Den Mark Pharmaceutical’s top-quality Tretinoin Gel (0.050%w/w) may elicit common side effects like skin irritation, redness, dryness, and peeling, especially during initial use. However, these usually subside with continued application. Some users may experience heightened sensitivity to sunlight, necessitating adequate sun protection. Rarely allergic reactions like itching or swelling may occur. Consultation with a healthcare professional is recommended for severe or persistent side effects.
Overall, Den Mark Pharmaceuticals is a bulk drug manufacturing company that prioritizes the safety and efficacy of its products while aiming for optimal dermatological care.
1. Starting Materials and Packaging Components:
- All starting materials (tretinoin API, gel base components, preservatives, etc.) undergo stringent quality control testing as per specifications before acceptance.
- Packaging components (tubes, caps, labels) are inspected for defects and conformity to predetermined standards.
2. Pre-Production:
- A production planning team prepares a detailed Batch Production Record (BPR) outlining the specific quantities of materials, equipment to be used, and designated personnel for each step.
- The BPR references the approved master formula and ensures adherence to WHO GMP guidelines.
- Manufacturing areas are sanitized, and qualified personnel, attired in appropriate garments, perform cleaning and disinfection procedures.
3. Weighing and Dispensing:
- A designated weighing area, with calibrated balances, is used to accurately dispense tretinoin API and other components as per the BPR.
- Dispensing personnel follow documented procedures to minimize errors and ensure batch consistency.
4. Mixing and Homogenization:
- The weighted components are transferred to a designated mixing vessel within a controlled manufacturing environment.
- Trained technicians operate mixing equipment following defined procedures to achieve a uniform gel with consistent tretinoin distribution (0.050%w/w).
- Homogenization ensures a smooth, air-bubble-free gel.
5. Filling and Packaging:
- The qualified personnel transfer the finished gel to a designated filling line.
- Automated or validated manual filling equipment ensures accurate and consistent filling into pre-sterilized tubes.
- Crimping machines ensure tamper-evident seals on the tubes.
- Packaged tubes are transferred to the labelling area.
6. Labelling and Coding:
- Labelling machines apply pre-printed labels containing product names, strengths (0.050%w/w Tretinoin), batch numbers, manufacturing and expiry dates, and storage instructions.
- Labels comply with regulatory requirements and Den Mark's labelling specifications.
- Coders imprint unique batch codes and expiry dates on each product for traceability.
7. In-Process and Finished Product Quality Control:
- Throughout the manufacturing process, samples are collected for in-process quality control testing.
- Parameters like gel pH, viscosity, drug content uniformity, and microbial limits are evaluated against predefined specifications.
- Finished product samples undergo final quality control testing to ensure conformance with pharmacopeial standards and batch release criteria.
8. Quarantine and Release:
- Manufactured batches are quarantined until final quality control results are approved.
- A designated quality assurance personnel authorizes batch release after successful testing and documentation review.
9. Storage and Distribution:
- Released batches are stored under appropriate conditions (temperature, humidity) per product specifications.
- Finished product packaging ensures protection from light and contamination.
- Den Mark's distribution network ensures proper transportation and storage throughout the supply chain.
10. Compliance and Documentation:
- All manufacturing steps are documented in detail, following WHO GMP guidelines.
- Batch records, including raw material certificates, production logs, and quality control data, are meticulously maintained for traceability and audit purposes.
- Den Mark's quality management system ensures continuous monitoring and improvement of the manufacturing process.