In the pharmaceutical industry, Quality Assurance (QA), Quality Control (QC), Packing, and the Tablet Department are critical areas that ensure the production of high-quality and safe medications. Here's a detailed breakdown of each department and its responsibilities:
1. Quality Assurance (QA)
Role: QA ensures that processes and procedures are followed throughout the manufacturing cycle to produce products that meet predefined quality standards.
Responsibilities:
- Implement and maintain Good Manufacturing Practices (GMP).
- Review and approve Standard Operating Procedures (SOPs) and batch records.
- Conduct internal audits and inspections.
- Validate equipment, processes, and cleaning procedures.
- Handle deviations, change controls, and corrective actions/preventive actions (CAPA).
- Ensure regulatory compliance (FDA, WHO, EU-GMP, etc.).
- Oversee training programs for staff.
2. Quality Control (QC)
Role: QC focuses on testing raw materials, in-process samples, and finished products to ensure they meet quality specifications.
Responsibilities:
- Perform chemical, physical, and microbiological testing of products.
- Analyze raw materials, intermediates, and finished goods.
- Develop and validate analytical methods.
- Ensure proper calibration of analytical instruments.
- Conduct stability studies for product shelf life determination.
- Release or reject batches based on test results.
3. Packing Department
Role: The Packing Department is responsible for packing pharmaceutical products while maintaining their integrity, quality, and compliance with regulatory and company standards.
Responsibilities:
- Execute primary and secondary packaging (blisters, bottles, cartons, etc.).
- Ensure proper labeling with batch numbers, expiry dates, and product details.
- Maintain packing area hygiene per GMP.
- Perform in-line quality checks for packaging defects.
- Validate packaging equipment.
- Ensure compliance with serialization and anti-counterfeiting measures.
4. Tablet Department
Role: This department is involved in the production of tablets, ensuring proper formulation and consistency.
Responsibilities:
- Handle tablet manufacturing processes, including:
- Granulation (wet or dry).
- Compression using tablet presses.
- Coating (film or sugar coating).
- Monitor critical process parameters like weight, hardness, friability, and dissolution rates.
- Perform in-process quality checks to ensure uniformity and compliance.
- Maintain equipment and process validation records.
- Adhere to safety and GMP standards during production.
Interdepartmental Collaboration
All these departments work closely to ensure seamless production and delivery of pharmaceutical products:
- QA oversees the entire process for compliance.
- QC ensures raw materials and final products meet quality standards.
- Packing ensures that the product reaches consumers in intact and compliant packaging.
- The Tablet Department ensures the core product (tablet) meets the required efficacy and safety standards.
