Elements of Quality Assurance Systems

Smilax Psyllium Impex believes in building quality products by closely monitoring and controlling various stages of production. We have introduced strict quality checks at each step of the manufacturing process and diligently document it.

1. In-house laboratory – We possess a thoroughly equipped modern testing laboratory to test all parameters of Psyllium husk and its other products as per specifications laid down in Indian Pharmacopoeia/ European Pharmacopoeia/ United States Pharmacopoeia and British Pharmacopoeia. Also, a comparative chart of our “In-House Specifications” of Psyllium Husk vis-à-vis specifications laid down in the monograph of leading official compendiums has also been given.

Tests performed in-house are:

• Description of Material
• Identification of material as psyllium husk
• Total ash content of not more than 4.5% w/w
• Acid insoluble ash content of not more than 0.45% w/w
• Loss on drying measures amount of water and volatile matter in the material
• Swell volume per gram of the material
• Light extraneous matter present in material
• Purity of the material
• Particle size

Smilax Pharmaceuticals, the sister concern of Smilax Psyllium Impex Company, possesses in-house “Microbiological testing laboratory” facility. It helps Smilax Psyllium Impex Company in testing the bacterial load of husk/powder.

2. Documentation – The “Batch Manufacturing Record” compilation process is an intrinsic part of our system. BMR is a document specific to the product and its manufactured batch. It provides a comprehensive and reliable report of the manufacturing history of each batch of every product. The Theoretical and Actual yield at various stages of production is also calculated and reported.

Our BMR system is essentially based on the Master Formula Record and is compiled, checked, approved and authorized by competent technical person from the production and quality control team.

Maintenance of BMRs has helped us in closely controlling the Psyllium husk quality and keep a tight check on various stages of production. Some of the other important documents compiled are:

All departments are audited internally as per the Standard operating procedures for Self-Inspection. Reports thus generated:

1. Audit report
2. Compliance report

Documents related to Product Quality

1. Specifications raw materials (Psyllium seed), packing materials.
2. Specifications for in-process and finished products.
3. Quality control procedures.
4. Training procedures.
5. Documentation control of process deviations.
6. Calibration and test documents.
7. Verification report.
8. Reconciliation of batches and packing material.
9. Area activity and monitoring records.
10. Equipment usage records.