Operational Excellence: A Comprehensive List of SOPs in OSD Production

Contributing Author:   Super User Submitted Date: 06 May 2010

Oral Solid Dosage (OSD) production in the pharmaceutical industry requires strict adherence to Standard Operating Procedures (SOPs) to ensure product quality, safety, and regulatory compliance. Here is a list of some essential SOPs commonly used in OSD production:

1. Dispensing of Raw Materials:

   • Outlines procedures for weighing and dispensing raw materials, including active pharmaceutical ingredients (APIs), excipients, and other components.

2. Granulation Process:

   • Describes the steps for wet or dry granulation of powder blends to form granules suitable for tablet compression or capsule filling.

3. Blending and Mixing:

   • Details the procedures for blending and mixing granules or powders to ensure uniform distribution of components.

4. Tablet Compression:

   • Specifies the operation of tablet compression machines, including machine setup, cleaning, and maintenance.

5. Capsule Filling:

   • Outlines the procedures for capsule filling machines, including setup, filling, and cleaning.

6. Coating Process:

   • Describes the coating process for tablets or capsules, including the preparation of coating solutions and the application of coatings.

7. Tablet Dedusting and Polishing:

   • Details the process of removing excess powder and polishing tablets to improve their appearance.

8. In-Process Testing and Sampling:

   • Specifies the procedures for sampling and testing of tablets or capsules at various stages of production to ensure quality control.

9. Cleaning Validation:

   • Outlines the procedures for validating the cleaning process to prevent cross-contamination between batches.

10. Equipment Calibration and Maintenance:

    • Describes the calibration, maintenance, and verification of production equipment to ensure accuracy and reliability.

11. Material Handling and Storage:

    • Provides guidelines for the handling, storage, and labeling of raw materials, intermediates, and finished products.

12. Packaging Process:

    • Specifies the procedures for packaging tablets or capsules into containers, including labeling, sealing, and inspection.

13. Batch Record Review and Release:

    • Outlines the review and approval process for batch records and the release of finished products.

14. Change Control:

    • Details the procedures for managing and documenting changes to processes, equipment, or materials.

15. Quality Control and Assurance:

    • Describes the responsibilities and procedures for quality control and quality assurance activities, including product release and stability testing.

16. Environmental Monitoring:

    • Specifies procedures for monitoring and controlling environmental conditions, such as temperature and humidity, in production areas.

17. Handling of Deviations and Non-Conformities:

    • Outlines the procedures for documenting and investigating deviations or non-conformities during production.

18. Training and Competence:

    • Provides guidelines for employee training and competence assessment in OSD production.

19. Regulatory Compliance:

    • Ensures adherence to regulatory requirements and standards, including Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

20. Emergency Procedures and Safety:

    • Describes the procedures to be followed in case of emergencies, such as spills, fires, or equipment failures, to ensure the safety of personnel and products.

These SOPs are essential for maintaining product quality, consistency, and regulatory compliance in OSD production. Each pharmaceutical facility may have additional, site-specific SOPs based on its processes and equipment. It's important to regularly review, update, and train personnel on these SOPs to ensure their effectiveness and adherence.

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