actions, an electronic signature can be created to keep the record of who completed the action and when it has been completed. The entered data is recorded directly in the database. An audit trail can provide access to a complete history of the changes made including who, when, and why the changes were made if users modify any data.

  • Proper validation:

    • ComplianceQuest can manage data and information that support system validation including instrument calibration and sensitivity measurements.

  • Stable system and equipment:

    • ComplianceQuest can help validate and ensure facility, system, and equipment suitability. Results are recorded and previous results can also be reviewed to find out possible trends.

  • Maintain equipment:

    • ComplianceQuest can help maintain equipment, instrument, and calibration schedules.

  • Develop and define job competency:

    • Competency and training records are essential to prevent performing specific tasks without a valid training record.

  • Protect products from adulteration:

    • ComplianceQuest helps ensure ongoing product quality by supporting QA/QC testing regimes and monitoring adulteration at a specific location with the help of Environmental Monitoring functionality.

  • Adherence to quality products:

    • ComplianceQuest supports the standard QA/QC processes and workflows to ensure adherence to quality processes.

  • Ensure compliance:

    • ComplianceQuest performs both internal and external audit processes by providing access to the required information from a single integrated source. Training and maintenance records, the results of QA/QC testing, and other relevant information can be recorded with required electronic signatures and audit trail.

understanding gmp quality regulations

Understanding GMP Regulations & GMP Standards

GMP regulations are centred around cleanliness, sanitation, efficiency of equipment, complaint handling, record-keeping, and personnel qualifications. By integrating with a quality approach, GMP regulation can enable companies to minimize or eliminate instances of contamination, mix-ups, and errors. This also can regulate the validation, verification, and production of manufactured products. GMP regulation can help business owners and managers to understand the requirements in their own way and implement them efficiently.

Personnel should be trained and qualified to perform their roles and responsibilities. During production, ingredients and materials should meet quality attributes to prevent mix-ups. Procedures should be followed for the manufacture, testing, cleaning, validation, and stability activities associated with the product. All the equipment must be accurately recognized, maintained, and cleaned to avoid cross-contamination.

Each manufacturer can decide how to implement the essential controls with the most GMP requirements. If an organization doesn’t comply with GMP regulations, they can result in major implications including recall, fines, and seizure.

Adhering to GMP standards is essential for every organization as it can help to increase the safety of manufactured products such as pharmaceutical goods, and ensure consumers get the highest quality possible. Additionally, this can influence the company reputation and reduce negative reports and batch recalls from consumers.

As subject matter experts, they knew exactly how to translate our company processes, and do them more effectively within the application.

Glenn Cann, President,
AOC Global Services and AOC Program Solutions

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How to Comply with GMP Guidelines

Good Manufacturing Practices guidelines are a set of principles that address different problems that can influence the safety and quality of a product. An organization can maximize the quality of their products, enhance customer satisfaction, boost sales, and earn a profitable return of investment by complying with GMP standards. While setting up a quality program and manufacturing process an organization must fulfil GMP requirements. It’s their responsibility to determine the most effective and efficient quality process. Organizations can assess the compliance of the organization to manufacturing protocols and guidelines by conducting GMP audits. Regular checks must be done to minimize the risk of adulteration and mislabelling.

What are GMP Procedures?

GMP procedures focus on safety, honesty (e.g., labelling), effectiveness, and reliability. Following GMP procedures, you can understand how every aspect of manufacturing, spanning materials, facilities, equipment, production, packaging, training, and standard operating procedures (SOPs) work from production to the time the product is cleared for sale. There are a few important principles GMP procedures help to enforce such:

gmp quality procedures
Cleanliness & hygiene:

You should maintain cleanliness and hygiene to keep the environment free from contaminants and hazardous substances that could lead to the adulteration of a product or material.

Safety:

Every employee must get operational and critical safety training to ensure safety.

Recordkeeping:

FDA performs regular and unannounced audits of GMP procedures for the achievement of maximum safety and effectiveness of pharmaceuticals and other medical products. Workers should keep thorough records of all procedures to keep track of where problems may have happened during manufacturing.

Consistency:

Consistency makes the product safer for distribution and uses in the pharmaceutical industry. A complaint associated with products made in a GMP lab should be taken seriously and defective products should be recalled to prevent the issue from occurring again.

GMP compliance checklist

GMP Compliance Checklist is used during regular site inspections to assess overall adherence to manufacturing protocols. The checklist gives you an insight into how your audits are performing over time. The checklist also evaluates and checks whether your workers receive adequate training to carry out their tasks.

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Frequently Asked Questions

  • A GMP ensures that products are consistently controlled as per quality standards to reduce the risks that cannot be eliminated through testing the final product.

    The primary objective of Good Manufacturing Practice (GMP) standards and guidelines is to ensure that the products are safe, pure, and effective.

    GMP laboratory puts quality first and promotes production excellence at each step of the pharmaceutical manufacturing process by following and documenting adherence to Good Manufacturing Practice regulations.

  • Good manufacturing practice, or GMP, in pharma is a set of rules and best practices that help to control the quality of pharmaceutical products entering the market. GMP protects consumers from defective products and helps manufacturers to increase their quality and mitigate risks of potential liability.

  • GMP quality covers all aspects of a business from people to processes to mitigate the following risk as an example:

    • Contamination

    • Incorrect labels

    • Improper dosage of an ingredient

    GMP quality also helps to protect a company’s people and equipment ensuring that workers are fully trained, equipped, and safe.

  • Here are some benefits of implementing GMP quality:

    • Mitigate or avoid errors

    • Assure product safety

    • Avoid and control contamination and cross-contamination

    • Comply with the relevant laws and regulations

  • ComplianceQuest offers you seamless and compliant GMP and compliance solutions with the help of GMP certified and trained professionals. ComplianceQuest handles the complex risk-based GMP demands from qualification, conceptual design, and validation to practical implementation and execution of a quality system.

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