Pregabalin Capsules

2. Weighing and Blending:

• A designated person weighs the required quantities of Pregabalin API and each excipient according to the approved formulation.
• All materials are passed through a suitable sieve (e.g., mesh 40) to ensure uniformity.
• The API and excipients are blended for a predetermined time (as per formulation) in a closed blending station to achieve a homogeneous mixture.

3. Capsule Filling:

• The blended mixture is transferred carefully to the capsule-filling machine hopper.
• Empty hard gelatin capsules of the designated size are loaded into the machine.
• The capsule-filling machine is set up according to the capsule size and target fill weight.
• Production commences with close monitoring of capsule filling, ensuring proper filling and sealing of capsules.

4. In-process Controls:

• Throughout the process, samples are collected for weight uniformity testing at predetermined intervals. This ensures each capsule contains the prescribed amount of medication.
• A metal detector can be integrated into the filling line for optional foreign object detection.

5. Capsule Weight Checking:

• Filled capsules are discharged from the machine and passed through an automated capsule weight checker.
• Any capsule exceeding the pre-defined weight limits is rejected.

6. Packing and Labeling:

• Approved capsules are transferred to the packaging line.
• Blister packs or bottles are filled with the capsules and labeled according to product specifications. Labels must include product name, strength, batch number, expiry date, and manufacturer details (Den Mark Pharmaceuticals Pvt. Ltd.).

7. Documentation and Record Keeping:

• All production activities are documented in the batch record, including time, quantity, personnel involved, and any observations.
• Deviations from the production دستور (dastoor) must be documented and justified.
• Samples from each batch are retained for future reference.

8. Cleaning:

• After production process, the blending station and capsule filling machine are thoroughly cleaned and disinfected as per SOP to prevent cross-contamination.

• The entire process adheres to WHO GMP guidelines.
• Trained personnel perform the capsule-filling process.
• Regular calibration of equipment ensures accuracy.
• In-process controls and weight uniformity testing guarantee consistent product quality.
• Batch records and retained samples facilitate traceability and quality control.