The 10 basic principles of GMP should govern the day-to-day operations of a pharmaceutical company. There may be other principles also be part for basic principles of GMP. However the below are the basics need to follow:
Principle-1: Written Procedures
Make sure you have step-by-step written procedures that provide a roadmap for consistency in performance.
Principle-2: Compliance with Procedures
Follow the procedures closely to ensure consistency in product quality.
Principle-3: Documentation
Document your work promptly and accurately in chronological order to ensure compliance and trace any issues if there is ever a complaint regarding the product.
Principle-4: Validation
Validate all systems and processes to ensure that quality and consistency are fulfilled according to the plan.
Principle-5: Facility and Equipment
As per this principle, the productivity, product quality and safety must be integrated into the design and construction of the facilities and equipment.
Principle-6: Maintenance
Regularly maintain equipment and facilities to minimize safety issues of contamination and quality control. Maintain written records of the work performed.
Principle-7: Job Competency
Demonstrate job confidence in your role. Ensure you have clearly defined and developed job competencies required for specific roles.
Principle-8: Contamination Control
Practice good hygiene to protect the product from contamination. Make it part of your daily routine. Ensure you have documented standards guidelines to follow so that you do not deviate from the degree of cleanliness required for the product.
Principle-9: Quality Control
As per this principle, quality should be directly built into the product through methodical control of components and processes. Ensure that quality control measures are in place in the area you work whether manufacturing, packaging, labeling, distribution, and marketing.
Principle-10: Audits
To make sure how well the GMP is implemented, Audits at regular frequency must be in place according to this principle.
Read also:
- GMP Guidelines for Pharmaceutical Industry
- GMP Facility Design and 10 Golden Rules
- GMP Audit Checklist (As per WHO)
