
What is GMP?
- Quality management and complaints
- Building and facilities
- Equipment and raw materials
- Qualification and validation
- Recordkeeping and documentation
- Inspections & quality audit
Related Assets
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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.
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.

Important Components of Good Manufacturing Practice

People

Products

Processes

Procedure

Premises

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Top 10 Principles of GMP


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.
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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.
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
Cleanliness & hygiene:
Safety:
Recordkeeping:
Consistency:

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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
What is the GMP Laboratory?
What is GMP in Pharma?
What are the risks GMP quality covers?
- Contamination
- Incorrect labels
- Improper dosage of an ingredient
What are the 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