Folic Acid Tablets Manufacturing Process at Den Mark Pharmaceuticals Pvt. Ltd.
This Drug Development Services is provided by Den Mark Pharmaceuticals Pvt. Ltd.'s strict manufacturing process for folic acid tablets, which obeys to WHO Good Manufacturing Practices (GMP) guidelines.
1. Starting Materials:
- Active Pharmaceutical Ingredient (API): Folic acid powder will be procured from a qualified vendor with a valid Good Manufacturing Practice (GMP) certificate. Each batch will accompany a Certificate of Analysis (CoA), ensuring compliance with pharmacopeial specifications.
- Excipients: All excipients, including lactose, microcrystalline cellulose, pregelatinized starch, magnesium stearate, and colloidal silicon dioxide, will be sourced from approved vendors with valid COAs. They will be stored under appropriate conditions as per their specifications.
2. Pre-Production :
- Formula Review: The designated Quality Assurance (QA) personnel will review and approve the Bill of Materials (BOM) and manufacturing process before production commences.
- Weighing and Dispensing: Accurately weighed quantities of folic acid and each excipient will be dispensed based on the approved BOM for each batch. Weighing will be performed in a designated weighing area using calibrated balances.
3. Blending:
- The weighed API and excipients will be transferred to a blender for uniform mixing. Blending time will be predetermined and documented based on batch size and equipment capabilities.
- Samples will be drawn for blend uniformity testing before proceeding to the next stage.
4. Granulation (Optional) :
- Depending on the chosen formulation, a granulation step might be implemented. This involves adding a granulating agent to the blend to improve flowability and compressibility for tableting.
- The granules will be dried to a predetermined moisture content and passed through a sieve to ensure uniformity.
5. Compression:
- The approved blend or granules will be transferred to a tablet compression machine.
- Based on the specifications, the machine will be set to the desired tablet weight, size, and shape.
- In-process controls will be conducted throughout the compression process to ensure consistent tablet weight and physical characteristics.
6. Post-Compression :
- The compressed Folic Acid Tablet will be de-dusted and transferred for weight control testing. Any tablets exceeding the acceptable weight variation limits will be rejected.
- Samples will be collected for further quality control testing, including physical tests (hardness, friability, and disintegration) and chemical assays to ensure API content meets the specifications.
7. Packaging :
- Approved tablets will be transferred to a designated packaging area.
- Blister packs or bottles will be pre-printed with product information, batch number, expiry date, and the Den Mark Pharmaceuticals Pvt. Ltd. logo.
- Each pack will be filled with the correct number of tablets and sealed.
8. Packaging :
- Labels will be pre-printed with all mandatory information as per regulatory requirements.
- Each label will be affixed to the packaging and verified for accuracy.
9. Quarantine and Release :
- The finished product will be quarantined until all quality control tests are complete and approved by the QA department.
- A batch release certificate will be issued, authorizing the distribution of the manufactured folic acid tablets.
10. Documentation :
- All manufacturing activities will be documented and archived, including raw material receipts, weighing’s, blending records, compression parameters, and quality control data for Folic Acid Tablet Manufacturing.
Commitment to Quality:
Den Mark Pharmaceuticals Pvt. Ltd. is committed to manufacturing high-quality folic acid tablets that meet all regulatory requirements and international standards. We adhere to strict WHO-GMP guidelines throughout the manufacturing process which makes us one of the leading contract manufacturing companies in India for production of high grade Folic Acid Tablets.