The cream should be evenly applied to the skin's afflicted region or areas, generally twice a day or as prescribed by a medical practitioner. Before using the cream, wash and pat dry the skin in the afflicted region or areas. You must adhere to the advice given by your pharmacist or healthcare professional.
The following article describes Den Mark Pharmaceuticals Pvt. Ltd.'s manufacturing procedure for Beclomethasone + Clotrimazole Ointment (0.025% + 1% w/w), which complies with WHO GMP regulations.
1. Raw Material Acceptance and Storage:
- All incoming raw materials (APIs—beclomethasone Dipropionate, Clotrimazole, and ointment base components) will be inspected against predefined specifications and accompanied by certificates of analysis.
- Materials will be quarantined until released by the Quality Control (QC) department.
- Accepted materials will be stored in designated warehouses under appropriate conditions (temperature, humidity, light sensitivity).
2. Weighing and Dispensing:
- Based on the pre-determined production batch size, a designated weighing area will ensure accurate dispensing of Beclomethasone Dipropionate (0.025% w/w) and Clotrimazole (1% w/w).
- Weighing will be performed by trained personnel using calibrated balances. Double-checking by a second person is mandatory.
3. Ointment Base Preparation:
- The ointment base components will be weighed and blended according to a validated formula in a designated mixing vessel.
- Mixing will occur under controlled conditions (temperature, mixing speed) to ensure homogeneity.
4. Incorporation of Active Pharmaceutical Ingredients (APIs):
- Beclomethasone Dipropionate and Clotrimazole will be aseptically added to the pre-mixed ointment base.
- Homogenization will be achieved using a suitable mixer to ensure uniform distribution of APIs throughout the ointment.
5. Milling and Deaeration:
- The ointment will be passed through a mill to achieve the desired particle size and ensure a smooth texture.
- Deaeration will remove air bubbles trapped within the ointment to improve product stability and consistency.
6. Filling and Packaging:
- The finished ointment will be filled into pre-sterilized and labeled tubes using an automated or semi-automated filling machine.
- Filling volume will be controlled to ensure accurate dosage per unit.
- Tubes will be sealed and crimped using validated equipment.
7. Labeling and Coding:
- Labels will be pre-printed according to regulatory requirements, including product name, strength, batch number, expiry date, manufacturer's details, and storage instructions.
- Labels will be applied to each tube using a labeling machine.
- A unique batch code will be identified on each tube for traceability purposes.
8. In-Process Quality Control:
- Throughout manufacturing, samples will be collected at designated checkpoints for weight verification, appearance, pH, and uniformity of drug content.
- The QC department will perform analytical testing to ensure compliance with specifications.
9. Finished Product Quarantine and Release:
- The finished product batch will be quarantined until final QC approval is obtained.
- QC testing will include comprehensive analysis, including potency, sterility, and physical characteristics, according to the predefined specifications.
- After QC testing is completed, the batch will be released for packaging and distribution.
10. Documentation and Batch Records:
- All manufacturing steps will be meticulously documented and maintained for future reference and batch traceability, including raw material usage, production parameters, equipment calibration records, and QC test results.
Adherence to WHO-GMP:
- Den Mark Pharmaceuticals Pvt. Ltd., one of the leading drug manufacturers in India, ensures strict adherence to WHO GMP guidelines throughout the manufacturing process. This includes maintaining a clean and hygienic production environment, following validated procedures, proper personnel training, and robust quality control measures.
Den Mark Pharmaceuticals Pvt. Ltd. sticks to continual improvement of its pharmaceutical manufacturing processes. This capsule-filling process is reviewed and updated regularly to ensure ongoing compliance with WHO GMP and to produce the highest quality Clopidogrel + Aspirin capsules for patient safety and well-being.