By WHO GMP guidelines Den Mark Pharmaceuticals Pvt. Ltd. obeys a careful and precise process. This precision is crucial to ensure the safety, efficacy, and consistency of the final product. Here's a comprehensive overview of the contract manufacturing process of azithromycin tablets:
1. Raw Material Procurement and Testing:
- The first step is procuring high-quality pharmaceutical raw materials from approved suppliers, including active pharmaceutical ingredients (APIs), excipients, and packaging materials.
- Upon arrival, each batch of raw materials undergoes rigorous testing for identity, purity, potency, and microbiological contaminants as per WHO GMP guidelines.
2. Dispensing
- The approved raw materials are weighed and dispensed accurately according to the pharmaceutical formulation recipe.
- Dispensing is done in a dedicated area under controlled environmental conditions to prevent contamination.
3. Granulation and Blending:
- The dispensed ingredients are mixed and granulated to achieve uniform particle size and distribution.
- Blending of granules with additional excipients and lubricants is performed to ensure homogeneity and facilitate tablet compression.
4. Tablet Compression:
- The granules are compressed into tablets using high-quality tablet compression machines.
- Machine parameters such as compression force, speed, and dwell time are optimized to produce tablets with uniform weight, hardness, and thickness.
5. Coating (Optional):
- Sometimes, tablets may undergo a coating process to improve taste, stability, or appearance.
- Coating formulations are prepared and applied using coating pans under controlled conditions.
6. Packaging
- Finished tablets are inspected for defects and quality attributes before packaging.
- Packaging materials, including blister packs or bottles, are chosen based on compatibility and protection of the product.
- Tablets are packed into the chosen packaging format using automated equipment to minimize human handling and contamination risks.
7. Labelling and Batch Release:
- Each packaged batch of AZITHROMYCIN tablets is labeled with essential information such as product name, strength, dosage instructions, and expiration date.
- Before release for pharmaceutical distribution, the batch undergoes thorough quality control checks, including visual inspection, physical testing, and stability studies, to ensure compliance with WHO GMP standards and specifications.
8. Quality Assurance and Documentation:
- Stringent quality assurance measures are implemented throughout the manufacturing process to monitor and control all critical parameters.
- Comprehensive documentation, including batch records, standard operating procedures (SOPs), and quality control records, is maintained to provide traceability and accountability.
9. Regulatory Compliance:
- The manufacturing process follows WHO GMP guidelines and other applicable regulatory requirements.
- Regular audits and inspections by regulatory authorities ensure compliance and adherence to best practices in pharmaceutical manufacturing.
We at Den Mark pharmaceuticals Pvt. Ltd. are committed to providing Top quality pharmaceutical grade of azithromycin tablets to countries like Mexico, Philippines, Venezuela, Kenya, Tanzania, Angola, Uzbekistan, Tajikistan, Kyrgyzstan, Azerbaijan, Georgia and many other countries world-wide.