In the pharmaceutical industry, the Production, Packing, Quality Assurance (QA), and Quality Control (QC) departments play critical roles in ensuring the safe, efficient, and compliant manufacture of drugs. Here’s an overview of their roles and responsibilities:
1. Production Department
This department is responsible for the actual manufacturing of pharmaceutical products. Their tasks include:
- Raw Material Handling: Ensuring raw materials are available and of the required quality.
- Manufacturing Processes: Carrying out processes like mixing, granulation, drying, and compression for tablets, or sterilization and filling for sterile products.
- Batch Manufacturing: Producing drug batches according to the approved Master Formula Record (MFR) while adhering to Good Manufacturing Practices (GMP).
- Documentation: Maintaining records of every batch produced for traceability.
- Compliance: Ensuring that all processes meet regulatory and GMP standards.
2. Packing Department
The packing department handles the packaging of the final product, ensuring it is safely and appropriately packed for distribution.
- Primary Packaging: Packaging the product in direct contact with the drug (e.g., blister packs, vials, ampoules).
- Secondary Packaging: Placing the primary package into larger containers like boxes or cartons.
- Labeling: Ensuring that labels with correct information (such as batch number, expiry date, etc.) are affixed to the products.
- Documentation: Keeping records of packing operations for audit purposes.
- Regulatory Compliance: Ensuring that packaging materials and processes comply with regulations.
3. Quality Assurance (QA) Department
QA is responsible for ensuring that all processes involved in manufacturing and packaging meet the set standards.
- Oversight: Ensuring compliance with all regulatory guidelines and GMP.
- Documentation Review: Approving batch records, MFRs, Standard Operating Procedures (SOPs), and other quality documents.
- Validation: Conducting and overseeing process validation, equipment validation, and cleaning validation.
- Audit: Performing internal audits and ensuring readiness for external inspections.
- Change Control: Managing changes to processes or equipment through proper approval procedures.
4. Quality Control (QC) Department
The QC department focuses on the testing and verification of the quality of raw materials, in-process samples, and finished products.
- Sampling and Testing: Performing analytical testing on raw materials, in-process materials, and final products to ensure they meet predefined standards.
- Stability Testing: Conducting stability studies to determine the shelf life and proper storage conditions of products.
- Environmental Monitoring: Monitoring the production and storage environments to prevent contamination.
- Release Testing: Conducting tests to release batches for packaging and sale.
- Documentation: Maintaining detailed test records, including certificates of analysis (CoAs).
Together, these departments ensure that pharmaceutical products are consistently manufactured and controlled to meet the quality standards appropriate for their intended use.
WALK IN INTERVIEW
Ashish Life Science Pvt. Ltd., Global Leader in Veterinary Science.
We are hiring for our world class facility at Tarapur
We are hiring for below positions
Ashish Life Science Pvt. Ltd., Global Leader in Veterinary Science.
Date: 25th Oct 2024,
Time :- 09 AM to 03 PM.
Venue:
Ashish Life Science Pvt. Limited.
J-137, MIDC Tarapur, Boisar, Dist. Palghar. 401 501, India.
This drive is only for experienced candidate
Candidate may walk in with their updated resume, 2 passport size photographs, last 3 months salary slips & latest increment letter.
Incase you are not able to attend walk-in, you can send your cv on ashwini.thakur@ashishlifescience.com
This drive is only for experienced candidate.
