Good Manufacturing Practices (GMP)
3rd Level Docs
SOPs
2nd Level Docs
breakdown of regs in subjects & topics
Standard Operating Procedures (SOP)
step-by-step for operational tasks
4th Level Docs
step-by-step for production tasks (Ex: data sheets, forms, batch records)
GMP's aim
to diminish the risks inherent in any pharmaceutical productions (Ex: cross contamination, mix-ups)
Logbooks
forms for operation, maintenance, and calibration of equipment and critical activities
Policies
general docs of how specific GMP aspects will be implemented
Quality Manual
global company doc of regs
1st Level Docs
guidelines of how the company will follow the cGMP
GMP and following SOPs
- Document owners are required to ensure that all aspects of documentation and records management is specified in forms of SOPs - any deviations in procedure are reported to their supervisor and are adequately documented
Specifications
- doc of supply, material, or product requirements - used by the QC dept
Good Manufacturing Practices (GMP)
- part of Quality Assurance (QA) - ensures that products are consistently produced and controlled to the quality standards
Batch Records
- step-by-step for production tasks - made by manufacturing dept
Test Methods
- step-by-step for testing supplies - made by QC dept
Golden Rules of GMPs (10)
1. Get the facility design right from the start 2. Validate processes 3. Write good procedures and follow them 4. Identify who does what 5. Keep good records 6. Train and develop staff 7. Practice good hygiene 8. Maintain facilities and equipment 9. Build quality into the whole product lifecycle 10. Perform regular audits
Common Documents used in GMP (7)
1. Quality manual 2. Policies 3. Standard Operating Procedures 4. Batch Records 5. Test Methods 6. Specifications 7. Logbooks
Hierarchical Document System (5)
1. Top level 2. 1st level 3. 2nd level 4. 3rd level 5. 4th level
Top Level Docs
GMP regs set by the FDA
Documentation and GMP compliance
ensure traceability of all development, manufacturing, and testing activities
Responsibilities of QA
ensuring via organizational measurements and auditing that GMP documentation and records system used within the operational unit are complete and comply with the relevant GMP requirements
