GMP System
What is "GMP"?
It stands for “Good Manufacturing Practice”, and is the standard for managing production and quality for pharmaceuticals.
Quality policy
We at Nippon Fine Chemical follow the policy below in order to provide our customers with reliably high quality pharmaceuticals and pharmaceutical ingredients.
- Our highest priority will be to ensure both product quality and patient safety, and our decisions will be made rationally, based on scientific evidence.
- We will gather information about laws, regulations, and guidelines both in Japan and overseas and ensure compliance with these. In addition, we will continually improve our pharmaceutical quality system.
- We will continue efforts to improve our Quality Culture through appropriate systems and continual training that encourage all of us employees to act in ways that emphasize quality.
- We, all employees, will be aware of how our actions can influence the assurance of product quality and patient safety, and will be accountable by creating complete records regarding all GMP activities.
Established May 2021
Improving GMP responsiveness and Quality Culture
- We actively utilize both external consultants well-versed in inspections and consultants with years of experience in GMP in products similar to ours. We work to improve our GMP level through optimal responses based on consultations whenever needed regarding GMP or through taking seminars, and also work to sustain and improve our ability to respond to inspections through GMP mock inspections.
- Our main activities related to top management involvement are holding quality management reviews every quarter to report quality issue trends or work delays to top management as soon as possible. Top management works to ensure the appropriate allocation of management resources, and also works to continually improve the GMP system through top-down directives regarding improvements.
- “Quality Culture” refers to “A work environment that permits transparent and open reporting and active discussions between personnel at all levels of the organization when faced with deviations, errors, overlooked work, unusual results, or potential risks”, and is a foundation for continual improvements.
To improve Quality Culture, we carry out a small-group activity entitled “Challenge Task Contest”, and certificates are presented for especially meritorious activities as a way to help improve employee motivation even further.
GMP Organization
Hierarchical document system
- Level 0 Rules for which the company is responsible
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- cGMP, J-GMP
- ICH-related guidelines
- Other related laws and regulations from the regulatory authorities
- Level 1 Quality manual / Quality policy
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- Quality manual “Basic Policy for the Quality System”
- Quality policy
- Level 2 GMP management standard document
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- Principle quality system procedures (product quality review, change control, validation, quality risk management, data integrity, complaints, deviation, CAPA, rejection, return, recall, reprocessing/reworking, OOS, stability testing, training/qualification)
- Level 3 Procedures/operation instructions/documents by department and function
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- Production batch records, individual procedures related to production, instructions/records, etc.
- Testing procedures, specifications, individual procedures related to QC, instructions/records, etc.
- Validation documents, protocols/reports, other records, etc.
