GMP which stands for good manufacturing practice is a systematic process approach for ensuring that the products produced in industries are consistently produced and controlled according to quality standards. It is mainly designed to minimize the risks involved in any drug or food production that cannot be eliminated through testing the final product.
10 Principles that needs to be followed for having good manufacturing practice.
- Writing steps by steps operation procedures and work instructions.
- Carefully following written procedures and instructions to prevent contamination, mix-ups and errors.
- Properly and accurately documenting work for compliance and traceability.
- Proving the systems doing they are design to do by validating their work.
- Integrating productivity, product quality and employee safety into the designing and construction facilities and equipment.
- Properly maintaining facilities and equipments.
- Clearly defining, developing and demonstrating job competence.
- Protecting products against contamination by maintaining cleanliness sand hygienic in daily life.
- Brining quality into product by systematically controlling components and product related process such as manufacturing, packaging and labeling, testing, distribution and marketing.
- Conducting planned and periodic audits for compliance and performance.
Benefits
- This standard system outline a Quality System that reduces or prevents errors
- Ensures products are safe for use in humans
- Prevent/control contamination and cross-contamination
- Minimizes variations in potency of the drug.
- Ensures reproducible physiological activity
- Prevents mislabeling and adulteration.
Certification process.
A Good Manufacturing Practices (GMP) certification scheme provides independent verification and certification that the basic manufacturing practices and prerequisites necessary for the implementation of an effective Hazard Analysis Critical Control Point (HACCP) food safety program are being followed.
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