CPOB_Implementation_Presentation.pptxCPOB_Implementation_Presentation.pptx

CPOB_Implementation_Presentation.pptx

1. Implementation of Good Manufacturing Practices (CPOB) Solid Dosage Form Manufacturing

2. What is CPOB? • CPOB (Cara Pembuatan Obat yang Baik) is the Indonesian equivalent of GMP. • Provides guidelines to ensure consistent production and quality standards. • Particularly critical in solid dosage forms (tablets, capsules, granules, powders). • Large production volumes and high risk of contamination.

3. Facilities and Equipment • Layouts designed to prevent cross-contamination. • Equipment must be easily cleanable and validated. • HVAC system required for dust and clean air control.

4. Raw Material Management • All raw materials tested and meet specifications. • Sampling and weighing in controlled areas. • Proper labeling and traceability ensured.

5. Manufacturing Processes • Granulation: control of mixing and drying times. • Compression/Encapsulation: weight, hardness, disintegration. • Coating: uniform application under validated conditions. • Blending: homogeneity testing.

6. Documentation and Quality Control • Complete and accurate Batch Manufacturing Record (BMR). • In-process and finished product testing: assay, dissolution, disintegration, friability. • Stability studies and reference sample storage.

7. Personnel and Hygiene • Personnel trained in hygiene and documentation. • Use of PPE according to procedures. • Cleaning validation of equipment and production areas.

8. Packaging and Quality Assurance • Line clearance to prevent mix-ups. • Sealed packaging and correct labeling. • QA approves each batch before release. • Internal audits and recall procedures established.

9. Conclusion • CPOB ensures medicine quality, safety, and consistency. • Applied from raw material to finished product. • Focus on process control, validation, and documentation. • Ensures safe and effective medicines for patients.

10. Workflow of CPOB Implementation 1. Receipt and Testing of Raw Materials 2. Weighing and Preparation 3. Granulation / Mixing 4. Compression / Capsule Filling 5. Coating 6. Packaging 7. Storage and Distribution